EDITORIAL REVIEW
A systematic review of interventions for reducing HIV risk behaviors among people living with HIV in the United States, 1988–2012 Nicole Crepaza, Malu V. Tungol-Ashmona, Darrel H. Higaa, Waverly Vosburgha, Mary M. Mullinsa, Terrika Barhamb, Adebukola Adegbiteb, Julia B. DeLucaa, Theresa A. Sipea, Christina M. Whiteb, Brittney N. Baacka and Cynthia M. Lylesa Objective: To conduct a systematic review to examine interventions for reducing HIV risk behaviors among people living with HIV (PLWH) in the United States. Methods: Systematic searches included electronic databases from 1988 to 2012, hand searches of journals, reference lists of articles, and HIV/AIDS Internet listservs. Each eligible study was evaluated against the established criteria on study design, implementation, analysis, and strength of findings to assess the risk of bias and intervention effects. Results: Forty-eight studies were evaluated. Fourteen studies (29%) with both low risk of bias and significant positive intervention effects in reducing HIV transmission risk behaviors were classified as evidence-based interventions (EBIs). Thirty-four studies were classified as non-EBIs due to high risk of bias or nonsignificant positive intervention effects. EBIs varied in delivery from brief prevention messages to intensive multisession interventions. The key components of EBIs included addressing HIV risk reduction behaviors, motivation for behavioral change, misconception about HIV, and issues related to mental health, medication adherence, and HIV transmission risk behavior. Conclusion: Moving evidence-based prevention for PLWH into practice is an important step in making a greater impact on the HIV epidemic. Efficacious EBIs can serve as model programs for providers in healthcare and nonhealthcare settings looking to implement evidence-based HIV prevention. Clinics and public health agencies at the state, local, and federal levels can use the results of this review as a resource when making decisions that meet the needs of PLWH to achieve the greatest impact on the ß 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins HIV epidemic.
AIDS 2014, 28:633–656 Keywords: evidence-based intervention, HIV prevention, people living with HIV, risk reduction, systematic review
a
Prevention Research Branch, Division of HIV/AIDS Prevention, The U.S. Centers for Disease Control and Prevention, and bICF International Inc., Atlanta, Georgia, USA. Correspondence to Nicole Crepaz, PhD, Prevention Research Branch, Division of HIV/AIDS Prevention, The U.S. Centers for Disease Control and Prevention, 1600 Clifton Rd., Mailstop E-37, Atlanta, GA 30333, USA. Tel: +1 404 639 6149; fax: +1 404 639 1950; e-mail: [email protected] Received: 31 May 2013; revised: 7 October 2013; accepted: 7 October 2013. DOI:10.1097/QAD.0000000000000108
ISSN 0269-9370 Q 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins
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Introduction In the United States, it is estimated that 1 144 500 persons aged 13 and older were living with HIV at the end of 2010 [1] and there were an estimated 47 500 new HIV infections in 2010 [2]. People living with HIV (PLWH) are key partners in reducing the number of new HIV infections. Many PLWH reduce their risk behaviors after learning about their HIV-seropositive status [3,4]. However, adopting and maintaining safer behaviors can be challenging for some [5,6]. Providing prevention interventions that reduce the risk of HIV transmission or acquisition of other sexually transmitted diseases (STDs), in addition to HIV treatment and care for improving the health of PLWH, are critical components of the US National HIV/AIDS Strategy (NHAS) [7]. Identifying evidence-based interventions (EBIs) to help PLWH protect themselves and uninfected partners is considered to be the high priority of NHAS. Meta-analyses and systematic reviews [8–10] show that behavioral interventions for PLWH significantly reduce sexual risk behaviors. These systematic reviews are useful for understanding the overall effect on reducing HIV risk behaviors among PLWH. However, these reviews typically do not critically assess the quality of evidence by closely examining study design, implementation, analysis, and findings of individual interventions. Several evidence-based review groups such as the Cochrane Collaboration [11] and the Agency for Healthcare Research and Quality (AHRQ) [12] have emphasized the importance of assessing the risk of bias of individual studies as part of assessing the body of evidence. A thorough assessment of the risk of bias and findings of individual interventions can identify rigorously designed and implemented programs that show significant effects. Prevention providers can then use these efficacious interventions within their own clinics or communities. Since 1996, the US Centers for Disease Control and Prevention’s (CDC) HIV/AIDS Prevention Research Synthesis (PRS) project has been conducting an ongoing systematic review to identify behavioral interventions with evidence of intervention efficacy [13]. Through multiple consultations with internal and external HIV prevention researchers and methodology experts, PRS developed the risk-reduction efficacy criteria to assess various sources of bias in a study’s design, implementation, analysis, and findings [14]. The PRS criteria are similar to the evaluation components used or recommended by other groups such as the Cochrane Collaboration [11], AHRQ [12], Community Guide [15], Office of Adolescent Health [16], Office of Justice’s Crime Solutions [17], and Grades of Recommendation Assessment, Development and Evaluation (GRADE) [18]. To ensure a reasonable level of confidence that the observed changes can be attributed to the intervention [13], interventions that meet all the study design,
implementation, and analysis criteria are considered low risk of bias, whereas interventions that do not meet all of these criteria are considered high risk of bias. Interventions with low risk of bias that show significant positive intervention effects on reducing HIV risk behaviors are defined as EBIs and the interventions with high risk in bias, regardless of intervention effects, are defined as non-EBIs. The EBI classification approach is consistent with other systematic review efforts (e.g., Office of Adolescent Health [16], National Registry of Evidence-Based Programs and Practices [19,20], Office of Justice’s Crime Solutions [17]) in identifying evidencebased programs and interventions. In this systematic review, we reviewed all US-based HIV risk-reduction studies for PLWH available in the literature. Our goals were to describe the characteristics of the studies and interventions and to compare the similarities and differences between EBIs and non-EBIs. More specifically, we compared EBIs against two groups of non-EBIs: rigorous non-EBIs (i.e., interventions with low risk of bias, but without significant positive intervention effects) and positive non-EBIs (i.e. interventions with high risk of bias, but with significant positive intervention effects). These comparisons can provide helpful guidance for identifying research gaps, informing intervention development, and guiding prevention efforts.
Methods We used the CDC’s PRS project’s cumulative HIV/ AIDS/STD prevention database [21] for identifying relevant reports (see eligibility criteria below). For the PRS database, M.M.M. and J.D. with substantial expertise in systematic searches developed and conducted a comprehensive search strategy, including automated and manual searches. The annual automated search component focused on literature published between 1988 and 2012 using the following electronic databases (and platforms): EMBASE (OVID) [22], MEDLINE (OVID) [23], PsycINFO (OVID) [24], and Sociological Abstracts (PROQUEST) [25]. For the automated search, indexing and keywords terms were cross-referenced using Boolean logic in three areas: HIV/AIDS; prevention and intervention evaluation; and behavioral or biologic outcomes related to HIV infection or transmission (e.g. unprotected sex, condom use, needle sharing, STD). No language restriction was applied to the automated search. The last automated search was conducted in January 2013. The full search strategy of the MEDLINE database is provided in Appendix A, http://links.lww.com/QAD/ A427 as an example. The searches of the other databases are available from the corresponding author. The manual search included three components. First, searches of all reports published in the previous 3 months of 36 journals
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Behavioral prevention for people living with HIV Crepaz et al.
(see Appendix B, http://links.lww.com/QAD/A427) to identify potentially relevant citations not yet indexed in electronic databases. The last quarterly search was conducted in January 2013. Second, the reference lists of pertinent articles. Third, HIV/AIDS Internet listservs (i.e. www.RobertMalow.org) and other research databases (e.g., ISI Web of Knowledge [26], RePORTER [27], Cochrane Library [28]). Studies were included for this review if they were interventions to reduce HIV risk behavior; specifically designed for PLWH; conducted in the United States; tested in controlled trials with a comparison arm; measured HIV behavioral or biological outcomes (e.g. condom use, unprotected sex, number of sex partners, needle sharing, STD); and published between January 1988 and December 2012. We excluded pilot studies if the full-scale efficacy trials were eligible. Linked citations, defined as publications offering additional information on the same study, were included if they provided relevant intervention evaluation information. Pairs of trained coders independently coded each eligible intervention against the established PRS risk-reduction efficacy criteria, which are publically available at http:// www.cdc.gov/hiv/topics/research/prs/efficacy_criteria. htm [14]. If a study did not report critical information needed to determine intervention efficacy, we contacted the primary study investigator to obtain missing information or clarification. The final efficacy determination for each study was reached by PRS team consensus. Additionally, each eligible study was coded using a standardized coding form for the following: study characteristics (e.g. study date, location, study design, sample size, data collection method), participant characteristics (e.g., target population, gender, race/ethnicity, sexual orientation), intervention characteristics (e.g. components, delivery method, duration, time span), and HIV risk outcomes [e.g. HIV transmission risk behavior (TRB) defined as unprotected sex with HIVnegative or serostatus unknown partners or sharing needles with HIV-negative or serostatus unknown partners, unprotected sex or condom use with any sex partners, injecting drugs, needle sharing, STD]. Eligible studies were classified into four groups based on the risk of bias and evidence of intervention effects: (1) EBIs: low risk of bias with statistically significant positive intervention effects on at least one relevant HIV risk outcome. (2) Rigorous non-EBIs: low risk of bias without significant positive intervention effects. (3) Positive non-EBIs: high risk of bias with statistically significant positive intervention effects on at least one relevant HIV risk outcome.
(4) Other non-EBIs: high risk of bias without significant positive intervention effects.
For each of the two a-priori comparisons (i.e., EBIs vs. rigorous non-EBIs and EBIs vs. positive non-EBIs), we conducted Fisher’s exact tests using SPSS version 21. In the results section, we highlighted the findings if the differences between groups reached P 0.05).
Sex, drug and biological outcomes
AIDS
Category
Table 1 (continued )
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Kalichman et al. [45], 2005–2009, S
McKirnan et al. [54], 2004–2006, MW
NIMH et al. [31], 2000– 2004, NE, MW, W
EBI
EBI
EBI
Engaged in HIV transmission risk behavior (936)
MSM (313)
None (436)
RCT, Waitlist
RCT, Standard of care
RCT, Attention control
Healthy Living Project (15/22.5), Individual
Treatment Advocacy Program (4/9), Individual
Integrated Risk Reduction and Adherence Intervention (7/12), Group
(continued overleaf )
Sex outcome Significant positive intervention effects on TRB: greater reduction in the mean number of unprotected anal or vaginal TRB from 5–25 months postbaseline (x2 ¼ 27.8, df ¼ 5, P < 0.0001) and 20 months postbaseline (8 months after intervention) (P ¼ 0.0014).
Sex outcome Significant positive intervention effects on TRB: (1) decrease in the percentage of participants reporting any TRB across the 12-month assessment period (x2 (2, N ¼ 249) ¼ 6.59, P ¼ 0.037), from baseline to 4 months postintervention (x2 (1, N ¼ 249) ¼ 6.57, P ¼ 0.01), and from baseline to the mean of 4 and 10 months postintervention (x2 (1, N ¼ 249) ¼ 5.47, P ¼ 0.019); (2) decrease in the mean number of TRB sex partners across the 12-month assessment period (x2 (2, N ¼ 249) ¼ 7.16, P ¼ 0.008), from baseline to 4 months postintervention (x2 (1, N ¼ 249) ¼ 7.01, P ¼ 0.008), and from baseline to the mean of 4 and 10 months postintervention (x2 (1, N ¼ 249) ¼ 6.3, P ¼ 0.012).
Sex outcome Significant positive intervention effects on TRB: fewer TRB at 1.5 months after intervention (Mean ¼ 0.9 [SD ¼ 5.3] vs. Mean ¼ 2.3 [SD ¼ 15.0], P < 0.05) and at 4.5 months after intervention (Mean ¼ 0.2 [SD ¼ 1.0] vs. Mean ¼ 1.0 [SD ¼ 3.8], P < 0.05). No significant effect on the number of TRB sex partners over the assessment points (P ¼ 0.1).
Behavioral prevention for people living with HIV Crepaz et al.
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Richardson et al. [59], 1998–2001, W
Rotheram-Borus et al. [62], 1994–1996, W, NE, S
Rotheram-Borus et al. [63], 1999–2003, W, NE
Sikkema et al. [67], 2002–2005, NE
EBI
EBI
EBI
EBI
First author [citation number], study years, region
With childhood sexual abuse history (247)
Young substance abusers (175)
HIVþ youth (310)
HIV clinic patients (886)
HIV-positive subpopulation (baseline sample size)
RCT, HIV demand control
RCT, Waitlist
Non-RCT, Standard of care
RCT, Attention control
Study design, comparison group
LIFT (15/22.5), Group
Choosing Life: Empowerment, Actions, Results (CLEAR) (18/36), Individual
Teens Linked to Care (31/62), Group
Partnership for Health (3–5 min each clinic visit), Individual
Intervention name (# of sessions/ total hours), intervention level
Sex outcome Significant positive intervention effects on TRB and other outcomes across 4-month, 8-month, and 12-month assessments: fewer unprotected anal or vaginal sex acts with all partners (b¼0.233; F ¼ 131.61, df ¼ 1,540, P < 0.001) and with HIV-negative and unknown serostatus partners (b¼0.315; F ¼ 57.22, df ¼ 1,221, P < 0.001).
Sex outcome Significant positive intervention effects on TRB and other outcomes at 15 months postbaseline: Increased proportion of protected acts with all sex partners (58 vs. 22%, P < 0.01) and with HIV-negative partners (73 vs. 32%, P < 0.01). No significant effect on 100% condom use or abstinent (58 vs. 59%, P value NR). Drug outcome No significant effect on the percentage of participants injected drugs (11 vs. 20%, P value NR).
Sex outcome Significant positive intervention effects on TRB and other outcomes at 3 months after Act Safe intervention module: (1) lower mean percentage of unprotected anal or vaginal TRB (2.8 vs. 15.5%, P < 0.05); (2) more likely to report no sex or 100% condom use (80 vs. 67%, P < 0.01). No significant effect on the number of sex partners (0.2 vs. 0.2, P value NR).
Sex outcome Significant positive intervention effects: less likely to report unprotected anal or vaginal sex at 1–7 months among those who had 2 or more sex partners at baseline (OR ¼ 0.42, 95% CI ¼ 0.19–0.91, P ¼ 0.03), among men who have sex with men with 2 more sex partners at baseline (OR ¼ 0.43, 95% CI ¼ 0.19–0.94, P ¼ 0.04), and among those who had any casual or exchange partners at baseline (OR ¼ 0.51, 95% CI ¼ 0.27 to 0.95, P ¼ 0.04). No significant effect among those who had only main partners at baseline (OR ¼ 1.31, 95% CI ¼ 0.67–2.57, P ¼ .44).
Sex, drug and biological outcomes
AIDS
Category
Table 1 (continued )
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Wingood et al. [74], 1997–2002, S
Wolitski et al. [75], 2000–2002, NE, W
Holstad et al. [42], 2005–2008, S
Illa et al. [43], 2004–2007, S
Metsch et al. [55], 2001–2003, S, W
EBI
EBI
Rigorous non-EBI
Rigorous non-EBI
Rigorous non-EBI
Recently diagnosed (316)
Sexually active older clinic patients (241)
Women (203)
MSM who engaged in HIV transmission risk behavior (811)
Sexually active HIVþ female clinic patients (391)
RCT, Standard of care
RCT, HIV demand control
RCT, Attention control
RCT, HIV demand control
RCT, Attention control
ARTAS - Antiretroviral Treatment Access Study (5/NR), Individual
Project ROADMAP (4/6), Group
Group Motivational Interviewing (8/16), Group
Summit Enhanced Peer- Led (6/18), Group
WILLOW (4/16), Group
(continued overleaf )
Sex outcome No significant effects on TRB: unprotected anal or vaginal TRB over 12 months (OR ¼ 0.96, 95% CI ¼ 0.62–1.50, P ¼ 0.865).
Sex outcome No significant effects on TRB and other outcomes: inconsistent condom use at 6 months postbaseline with the following type of partners: (1) any sex partners (7 vs. 8%, P value NR); (2) TRB partners (1.3 vs. 3%, P value NR); (3) HIV-positive partners (5 vs. 6.5%, P value NR).
Sex outcome No significant effects: (1) abstinence, (2) use of condom during anal, oral, or vaginal sex during the assessment periods (baseline, 2 weeks, 3 months, 6 months, and 9 months) (test results and P values NR).
Sex outcome Significant positive intervention effects on TRB: less likely to report unprotected receptive anal TRB at 3 months after intervention (OR ¼ 0.65, 95% CI ¼ 0.44–0.97, P < 0.05). No significant effect on unprotected insertive TRB (OR ¼ 0.74, 95% CI ¼ 0.48–1.16). Biologic outcome No significant effect: STDs (syphilis, gonorrhea, chlamydia, and herpes simplex virus 1 and 2) at 6 months after intervention (test results and P value NR).
Sex outcome Significant positive intervention effects: (1) fewer unprotected vaginal sex acts at 6 months (mean difference ¼ -0.05, P ¼ 0.037) and at 12 months (mean difference ¼ 1.3, P ¼ 0.029) after intervention; (2) less likely to report never using condoms at 6 months (OR ¼ 0.3, 95% CI ¼ 0.7–0.9), P ¼ 0.043) and 12 months (OR ¼ 0.2, 95% CI ¼ 0.5– 0.8, P ¼ 0.026) after intervention. Biologic outcome Significant positive intervention effect: less likely to acquire new bacterial STDs (chlamydia and gonorrhea) over the 12month period (OR ¼ 0.2, 95% CI ¼ 0.1–0.6, P ¼ 0.006).
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Purcell et al. [58], 2001–2004, NE, S, W
Safren et al. [64], 2004–2008, NE
Sorensen et al. [69], 1994–1998, W
Rosser et al. [61], 2005–2007, NE, S, W
Velasquez et al. [71], 1999–2003, NR
Williams et al. [73], NR, NR
Rigorous non-EBI
Rigorous non-EBI
Rigorous non-EBI
Rigorous non-EBI
Rigorous non-EBI
Rigorous non-EBI
First author [citation number], study years, region
Heterosexual African–American crack smokers (347)
MSM with alcohol abuse (253)
MSM who engaged in HIV transmission risk behavior (675)
Out of treatment substance abusers (190)
MSM who engaged in HIV transmission risk behavior (201)
Injection drug users (966)
HIV-positive subpopulation (baseline sample size)
RCT, Attention control
RCT, HIV demand control
RCT, HIV demand control
RCT, HIV demand control
RCT, Standard of care
RCT, HIV demand control
Study design, comparison group
Positive Choices (6/6), Group
Motivational Interviewing (8/NR), Group
Positive Connections (1/16), Group
Case Management (ongoing), Individual
Project Enhance (5/7.5 plus 4 boosters), Individual
INSPIRE (10/20), Group
Intervention name (# of sessions/ total hours), intervention level
Sex outcome No significant effects on consistent condom use during vaginal sex, condition by time (baseline, 3 and 9 months) (F ¼ 0.61, df NR, P ¼ 0.43).
Sex outcome No significant effects on the number of unprotected-sex days from baseline to 12 months (x2 ¼ 2.92, df ¼ 8; P ¼ 0.94)a.
Sex outcome No significant effects on TRB: unprotected anal TRB, condition by time (baseline, 6, 12, and 18 months after intervention) (test results and P values NR).
Sex outcome No significant effect on sex risk behaviors at 6 months after intervention (OR ¼ 0.97, 95% CI ¼ 0.54–1.74)b. Drug outcome No significant effect on needle-sharing behavior at 6 months after intervention (OR ¼ 0.63, 95% CI ¼ 0.35–1.13)b.
Sex outcome No significant effects on TRB: unprotected insertive or receptive anal TRB over time (baseline, 3, 6, 9 and 12 months) (OR ¼ 0.94, 95% CI ¼ 0.78–1.16).
Sex outcome No significant effects on TRB: unprotected anal or vaginal TRB at (1) 3 months after intervention (OR ¼ 1.22, 95% CI ¼ 0.79– 1.89); (2) 6 months after intervention (OR ¼ 1.32, 95% CI ¼ 0.83–2.12); (2) 12 months after intervention (OR ¼ 1.01, 95% CI ¼ 0.63–1.61). Drug outcome No significant effects on lending a needle or sharing drug paraphernalia with HIVnegative or serostatus unknown partners at (1) 3 months after intervention (OR ¼ 0.78, 95% CI ¼ 0.49–1.25); (2) 6 months after intervention (OR ¼ 0.68, 95% CI ¼ 0.40– 1.13); (2) 12 months after intervention (OR ¼ 0.77, 95% CI ¼ 0.42–1.41).
Sex, drug and biological outcomes
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Category
Table 1 (continued )
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Wolitski et al. [76], 2004–2007, MW, S, W
Chen et al. [30], 2005–2007, MW, NE, S, W
Coates et al. [33], NR, W
Cosio et al. [35], 2007– 2008, MW, NE, S, W
Grinstead et al. [41], 1996–1998, W
Rigorous non-EBI
Positive non-EBI
Positive non-EBI
Positive non-EBI
Positive non-EBI
Male prison inmates (123)
Rural & engaged in HIV transmission risk behavior (79)
Gay men (64)
Youth with medication adherence, substance abuse or sexual risk problems (142)
Homeless or at severe risk of homelessness (644)
Non-RCT, Waitlist
RCT, HIV demand control
RCT, Waitlist
RCT, Standard of care
RCT, HIV demand control
Health Promotion (8/20), Group
Telephone Motivational Interviewing (2/NR), Individual
Stress Reduction Training (9/NR), Group
Healthy Choices (4/6), Individual
Housing Assistance & HIV Prevention (case management þ 2 HIV sessions/1.25), Individual
(continued overleaf )
Sex outcome No significant effect on the percentage condom use at first sex since release (OR, 0.57; 95% CI, 0.18–1.80)b. Drug outcome Significant positive intervention effect: Among injectors, less likely to report needle sharing at postrelease (OR ¼ 0.11; 95% CI ¼ 0.03– 0.41)b. No significant effect on the percentage of participants injected drugs since release (48 vs. 48%, P value NR).
Sex outcome Significant positive intervention effect on the mean percentage of vaginal sex partners with whom condoms were used all the time at 2 months after intervention (27.1 vs. 22.5%, F ) ¼ 3.2, df ¼ 1,77, P < 0.05). No significant effect on the mean percentage of anal sex partners with whom condoms were used all the time at 2 months after intervention (20.1 vs. 19.4%, F value NR, P ¼ 0.35).
Sex outcome Significant positive intervention effect on the number of sex partners at postintervention (mean difference ¼ 1.20, 95% CI ¼ 0.14– 2.28, P value NR).
Sex outcome Significant positive intervention effects from baseline to 15-month assessment: (1) increased odds of persistent low sex risk (0–2 times no condom use during study period, OR ¼ 2.71, 95% CI ¼ 1.33–5.52, P < 0.01); (2) reduced odds of high sex risk (10 or more times no condom use during study period, OR ¼ 0.41, 95% CI ¼ 0.17– 0.99, P < 0.05).
Sex outcome No significant effects on TRB and other outcomes: (1) unprotected anal or vaginal TRB, condition by time (baseline, 6, 12, and 18 months) (F ¼ 0.28, df NR, P ¼ 0.84), (2) the number of partners, condition by time (baseline, 6, 12, and 18 months) (F ¼ 1.01, df NR, P ¼ 0.39).
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Lightfoot et al. [48], 2001–2006, W
Lovejoy et al. [49], 2009–2010, NE, MW, S
Margolin et al. [50], 1997–2001, NE
Mausbach et al. [52], 1999–2005, W
McCoy et al. [53], 1990–1992, S
Positive non-EBI
Positive non-EBI
Positive non-EBI
Positive non-EBI
Positive non-EBI
First author [citation number], study years, region
Injection drug users (140)
Meth-using MSM who engaged in HIV transmission risk behavior (341)
Injection drug users in methadone maintenance treatment (90)
Older adults who engaged in HIV transmission risk behavior (100)
HIV clinic patients (529)
HIV-positive subpopulation (baseline sample size)
RCT, Standard of care
RCT, Attention control
RCT, HIV demand control
RCT, Standard of care
RCT, Waitlist
Study design, comparison group
Case Management Services (on-going), Individual
EDGE (8/12), Individual
HHRPþ (48/minimum of 96), Group
Telephone-delivered Motivational Interviewing (4/3), Individual
MD4LIFE computerdelivered (11/2), Individual
Intervention name (# of sessions/ total hours), intervention level
Sex outcome No significant effect on the number of sex partner (multiple R ¼ 0.15, P value NR) and use of condoms (multiple R ¼ 0.38, P value NR) at 6 months after baseline. Drug outcome Significant intervention effect on the number of injecting partners at 6 months after baseline (multiple R ¼ .62, P < 0.01). No significant effect on injecting heroin and cocaine at 6 months after baseline (multiple R ¼ 0.40, P value NR).
Sex outcome Significant positive intervention effects: a greater (log) number of anal, oral and vaginal sex protected by a condom or oral dam at 5 months after intervention/8 months postbaseline (t ¼ 2.13, df ¼ 283, P ¼ 0.034) and at 9 months after intervention/12 months postbaseline (t ¼ 2.72, df ¼ 480, P ¼ 0.007). No significant effects: (1) (log) number of unprotected anal, oral, or vaginal sex (test results and P value NR); (2) ratio of total protected-to-total sex acts (test results and P value NR).
Sex and drug outcomes Significant positive intervention effect: less likely to engage in either unprotected sex or needle sharing or needle sharing 3 months after intervention (OR ¼ 2.96, 95% CI ¼ 1.05–8.36, P < 0.04).
Sex outcome Significant positive intervention effects: the fewer number of unprotected anal or vaginal sex at 3 months (OR ¼ 0.32, 95% CI ¼ 0.17–0.56)b and 6 months (OR ¼ 0.37, 95% CI ¼ 0.2–0.69)b after intervention.
Sex outcome Significant positive intervention effects on TRB over the 30-month postbaseline period: (1) decreased the number of TRB partners (t ¼ 2.79, df ¼ 1952, P ¼ 0.02); (2) decreased the number of unprotected anal or vaginal TRB (t ¼ 3.23, df ¼ 2029, P < 0.01).
Sex, drug and biological outcomes
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Category
Table 1 (continued )
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Petry et al. [57], 2003–2008, NE
Rose et al. [60], 2004–2006, W
Teti et al. [70], 2004–2008, NE
Wyatt et al. [77], NR, W
Cleary et al. [32], 1986–1989, NE
Coleman et al. [34], 2006–2007, NE
Positive non-EBI
Positive non-EBI
Positive non-EBI
Positive non-EBI
Other non-EBI
Other non-EBI
Older African–American MSM (60)
Recently diagnosed blood donors (271)
Women with histories of childhood sexual abuse (147)
Women (184)
HIV clinic patients who engaged in HIV transmission risk behavior(386)
Patients with cocaine or opioid use disorders (170)
RCT, Attention control
RCT, Standard of care
RCT, HIV demand control
RCT, HIV demand control
RCT, Standard of care
RCT, Attention control
Social Cognitive (4/8), Group
Cognitive Behavioral and Skills Training Support Group (6/9), Group
Enhance Sexual Health Intervention (11/1.5), Group
Protect and Respect (5/7.5), Group
HIV Intervention for Provider (ongoing), Individual
Contingency Management (24/24), Group
(continued overleaf )
Sex outcome No significant effects at 3 months after intervention: (1) reported consistent condom use (OR ¼ 2.04, 95% CI ¼ 0.48– 8.77, P ¼ 0.336); (2) had multiple sex partners (OR ¼ 1.43, 95% CI ¼ 0.35–5.79, P ¼ 0.062).
Sex outcome No significant effect on the percentage of participants reporting unprotected sex at 10.5 months after intervention (30.9 vs. 37.7%, P value NR).
Sex outcome Significant positive intervention effects: greater percentage of participants reporting vaginal sex protected by condom (OR ¼ 2.96, 95% CI NR, P ¼ 0.039, one-tailed).
Sex outcome Significant positive intervention effects: (1) greater odds of reporting condom use during anal or vaginal sex at 6 months (OR ¼ 17.13, 95% CI ¼ 2.96–99.10, P < 0.01) and at 18 months (OR ¼ 270.04, 95% CI ¼ 24.53–2971.94, P < 0.01) postbaseline.
Sex outcome Significant positive intervention effects: reduced number of sex partners (OR ¼ 0.49, 95% CI ¼ 0.26–0.92, P < 0.03) at 6 months postbaseline. No significant effects on TRB: (1) the number of TRB partners (OR ¼ 0.93, 95% CI ¼ 0.82–1.69, P ¼ 0.86); (2) unprotected anal or vaginal TRB (OR ¼ 1.44, 95% CI ¼ 0.90– 2.30, P ¼ 0.42).
Sex and drug outcomes Significant positive intervention effects: reduced scores on the HIV Risk Behavior Scale, including risky sex and drug use behaviors, between baseline and 6 months (F ¼ 4.75, df ¼ 1,133, P < 0.05) and baseline and 12 months (F ¼ 5.23, df ¼ 1,139, P < 0.05).
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Fogarty et al. [38], 1993–1996, S
Kelly et al. [46], 1991, MW
Lapinski et al. [47], NR, MW
Margolin et al. [51], NR, NE
Patterson et al. [56], 1996–2001, W
Schwarcz et al. [65], 2006–2010, W
Other non-EBI
Other non-EBI
Other non-EBI
Other non-EBI
Other non-EBI
Other non-EBI
First author [citation number], study years, region
MSM engaged in HIV transmission risk behavior (411)
Engaged in HIV transmission risk behavior (387)
Injection drug users in methadone maintenance treatment (38)
MSM (72)
Depressed Men (115)
Women (322)
HIV-positive subpopulation (baseline sample size)
RCT, HIV demand control
RCT, Attention control
Non-RCT, Standard of care
Non-RCT, HIV demand control
RCT, Standard of care
RCT, Standard of care
Study design, comparison group
Personalized Cognitive Counseling (2/2), Individual
Share Safer Sex (3/4.5), Individual
3-Sþ for HIVþ drug users (12/NR), Group
Prevention Options for Positives (6/9), Group
Support Group (8/12), Group
Women and Infants Demonstration Project (1–24/NR), Group
Intervention name (# of sessions/ total hours), intervention level
Sex outcome No significant effect on TRB: (1) mean number of unprotected anal TRB at the 12-month assessment (6 months after intervention; incident rate ratio: 0.48, 95% CI ¼ 0.121.84, P ¼ 0.34), (2) percentage of participants reporting unprotected anal TRB at 6 months after intervention (27.8 vs. 22.3%, P value NR).
Sex outcome Significant negative intervention effect on TRB at 8 months after intervention: intervention group reporting more unprotected anal, oral, and vaginal TRB (test result and P value NR). No significant effect on TRB at 12 months after intervention: the mean number of unprotected anal, oral, and vaginal TRB (OR ¼ 0.66; 95% CI ¼ 0.33–1.33)b. Biologic outcome No significant effect on the mean number of STDs (not defined) across 12 months after intervention (test results and P value NR).
Sex and drug outcomes No significant effect on the mean score of the Risk Assessment Battery assessing a range of drug- and sex-related HIV risk behaviors after intervention (0.03 vs. 0.03, P value NR).
Sex outcome No significant effect on the mean score of risk reduction index at 6 weeks after intervention (1.45 vs. 1.23, P value NR).
Sex outcome No significant effect on the mean number of unprotected insertive anal sex acts at 3 months after intervention (OR ¼ 0.92; 95% CI ¼ 0.35– 2.45, P value NR)b.
Sex outcome No significant effects: (1) the odds of progressing in use of condoms with main male partner at 6–12 months (OR ¼ 1.95, P ¼ .19) and at 12–18 months (OR ¼ 2.13, P ¼ 0.13) postbaseline; (2) the odds of relapsing in use of condoms with main male partner at 6–12 months (OR ¼ 0.38, P ¼ 0.10) and at 12–18 months (OR ¼ 0.47, P ¼ 0.15) postbaseline.
Sex, drug and biological outcomes
AIDS
Category
Table 1 (continued )
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Sikkema et al. [68], 2006–2008, NE
Williams et al. [72], 2003–2006, W
Other non-EBI
Other non-EBI
African–American, Latino MSM (137)
Newly diagnosed bisexual/ gay men in care (65)
MSM (77)
RCT, Attention control
RCT, Standard of care
RCT, Waitlist
Sexual Health Intervention for Men (S-HIM) (6/12), Group
Positive Choices (3/3), Individual
HIV-related Disclosure (4/5), Group
Sex outcome No significant effects: (1) the score of sex risk behavior scale, including oral, anal or vaginal sex (F ¼ 1.15, df ¼ 3,130, P ¼ 0.33, condition by time interaction), (2) the number of sex partners (F < 1.00, df ¼ 3,129, P value NR, condition by time interaction).
Sex outcome No significant effects at 3 months after intervention/6 months postbaseline: (1) unprotected anal or vaginal sex acts with any partners (OR ¼ 0.54, 95% CI ¼ 0.21– 1.38)b; (2) the number of sex partners (OR ¼ 0.72, 95% CI ¼ 0.28–1.82)b. Biologic outcome No significant effect on STDs symptoms (not defined) at 3 months after intervention (24.1 vs. 28.6%, P value NR).
Sex outcome Statistically significant negative intervention effect: intervention group had a greater odds of unprotected insertive anal sex at 3 months after intervention (OR ¼ 2.54, 95% CI NR, P < 0.05). No significant effect on the odds of unprotected receptive anal sex at 2 months after intervention (OR ¼ 1.55, 95% CI and P value NR).
Category: EBI ¼ evidence-based interventions show at least one significant positive intervention effect and have low risk of bias in study design, implementation, and analysis; Rigorous nonEBI ¼ interventions show no significant positive intervention effects but have low risk of bias; Positive non-EBI ¼ interventions show at least one significant positive intervention effect but have high risk of bias; Other non-EBI ¼ interventions show no significant positive intervention effect and have high risk of bias. Region: NE ¼ northeast; MW ¼ midwest; S ¼ south; W ¼ west. NR, not reported; TRB, HIV transmission risk behavior defined as unprotected sex with HIV-negative or serostatus unknown partners. a Additional info obtained from authors. b OR calculated based on descriptive data reported or provided by author.
Serovich et al. [66], 2005–2006, MW
Other non-EBI
Biologic outcome No significant effect on the laboratoryconfirmed diagnosis of STD (gonorrhea or Chlamydia; test results and P value NR).
Behavioral prevention for people living with HIV Crepaz et al.
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studies that measured STD (laboratory confirmed or doctor’s diagnosis) showed a significant positive intervention effect.
Classification of evidence-based interventions and nonevidence-based interventions based on the risk of bias and significant positive intervention effects Of the 48 included studies, 24 interventions (50%) had low risk of bias. Among these, 14 were EBIs that also showed significant positive intervention effects [31,36,37, 39,40,44,45,54,59,62,63,67,74,75] and the other 10 interventions were rigorous non-EBIs [42,43,55,58,61, 69,71,73,76]. Twenty-four interventions had high risk of bias, including 13 positive non-EBIs [30,33,35,41,48– 50,52,53,57,60,70,77] and 11 other non-EBIs [32,34,38, 46,47,51,56,65,66,68,72]. Eighteen positive and other non-EBIs (75%) had multiple sources of bias. The common sources of bias included analytic sample sizes less than 40 per arm, less than a 60% retention rate of study participants per arm, greater than 10% differential attrition between arms, substantial missing data, not conducting intent-to-treat analysis, or significant negative findings. Another way of looking at the breakdown of 34 non-EBIs is that 21 interventions (61%) did not find any significant positive intervention effects. Comparisons between evidence-based interventions and rigorous nonevidence-based interventions Table 2 and Table 3 show comparisons between EBIs and rigorous non-EBIs. The two groups were similar in terms of target populations (i.e. MSM, those who engaged in HIV transmission risk), sample characteristics (i.e. race/ ethnicity, gender, age), reporting of power analysis and theories, use of audio computer-assisted self-administered interview (ACASI) for data collection, several intervention components (i.e. self-efficacy, skills building, serostatus disclosure, social support, personalized risk reduction plan, personal responsibility, normative influence, intimate partner violence), and type of outcomes reported (e.g. TRB, unprotected sex behavior, injection drug use, or needle sharing). Despite the similarities, EBIs and rigorous non-EBIs differed in a few ways. More EBIs than rigorous non-EBIs were evaluated in the earlier HAART era (1996–2003), carried out at multiple study locations, targeted clinic patients, delivered to individuals, conducted in healthcare settings, used standard of care or non-HIV attention controls (defined as receiving non-HIV intervention such as general health promotion that matched length and doses of HIV intervention) as comparison groups. There was a higher percentage of EBIs than non-EBIs that addressed the following intervention components: discussing HIV risk reduction, promoting motivation for behavioral change, addressing misperception about HIV, reducing negative effect such as depression or anxiety,
enhancing medication adherence, and conducting risk screening to guide prevention messages. In contrast, more rigorous non-EBIs were conducted in the later-ARTera, targeted substance users, used HIV demand controls as comparisons (defined as participants in the comparison group who were aware that the intervention they received was intended to change their sex or drug risk behaviors), and had three to 12 intervention sessions over a period of 1–3 months.
Comparison between evidence-based interventions and positive nonevidence-based interventions There were several similarities between EBIs and positive non-EBIs. Comparable percentages of EBIs and positive non-EBIs were observed on the following: intervention level (i.e. individual, group, couple), intervention intensity and time span, and some intervention components (e.g. building skills and self-efficacy, conducting risk screening to guide personalized prevention messages, working with participants on personalized risk-reduction plans, emphasizing personal responsibility to take care of one’s and partner’s health, and addressing medication adherence issues). However, positive non-EBIs were more likely to be small-scale studies conducted with subgroups of PLWH (e.g. rural areas, depressed MSM, meth-using MSM, injection drug users, substance users, women) compared to EBIs. Positive non-EBIs were less often conducted as multisite studies and in healthcare settings or community-based establishments in contrast to EBIs. Positive non-EBIs were also less likely than EBIs to use non-HIV attention controls, use ACASI for data collection, report theories, and report and show positive intervention effects on TRB. Highlights of evidence-based interventions While the comparisons between EBIs and two non-EBIs groups (i.e. rigorous and positive) can inform research gaps and future intervention development, a closer examination of the EBIs can provide helpful direction for providers in healthcare and nonhealthcare settings in selecting model programs suitable for their target populations. More than half of EBIs targeted HIV clinic patients [37,39,40,54,59,62,74], but none targeted newly diagnosed PLWH. Six EBIs targeted specific subgroups of PLWH: MSM [54,75], heterosexual African–American discordant couples [36], substance using youth and young adults [63], women [74], and PLWH with a history of childhood sexual abuse [67]. All 14 EBIs had greater than 50% ethnic minority participants (range: 53–100%), seven of which included a majority of African–Americans. The key components of EBIs included addressing HIV riskreduction behaviors, motivation for behavioral change, misconception about HIV, and issues related to mental health, medication adherence, and HIV TRB. A variety of intervention delivery methods, ranging from brief prevention messages delivered during regular HIV
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Behavioral prevention for people living with HIV Crepaz et al. Table 2. Percentages and medians of select characteristics of evidence-based interventions and nonevidence-based interventions. Non-EBIs by type All interventions k (%) Total (% of total) Conducted Pre-ART (1988– 1995) Early ART (1996–2003) Later ART (2004–2012) >1 Study site No significant positive findings Sources of bias Small sample size Retention Differential attrition Other limitations (missing data, etc.) Follow-up Allocation method Intent-to-treat analysis Negative intervention effect Target groupsa Clinic patients MSM Engaged in HIV transmission risky Substance use Female African–American Depressed or childhood abuse Younger age (13–25 years) Older age group (>45 years) Newly diagnosed Substance using MSM Male prison inmate Homeless Rural residents Sample characteristics (median)a Black Latino White Male Female Average age (years) Comparison group Standard of care or waitlist Non-HIV attention controlL HIV demand controly Power analysis reported Used ACASI for data collection Theory reported Intervention settinga Healthcareb Community-based establishment6¼ Public area^ Commericalþ Intervention level Individual Group Couple Deliverera,f Professional Counselor or health educator Healthcare worker Peer Computer-based Intervention componentsa Skills building HIV risk reductiont Motivation Self-efficacy Serostatus disclosure Social support
EBIs k (%)
Non-EBIs k (%)
Rigorous k (%)
48
14 (29%)
34 (71%)
10 (21%)
6 24 18 20 21
(13%) (50%) (38%) (42%) (44%)
0 11 3 10 0
(0%) (79%)a,d (21%)b (71%)b,d (0%)a
6 13 15 10 21
(18%) (38%) (44%) (29%) (62%)
1 3 6 5 10
16 9 8 7 5 2 2 2
(33%) (19%) (17%) (15%) (10%) (4%) (4%) (4%)
0 0 0 0 0 0 0 0
(0%)c (0%)c (0%)d (0%)c (0%)c (0%) (0%) (0%)
16 9 8 7 5 2 2 2
(47%) (26%) (24%) (21%) (15%) (6%) (6%) (6%)
17 13 11 10 5 4 4 3 3 3 2 1 1 1
(35%) (27%) (23%) (21%) (10%) (8%) (8%) (6%) (6%) (6%) (4%) (2%) (2%) (2%)
7 2 3 1 1 1 1 2 0 0 0 0 0 0
(50%)b (14%) (21%) (7%)b,d (7%) (7%) (7%) (14%) (0%) (0%) (0%) (0%) (0%) (0%)
10 11 8 9 4 3 3 1 3 3 3 1 1 1
(29%) (32%) (24%) (26%) (12%) (9%) (9%) (3%) (9%) (9%) (9%) (3%) (3%) (3%)
50% 15% 23% 72% 27%
48% 17% 22% 71% 28% 42
Positive k (%)
Other k (%)
13 (27%)
11 (23%)
(10%) (30%)a (60%)b (50%)b (100%)a
2 6 5 5 0
(15%) (46%)d (38%) (38%)d (0%)
3 4 4 0 11
(27%) (36%) (36%) (0%) (100%)
0 0 0 0 0 0 0 0
(0%) (0%) (0%) (0%) (0%) (0%) (0%) (0%)
8 4 3 5 4 0 0 0
(62%)c (31%)c (23%)d (38%)c (31%)c (0%) (0%) (0%)
8 5 5 2 1 2 2 2
(73%) (45%) (45%) (18%) (9%) (18%) (18%) (18%)
3 3 2 4 1 1 0 0 1 1 1 0 1 0
(30%)b (30%) (20%) (40%)b (10%) (10%) (0%) (0%) (10%) (10%) (10%) (0%) (10%) (0%)
5 2 4 4 2 0 1 1 1 0 1 1 0 1
(38%) (15%) (31%) (31%)d (15%) (0%) (8%) (8%) (8%) (0%) (8%) (8%) (0%) (8%)
2 6 2 1 1 2 2 0 1 2 1 0 0 0
(18%) (55%) (18%) (9%) (9%) (18%) (18%) (0%) (9%) (18%) (9%) (0%) (0%) (0%)
54% 13% 32% 78% 27% 41
63% 12% 9% 70% 29% 42
51% 14% 23% 70% 37% 41
37% 13% 49% 100% 36% 39
20 12 16 20 20 42
(42%) (25%) (33%) (42%) (42%) (88%)
6 6 2 8 9 14
(43%)b (43%)b,d (14%)a (57%) (64%)d (100%)d
14 6 14 12 11 28
(41%) (18%) (41%) (35%) (32%) (82%)
2 1 7 5 6 9
(20%)b (10%)b (70%)a (50%) (60%) (90%)
7 2 4 5 3 10
(54%) (15%)d (31%) (38%) (23%)d (77%)d
5 3 3 2 2 9
(45%) (27%) (27%) (18%) (18%) (82%)
24 11 4 2
(50%) (23%) (8%) (4%)
10 5 2 1
(71%)b,d (36%) (14%) (7%)
14 6 2 1
(41%) (18%) (6%) (3%)
5 2 0 0
(50%)b (20%) (0%) (0%)
5 1 2 0
(38%)d (8%) (15) (0%)
4 3 0 1
(36%) (27%) (0%) (9%)
21 (44%) 26 (54%) 1 (2%)
7 (50%)b 6 (43%)b 1 (7%)
28 19 9 13 2
(58%) (40%) (19%) (27%) (4%)
7 4 3 4 1
32 31 29 27 23 21
(67%) (65%) (60%) (56%) (48%) (44%)
9 12 11 8 9 8
14 (41%) 20 (59%) 0 (0%)
(50%)d (29%)d (21%) (29%) (7%)
21 15 6 9 1
(62%) (44%) (18%) (26%) (3%)
(64%) (86%)a,d (79%)b,d (57%) (64%)d (57%)
23 19 18 19 14 13
(68%) (56%) (53%) (56%) (41%) (38%)
3 (30%)b 7 (70%)b 0 (0%) 4 (40%) 3 (30%) 1 (10%) 3 (30%) 0 (0%) 6 4 5 6 5 4
(60%) (40%)a (50%)b (60%) (50%) (40%)
7 (54%) 6 (46%) 0 (0%)
4 (36%) 7 (64%) 0 (0%)
10 (77%)d 8 (62%)d 3 (23%) 3 (23%) 1 (8%)
8 (73%) 6 (55%) 2 (18%) 3 (27%) 0 (0%)
8 8 6 7 4 5
(62%) (62%)d (46%)d (54%) (31%)d (38%)
9 7 7 6 5 4
(82%) (64%) (64%) (55%) (45%) (36%)
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Table 2 (continued ) Non-EBIs by type All interventions k (%) Personalized risk-reduction plan Misperception about HIV Personal responsibility Depression and anxiety Risk screening Medication adherence Normative influencee Intimate partner violence Intervention intensity 1–2 sessions 3–10 sessions >10 sessions Intervention time span 1–3 months >3 months
21 16 16 15 12 10 9 4
(44%) (33%) (33%) (31%) (25%) (21%) (19%) (8%)
8 8 5 7 5 5 4 1
EBIs k (%)
Non-EBIs k (%)
Rigorous k (%)
Positive k (%)
(57%) (57%)b,c (36%) (50%)b,d (36%)b (36%)b (29%)d (7%)
13 8 11 8 7 5 5 3
4 3 2 3 1 1 2 1
6 2 6 1 5 3 0 2
(38%) (24%) (32%) (24%) (21%) (15%) (15%) (9%)
(40%) (30%)b (20%) (30%)b (10%)b (10%)b (20%) (10%)
(46%) (15%)c (46%) (8%)d (38%) (23%) (0%)d (15%)
Other k (%) 3 3 3 4 1 1 3 0
(27%) (27%) (27%) (36%) (9%) (9%) (27%) (0%)
6 (13%) 30 (63%) 12 (25%)
2 (14%) 8 (57%)b 4 (29%)
4 (12%) 22 (65%) 8 (24%)
1 (10%) 8 (80%)b 1 (10%)
2 (15%) 6 (46%) 5 (38%)
1 (9%) 8 (73%) 2 (18%)
33 (69%) 15 (31%)
7 (50%)a 7 (50%)
26 (76%) 8 (24%)
9 (90%)a 1 (10%)
8 (62%) 5 (38%)
9 (82%) 2 (18%)
k ¼ the number of interventions. EBI ¼ evidence-based interventions show at least one significant positive intervention effect and have low risk of bias in study design, implementation and analysis. Rigorous non-EBI ¼ interventions show no significant positive intervention effects, but have low risk of bias in study design, implementation and analysis. Positive non-EBI ¼ interventions show at least one significant positive intervention effect, but have high risk of bias in study design, implementation and analysis. Other non-EBI ¼ interventions show no significant positive intervention effect and have high risk of bias in study design, implementation and analysis. ACASI, audio computer-assisted self-administered interview. a Significant Fisher’s exact test between EBIs and rigorous non-EBIs (P
A systematic review of interventions for reducing HIV risk behaviors among people living with HIV in the United States, 1988–2012 Nicole Crepaza, Malu V. Tungol-Ashmona, Darrel H. Higaa, Waverly Vosburgha, Mary M. Mullinsa, Terrika Barhamb, Adebukola Adegbiteb, Julia B. DeLucaa, Theresa A. Sipea, Christina M. Whiteb, Brittney N. Baacka and Cynthia M. Lylesa Objective: To conduct a systematic review to examine interventions for reducing HIV risk behaviors among people living with HIV (PLWH) in the United States. Methods: Systematic searches included electronic databases from 1988 to 2012, hand searches of journals, reference lists of articles, and HIV/AIDS Internet listservs. Each eligible study was evaluated against the established criteria on study design, implementation, analysis, and strength of findings to assess the risk of bias and intervention effects. Results: Forty-eight studies were evaluated. Fourteen studies (29%) with both low risk of bias and significant positive intervention effects in reducing HIV transmission risk behaviors were classified as evidence-based interventions (EBIs). Thirty-four studies were classified as non-EBIs due to high risk of bias or nonsignificant positive intervention effects. EBIs varied in delivery from brief prevention messages to intensive multisession interventions. The key components of EBIs included addressing HIV risk reduction behaviors, motivation for behavioral change, misconception about HIV, and issues related to mental health, medication adherence, and HIV transmission risk behavior. Conclusion: Moving evidence-based prevention for PLWH into practice is an important step in making a greater impact on the HIV epidemic. Efficacious EBIs can serve as model programs for providers in healthcare and nonhealthcare settings looking to implement evidence-based HIV prevention. Clinics and public health agencies at the state, local, and federal levels can use the results of this review as a resource when making decisions that meet the needs of PLWH to achieve the greatest impact on the ß 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins HIV epidemic.
AIDS 2014, 28:633–656 Keywords: evidence-based intervention, HIV prevention, people living with HIV, risk reduction, systematic review
a
Prevention Research Branch, Division of HIV/AIDS Prevention, The U.S. Centers for Disease Control and Prevention, and bICF International Inc., Atlanta, Georgia, USA. Correspondence to Nicole Crepaz, PhD, Prevention Research Branch, Division of HIV/AIDS Prevention, The U.S. Centers for Disease Control and Prevention, 1600 Clifton Rd., Mailstop E-37, Atlanta, GA 30333, USA. Tel: +1 404 639 6149; fax: +1 404 639 1950; e-mail: [email protected] Received: 31 May 2013; revised: 7 October 2013; accepted: 7 October 2013. DOI:10.1097/QAD.0000000000000108
ISSN 0269-9370 Q 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins
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Introduction In the United States, it is estimated that 1 144 500 persons aged 13 and older were living with HIV at the end of 2010 [1] and there were an estimated 47 500 new HIV infections in 2010 [2]. People living with HIV (PLWH) are key partners in reducing the number of new HIV infections. Many PLWH reduce their risk behaviors after learning about their HIV-seropositive status [3,4]. However, adopting and maintaining safer behaviors can be challenging for some [5,6]. Providing prevention interventions that reduce the risk of HIV transmission or acquisition of other sexually transmitted diseases (STDs), in addition to HIV treatment and care for improving the health of PLWH, are critical components of the US National HIV/AIDS Strategy (NHAS) [7]. Identifying evidence-based interventions (EBIs) to help PLWH protect themselves and uninfected partners is considered to be the high priority of NHAS. Meta-analyses and systematic reviews [8–10] show that behavioral interventions for PLWH significantly reduce sexual risk behaviors. These systematic reviews are useful for understanding the overall effect on reducing HIV risk behaviors among PLWH. However, these reviews typically do not critically assess the quality of evidence by closely examining study design, implementation, analysis, and findings of individual interventions. Several evidence-based review groups such as the Cochrane Collaboration [11] and the Agency for Healthcare Research and Quality (AHRQ) [12] have emphasized the importance of assessing the risk of bias of individual studies as part of assessing the body of evidence. A thorough assessment of the risk of bias and findings of individual interventions can identify rigorously designed and implemented programs that show significant effects. Prevention providers can then use these efficacious interventions within their own clinics or communities. Since 1996, the US Centers for Disease Control and Prevention’s (CDC) HIV/AIDS Prevention Research Synthesis (PRS) project has been conducting an ongoing systematic review to identify behavioral interventions with evidence of intervention efficacy [13]. Through multiple consultations with internal and external HIV prevention researchers and methodology experts, PRS developed the risk-reduction efficacy criteria to assess various sources of bias in a study’s design, implementation, analysis, and findings [14]. The PRS criteria are similar to the evaluation components used or recommended by other groups such as the Cochrane Collaboration [11], AHRQ [12], Community Guide [15], Office of Adolescent Health [16], Office of Justice’s Crime Solutions [17], and Grades of Recommendation Assessment, Development and Evaluation (GRADE) [18]. To ensure a reasonable level of confidence that the observed changes can be attributed to the intervention [13], interventions that meet all the study design,
implementation, and analysis criteria are considered low risk of bias, whereas interventions that do not meet all of these criteria are considered high risk of bias. Interventions with low risk of bias that show significant positive intervention effects on reducing HIV risk behaviors are defined as EBIs and the interventions with high risk in bias, regardless of intervention effects, are defined as non-EBIs. The EBI classification approach is consistent with other systematic review efforts (e.g., Office of Adolescent Health [16], National Registry of Evidence-Based Programs and Practices [19,20], Office of Justice’s Crime Solutions [17]) in identifying evidencebased programs and interventions. In this systematic review, we reviewed all US-based HIV risk-reduction studies for PLWH available in the literature. Our goals were to describe the characteristics of the studies and interventions and to compare the similarities and differences between EBIs and non-EBIs. More specifically, we compared EBIs against two groups of non-EBIs: rigorous non-EBIs (i.e., interventions with low risk of bias, but without significant positive intervention effects) and positive non-EBIs (i.e. interventions with high risk of bias, but with significant positive intervention effects). These comparisons can provide helpful guidance for identifying research gaps, informing intervention development, and guiding prevention efforts.
Methods We used the CDC’s PRS project’s cumulative HIV/ AIDS/STD prevention database [21] for identifying relevant reports (see eligibility criteria below). For the PRS database, M.M.M. and J.D. with substantial expertise in systematic searches developed and conducted a comprehensive search strategy, including automated and manual searches. The annual automated search component focused on literature published between 1988 and 2012 using the following electronic databases (and platforms): EMBASE (OVID) [22], MEDLINE (OVID) [23], PsycINFO (OVID) [24], and Sociological Abstracts (PROQUEST) [25]. For the automated search, indexing and keywords terms were cross-referenced using Boolean logic in three areas: HIV/AIDS; prevention and intervention evaluation; and behavioral or biologic outcomes related to HIV infection or transmission (e.g. unprotected sex, condom use, needle sharing, STD). No language restriction was applied to the automated search. The last automated search was conducted in January 2013. The full search strategy of the MEDLINE database is provided in Appendix A, http://links.lww.com/QAD/ A427 as an example. The searches of the other databases are available from the corresponding author. The manual search included three components. First, searches of all reports published in the previous 3 months of 36 journals
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Behavioral prevention for people living with HIV Crepaz et al.
(see Appendix B, http://links.lww.com/QAD/A427) to identify potentially relevant citations not yet indexed in electronic databases. The last quarterly search was conducted in January 2013. Second, the reference lists of pertinent articles. Third, HIV/AIDS Internet listservs (i.e. www.RobertMalow.org) and other research databases (e.g., ISI Web of Knowledge [26], RePORTER [27], Cochrane Library [28]). Studies were included for this review if they were interventions to reduce HIV risk behavior; specifically designed for PLWH; conducted in the United States; tested in controlled trials with a comparison arm; measured HIV behavioral or biological outcomes (e.g. condom use, unprotected sex, number of sex partners, needle sharing, STD); and published between January 1988 and December 2012. We excluded pilot studies if the full-scale efficacy trials were eligible. Linked citations, defined as publications offering additional information on the same study, were included if they provided relevant intervention evaluation information. Pairs of trained coders independently coded each eligible intervention against the established PRS risk-reduction efficacy criteria, which are publically available at http:// www.cdc.gov/hiv/topics/research/prs/efficacy_criteria. htm [14]. If a study did not report critical information needed to determine intervention efficacy, we contacted the primary study investigator to obtain missing information or clarification. The final efficacy determination for each study was reached by PRS team consensus. Additionally, each eligible study was coded using a standardized coding form for the following: study characteristics (e.g. study date, location, study design, sample size, data collection method), participant characteristics (e.g., target population, gender, race/ethnicity, sexual orientation), intervention characteristics (e.g. components, delivery method, duration, time span), and HIV risk outcomes [e.g. HIV transmission risk behavior (TRB) defined as unprotected sex with HIVnegative or serostatus unknown partners or sharing needles with HIV-negative or serostatus unknown partners, unprotected sex or condom use with any sex partners, injecting drugs, needle sharing, STD]. Eligible studies were classified into four groups based on the risk of bias and evidence of intervention effects: (1) EBIs: low risk of bias with statistically significant positive intervention effects on at least one relevant HIV risk outcome. (2) Rigorous non-EBIs: low risk of bias without significant positive intervention effects. (3) Positive non-EBIs: high risk of bias with statistically significant positive intervention effects on at least one relevant HIV risk outcome.
(4) Other non-EBIs: high risk of bias without significant positive intervention effects.
For each of the two a-priori comparisons (i.e., EBIs vs. rigorous non-EBIs and EBIs vs. positive non-EBIs), we conducted Fisher’s exact tests using SPSS version 21. In the results section, we highlighted the findings if the differences between groups reached P 0.05).
Sex, drug and biological outcomes
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Category
Table 1 (continued )
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Kalichman et al. [45], 2005–2009, S
McKirnan et al. [54], 2004–2006, MW
NIMH et al. [31], 2000– 2004, NE, MW, W
EBI
EBI
EBI
Engaged in HIV transmission risk behavior (936)
MSM (313)
None (436)
RCT, Waitlist
RCT, Standard of care
RCT, Attention control
Healthy Living Project (15/22.5), Individual
Treatment Advocacy Program (4/9), Individual
Integrated Risk Reduction and Adherence Intervention (7/12), Group
(continued overleaf )
Sex outcome Significant positive intervention effects on TRB: greater reduction in the mean number of unprotected anal or vaginal TRB from 5–25 months postbaseline (x2 ¼ 27.8, df ¼ 5, P < 0.0001) and 20 months postbaseline (8 months after intervention) (P ¼ 0.0014).
Sex outcome Significant positive intervention effects on TRB: (1) decrease in the percentage of participants reporting any TRB across the 12-month assessment period (x2 (2, N ¼ 249) ¼ 6.59, P ¼ 0.037), from baseline to 4 months postintervention (x2 (1, N ¼ 249) ¼ 6.57, P ¼ 0.01), and from baseline to the mean of 4 and 10 months postintervention (x2 (1, N ¼ 249) ¼ 5.47, P ¼ 0.019); (2) decrease in the mean number of TRB sex partners across the 12-month assessment period (x2 (2, N ¼ 249) ¼ 7.16, P ¼ 0.008), from baseline to 4 months postintervention (x2 (1, N ¼ 249) ¼ 7.01, P ¼ 0.008), and from baseline to the mean of 4 and 10 months postintervention (x2 (1, N ¼ 249) ¼ 6.3, P ¼ 0.012).
Sex outcome Significant positive intervention effects on TRB: fewer TRB at 1.5 months after intervention (Mean ¼ 0.9 [SD ¼ 5.3] vs. Mean ¼ 2.3 [SD ¼ 15.0], P < 0.05) and at 4.5 months after intervention (Mean ¼ 0.2 [SD ¼ 1.0] vs. Mean ¼ 1.0 [SD ¼ 3.8], P < 0.05). No significant effect on the number of TRB sex partners over the assessment points (P ¼ 0.1).
Behavioral prevention for people living with HIV Crepaz et al.
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639
Richardson et al. [59], 1998–2001, W
Rotheram-Borus et al. [62], 1994–1996, W, NE, S
Rotheram-Borus et al. [63], 1999–2003, W, NE
Sikkema et al. [67], 2002–2005, NE
EBI
EBI
EBI
EBI
First author [citation number], study years, region
With childhood sexual abuse history (247)
Young substance abusers (175)
HIVþ youth (310)
HIV clinic patients (886)
HIV-positive subpopulation (baseline sample size)
RCT, HIV demand control
RCT, Waitlist
Non-RCT, Standard of care
RCT, Attention control
Study design, comparison group
LIFT (15/22.5), Group
Choosing Life: Empowerment, Actions, Results (CLEAR) (18/36), Individual
Teens Linked to Care (31/62), Group
Partnership for Health (3–5 min each clinic visit), Individual
Intervention name (# of sessions/ total hours), intervention level
Sex outcome Significant positive intervention effects on TRB and other outcomes across 4-month, 8-month, and 12-month assessments: fewer unprotected anal or vaginal sex acts with all partners (b¼0.233; F ¼ 131.61, df ¼ 1,540, P < 0.001) and with HIV-negative and unknown serostatus partners (b¼0.315; F ¼ 57.22, df ¼ 1,221, P < 0.001).
Sex outcome Significant positive intervention effects on TRB and other outcomes at 15 months postbaseline: Increased proportion of protected acts with all sex partners (58 vs. 22%, P < 0.01) and with HIV-negative partners (73 vs. 32%, P < 0.01). No significant effect on 100% condom use or abstinent (58 vs. 59%, P value NR). Drug outcome No significant effect on the percentage of participants injected drugs (11 vs. 20%, P value NR).
Sex outcome Significant positive intervention effects on TRB and other outcomes at 3 months after Act Safe intervention module: (1) lower mean percentage of unprotected anal or vaginal TRB (2.8 vs. 15.5%, P < 0.05); (2) more likely to report no sex or 100% condom use (80 vs. 67%, P < 0.01). No significant effect on the number of sex partners (0.2 vs. 0.2, P value NR).
Sex outcome Significant positive intervention effects: less likely to report unprotected anal or vaginal sex at 1–7 months among those who had 2 or more sex partners at baseline (OR ¼ 0.42, 95% CI ¼ 0.19–0.91, P ¼ 0.03), among men who have sex with men with 2 more sex partners at baseline (OR ¼ 0.43, 95% CI ¼ 0.19–0.94, P ¼ 0.04), and among those who had any casual or exchange partners at baseline (OR ¼ 0.51, 95% CI ¼ 0.27 to 0.95, P ¼ 0.04). No significant effect among those who had only main partners at baseline (OR ¼ 1.31, 95% CI ¼ 0.67–2.57, P ¼ .44).
Sex, drug and biological outcomes
AIDS
Category
Table 1 (continued )
640 2014, Vol 28 No 5
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Wingood et al. [74], 1997–2002, S
Wolitski et al. [75], 2000–2002, NE, W
Holstad et al. [42], 2005–2008, S
Illa et al. [43], 2004–2007, S
Metsch et al. [55], 2001–2003, S, W
EBI
EBI
Rigorous non-EBI
Rigorous non-EBI
Rigorous non-EBI
Recently diagnosed (316)
Sexually active older clinic patients (241)
Women (203)
MSM who engaged in HIV transmission risk behavior (811)
Sexually active HIVþ female clinic patients (391)
RCT, Standard of care
RCT, HIV demand control
RCT, Attention control
RCT, HIV demand control
RCT, Attention control
ARTAS - Antiretroviral Treatment Access Study (5/NR), Individual
Project ROADMAP (4/6), Group
Group Motivational Interviewing (8/16), Group
Summit Enhanced Peer- Led (6/18), Group
WILLOW (4/16), Group
(continued overleaf )
Sex outcome No significant effects on TRB: unprotected anal or vaginal TRB over 12 months (OR ¼ 0.96, 95% CI ¼ 0.62–1.50, P ¼ 0.865).
Sex outcome No significant effects on TRB and other outcomes: inconsistent condom use at 6 months postbaseline with the following type of partners: (1) any sex partners (7 vs. 8%, P value NR); (2) TRB partners (1.3 vs. 3%, P value NR); (3) HIV-positive partners (5 vs. 6.5%, P value NR).
Sex outcome No significant effects: (1) abstinence, (2) use of condom during anal, oral, or vaginal sex during the assessment periods (baseline, 2 weeks, 3 months, 6 months, and 9 months) (test results and P values NR).
Sex outcome Significant positive intervention effects on TRB: less likely to report unprotected receptive anal TRB at 3 months after intervention (OR ¼ 0.65, 95% CI ¼ 0.44–0.97, P < 0.05). No significant effect on unprotected insertive TRB (OR ¼ 0.74, 95% CI ¼ 0.48–1.16). Biologic outcome No significant effect: STDs (syphilis, gonorrhea, chlamydia, and herpes simplex virus 1 and 2) at 6 months after intervention (test results and P value NR).
Sex outcome Significant positive intervention effects: (1) fewer unprotected vaginal sex acts at 6 months (mean difference ¼ -0.05, P ¼ 0.037) and at 12 months (mean difference ¼ 1.3, P ¼ 0.029) after intervention; (2) less likely to report never using condoms at 6 months (OR ¼ 0.3, 95% CI ¼ 0.7–0.9), P ¼ 0.043) and 12 months (OR ¼ 0.2, 95% CI ¼ 0.5– 0.8, P ¼ 0.026) after intervention. Biologic outcome Significant positive intervention effect: less likely to acquire new bacterial STDs (chlamydia and gonorrhea) over the 12month period (OR ¼ 0.2, 95% CI ¼ 0.1–0.6, P ¼ 0.006).
Behavioral prevention for people living with HIV Crepaz et al.
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641
Purcell et al. [58], 2001–2004, NE, S, W
Safren et al. [64], 2004–2008, NE
Sorensen et al. [69], 1994–1998, W
Rosser et al. [61], 2005–2007, NE, S, W
Velasquez et al. [71], 1999–2003, NR
Williams et al. [73], NR, NR
Rigorous non-EBI
Rigorous non-EBI
Rigorous non-EBI
Rigorous non-EBI
Rigorous non-EBI
Rigorous non-EBI
First author [citation number], study years, region
Heterosexual African–American crack smokers (347)
MSM with alcohol abuse (253)
MSM who engaged in HIV transmission risk behavior (675)
Out of treatment substance abusers (190)
MSM who engaged in HIV transmission risk behavior (201)
Injection drug users (966)
HIV-positive subpopulation (baseline sample size)
RCT, Attention control
RCT, HIV demand control
RCT, HIV demand control
RCT, HIV demand control
RCT, Standard of care
RCT, HIV demand control
Study design, comparison group
Positive Choices (6/6), Group
Motivational Interviewing (8/NR), Group
Positive Connections (1/16), Group
Case Management (ongoing), Individual
Project Enhance (5/7.5 plus 4 boosters), Individual
INSPIRE (10/20), Group
Intervention name (# of sessions/ total hours), intervention level
Sex outcome No significant effects on consistent condom use during vaginal sex, condition by time (baseline, 3 and 9 months) (F ¼ 0.61, df NR, P ¼ 0.43).
Sex outcome No significant effects on the number of unprotected-sex days from baseline to 12 months (x2 ¼ 2.92, df ¼ 8; P ¼ 0.94)a.
Sex outcome No significant effects on TRB: unprotected anal TRB, condition by time (baseline, 6, 12, and 18 months after intervention) (test results and P values NR).
Sex outcome No significant effect on sex risk behaviors at 6 months after intervention (OR ¼ 0.97, 95% CI ¼ 0.54–1.74)b. Drug outcome No significant effect on needle-sharing behavior at 6 months after intervention (OR ¼ 0.63, 95% CI ¼ 0.35–1.13)b.
Sex outcome No significant effects on TRB: unprotected insertive or receptive anal TRB over time (baseline, 3, 6, 9 and 12 months) (OR ¼ 0.94, 95% CI ¼ 0.78–1.16).
Sex outcome No significant effects on TRB: unprotected anal or vaginal TRB at (1) 3 months after intervention (OR ¼ 1.22, 95% CI ¼ 0.79– 1.89); (2) 6 months after intervention (OR ¼ 1.32, 95% CI ¼ 0.83–2.12); (2) 12 months after intervention (OR ¼ 1.01, 95% CI ¼ 0.63–1.61). Drug outcome No significant effects on lending a needle or sharing drug paraphernalia with HIVnegative or serostatus unknown partners at (1) 3 months after intervention (OR ¼ 0.78, 95% CI ¼ 0.49–1.25); (2) 6 months after intervention (OR ¼ 0.68, 95% CI ¼ 0.40– 1.13); (2) 12 months after intervention (OR ¼ 0.77, 95% CI ¼ 0.42–1.41).
Sex, drug and biological outcomes
AIDS
Category
Table 1 (continued )
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Wolitski et al. [76], 2004–2007, MW, S, W
Chen et al. [30], 2005–2007, MW, NE, S, W
Coates et al. [33], NR, W
Cosio et al. [35], 2007– 2008, MW, NE, S, W
Grinstead et al. [41], 1996–1998, W
Rigorous non-EBI
Positive non-EBI
Positive non-EBI
Positive non-EBI
Positive non-EBI
Male prison inmates (123)
Rural & engaged in HIV transmission risk behavior (79)
Gay men (64)
Youth with medication adherence, substance abuse or sexual risk problems (142)
Homeless or at severe risk of homelessness (644)
Non-RCT, Waitlist
RCT, HIV demand control
RCT, Waitlist
RCT, Standard of care
RCT, HIV demand control
Health Promotion (8/20), Group
Telephone Motivational Interviewing (2/NR), Individual
Stress Reduction Training (9/NR), Group
Healthy Choices (4/6), Individual
Housing Assistance & HIV Prevention (case management þ 2 HIV sessions/1.25), Individual
(continued overleaf )
Sex outcome No significant effect on the percentage condom use at first sex since release (OR, 0.57; 95% CI, 0.18–1.80)b. Drug outcome Significant positive intervention effect: Among injectors, less likely to report needle sharing at postrelease (OR ¼ 0.11; 95% CI ¼ 0.03– 0.41)b. No significant effect on the percentage of participants injected drugs since release (48 vs. 48%, P value NR).
Sex outcome Significant positive intervention effect on the mean percentage of vaginal sex partners with whom condoms were used all the time at 2 months after intervention (27.1 vs. 22.5%, F ) ¼ 3.2, df ¼ 1,77, P < 0.05). No significant effect on the mean percentage of anal sex partners with whom condoms were used all the time at 2 months after intervention (20.1 vs. 19.4%, F value NR, P ¼ 0.35).
Sex outcome Significant positive intervention effect on the number of sex partners at postintervention (mean difference ¼ 1.20, 95% CI ¼ 0.14– 2.28, P value NR).
Sex outcome Significant positive intervention effects from baseline to 15-month assessment: (1) increased odds of persistent low sex risk (0–2 times no condom use during study period, OR ¼ 2.71, 95% CI ¼ 1.33–5.52, P < 0.01); (2) reduced odds of high sex risk (10 or more times no condom use during study period, OR ¼ 0.41, 95% CI ¼ 0.17– 0.99, P < 0.05).
Sex outcome No significant effects on TRB and other outcomes: (1) unprotected anal or vaginal TRB, condition by time (baseline, 6, 12, and 18 months) (F ¼ 0.28, df NR, P ¼ 0.84), (2) the number of partners, condition by time (baseline, 6, 12, and 18 months) (F ¼ 1.01, df NR, P ¼ 0.39).
Behavioral prevention for people living with HIV Crepaz et al.
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643
Lightfoot et al. [48], 2001–2006, W
Lovejoy et al. [49], 2009–2010, NE, MW, S
Margolin et al. [50], 1997–2001, NE
Mausbach et al. [52], 1999–2005, W
McCoy et al. [53], 1990–1992, S
Positive non-EBI
Positive non-EBI
Positive non-EBI
Positive non-EBI
Positive non-EBI
First author [citation number], study years, region
Injection drug users (140)
Meth-using MSM who engaged in HIV transmission risk behavior (341)
Injection drug users in methadone maintenance treatment (90)
Older adults who engaged in HIV transmission risk behavior (100)
HIV clinic patients (529)
HIV-positive subpopulation (baseline sample size)
RCT, Standard of care
RCT, Attention control
RCT, HIV demand control
RCT, Standard of care
RCT, Waitlist
Study design, comparison group
Case Management Services (on-going), Individual
EDGE (8/12), Individual
HHRPþ (48/minimum of 96), Group
Telephone-delivered Motivational Interviewing (4/3), Individual
MD4LIFE computerdelivered (11/2), Individual
Intervention name (# of sessions/ total hours), intervention level
Sex outcome No significant effect on the number of sex partner (multiple R ¼ 0.15, P value NR) and use of condoms (multiple R ¼ 0.38, P value NR) at 6 months after baseline. Drug outcome Significant intervention effect on the number of injecting partners at 6 months after baseline (multiple R ¼ .62, P < 0.01). No significant effect on injecting heroin and cocaine at 6 months after baseline (multiple R ¼ 0.40, P value NR).
Sex outcome Significant positive intervention effects: a greater (log) number of anal, oral and vaginal sex protected by a condom or oral dam at 5 months after intervention/8 months postbaseline (t ¼ 2.13, df ¼ 283, P ¼ 0.034) and at 9 months after intervention/12 months postbaseline (t ¼ 2.72, df ¼ 480, P ¼ 0.007). No significant effects: (1) (log) number of unprotected anal, oral, or vaginal sex (test results and P value NR); (2) ratio of total protected-to-total sex acts (test results and P value NR).
Sex and drug outcomes Significant positive intervention effect: less likely to engage in either unprotected sex or needle sharing or needle sharing 3 months after intervention (OR ¼ 2.96, 95% CI ¼ 1.05–8.36, P < 0.04).
Sex outcome Significant positive intervention effects: the fewer number of unprotected anal or vaginal sex at 3 months (OR ¼ 0.32, 95% CI ¼ 0.17–0.56)b and 6 months (OR ¼ 0.37, 95% CI ¼ 0.2–0.69)b after intervention.
Sex outcome Significant positive intervention effects on TRB over the 30-month postbaseline period: (1) decreased the number of TRB partners (t ¼ 2.79, df ¼ 1952, P ¼ 0.02); (2) decreased the number of unprotected anal or vaginal TRB (t ¼ 3.23, df ¼ 2029, P < 0.01).
Sex, drug and biological outcomes
AIDS
Category
Table 1 (continued )
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Petry et al. [57], 2003–2008, NE
Rose et al. [60], 2004–2006, W
Teti et al. [70], 2004–2008, NE
Wyatt et al. [77], NR, W
Cleary et al. [32], 1986–1989, NE
Coleman et al. [34], 2006–2007, NE
Positive non-EBI
Positive non-EBI
Positive non-EBI
Positive non-EBI
Other non-EBI
Other non-EBI
Older African–American MSM (60)
Recently diagnosed blood donors (271)
Women with histories of childhood sexual abuse (147)
Women (184)
HIV clinic patients who engaged in HIV transmission risk behavior(386)
Patients with cocaine or opioid use disorders (170)
RCT, Attention control
RCT, Standard of care
RCT, HIV demand control
RCT, HIV demand control
RCT, Standard of care
RCT, Attention control
Social Cognitive (4/8), Group
Cognitive Behavioral and Skills Training Support Group (6/9), Group
Enhance Sexual Health Intervention (11/1.5), Group
Protect and Respect (5/7.5), Group
HIV Intervention for Provider (ongoing), Individual
Contingency Management (24/24), Group
(continued overleaf )
Sex outcome No significant effects at 3 months after intervention: (1) reported consistent condom use (OR ¼ 2.04, 95% CI ¼ 0.48– 8.77, P ¼ 0.336); (2) had multiple sex partners (OR ¼ 1.43, 95% CI ¼ 0.35–5.79, P ¼ 0.062).
Sex outcome No significant effect on the percentage of participants reporting unprotected sex at 10.5 months after intervention (30.9 vs. 37.7%, P value NR).
Sex outcome Significant positive intervention effects: greater percentage of participants reporting vaginal sex protected by condom (OR ¼ 2.96, 95% CI NR, P ¼ 0.039, one-tailed).
Sex outcome Significant positive intervention effects: (1) greater odds of reporting condom use during anal or vaginal sex at 6 months (OR ¼ 17.13, 95% CI ¼ 2.96–99.10, P < 0.01) and at 18 months (OR ¼ 270.04, 95% CI ¼ 24.53–2971.94, P < 0.01) postbaseline.
Sex outcome Significant positive intervention effects: reduced number of sex partners (OR ¼ 0.49, 95% CI ¼ 0.26–0.92, P < 0.03) at 6 months postbaseline. No significant effects on TRB: (1) the number of TRB partners (OR ¼ 0.93, 95% CI ¼ 0.82–1.69, P ¼ 0.86); (2) unprotected anal or vaginal TRB (OR ¼ 1.44, 95% CI ¼ 0.90– 2.30, P ¼ 0.42).
Sex and drug outcomes Significant positive intervention effects: reduced scores on the HIV Risk Behavior Scale, including risky sex and drug use behaviors, between baseline and 6 months (F ¼ 4.75, df ¼ 1,133, P < 0.05) and baseline and 12 months (F ¼ 5.23, df ¼ 1,139, P < 0.05).
Behavioral prevention for people living with HIV Crepaz et al.
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645
Fogarty et al. [38], 1993–1996, S
Kelly et al. [46], 1991, MW
Lapinski et al. [47], NR, MW
Margolin et al. [51], NR, NE
Patterson et al. [56], 1996–2001, W
Schwarcz et al. [65], 2006–2010, W
Other non-EBI
Other non-EBI
Other non-EBI
Other non-EBI
Other non-EBI
Other non-EBI
First author [citation number], study years, region
MSM engaged in HIV transmission risk behavior (411)
Engaged in HIV transmission risk behavior (387)
Injection drug users in methadone maintenance treatment (38)
MSM (72)
Depressed Men (115)
Women (322)
HIV-positive subpopulation (baseline sample size)
RCT, HIV demand control
RCT, Attention control
Non-RCT, Standard of care
Non-RCT, HIV demand control
RCT, Standard of care
RCT, Standard of care
Study design, comparison group
Personalized Cognitive Counseling (2/2), Individual
Share Safer Sex (3/4.5), Individual
3-Sþ for HIVþ drug users (12/NR), Group
Prevention Options for Positives (6/9), Group
Support Group (8/12), Group
Women and Infants Demonstration Project (1–24/NR), Group
Intervention name (# of sessions/ total hours), intervention level
Sex outcome No significant effect on TRB: (1) mean number of unprotected anal TRB at the 12-month assessment (6 months after intervention; incident rate ratio: 0.48, 95% CI ¼ 0.121.84, P ¼ 0.34), (2) percentage of participants reporting unprotected anal TRB at 6 months after intervention (27.8 vs. 22.3%, P value NR).
Sex outcome Significant negative intervention effect on TRB at 8 months after intervention: intervention group reporting more unprotected anal, oral, and vaginal TRB (test result and P value NR). No significant effect on TRB at 12 months after intervention: the mean number of unprotected anal, oral, and vaginal TRB (OR ¼ 0.66; 95% CI ¼ 0.33–1.33)b. Biologic outcome No significant effect on the mean number of STDs (not defined) across 12 months after intervention (test results and P value NR).
Sex and drug outcomes No significant effect on the mean score of the Risk Assessment Battery assessing a range of drug- and sex-related HIV risk behaviors after intervention (0.03 vs. 0.03, P value NR).
Sex outcome No significant effect on the mean score of risk reduction index at 6 weeks after intervention (1.45 vs. 1.23, P value NR).
Sex outcome No significant effect on the mean number of unprotected insertive anal sex acts at 3 months after intervention (OR ¼ 0.92; 95% CI ¼ 0.35– 2.45, P value NR)b.
Sex outcome No significant effects: (1) the odds of progressing in use of condoms with main male partner at 6–12 months (OR ¼ 1.95, P ¼ .19) and at 12–18 months (OR ¼ 2.13, P ¼ 0.13) postbaseline; (2) the odds of relapsing in use of condoms with main male partner at 6–12 months (OR ¼ 0.38, P ¼ 0.10) and at 12–18 months (OR ¼ 0.47, P ¼ 0.15) postbaseline.
Sex, drug and biological outcomes
AIDS
Category
Table 1 (continued )
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Sikkema et al. [68], 2006–2008, NE
Williams et al. [72], 2003–2006, W
Other non-EBI
Other non-EBI
African–American, Latino MSM (137)
Newly diagnosed bisexual/ gay men in care (65)
MSM (77)
RCT, Attention control
RCT, Standard of care
RCT, Waitlist
Sexual Health Intervention for Men (S-HIM) (6/12), Group
Positive Choices (3/3), Individual
HIV-related Disclosure (4/5), Group
Sex outcome No significant effects: (1) the score of sex risk behavior scale, including oral, anal or vaginal sex (F ¼ 1.15, df ¼ 3,130, P ¼ 0.33, condition by time interaction), (2) the number of sex partners (F < 1.00, df ¼ 3,129, P value NR, condition by time interaction).
Sex outcome No significant effects at 3 months after intervention/6 months postbaseline: (1) unprotected anal or vaginal sex acts with any partners (OR ¼ 0.54, 95% CI ¼ 0.21– 1.38)b; (2) the number of sex partners (OR ¼ 0.72, 95% CI ¼ 0.28–1.82)b. Biologic outcome No significant effect on STDs symptoms (not defined) at 3 months after intervention (24.1 vs. 28.6%, P value NR).
Sex outcome Statistically significant negative intervention effect: intervention group had a greater odds of unprotected insertive anal sex at 3 months after intervention (OR ¼ 2.54, 95% CI NR, P < 0.05). No significant effect on the odds of unprotected receptive anal sex at 2 months after intervention (OR ¼ 1.55, 95% CI and P value NR).
Category: EBI ¼ evidence-based interventions show at least one significant positive intervention effect and have low risk of bias in study design, implementation, and analysis; Rigorous nonEBI ¼ interventions show no significant positive intervention effects but have low risk of bias; Positive non-EBI ¼ interventions show at least one significant positive intervention effect but have high risk of bias; Other non-EBI ¼ interventions show no significant positive intervention effect and have high risk of bias. Region: NE ¼ northeast; MW ¼ midwest; S ¼ south; W ¼ west. NR, not reported; TRB, HIV transmission risk behavior defined as unprotected sex with HIV-negative or serostatus unknown partners. a Additional info obtained from authors. b OR calculated based on descriptive data reported or provided by author.
Serovich et al. [66], 2005–2006, MW
Other non-EBI
Biologic outcome No significant effect on the laboratoryconfirmed diagnosis of STD (gonorrhea or Chlamydia; test results and P value NR).
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studies that measured STD (laboratory confirmed or doctor’s diagnosis) showed a significant positive intervention effect.
Classification of evidence-based interventions and nonevidence-based interventions based on the risk of bias and significant positive intervention effects Of the 48 included studies, 24 interventions (50%) had low risk of bias. Among these, 14 were EBIs that also showed significant positive intervention effects [31,36,37, 39,40,44,45,54,59,62,63,67,74,75] and the other 10 interventions were rigorous non-EBIs [42,43,55,58,61, 69,71,73,76]. Twenty-four interventions had high risk of bias, including 13 positive non-EBIs [30,33,35,41,48– 50,52,53,57,60,70,77] and 11 other non-EBIs [32,34,38, 46,47,51,56,65,66,68,72]. Eighteen positive and other non-EBIs (75%) had multiple sources of bias. The common sources of bias included analytic sample sizes less than 40 per arm, less than a 60% retention rate of study participants per arm, greater than 10% differential attrition between arms, substantial missing data, not conducting intent-to-treat analysis, or significant negative findings. Another way of looking at the breakdown of 34 non-EBIs is that 21 interventions (61%) did not find any significant positive intervention effects. Comparisons between evidence-based interventions and rigorous nonevidence-based interventions Table 2 and Table 3 show comparisons between EBIs and rigorous non-EBIs. The two groups were similar in terms of target populations (i.e. MSM, those who engaged in HIV transmission risk), sample characteristics (i.e. race/ ethnicity, gender, age), reporting of power analysis and theories, use of audio computer-assisted self-administered interview (ACASI) for data collection, several intervention components (i.e. self-efficacy, skills building, serostatus disclosure, social support, personalized risk reduction plan, personal responsibility, normative influence, intimate partner violence), and type of outcomes reported (e.g. TRB, unprotected sex behavior, injection drug use, or needle sharing). Despite the similarities, EBIs and rigorous non-EBIs differed in a few ways. More EBIs than rigorous non-EBIs were evaluated in the earlier HAART era (1996–2003), carried out at multiple study locations, targeted clinic patients, delivered to individuals, conducted in healthcare settings, used standard of care or non-HIV attention controls (defined as receiving non-HIV intervention such as general health promotion that matched length and doses of HIV intervention) as comparison groups. There was a higher percentage of EBIs than non-EBIs that addressed the following intervention components: discussing HIV risk reduction, promoting motivation for behavioral change, addressing misperception about HIV, reducing negative effect such as depression or anxiety,
enhancing medication adherence, and conducting risk screening to guide prevention messages. In contrast, more rigorous non-EBIs were conducted in the later-ARTera, targeted substance users, used HIV demand controls as comparisons (defined as participants in the comparison group who were aware that the intervention they received was intended to change their sex or drug risk behaviors), and had three to 12 intervention sessions over a period of 1–3 months.
Comparison between evidence-based interventions and positive nonevidence-based interventions There were several similarities between EBIs and positive non-EBIs. Comparable percentages of EBIs and positive non-EBIs were observed on the following: intervention level (i.e. individual, group, couple), intervention intensity and time span, and some intervention components (e.g. building skills and self-efficacy, conducting risk screening to guide personalized prevention messages, working with participants on personalized risk-reduction plans, emphasizing personal responsibility to take care of one’s and partner’s health, and addressing medication adherence issues). However, positive non-EBIs were more likely to be small-scale studies conducted with subgroups of PLWH (e.g. rural areas, depressed MSM, meth-using MSM, injection drug users, substance users, women) compared to EBIs. Positive non-EBIs were less often conducted as multisite studies and in healthcare settings or community-based establishments in contrast to EBIs. Positive non-EBIs were also less likely than EBIs to use non-HIV attention controls, use ACASI for data collection, report theories, and report and show positive intervention effects on TRB. Highlights of evidence-based interventions While the comparisons between EBIs and two non-EBIs groups (i.e. rigorous and positive) can inform research gaps and future intervention development, a closer examination of the EBIs can provide helpful direction for providers in healthcare and nonhealthcare settings in selecting model programs suitable for their target populations. More than half of EBIs targeted HIV clinic patients [37,39,40,54,59,62,74], but none targeted newly diagnosed PLWH. Six EBIs targeted specific subgroups of PLWH: MSM [54,75], heterosexual African–American discordant couples [36], substance using youth and young adults [63], women [74], and PLWH with a history of childhood sexual abuse [67]. All 14 EBIs had greater than 50% ethnic minority participants (range: 53–100%), seven of which included a majority of African–Americans. The key components of EBIs included addressing HIV riskreduction behaviors, motivation for behavioral change, misconception about HIV, and issues related to mental health, medication adherence, and HIV TRB. A variety of intervention delivery methods, ranging from brief prevention messages delivered during regular HIV
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Behavioral prevention for people living with HIV Crepaz et al. Table 2. Percentages and medians of select characteristics of evidence-based interventions and nonevidence-based interventions. Non-EBIs by type All interventions k (%) Total (% of total) Conducted Pre-ART (1988– 1995) Early ART (1996–2003) Later ART (2004–2012) >1 Study site No significant positive findings Sources of bias Small sample size Retention Differential attrition Other limitations (missing data, etc.) Follow-up Allocation method Intent-to-treat analysis Negative intervention effect Target groupsa Clinic patients MSM Engaged in HIV transmission risky Substance use Female African–American Depressed or childhood abuse Younger age (13–25 years) Older age group (>45 years) Newly diagnosed Substance using MSM Male prison inmate Homeless Rural residents Sample characteristics (median)a Black Latino White Male Female Average age (years) Comparison group Standard of care or waitlist Non-HIV attention controlL HIV demand controly Power analysis reported Used ACASI for data collection Theory reported Intervention settinga Healthcareb Community-based establishment6¼ Public area^ Commericalþ Intervention level Individual Group Couple Deliverera,f Professional Counselor or health educator Healthcare worker Peer Computer-based Intervention componentsa Skills building HIV risk reductiont Motivation Self-efficacy Serostatus disclosure Social support
EBIs k (%)
Non-EBIs k (%)
Rigorous k (%)
48
14 (29%)
34 (71%)
10 (21%)
6 24 18 20 21
(13%) (50%) (38%) (42%) (44%)
0 11 3 10 0
(0%) (79%)a,d (21%)b (71%)b,d (0%)a
6 13 15 10 21
(18%) (38%) (44%) (29%) (62%)
1 3 6 5 10
16 9 8 7 5 2 2 2
(33%) (19%) (17%) (15%) (10%) (4%) (4%) (4%)
0 0 0 0 0 0 0 0
(0%)c (0%)c (0%)d (0%)c (0%)c (0%) (0%) (0%)
16 9 8 7 5 2 2 2
(47%) (26%) (24%) (21%) (15%) (6%) (6%) (6%)
17 13 11 10 5 4 4 3 3 3 2 1 1 1
(35%) (27%) (23%) (21%) (10%) (8%) (8%) (6%) (6%) (6%) (4%) (2%) (2%) (2%)
7 2 3 1 1 1 1 2 0 0 0 0 0 0
(50%)b (14%) (21%) (7%)b,d (7%) (7%) (7%) (14%) (0%) (0%) (0%) (0%) (0%) (0%)
10 11 8 9 4 3 3 1 3 3 3 1 1 1
(29%) (32%) (24%) (26%) (12%) (9%) (9%) (3%) (9%) (9%) (9%) (3%) (3%) (3%)
50% 15% 23% 72% 27%
48% 17% 22% 71% 28% 42
Positive k (%)
Other k (%)
13 (27%)
11 (23%)
(10%) (30%)a (60%)b (50%)b (100%)a
2 6 5 5 0
(15%) (46%)d (38%) (38%)d (0%)
3 4 4 0 11
(27%) (36%) (36%) (0%) (100%)
0 0 0 0 0 0 0 0
(0%) (0%) (0%) (0%) (0%) (0%) (0%) (0%)
8 4 3 5 4 0 0 0
(62%)c (31%)c (23%)d (38%)c (31%)c (0%) (0%) (0%)
8 5 5 2 1 2 2 2
(73%) (45%) (45%) (18%) (9%) (18%) (18%) (18%)
3 3 2 4 1 1 0 0 1 1 1 0 1 0
(30%)b (30%) (20%) (40%)b (10%) (10%) (0%) (0%) (10%) (10%) (10%) (0%) (10%) (0%)
5 2 4 4 2 0 1 1 1 0 1 1 0 1
(38%) (15%) (31%) (31%)d (15%) (0%) (8%) (8%) (8%) (0%) (8%) (8%) (0%) (8%)
2 6 2 1 1 2 2 0 1 2 1 0 0 0
(18%) (55%) (18%) (9%) (9%) (18%) (18%) (0%) (9%) (18%) (9%) (0%) (0%) (0%)
54% 13% 32% 78% 27% 41
63% 12% 9% 70% 29% 42
51% 14% 23% 70% 37% 41
37% 13% 49% 100% 36% 39
20 12 16 20 20 42
(42%) (25%) (33%) (42%) (42%) (88%)
6 6 2 8 9 14
(43%)b (43%)b,d (14%)a (57%) (64%)d (100%)d
14 6 14 12 11 28
(41%) (18%) (41%) (35%) (32%) (82%)
2 1 7 5 6 9
(20%)b (10%)b (70%)a (50%) (60%) (90%)
7 2 4 5 3 10
(54%) (15%)d (31%) (38%) (23%)d (77%)d
5 3 3 2 2 9
(45%) (27%) (27%) (18%) (18%) (82%)
24 11 4 2
(50%) (23%) (8%) (4%)
10 5 2 1
(71%)b,d (36%) (14%) (7%)
14 6 2 1
(41%) (18%) (6%) (3%)
5 2 0 0
(50%)b (20%) (0%) (0%)
5 1 2 0
(38%)d (8%) (15) (0%)
4 3 0 1
(36%) (27%) (0%) (9%)
21 (44%) 26 (54%) 1 (2%)
7 (50%)b 6 (43%)b 1 (7%)
28 19 9 13 2
(58%) (40%) (19%) (27%) (4%)
7 4 3 4 1
32 31 29 27 23 21
(67%) (65%) (60%) (56%) (48%) (44%)
9 12 11 8 9 8
14 (41%) 20 (59%) 0 (0%)
(50%)d (29%)d (21%) (29%) (7%)
21 15 6 9 1
(62%) (44%) (18%) (26%) (3%)
(64%) (86%)a,d (79%)b,d (57%) (64%)d (57%)
23 19 18 19 14 13
(68%) (56%) (53%) (56%) (41%) (38%)
3 (30%)b 7 (70%)b 0 (0%) 4 (40%) 3 (30%) 1 (10%) 3 (30%) 0 (0%) 6 4 5 6 5 4
(60%) (40%)a (50%)b (60%) (50%) (40%)
7 (54%) 6 (46%) 0 (0%)
4 (36%) 7 (64%) 0 (0%)
10 (77%)d 8 (62%)d 3 (23%) 3 (23%) 1 (8%)
8 (73%) 6 (55%) 2 (18%) 3 (27%) 0 (0%)
8 8 6 7 4 5
(62%) (62%)d (46%)d (54%) (31%)d (38%)
9 7 7 6 5 4
(82%) (64%) (64%) (55%) (45%) (36%)
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Table 2 (continued ) Non-EBIs by type All interventions k (%) Personalized risk-reduction plan Misperception about HIV Personal responsibility Depression and anxiety Risk screening Medication adherence Normative influencee Intimate partner violence Intervention intensity 1–2 sessions 3–10 sessions >10 sessions Intervention time span 1–3 months >3 months
21 16 16 15 12 10 9 4
(44%) (33%) (33%) (31%) (25%) (21%) (19%) (8%)
8 8 5 7 5 5 4 1
EBIs k (%)
Non-EBIs k (%)
Rigorous k (%)
Positive k (%)
(57%) (57%)b,c (36%) (50%)b,d (36%)b (36%)b (29%)d (7%)
13 8 11 8 7 5 5 3
4 3 2 3 1 1 2 1
6 2 6 1 5 3 0 2
(38%) (24%) (32%) (24%) (21%) (15%) (15%) (9%)
(40%) (30%)b (20%) (30%)b (10%)b (10%)b (20%) (10%)
(46%) (15%)c (46%) (8%)d (38%) (23%) (0%)d (15%)
Other k (%) 3 3 3 4 1 1 3 0
(27%) (27%) (27%) (36%) (9%) (9%) (27%) (0%)
6 (13%) 30 (63%) 12 (25%)
2 (14%) 8 (57%)b 4 (29%)
4 (12%) 22 (65%) 8 (24%)
1 (10%) 8 (80%)b 1 (10%)
2 (15%) 6 (46%) 5 (38%)
1 (9%) 8 (73%) 2 (18%)
33 (69%) 15 (31%)
7 (50%)a 7 (50%)
26 (76%) 8 (24%)
9 (90%)a 1 (10%)
8 (62%) 5 (38%)
9 (82%) 2 (18%)
k ¼ the number of interventions. EBI ¼ evidence-based interventions show at least one significant positive intervention effect and have low risk of bias in study design, implementation and analysis. Rigorous non-EBI ¼ interventions show no significant positive intervention effects, but have low risk of bias in study design, implementation and analysis. Positive non-EBI ¼ interventions show at least one significant positive intervention effect, but have high risk of bias in study design, implementation and analysis. Other non-EBI ¼ interventions show no significant positive intervention effect and have high risk of bias in study design, implementation and analysis. ACASI, audio computer-assisted self-administered interview. a Significant Fisher’s exact test between EBIs and rigorous non-EBIs (P
