Help Us, Save Us! HIV/STI Risk Reduction for Black Men Who Have Sex With Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 595
- 试验地点
- 2
- 主要终点
- Consistent (100%) condom use during anal and vaginal intercourse in the past 3 months
研究概览
简要总结
The incidence of HIV/AIDS among African American men who have sex with men (MSM) is alarming, and the public health response to this urgent situation has been hampered by a lack of sexual risk reduction interventions with solid evidence of efficacy in this population. Accordingly, the broad, long-term objective of the proposed research is to identify interventions to reduce the risk of sexually transmitted infection (STI) among African American MSM. This application seeks funds to develop and test the efficacy of a theory-based, contextually appropriate behavioral intervention to reduce sexual risk behavior among African American MSM. Intervention development will be guided by social cognitive theory, the theory of planned behavior, qualitative information from focus groups, and findings from a longitudinal survey of men from the study population. A one-on-one intervention will be utilized to address the specific prevention needs of each man and to allay participants' concerns about revealing their sexual involvement with men by virtue of participating in a group or workshop intervention. The study will utilize a randomized controlled trial design, with baseline, immediate post intervention, and 6 and 12 months post intervention assessments. The participants will be African American MSM who will be randomized to a one-on-one sexual risk reduction intervention or a one-on-one health promotion intervention that will serve as the control condition. The primary outcome is consistent condom use during anal and vaginal intercourse. The study will test whether the intervention increases the consistent use of condoms during anal intercourse, the primary outcome, whether it decreases other sexual risk behaviors, and whether social cognitive theory variables mediate the effects of the intervention on consistent condom use. This study will provide an urgently needed intervention to reduce the risk of HIV and other STIs in one of the highest risk populations in the United States.
详细描述
HIV/AIDS has had a devastating impact on African American MSM. Although African Americans represent only 13% of the US population, 49% of AIDS diagnoses in 2004 were in African Americans. That HIV/AIDS has taken an increasing toll on African American injection drug users and heterosexuals during the last decade is well documented. Nevertheless, MSM continue to account for the largest number of African Americans with HIV/AIDS. Through 2004, the MSM exposure category accounted for 37% of the cumulative AIDS cases in African American men, whereas injection drug use accounted for 31% and heterosexual transmission accounted for 10%. Consonant with these figures on HIV/AIDS cases, the HIV infection rates in several studies the Centers for Disease Control and Prevention (CDC) conducted on African American MSM have rivaled those found in many sub-Saharan African nations. For instance, a CDC 5-city study found that of the African American MSM who were tested for HIV, two-thirds were unaware of their status and 46% were HIV positive. Similarly, the 7-city CDC Young Men's Survey found an HIV prevalence rate of 32% in African American MSM. Interestingly, although African American MSM have relatively high HIV infection rates, evidence does not suggest that they engage in riskier sexual practices than do other MSM. This may mean that African American MSM are drawing their sexual partners from pools of people where HIV prevalence is relatively high, which underscores the urgency of targeting interventions to this population.
Quite apart from risk of HIV, African American MSM are at high risk for other STIs. The CDC MSM Prevalence Monitoring Project conducted in 9 US cities, in 1999 through 2004 found that the rates of gonorrhea and chlamydia were high in MSM, but especially high in African American MSM. In 2004, urethral gonorrhea positivity was 16% in African Americans, as compared with 11% in Whites, and 9% in Hispanics. The median urethral chlamydia positivity was 6% overall, but 9% in African Americans. To curb the HIV epidemic and the high rates of other STIs in African American MSM now, prevention efforts must be urgently undertaken.
Although several researchers have stressed the need for culturally appropriate prevention interventions targeting African American MSM, scant progress has been made toward the identification of such interventions. Ample evidence indicates that theory-based interventions can decrease sexual risk behavior among MSM. A meta-analysis 40 controlled studies of HIV prevention behavioral interventions for MSM found that the interventions reduced the amount of reported unprotected sex by as much as 27%, but revealed that the MSM populations at the highest risk, including African American MSM, have been underserved by intervention research. Consider, for example, Project EXPLORE, a large-scale multi-site controlled trial (RCT) that enrolled over 4,200 MSM and followed them for up to 4 years. Fewer than 7% of participants were African American, eligible African Americans were less likely to enroll in the trial than were eligible Whites, and African Americans were more likely to drop out. Another meta-analysis found that, of 33 HIV sexual risk reduction intervention trials on MSM, only 6 employed a sample that was at least a 10% African American. The insufficient number of rigorous intervention trials directed at African American MSM has hindered the ability to make definitive conclusions about how to combat men's attitudes and beliefs concerning sexual risk behavior and ultimately determine the effectiveness of HIV prevention strategies targeting African American MSM.
Reaching African American MSM may be particularly challenging because many African American MSM do not use traditional resources and organizations that serve gay men because they do not identify with White gay culture. In addition, African American MSM may also be difficult to reach within African American communities because they are often closeted and isolated due to real and perceived homophobia. That isolation, in turn, contributes to internalized repression of gay sexual identity, which may further isolate them from resources available to gay men. The investigators' approach to addressing the problem of reaching African American MSM is to develop an intervention that can be used by community-based organizations (CBOs) that already serve African American MSM. The investigators will create a Community Advisory Board that includes representatives of CBOs that serve African American MSM and representatives of the study population to advise them on the intervention design and other aspects of the trial. In addition, the investigators have held a focus group with representatives of CBOs that serve African Americans and have frequently consulted with them regarding their approach.
Reviews of the literature have suggested that there have been 3 basic approaches to the design of HIV/STI risk reduction programs aimed at MSM. One approach is to seek to reduce risk through the implementation of small group or workshop interventions. The second approach is through the use of community-level interventions. A third approach is the individual one-on-one intervention. All three approaches have merit and have reduced risk behavior among men in controlled trials. An advantage of the one-on-one is that it avoids the problem of men having to risk revealing that they have sex with other men in order to participate in the prevention program. There are added benefits of the one-on-one approach. It permits tailoring the intervention to the specific needs of the man. A recent meta-analysis has identified characteristics of effective HIV behavioral interventions for MSM. Efficacy was associated with interventions having more than one session, duration of 4 or more hours, and a time span of at least 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Self-identified as black or African American
- •Born a male
- •Reported having anal intercourse with a man in the previous 90 days.
排除标准
- •Reported having anal intercourse with only one main male partner in the past 90 days
- •Participated in an HIV/STI risk-reduction intervention in the past 12 months
研究组 & 干预措施
HIV risk reduction
BRO HIV Risk Reduction Intervention
干预措施: BRO HIV Risk Reduction Intervention (Behavioral)
Health promotion control
Health Promotion Intervention
干预措施: Health Promotion Intervention (Behavioral)
结局指标
主要结局
Consistent (100%) condom use during anal and vaginal intercourse in the past 3 months
时间窗: 6 and 12 months post-intervention
Men who reported at least one intercourse act and whose number of reported protected acts equaled their number of acts were coded as practicing consistent condom use. Men who reported at least one intercourse act and whose reported number of protected acts was less than their number of acts were coded as not practicing consistent condom use.
次要结局
- Insertive anal intercourse in the past 3 months(6 and 12 months post-intervention)
- Unprotected intercourse in the past 3 months(6 and 12 months post-intervention)
- Receptive anal intercourse in the past 3 months(6 and 12 months post-intervention)
- Proportion condom-protected intercourse in the past 3 months(6 and 12 months post-intervention)
- Multiple sexual partners in the past 3 months(6 and 12 months post-intervention)
