Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men
|ClinicalTrials.gov Identifier: NCT01490359|
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus Infection Sexually Transmitted Diseases||Behavioral: Men Making a Difference HIV/STD Risk Reduction Intervention Behavioral: Health Promotion Control||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1181 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Participants were masked to intervention arm at time of recruitment.|
|Official Title:||South African Men Health Promotion Project|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||April 2011|
Experimental: 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.
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
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.
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
- Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months [ Time Frame: 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.
- The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months [ Time Frame: Baseline, 6 months, 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: Baseline, 6 months, 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: Baseline, 6 months, 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.
- Talked to Partner About Condom Use [ Time Frame: Baseline, 6 months, 12 months post intervention ]A binary variable indicating whether the participants talked to partner about using condoms in the past 90 days.
- Condomless Vaginal Intercourse in the Past 3 Months [ Time Frame: Baseline, 6 months, and 12 months post-intervention ]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)
- Heterosexual Anal Intercourse in the Past 3 Months [ Time Frame: Baseline, 6 months, 12 months post intervention ]The report of having anal intercourse with a woman in the past 3 months
- Multiple Vaginal Partners in the Past 3 Months [ Time Frame: Baseline, 6 months, 12 months post intervention ]The report of having vaginal intercourse with 2 or more women in the past 3 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490359
|Principal Investigator:||John B Jemmott III, PhD||Trustees of the University of Pennsylvania|