South African Men Health Promotion Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,181
- 主要终点
- Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months
研究概览
简要总结
Sub-Saharan Africa has about 10% of the world's population, but was home to more than 60% of all people living with HIV in 2003. South Africa continues to have the largest number of people living with HIV in the world, and as in other parts of sub-Saharan Africa, heterosexual exposure is the primary HIV transmission category. Worldwide, efforts to stem the spread of HIV among heterosexuals have stressed the impact of HIV on women. Oft-cited statistics indicate that about half of all people living with HIV are women. The strategies typically offered to address the impact of HIV on women are interventions with women. An alternative approach to addressing women's risk of heterosexual transmission of HIV, one that would be an important complement to the predominant approach, is focusing on men. By reducing sexual risk behavior of men, it should be possible to reduce rates of HIV in both men and women. The rates in men would decline because they are the recipients of the intervention; rates in women would decline because they have sex with men. Interventions aimed at men could take into account the power that men have in sexual decision-making and risk taking. However, whether one considers the US literature or the international literature, few randomized controlled trials of HIV/STD risk-reduction interventions have focused on heterosexual men. Accordingly, the purpose of this research is to develop and test the efficacy of an intervention to curb HIV/STD risk-associated behavior in South African men who have sex with women. A cluster-randomized controlled trial design will be used to reduce the potential for contamination between treatment arms that would be present if individuals were randomized. An attention control group will be used to control for Hawthorne effects, special attention, and group interaction. Matched pairs of neighborhoods in Black townships in Eastern Cape Province, South Africa similar on key characteristics will be created, 22 pairs will be randomly selected, and men will be recruited. One neighborhood in each pair will be randomly assigned to each of the 2 study arms. We hypothesized that men who receive a culturally appropriate theory-based HIV/STD risk-reduction intervention will be more likely to report consistently using condoms during intercourse in the 12-month post intervention period than will men who receive an attention-control intervention, adjusting for baseline condom use.
详细描述
Sub-Saharan Africa has just over 10% of the world's population, but according to UNAIDS was home to more than 60% of all people living with HIV in 2003-some 25.4 million people. South Africa continues to have the largest number of people living with HIV in the world. As in other parts of sub-Saharan Africa, heterosexual exposure is the primary HIV transmission category. An estimated 5.3 million South Africans-2.9 million women and 2.4 million men-were living with HIV at the end of 2003.
Worldwide, efforts to stem the spread of HIV among heterosexuals have stressed the impact of HIV on women. Oft-cited statistics indicate that about half of all people living with HIV are women. It is often suggested that women are seldom free to make empowered choices and face a range of HIV-related vulnerabilities that men do not face-many of which are embedded in the social relations and economic realities of their societies. Women's economic dependence on their male partners and the fact that women do not have the power to abstain from sex or to insist on condom use-even when they suspect that their man has other sexual partners and might have HIV-is emphasized. The hazards of young women's sexual relationships with older men and the high rate of rape and other forms of sexual coercion are cited. Men are typically mentioned as injection drug users, as having sex with other men-whether as MSMs or being on the "down low"-or as being the cause of the spread of HIV in women. The strategies typically offered to address the impact of HIV on women are interventions with women. For instance, it is recommended that women be taught the information and skills to make decisions about the terms of their sexual relationships, that methods of protection that women can control (e.g., microbicides) be developed, and that boosting women's economic opportunities and social power should be seen as part and parcel of potentially successful and sustainable HIV prevention strategies.
To be sure, there is an alternative approach to addressing women's risk of heterosexual transmission of HIV, one that would be important complement to the predominant approach: namely, focusing on men. Although it is noted that HIV is affecting women most severely in places where heterosexual exposure is a dominant mode of transmission, this seldom leads to a recommendation that interventions be developed to change men's behavior. Yet, by reducing men's sexual risk behavior, it should be possible to reduce rates of HIV in both men and women. Men's rates would decline because they are the recipients of the intervention; women's rates would decline because they have sex with men. Interventions targeting men could take into account the power that men have in sexual decision-making and risk taking.
However, whether one considers the US literature or the international literature, few randomized controlled trials (RCTs) of HIV/STD risk-reduction interventions have targeted heterosexual men. Elwy and colleagues 2002 review of HIV/STD prevention intervention studies revealed that only 12 of 1157 studies worldwide were conducted on males only. Most were not RCTs demonstrating intervention efficacy. Only 2 demonstrated significant effects on mediators and behaviors, and neither was a RCT. In addition, scant attention has focused on the general population of heterosexual men in any region. Indeed, 8 of the 12 studies focused on incarcerated men, STD patients, substance abusers, miners, or truck drivers. To address this gap in the literature, the proposed trial will focus on men who are more representative of the general population. In many developing countries, including South Africa, the HIV/AIDS epidemic is generalized, and there is a need to develop and test interventions for a broad range of the population, not just special high-risk sub-populations.
Accordingly, the purpose of this research is to develop and test the efficacy of an intervention to reduce behaviors that create the risk for contracting and transmitting STD, including HIV, among South African men who have sex with women. A cluster-randomized control trial design will be used to reduce the potential for contamination between treatment arms that would be present if individuals were randomized. An attention control group will be used to control for Hawthorne effects, special attention, and group interaction. Men will be recruited from Black townships surrounding East London, including Mdantsane, Scenery Park, Duncan, Village, and Gompo Town, and the semi-rural area of Berlin in the Eastern Cape Province of South Africa. More than 98% of the residents of these areas are Black Africans, and isiXhosa is the first language for 98.8% of the population. There are 206 neighborhoods defined as geographical clusters tied to census data in this catchment area, allowing the creation of 103 matched pairs of neighborhoods similar on the percentage isiXhosa-speaking, percentage married, percentage male, percentage living in informal dwellings, percentage unemployed, and population size. From the 103 matched pairs, 22 pairs will be randomly selected for the trial. One neighborhood in each pair will be randomly assigned to each of the 2 study arms.
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 (Participant)
盲法说明
Participants were masked to intervention arm at time of recruitment.
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
- •Men ages 18 to 45 years
- •Reside in a randomly selected neighborhoods
- •Report vaginal intercourse in the previous 3 months
- •Have a photo identification
排除标准
- •Plan to relocate from the area within the next 15 months
研究组 & 干预措施
HIV/STD risk-reduction
Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.
干预措施: Men Making a Difference HIV/STD Risk Reduction Intervention (Behavioral)
Health Promotion Control
Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.
干预措施: Health Promotion Control (Behavioral)
结局指标
主要结局
Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months
时间窗: Baseline, 6 months, 12 months post-intervention
Men who reported at least 1 vaginal intercourse act in the past 3 months and whose number of reported condom-protected vaginal intercourse acts equaled their number of vaginal intercourse acts were coded as practicing consistent or 100% condom use. Men who reported at least 1 vaginal intercourse act and whose reported number of condom-protected vaginal intercourse acts was less than their number of vaginal intercourse acts were coded as not practicing consistent condom use. Separate binary variables reflected consistent condom use with primary partners and casual partners.
次要结局
- The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months(Baseline, 6 months, 12 months post intervention)
- Self-reported Condom Use at Most Recent Vaginal Intercourse(Baseline, 6 months, 12 months post intervention)
- Frequency of Condom Use in the Past 3 Months(Baseline, 6 months, 12 months post intervention)
- Talked to Partner About Condom Use(Baseline, 6 months, 12 months post intervention)
- Condomless Vaginal Intercourse in the Past 3 Months(Baseline, 6 months, and 12 months post-intervention)
- Heterosexual Anal Intercourse in the Past 3 Months(Baseline, 6 months, 12 months post intervention)
- Multiple Vaginal Partners in the Past 3 Months(Baseline, 6 months, 12 months post intervention)
研究者
John Jemmott
Kenneth B. Clark Professor of Communication in Psychiatry
University of Pennsylvania
