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AIDS:
doi: 10.1097/QAD.0000000000000108
Editorial Reviews

A systematic review of interventions for reducing HIV risk behaviors among people living with HIV in the United States, 1988–2012

Crepaz, Nicolea; Tungol-Ashmon, Malu V.a; Higa, Darrel H.a; Vosburgh, Waverlya; Mullins, Mary M.a; Barham, Terrikab; Adegbite, Adebukolab; DeLuca, Julia B.a; Sipe, Theresa A.a; White, Christina M.b; Baack, Brittney N.a; Lyles, Cynthia M.a

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Author Information

aPrevention Research Branch, Division of HIV/AIDS Prevention, The U.S. Centers for Disease Control and Prevention

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: ncrepaz@cdc.gov

Received 31 May, 2013

Revised 7 October, 2013

Accepted 7 October, 2013

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (http://www.AIDSonline.com).

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Abstract

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 HIV epidemic.

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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 evidence-based 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.

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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 (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 HIV-negative 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, two-sided, on Fisher's exact tests or if the P value approached 0.10 or percentage differences between the groups were 20% or more.

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Results

As of December 2012, PRS evaluated 405 US-based risk-reduction interventions that were evaluated with a comparison group (Fig. 1). Although PLWH comprise an important group in the HIV prevention effort, only 49 of 405 (12%) HIV prevention studies conducted in the United States met inclusion criteria and were specifically designed for this group. One pilot study [29] was excluded as the full-scale efficacy trial [30] was later published.

Fig. 1
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Overall characteristics of interventions for people living with HIV in the United States

Table 1 provides brief descriptive characteristics of the 48 included interventions [30–77] and Table 2 provides a summary of the characteristics across interventions. Among 48 studies, the majority of the studies were conducted in earlier HAART era (1996–2003) and later HAART era (2004–2012). Forty-three studies (90%) were randomized control trials (RCTs). Regionally, most interventions were carried out in the west, followed by the northeast and south. The fewest interventions were conducted in the midwest. Not surprisingly, most of the studies were conducted in urban settings, such as Atlanta, Baltimore, Boston, Chicago, Houston, Los Angeles, Miami, Milwaukee, New York City, Philadelphia, San Francisco, and Washington DC, except one study that was conducted by phone in rural areas of 27 states.

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The most commonly targeted groups were clinic patients [30,37–40,43,48,54,59,60,62,64,65,68–70,74], followed by MSM [33,34,47,52,54,61,64–66,68,71,72,75] and PLWH who engaged in TRB [31,35,36,49,52,56,60,61,64,65,75]. Another frequently targeted group was substance-abusing PLWH, including injection drug users [50,53,58], general drug users [51,63,69], substance-using MSM [52,71], methamphetamine users [52], cocaine users [57], crack users [73], and alcohol abusers [71]. Fewer studies specifically targeted the following subgroups of PLWH: women [38,42,70,74,77], African–Americans [34,36,72,73], persons with depression or a history of childhood abuse [46,67,77], younger age groups (13–29 years) [30,62,63], older adults (45 years and older) [34,43,49], newly HIV-diagnosed persons [32,55,68], male prison inmates [41], and persons who were homeless or at risk of homelessness [76].

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The majority of the studies (88%) reported the theoretical principles used in designing the interventions. The most commonly used theories included Social Cognitive Theory [78], Information Motivation and Behavioral Skills (IMB) model [79,80], Theory of Reasoned Action, Social Action Theory [81], Motivational Interviewing [82], Transtheoretical Model of Stage of Change [83], and Theory of Gender and Power [84]. Half of the interventions were conducted in healthcare settings, such as HIV outpatient clinics, community health centers, hospitals, or methadone treatment clinics. More than half of the interventions were delivered by professionals such as healthcare providers (19%), counselors, or health educators (40%). Some were delivered by peers (27%). Two were computer-delivered interventions using interactive video doctors [39,48]. The majority of the interventions consisted of three to 10 sessions (63%) and lasted 1–3 months (69%). The median time per session was 90 min, ranging from 3–5 min to 3 h.

The most commonly reported outcomes (see Table 3) were TRB (21 studies) and unprotected sex behavior (partner serostatus not reported, 33 studies). About half of the studies that reported these two outcomes showed significant positive intervention effects (12 and 16 studies, respectively). There were fewer studies that reported injection drug use or needle sharing behaviors (five studies). Additional three studies combined sex and drug behavior in a risk index. About half of these studies showed significant positive intervention effects. All the sex and drug use behaviors were based on self-report. Regarding biologic outcomes, only one study out of six studies that measured STD (laboratory confirmed or doctor's diagnosis) showed a significant positive intervention effect.

Table 3
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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.

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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-ART era, 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.

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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.

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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 risk-reduction 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 care visits to intensive multisession interventions over several weeks or months, were shown to be successful in reducing TRB as well as unprotected sex with any sex partners. Three EBIs were brief interventions. In one intervention, the healthcare provider delivered 3–5-min prevention messages that focused on self-protection, partner protection, and disclosure. Posters and patient education brochures in the clinics reinforced provider-delivered prevention messages [59]. Another intervention used clinicians to deliver the 5–10-min tailored prevention message based on risk screening information that patients provided [37]. In the third intervention, patients completed a computer-based risk assessment and then viewed a 24-min video clip in which an actor-portrayed physician delivered risk-reduction messages tailored to the patient's unique risks. At the conclusion of the video section, patients received an educational worksheet for self-reflection, harm reduction tips, and local resources and clinicians received a cueing sheet that summarized patient's risk profile and suggested counseling statements [39].

Intensive behavioral risk-reduction interventions (defined as multiple sessions over weeks and months with a median of 90 min per session) in healthcare [40,54,62,74] and nonhealthcare settings [31,36,44,45,63,67,75] can also lead to reductions in risky sexual behaviors among PLWH. In 11 EBIs, peer educators [44,54,74,75] or health educators/counselors [31,36,40,45,62,63,67] provided multisession interventions to individual PLWH [31,40,54,63], small groups of adult PLWH [44,45,62,67,74,75], or discordant couples with HIV [36] with varied demographic characteristics. Interactive sessions focused on many topics such as coping with an HIV diagnosis, addressing serostatus disclosure, building condom use skills, negotiating safe sex behaviors, avoiding risky drug use, or medication adherence. Participants of all 11 EBIs were significantly less likely to report TRB or unprotected sex with any partners at some point within 3–12 months after interventions.

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Discussion

Given the importance of reducing risk behaviors among PLWH for preventing new HIV infection and STDs, it is encouraging to have identified 14 EBIs that had low risk of bias and showed significant positive intervention effects on reducing HIV risk behavior, especially for reducing TRB. These interventions can serve as model programs for providers in healthcare and nonhealthcare settings seeking EBIs best suited for their target populations.

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Brief interventions in healthcare settings

The healthcare setting affords a great opportunity to integrate behavioral prevention with routine medical care and address behavior change over time. Consistent with a previous meta-analysis [8], we found two EBIs that showed brief prevention counseling messages (e.g. 3–10 min) delivered by healthcare providers during routine HIV care visits can lead to significant reductions in HIV transmission risk among PLWH. This brief provider-delivered risk-reduction approach has been implemented and evaluated in two large-scale demonstration projects [85,86]. Both studies showed the feasibility of conducting brief provider-delivered risk-reduction interventions in busy healthcare settings and the effectiveness of this approach in reducing HIV TRBs of PLWH. On the basis of body of evidence, the brief provider-delivered risk-reduction intervention during HIV patient's routine care visits has been recommended and currently promoted to be standard of HIV clinic care by CDC (i.e. Prevention IS Care [87]).

The importance of clinic provider's role in facilitating healthier behaviors of patients is not new. However, evidence suggests that providers are not consistently talking to patients about safer sex, injection drug use, and HIV prevention methods. Approximately, 23–29% of HIV patients reported that their providers have never talked to them about safer sex [88,89]. The data on provider-patient communication in the most recent HIV primary care visit showed that 65% of HIV-seropositive injection drug users reported having discussed HIV prevention with their provider [90] and 53% of Ryan White CARE Act patients from nine states reported having discussed safer sex and HIV prevention methods with their providers [91]. These percentages are similar to the percentages reported by healthcare providers [92]. Studies also showed that providers were more likely to provide prevention counseling to new patients rather than established patients [92,93]. These findings highlight considerable room to increase the delivery of brief prevention counseling by providers during routine HIV care visits, especially among returning patients.

Published studies in the literature indicate several common barriers to providing risk screening and risk-reduction interventions in healthcare settings, including lack of time, competing priorities, limited staffing, providers’ lack of risk-reduction counseling skills, discomfort with talking about risk behaviors, and the belief that interventions will not change behavior [91,92,94–98]. However, evidence suggests that training on brief risk screening methods requires minimal time and training on brief risk-reduction interventions enhances the provider's comfort, skill, efficiency, and motivation [60,93,95,98]. Providers are more likely to engage in risk-reduction prevention counseling if other providers in the same clinics are also providing prevention counseling. Additionally, providers who agree that risk-reduction prevention is part of the clinic's mission are more likely to conduct counseling to HIV patients [93]. Innovative approaches are needed to prepare and support providers for delivering more consistent risk-reduction interventions to their HIV patients. Some approaches to consider include integrating behavioral prevention into the clinic mission, providing training to enhance the provider's ability, motivation, and comfort to deliver brief preventions, reimbursing counseling time, and educating medical students about HIV prevention.

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More intensive, multisession interventions in healthcare and nonhealthcare settings

Our systematic review also found that longer and multisession HIV interventions are efficacious in changing HIV TRBs of PLWH. The feasibility of delivering interventions with multiple sessions over time is not clear, especially in busy clinic facilities. However, these interventions are not without merit because some PLWH require additional help to address multiple interconnected factors (e.g., substance use, depression, childhood sexual abuse, interpersonal and partner dynamics) underlying their risk behaviors. Several intensive EBIs are successful in reducing risk behaviors among PLWH at high risk of transmitting HIV. Referrals for evidence-based, multisession risk-reduction interventions for PLWH who report high levels of risk or continue risk behaviors may be a beneficial component of comprehensive HIV prevention efforts at the clinic/agency, state, and federal levels. Creating directories of local clinics or agencies that offer evidence-based, intensive risk-reduction interventions, facilitating the collaboration between clinic and community providers, and establishing policies and procedures regarding patient's referrals to intensive interventions can also be helpful to ensure the services are in place as needed [99].

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Considerations for future interventions for people living with HIV

Although our review identified several EBIs for healthcare and nonhealthcare settings, the dissemination of the interventions remains limited, as these settings often do not have the human or financial resources to devote to interventions. One potential solution is the use of new technologies. Computer-based interventions are shown to be efficacious in increasing condom use and reducing sexual activity, numbers of sexual partners, and incident STD [100]. The advantages include greater intervention fidelity, lower delivery costs, and greater flexibility in dissemination channels such as in person, by mail, on the web, and through cell phones [100]. Several computer-based interventions that address HIV risk behavior as well as medication adherence and other issues (e.g. retention, treatment readiness) for PLWH are on the way (e.g. CDC and NIH-funded comprehensive prevention with positives project, CDC-funded Computer-Based Interactive Screening and Counseling Tool, CBISCT). More research is needed to explore the best way to incorporate new technologies to deliver HIV behavioral interventions that address the prevention needs of PLWH.

Several identified differences and similarities between EBIs and the two groups of non-EBIs (i.e. rigorous and positive) can inform the design and testing of future behavioral interventions for PLWH. EBIs tended to target HIV clinic patients, whereas more of the two non-EBI groups targeted specific high-risk populations (e.g. substance-using MSM, IDUs, substance abusers, sexual actively older adults, inmates, homeless) or understudied populations (e.g. rural residents, newly diagnosed).

When comparing EBIs and rigorous non-EBIs, there were many more similarities than differences in study design, implementation and analysis, outcome measures, and intervention components. One unique difference is that EBIs were more likely to use standard of care or non-HIV attention controls and less likely to use HIV demand controls. For HIV-related comparison groups, using variations of the interventions as comparison groups may greatly reduce the ability to detect intervention effects [101]. Using a standardized comparison arm that the HIV prevention field could agree upon as a prevention standard can facilitate comparing intervention effects across studies.

Unsurprisingly, when comparing EBIs and positive non-EBIs, there were obvious differences in the sources of bias. More positive non-EBIs than EBIs were small sample size studies intended as pilot studies to test the feasibility of the intervention implementation. Several of non-EBIs also suffered from substantial attrition, differential retention, and missing data issues. While positive non-EBIs showed at least one significant positive finding on sex or injection drug use outcomes, few reported and found significant positive findings on TRB. Positive non-EBIs are good candidates for further evaluation and they should be evaluated with more rigorous methods that reduce the risk of bias in study design, implementation, and analysis and that measure HIV TRB.

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Limitations

The findings of our review must be viewed within the context of the limitations of the available evidence. First, although the majority of the studies were RCTs, many were unblinded and relied on self-reported sexual behavior, which may open to social desirability bias [102]. Given that blinded trials are not feasible in HIV behavioral prevention research, future intervention trials should consider complementing self-reported behavioral measures with biologic outcomes such as STD to assess intervention efficacy [103]. There were very few studies in the current literature that measured both behavioral and biologic outcomes. Second, although the majority of EBIs demonstrated significant positive intervention effects on reducing unprotected sex with HIV-negative and serostatus unknown partners, it is unclear how the observed behavioral changes may translate into averted new infections. Many factors such as individual's viral load level, type of sex acts, and presence of other STDs may affect the probability of new HIV transmission. Although the complexity of the multiple influencing factors that could affect HIV transmission potential makes it impossible to estimate the number of new infections averted by the interventions reviewed here, our findings showed that some interventions are more successful than others in promoting positive behavior changes that are important factors in HIV transmission risk.

In addition, there are several limitations specific to this review that merit consideration when interpreting the findings. First, we classified all the US-based interventions for PLWH into EBIs vs. non-EBIs based on the risk of bias and evidence of positive intervention effects. Although this classification approach is intended to identify model programs, it differs from meta-analytic approaches, which provide the overall estimate of the intervention effects. Second, although we contacted primary investigators to confirm our evaluation of the risk of bias and intervention effects, the coding of study and intervention characteristics are based on published reports that may not provide complete information about the intervention. Third, our review relied on the published literature and our findings might be susceptible to publication bias. Fourth, although we observed some patterns that may explain differences among EBIs and non-EBIs, there are multiple factors that may contribute to an intervention's lack of evidence and it is difficult to disentangle a specific reason or combination of reasons.

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Conclusion

Despite these limitations, our findings offer several implications for research and HIV prevention. Moving evidence-based prevention for PLWH into practice is an important step in making a greater impact on the HIV epidemic. Our systematic review identified several EBIs that can serve as model programs for providers in healthcare and nonhealthcare settings who are looking to implement EBIs best suited for the populations they serve. The differences between EBIs and non-EBIs identified in this review point out that more EBIs are needed for the subgroups of PLWH such as substance-using MSM, injection drug users, sexually active older adults, inmates, homeless persons, rural residents, and newly diagnosed persons. Healthcare settings in which PLWH receive routine HIV medical care and other services continue to be an ideal setting to deliver behavioral interventions. 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 HIV epidemic.

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Acknowledgements

N.C. conceptualized the review, analyzed and interpreted the data, and wrote the article. M.M.M. and J.D. undertook the comprehensive literature search. All authors did coding, provided technical and material support, and were involved in article review and editing. N.C. has full access to all the data and takes responsibility for the integrity of the data and the accuracy of the data analysis.

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the US Centers for Disease Control and Prevention.

This work was supported by the Prevention Research Branch, Division of HIV/AIDS Prevention at the US Centers for Disease Control and Prevention and was not funded by any other organization.

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Conflicts of interest

There are no conflicts of interest.

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Keywords:

evidence-based intervention; HIV prevention; people living with HIV; risk reduction; systematic review

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