Reducing the Risk of HIV/STD Infection Among African American Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 2
- 主要终点
- Consistent (100%) Condom Use
研究概览
简要总结
African American men have by far the highest rates of HIV in the US, but there are few randomized controlled trials (RCTs) of interventions to dissuade heterosexually active African American men from engaging sexual risk behavior. This research seeks to address this gap in the behavioral intervention literature. That self-initiated behavior change, as well as intervention-induced behavior change, is often short-lived, eroding over time, is widely known; accordingly, this research also seeks to test a strategy to sustain intervention efficacy. In a RCT, African American men 18 to 45 years reporting recent unprotected intercourse with a woman will be randomized to the Steering Together in a New Direction (STAND) HIV Risk Reduction Intervention or a No-Intervention Control Condition. To test a strategy to sustain intervention effects, the men also will be randomized to receive or not receive individually tailored text messages. The theoretical basis of the interventions is social cognitive theory and the reasoned action approach, which is an extension of the theory of planned behavior and the theory of reasoned action. Men will complete self-report measures via audio computer-assisted self-interviewing at baseline and immediately post and 6 and 12 months post-intervention. The trial will test whether the STAND HIV Risk Reduction Intervention as compared with the No-Intervention Control Condition, increases consistent condom use, the primary outcome. Secondary outcomes include unprotected intercourse, multiple sexual partners, insertive anal intercourse, and proportion condom-protected intercourse. The trial will also test whether STAND's efficacy is greater among men in the Text Messaging Intervention compared with men not receiving text messages. This will provide information on the utility of a low-cost strategy to extend an intervention's efficacy. Finally, the study will test for mediation of intervention effects: the hypothesis that STAND affects outcome expectancies and self-efficacy, which, in turn, affect consistent condom use.
详细描述
HIV/AIDS has had a devastating impact on African Americans, who have the highest rates of HIV/AIDS as compared with Whites, Hispanics, Asians, and Native Americans. Although African Americans comprise only 13% of the US population, more than 40% of people living with HIV/AIDS in the US are African American-some 192,277 people. New diagnoses of HIV/AIDS underscore the epidemic's impact on African Americans. Almost 50% of the people newly diagnosed with HIV/AIDS in the 33 states with confidential name-based HIV infection reporting in 2006 were African Americans. The overall rate of newly diagnosed cases was 19 cases per 100,000, but among African Americans, it was 68 per 100,000. The estimated rates of HIV/AIDS in 2006 were higher among African American men (121 per 100,000) as compared with White men (17 per 100,000), Latino/Hispanic men (51 per 100,000), and African American women (57 per 100,000). Heterosexual exposure is a key HIV transmission category among African Americans. To be sure, the largest number of estimated cases of HIV/AIDS among African American men fell in the men who have sex with men (MSM) HIV-transmission category. However, the second largest number of cases was attributed to heterosexual transmission, with the injection-drug-use HIV-transmission category ranking third. Moreover, heterosexual exposure was a more important HIV-transmission category among African American men than among other men. It accounted for 23% of HIV/AIDS cases among African American men, but 19% among Hispanic men and only 7% of cases among White men. Furthermore, among African American women, who comprised over 60% of the women with HIV/AIDS in 2006, heterosexual exposure was by far the most important transmission category, accounting for 83% of cases. Heterosexual exposure is especially important in Philadelphia, Pennsylvania, where the proposed study will be conducted. According to the Philadelphia Department of Public Health, among African American men, heterosexual exposure surpassed male-to-male contact as the modal exposure category in 2006, 2007, and 2008.
Furthermore, another important health disparity affecting African Americans particularly in urban areas is the high rate of sexually transmitted disease (STD). About 47% of the cases of Chlamydia trachomatis (CT) reported to Centers for Disease Control and Prevention (CDC) in 2006 occurred in African Americans. The CT rate was 7 times higher among African American women than among White women. The Neisseria gonorrhea rate was 25 times higher among African American men than among White men and 14 times higher among African American women than among their White counterparts. Despite the high rate of heterosexual exposure to HIV and the high rates of other STDs in African American men and women, little research has focused on interventions targeting heterosexually active men.
Sexual Risk Behavior among Heterosexually Active African American Men
Two key behaviors that increase risk of STD, including HIV, are failing to use condom consistently and having multiple sexual partners. Although unmarried African American men were more likely to report consistent condom use than were their Hispanic or White counterparts, which may reflect recognition of higher risk of STD among African American men, a large percentage of African American men (47%) risked exposure to HIV and other STDs. Moreover, consistent condom use declined substantially with increasing age, from 68% in those 15 to 19 years of age, to 31% in those 25 to 29 years of age, and to only 26% in those 40 to 44 years of age. In the National Survey of Family Growth, among men 15-44 years of age, unmarried African American men were more likely to have had 4 or more partners in the past year (13%) compared with White (6%) and Hispanic men (7%).
Interventions to Reduce Risk of Heterosexual Transmission of HIV in African American Men
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ages 18 to 45 years
- •Self-identify as African American or Black
- •Born a male
- •Report having intercourse with a woman in the past 60 days without using a condom
排除标准
- •Report having intercourse with only 1 female partner in the past 60 days and being in a committed relationship with her for 6 or more months
- •Plan to relocate beyond a reasonable distance from the study in the next 18 months or do not have an address where he can receive mail
- •Report participating in an intervention research study on how to reduce HIV risks or negotiate safer sex in the previous 12 months
研究组 & 干预措施
HIV Risk Reduction Only
STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.
干预措施: STAND HIV Risk Reduction Intervention (Behavioral)
No-Intervention No-Text Message Control
Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
HIV Risk Reduction and Text Messaging
STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.
干预措施: Text Messaging Intervention (Behavioral)
HIV Risk Reduction and Text Messaging
STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.
干预措施: STAND HIV Risk Reduction Intervention (Behavioral)
Text Messaging Only
Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.
干预措施: Text Messaging Intervention (Behavioral)
结局指标
主要结局
Consistent (100%) Condom Use
时间窗: Baseline, 6 months, 12 months post-intervention
A binary variable reflecting whether or not the participant reports using a condom every time he had vaginal or anal intercourse with a woman in the previous 3 months. It will be based on a comparison of the number of protected intercourse acts and the number of intercourse acts. Men who report at least one intercourse act and whose number of reported protected acts equals their number of acts use condoms during 100% of intercourse acts and will be defined as practicing consistent condom use. Men who report at least one intercourse act and whose reported number of protected acts is less than their number of acts will be coded as not practicing consistent condom use. Separate binary variables reflect consistent condom use with steady partners and casual partners analyzed as a repeated outcome.
次要结局
- Insertive Anal Intercourse(Baseline, 6 months, 12 months post-intervention)
- Multiple Partners(Baseline, 6 months, 12 months post-intervention)
- Proportion Condom-protected Intercourse(Baseline, 6 months, 12 months post-intervention)
- Unprotected Intercourse(Baseline, 6 months, 12 months post-intervention)
