Clinical trial · Interventional
Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men
South African Men Health Promotion Project
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Immunodeficiency Virus Infection | — | UNRESOLVED | — |
| Sexually Transmitted Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Health Promotion Control | Behavioral | — | UNRESOLVED |
| Men Making a Difference HIV/STD Risk Reduction Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HIV/STD risk-reduction
- description
- 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.
- interventionNames
- Behavioral: Men Making a Difference HIV/STD Risk Reduction Intervention
- type
- ACTIVE_COMPARATOR
- label
- Health Promotion Control
- description
- 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.
- interventionNames
- Behavioral: Health Promotion Control
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDIcard LD, Jemmott JB 3rd, Teitelman A, O'Leary A, Heeren GA. Mediation effects of problem drinking and marijuana use on HIV sexual risk behaviors among childhood sexually abused South African heterosexual men. Child Abuse Negl. 2014 Feb;38(2):234-42. doi: 10.1016/j.chiabu.2013.08.002. Epub 2013 Sep 13. PMID 24041455
- BACKGROUNDHeeren GA, Icard LD, O'Leary A, Jemmott JB 3rd, Ngwane Z, Mtose X. Protective factors and HIV risk behavior among South African men. AIDS Behav. 2014 Oct;18(10):1991-7. doi: 10.1007/s10461-014-0767-2. PMID 24722765
- RESULTJemmott JB 3rd, Jemmott LS, O'Leary A, Ngwane Z, Icard LD, Heeren GA, Mtose X, Carty C. Cluster-randomized controlled trial of an HIV/sexually transmitted infection risk-reduction intervention for South African men. Am J Public Health. 2014 Mar;104(3):467-73. doi: 10.2105/AJPH.2013.301578. Epub 2014 Jan 16. PMID 24432923
- RESULTO'Leary A, Jemmott JB 3rd, Jemmott LS, Bellamy S, Icard LD, Ngwane Z. Mediation of an efficacious HIV risk reduction intervention for South African men. AIDS Behav. 2015 Oct;19(10):1842-9. doi: 10.1007/s10461-015-1042-x. PMID 25969177
- RESULTJemmott JB 3rd, Jemmott LS, Ngwane Z, Zhang J, Heeren GA, Icard LD, O'Leary A, Mtose X, Teitelman A, Carty C. Theory-based behavioral intervention increases self-reported physical activity in South African men: a cluster-randomized controlled trial. Prev Med. 2014 Jul;64:114-20. doi: 10.1016/j.ypmed.2014.04.012. Epub 2014 Apr 13. PMID 24736094
- RESULTJemmott JB 3rd, Stephens-Shields A, O'Leary A, Jemmott LS, Teitelman A, Ngwane Z, Mtose X. Mediation of effects of a theory-based behavioral intervention on self-reported physical activity in South African men. Prev Med. 2015 Mar;72:1-7. doi: 10.1016/j.ypmed.2014.12.022. Epub 2015 Jan 4. PMID 25565482