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Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men
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Purpose
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.
To be sure, there is an alternative approach to addressing women's risk of heterosexual transmission of HIV, one that would be an important complement to the predominant approach: namely, focusing on men. 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 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 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. 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.
The primary hypothesis is that men who receive a culturally appropriate theory-based HIV/STD risk-reduction intervention will be more likely to report consistently using condoms during vaginal intercourse in the 12-month post intervention period than will men who receive an attention-control intervention, controlling for baseline condom use.
| Condition | Intervention | Phase |
|---|---|---|
| Human Immunodeficiency Virus Infection Sexually Transmitted Diseases | Behavioral: Men Making a Difference HIV/STD Risk Reduction Intervention Behavioral: Health Promotion Control | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | South African Men Health Promotion Project |
- Self-reported consistent condom use during vaginal intercourse in the past 3 months [ Time Frame: 6 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.
- Self-reported consistent condom use during vaginal intercourse in the past 3 months [ Time Frame: 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.
- The self-reported proportion of condom-protected acts of vaginal intercourse in the past 3 months [ Time Frame: 6 months post intervention ]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.
- Self-reported condom use at most recent vaginal intercourse [ Time Frame: 6 months post intervention ]The respondents' self-report of using a condom during their most recent vaginal intercourse. Calculated separately for steady and casual partners.
- Frequency of condom use in the past 3 months [ Time Frame: 6 months post intervention ]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.
- Multiple vaginal partners in the past 3 months [ Time Frame: 6 months post intervention ]The report of having vaginal intercourse with 2 or more women in the past 3 months.
- Heterosexual anal intercourse in the past 3 months [ Time Frame: 6 months post intervention ]The report of having anal intercourse with a woman in the past 3 months
- Health promotion behaviors in the past 30 days [ Time Frame: 6 months post intervention ]Behaviors targeted by the control intervention, including 5 a day diet, physical activity, alcohol and drug use.
- The self-reported proportion of condom-protected acts of vaginal intercourse in the past 3 months [ Time Frame: 12 months post intervention ]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.
- Self-reported condom use at most recent vaginal intercourse [ Time Frame: 12 months post intervention ]The respondents' self-report of using a condom during their most recent vaginal intercourse. Calculated separately for steady and casual partners.
- Frequency of condom use in the past 3 months [ Time Frame: 12 months post intervention ]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.
- Multiple vaginal partners in the past 3 months [ Time Frame: 12 months post intervention ]The report of having vaginal intercourse with 2 or more women in the past 3 months.
- Heterosexual anal intercourse in the past 3 months [ Time Frame: 12 months post intervention ]The report of having anal intercourse with a woman in the past 3 months
- Health promotion behaviors in the past 30 days [ Time Frame: 12 months post intervention ]Behaviors targeted by the control intervention, including 5 a day diet, physical activity, alcohol and drug use.
| Enrollment: | 1181 |
| Study Start Date: | November 2007 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: HIV/STD risk-reduction |
Behavioral: Men Making a Difference HIV/STD Risk Reduction Intervention
Developed based on social cognitive theory and extensive formative research, Men Together Making a Difference HIV/STD risk-reduction intervention consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet).
Other Name: HIV/STD Risk Reduction Intervention
|
| Active Comparator: Health Promotion Control |
Behavioral: Health Promotion Control
The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption.
Other Name: Attention-Control
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01490359
| Principal Investigator: | John B Jemmott III, PhD | Trustees of the University of Pennsylvania |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | John Jemmott, Kenneth B. Clark Professor of Communication in Psychiatry, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01490359 History of Changes |
| Other Study ID Numbers: |
806038 1R01HD053270 ( U.S. NIH Grant/Contract ) |
| Study First Received: | December 7, 2011 |
| Last Updated: | December 8, 2011 |
Keywords provided by John Jemmott, University of Pennsylvania:
|
human immunodeficiency virus randomized controlled trial intervention studies South Africa |
men sexually behavior social cognitive theory |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Virus Diseases Sexually Transmitted Diseases Immune System Diseases Lentivirus Infections |
Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Infection Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on July 24, 2017