N/A
N=1,181
Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men
Human Immunodeficiency Virus Infection · Sexually Transmitted Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01490359 ↗Enrolled (actual)
1,181
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months — 121; 103; 125; 93 Participants — p=.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Men Making a Difference HIV/STD Risk Reduction Intervention (Behavioral); Health Promotion Control (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months |
121; 103; 125; 93; 119; 81 | .008 sig |
| SECONDARY The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months |
0.524; 0.516; 0.713; 0.665; 0.585; 0.549 | — |
| SECONDARY Self-reported Condom Use at Most Recent Vaginal Intercourse |
193; 175; 119; 108; 216; 162 | — |
| SECONDARY Frequency of Condom Use in the Past 3 Months |
2.991; 3.041; 3.712; 3.603; 3.309; 2.931 | — |
| SECONDARY Talked to Partner About Condom Use |
318; 269; 145; 124; 310; 243 | — |
| SECONDARY Condomless Vaginal Intercourse in the Past 3 Months |
281; 263; 231; 220; 231; 230 | — |
| SECONDARY Heterosexual Anal Intercourse in the Past 3 Months |
59; 58; 41; 35; 42; 48 | — |
| SECONDARY Multiple Vaginal Partners in the Past 3 Months |
256; 220; 199; 191; 199; 200 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Men ages 18 to 45 years
- Reside in a randomly selected neighborhoods
- Report vaginal intercourse in the previous 3 months
- Have a photo identification
Exclusion Criteria
- Plan to relocate from the area within the next 15 months
Data sourced from ClinicalTrials.gov (NCT01490359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.