Johnson Wayne D, Diaz Rafael M, Flanders William D, Goodman Michael, Hill Andrew N, Holtgrave David, Malow Robert, McClellan William M
Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Mailstop E-37, 1600 Clifton Road NE, Atlanta, GA 30333, USA.
Cochrane Database Syst Rev. 2008 Jul 16(3):CD001230. doi: 10.1002/14651858.CD001230.pub2.
Men who have sex with men (MSM) remain at great risk for HIV infection. Program planners and policy makers need descriptions of interventions and quantitative estimates of intervention effects to make informed decisions concerning prevention funding and research. The number of intervention strategies for MSM that have been examined with strong research designs has increased substantially in the past few years.
We searched electronic databases, current journals, manuscripts submitted by researchers, bibliographies of relevant articles, conference proceedings, and other reviews for published and unpublished reports from 1988 through December 2007. We also asked researchers working in HIV prevention about new and ongoing studies.
Studies were considered in scope if they examined the effects of behavioral interventions aimed at reducing risk for HIV or STD transmission among MSM. We reviewed studies in scope for criteria of outcome relevance (measurement of at least one of a list of behavioral or biologic outcomes, e.g., unprotected sex or incidence of HIV infections) and methodologic rigor (randomized controlled trials or certain strong quasi-experimental designs with comparison groups).
We used fixed and random effects models to summarize rate ratios (RR) comparing intervention and control groups with respect to count outcomes (number of occasions of or partners for unprotected anal sex), and corresponding prevalence ratios (PR) for dichotomous outcomes (any unprotected anal sex vs. none). We used published formulas to convert effect sizes and their variances for count and dichotomous outcomes where necessary. We accounted for intraclass correlation (ICC) in community-level studies and adjusted for baseline conditions in all studies. We present separate results by intervention format (small group, individual, or community-level) and by type of intervention delivered to the comparison group (minimal or no HIV prevention in the comparison condition versus standard or other HIV prevention in the comparison condition). We examine rate ratios stratified according to characteristics of participants, design, implementation, and intervention content. For small group and individual-level interventions we used a stepwise selection process to identify a multivariable model of predictors of reduction in occasions of or partners for unprotected anal sex. We used funnel plots to examine publication bias, and Q (a chi-squared statistic with degrees of freedom = number of interventions minus 1) to test for heterogeneity.
We found 44 studies evaluating 58 interventions with 18,585 participants. Formats included 26 small group interventions, 21 individual-level interventions, and 11 community-level interventions. Sixteen of the 58 interventions focused on HIV-positives. The 40 interventions that were measured against minimal to no HIV prevention intervention reduced occasions of or partners for unprotected anal sex by 27% (95% confidence interval [CI] = 15% to 37%). The other 18 interventions reduced unprotected anal sex by 17% beyond changes observed in standard or other interventions (CI = 5% to 27%). Intervention effects were statistically homogeneous, and no independent variable was statistically significantly associated with intervention effects at alpha=.05. However, a multivariable model selected by backward stepwise elimination identified four study characteristics associated with reduction in occasions of or partners for unprotected anal sex among small group and individual-level interventions at alpha=.10. The most favorable reductions in episodes of or partners for unprotected anal sex (33% to 35% decreases) were observed among studies with count outcomes, those with shorter intervention spans (<=1 month), those with better retention in the intervention condition than in the comparison condition, and those with minimal to no HIV prevention intervention delivered to the comparison condition. Because there were only 11 community-level studies we did not search for a multivariable model for community-level interventions. In stratified analyses including only one variable at a time, the greatest reductions (40% to 54% decreases) in number of episodes of or partners for unprotected anal sex among community-level interventions were observed among studies where groups were assigned randomly rather than by convenience, studies with shorter recall periods and longer follow-up, studies with more than 25% non-gay identifying MSM, studies in which at least 90% of participants were white, and studies in which the intervention addressed development of personal skills.
AUTHORS' CONCLUSIONS: Behavioral interventions reduce self-reported unprotected anal sex among MSM. These results indicate that HIV prevention for this population can work and should be supported. Results of previous studies provide a benchmark for expectations in new studies. Meta-analysis can inform future design and implementation in terms of sample size, target populations, settings, goals for process measures, and intervention content. When effects differ by design variables, which are deliberately selected and planned, awareness of these characteristics may be beneficial to future designs. Researchers designing future small group and individual-level studies should keep in mind that to date, effects of the greatest magnitude have been observed in studies that used count outcomes and a shorter intervention span (up to 1 month). Among small group and individual-level studies, effects were also greatest when the comparison condition included minimal to no HIV prevention content. Nevertheless, statistically significant favorable effects were also seen when the comparison condition included standard or other HIV prevention content. Researchers choosing the latter option for new studies should plan for larger sample sizes based on the smaller expected net intervention effect noted above. When effects differ by implementation variables, which become evident as the study is conducted but are not usually selected or planned, caution may be advised so that future studies can reduce bias. Because intervention effects were somewhat stronger (though not statistically significantly so) in studies with a greater attrition in the comparison condition, differential retention may be a threat to validity. Extra effort should be given to retaining participants in comparison conditions. Among community-level interventions, intervention effects were strongest among studies with random assignment of groups or communities. Therefore the inclusion of studies where assignment of groups or communities was by convenience did not exaggerate the summary effect. The greater effectiveness of interventions including more than 25% non-gay identifying MSM suggests that when they can be reached, these men may be more responsive than gay-identified men to risk reduction efforts. Non-gay identified MSM may have had less exposure to previous prevention messages, so their initial exposure may have a greater impact. The greater effectiveness of interventions that include efforts to promote personal skills such as keeping condoms available and behavioral self-management indicates that such content merits strong consideration in development and delivery of new interventions for MSM. And the finding that interventions were most effective for majority white populations underscores the critical need for effective interventions for MSM of African and Latino descent. Further research measuring the incidence of HIV and other STDs is needed. Because most studies were conducted among mostly white men in the US and Europe, more evaluations of interventions are needed for African American and Hispanic MSM as well as MSM in the developing world. More research is also needed to further clarify which behavioral strategies (e.g., reducing unprotected anal sex, having oral sex instead of anal sex, reducing number of partners, avoiding serodiscordant partners, strategic positioning, or reducing anal sex even with condom use) are most effective in reducing transmission among MSM, the messages most effective in promoting these behaviors, and the methods and settings in which these messages can be most effectively delivered.
男男性行为者(MSM)仍然面临着感染艾滋病毒的巨大风险。项目规划者和政策制定者需要了解干预措施的描述以及干预效果的定量估计,以便就预防资金和研究做出明智的决策。在过去几年中,采用强大研究设计进行检验的针对男男性行为者的干预策略数量大幅增加。
我们搜索了电子数据库、当前期刊、研究人员提交的手稿、相关文章的参考文献、会议论文集以及其他综述,以获取1988年至2007年12月期间已发表和未发表的报告。我们还询问了从事艾滋病毒预防工作的研究人员有关新的和正在进行的研究情况。
如果研究考察了旨在降低男男性行为者中艾滋病毒或性传播感染传播风险的行为干预措施的效果,则在范围内考虑这些研究。我们审查了范围内的研究,以确定结局相关性标准(测量一系列行为或生物学结局中的至少一项,例如无保护性行为或艾滋病毒感染发生率)和方法学严谨性(随机对照试验或某些具有对照组的强大准实验设计)。
我们使用固定效应模型和随机效应模型来总结干预组和对照组在计数结局(无保护肛交的次数或性伴侣数量)方面的率比(RR),以及二分结局(任何无保护肛交与无无保护肛交)的相应患病率比(PR)。必要时,我们使用已发表的公式转换计数结局和二分结局的效应量及其方差。我们在社区层面的研究中考虑了组内相关性(ICC),并在所有研究中对基线条件进行了调整。我们按干预形式(小组、个体或社区层面)以及给予对照组的干预类型(对照组中最小或无艾滋病毒预防与对照组中标准或其他艾滋病毒预防)呈现单独的结果。我们根据参与者、设计、实施和干预内容的特征对率比进行分层分析。对于小组和个体层面的干预措施,我们使用逐步选择过程来确定一个多变量模型,该模型可预测无保护肛交次数或性伴侣数量减少的预测因素。我们使用漏斗图来检查发表偏倚,并使用Q(自由度为干预措施数量减1的卡方统计量)来检验异质性。
我们发现44项研究评估了58项干预措施,涉及18,585名参与者。干预形式包括26项小组干预措施、21项个体层面的干预措施和11项社区层面的干预措施。58项干预措施中有16项侧重于艾滋病毒阳性者。与最小或无艾滋病毒预防干预措施相比,40项干预措施将无保护肛交的次数或性伴侣数量减少了27%(95%置信区间[CI]=15%至37%)。其他18项干预措施使无保护肛交减少的幅度超过了标准或其他干预措施中观察到的变化(CI=5%至27%)。干预效果在统计学上是同质的,在α=0.05时,没有独立变量与干预效果在统计学上显著相关。然而,通过向后逐步消除法选择的一个多变量模型确定了四项与小组和个体层面干预措施中无保护肛交次数或性伴侣数量减少相关的研究特征,在α=0.10时。在计数结局的研究、干预跨度较短(<=1个月)的研究、干预组比对照组保留率更高的研究以及对照组接受最小或无艾滋病毒预防干预的研究中,观察到无保护肛交次数或性伴侣数量最有利的减少(减少33%至35%)。由于社区层面的研究仅有11项,我们未寻找社区层面干预措施的多变量模型。在每次仅包括一个变量的分层分析中,在社区层面干预措施中,无保护肛交次数或性伴侣数量减少幅度最大(减少40%至54%)的情况出现在以下研究中:随机分组而非方便抽样的研究、回忆期较短且随访期较长的研究、非同性恋身份的男男性行为者超过25%的研究、至少90%的参与者为白人的研究以及干预措施涉及个人技能发展的研究。
行为干预措施可减少男男性行为者自我报告的无保护肛交行为。这些结果表明,针对该人群的艾滋病毒预防措施是有效的,应予以支持。先前研究的结果为新研究的预期提供了基准。荟萃分析可在样本量、目标人群、环境、过程测量目标和干预内容方面为未来的设计和实施提供参考。当效应因设计变量而异时,这些变量是经过刻意选择和规划的,了解这些特征可能对未来设计有益。设计未来小组和个体层面研究的研究人员应牢记,迄今为止,在使用计数结局和较短干预跨度(最长1个月)的研究中观察到了最大的效应。在小组和个体层面的研究中,当对照组的内容包括最小或无艾滋病毒预防时,效应也最大。然而,当对照组的内容包括标准或其他艾滋病毒预防时,也观察到了统计学上显著的有利效应。选择后一种选项进行新研究的研究人员应根据上述较小的预期净干预效果计划更大的样本量。当效应因实施变量而异时,这些变量在研究进行过程中变得明显,但通常不是经过选择或规划的,建议谨慎行事,以便未来的研究可以减少偏差。由于在对照组中损耗较大的研究中干预效果略强(尽管在统计学上不显著),差异保留可能对有效性构成威胁。应额外努力在对照组中保留参与者。在社区层面的干预措施中,在对组或社区进行随机分配选择的研究中干预效果最强。因此,纳入按方便抽样分配组或社区的研究并未夸大汇总效应。包括超过25%非同性恋身份的男男性行为者的干预措施具有更高的有效性,这表明当能够接触到这些男性时,他们可能比同性恋身份的男性对降低风险的努力反应更敏感。非同性恋身份的男男性行为者可能较少接触过以前的预防信息,因此他们的初次接触可能产生更大的影响。包括努力促进个人技能(如确保有避孕套和行为自我管理)的干预措施具有更高的有效性,这表明此类内容在为男男性行为者开发和提供新干预措施时值得充分考虑。并且干预措施对多数白人人群最有效的发现强调了为非洲裔和拉丁裔男男性行为者提供有效干预措施的迫切需求。需要进一步开展测量艾滋病毒和其他性传播感染发病率的研究。由于大多数研究是在美国和欧洲的白人男性中进行的,因此需要对非裔美国人和西班牙裔男男性行为者以及发展中国家的男男性行为者进行更多的干预措施评估。还需要更多的研究来进一步阐明哪些行为策略(例如减少无保护肛交、进行口交而非肛交、减少性伴侣数量、避免血清学不一致的性伴侣、策略性定位或即使使用避孕套也减少肛交)在减少男男性行为者之间的传播方面最有效,哪些信息在促进这些行为方面最有效,以及这些信息可以最有效传递的方法和环境。