Sexually Transmitted Diseases Clinical Trial
Official title:
South African Men Health Promotion Project
Verified date | November 2017 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1181 |
Est. completion date | April 2011 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Pennsylvania | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Temple University, University of Fort Hare |
Heeren 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. — View Citation
Icard 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. — View Citation
Jemmott 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 — View Citation
Jemmott 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 — View Citation
Jemmott 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.yp — View Citation
O'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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months | 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. | Baseline, 6 months, 12 months post-intervention | |
Secondary | The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months | The proportion of condom-protected acts of vaginal intercourse is defined as the self-reported number of acts of vaginal intercourse in which the respondent used a condom in the past 3 months divided by the total number of acts of vaginal intercourse the respondent reported in the past 3 months. Calculated separately for steady and casual partners. | Baseline, 6 months, 12 months post intervention | |
Secondary | Self-reported Condom Use at Most Recent Vaginal Intercourse | The respondents' self-report of using a condom during their most recent vaginal intercourse. Calculated separately for steady and casual partners. | Baseline, 6 months, 12 months post intervention | |
Secondary | Frequency of Condom Use in the Past 3 Months | Respondents' rating on a 5-point scale from 1 (never) to 5 (always) how often they used a condom during vaginal intercourse. Measured separately for steady and casual partners. | Baseline, 6 months, 12 months post intervention | |
Secondary | Talked to Partner About Condom Use | A binary variable indicating whether the participants talked to partner about using condoms in the past 90 days. | Baseline, 6 months, 12 months post intervention | |
Secondary | Condomless Vaginal Intercourse in the Past 3 Months | A binary variable indicating whether participant reported having vaginal intercourse without using a condom in the past 3 months (0 = did not have vaginal intercourse or always used a condom; 1= did have vaginal intercourse without using a condom) | Baseline, 6 months, and 12 months post-intervention | |
Secondary | Heterosexual Anal Intercourse in the Past 3 Months | The report of having anal intercourse with a woman in the past 3 months | Baseline, 6 months, 12 months post intervention | |
Secondary | Multiple Vaginal Partners in the Past 3 Months | The report of having vaginal intercourse with 2 or more women in the past 3 months. | Baseline, 6 months, 12 months post intervention |
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