Trial Outcomes & Findings for Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men (NCT NCT01490359)
NCT ID: NCT01490359
Last Updated: 2017-12-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1181 participants
Primary outcome timeframe
Baseline, 6 months, 12 months post-intervention
Results posted on
2017-12-19
Participant Flow
Participant milestones
| Measure |
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.
Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it 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).
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
609
|
572
|
|
Overall Study
Followed-up at 6 mo
|
558
|
535
|
|
Overall Study
Followed-up at 12 mo
|
569
|
537
|
|
Overall Study
COMPLETED
|
585
|
555
|
|
Overall Study
NOT COMPLETED
|
24
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men
Baseline characteristics by cohort
| Measure |
HIV/STD Risk-reduction
n=609 Participants
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.
Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it 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).
|
Health Promotion Control
n=572 Participants
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.
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.
|
Total
n=1181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
609 Participants
n=5 Participants
|
572 Participants
n=7 Participants
|
1181 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
609 Participants
n=5 Participants
|
572 Participants
n=7 Participants
|
1181 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black South African
|
609 participants
n=5 Participants
|
572 participants
n=7 Participants
|
1181 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Black South African
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
609 participants
n=5 Participants
|
572 participants
n=7 Participants
|
1181 participants
n=5 Participants
|
|
Married
Married
|
27 participants
n=5 Participants
|
41 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Married
Not Married
|
582 participants
n=5 Participants
|
531 participants
n=7 Participants
|
1113 participants
n=5 Participants
|
|
Employment Status
Not employed
|
425 participants
n=5 Participants
|
368 participants
n=7 Participants
|
793 participants
n=5 Participants
|
|
Employment Status
Employed
|
184 participants
n=5 Participants
|
204 participants
n=7 Participants
|
388 participants
n=5 Participants
|
|
Completed high school
Completed high school
|
279 participants
n=5 Participants
|
239 participants
n=7 Participants
|
518 participants
n=5 Participants
|
|
Completed high school
Less than high school
|
330 participants
n=5 Participants
|
333 participants
n=7 Participants
|
663 participants
n=5 Participants
|
|
Alcohol dependent
Alcohol dependent
|
377 participants
n=5 Participants
|
330 participants
n=7 Participants
|
707 participants
n=5 Participants
|
|
Alcohol dependent
Not alcohol dependent
|
232 participants
n=5 Participants
|
242 participants
n=7 Participants
|
474 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 months post-interventionPopulation: Participants with data at baseline and at least one follow-up.
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.
Outcome measures
| Measure |
HIV/STD Risk-reduction
n=418 Participants
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.
Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it 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).
|
Health Promotion Control
n=387 Participants
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.
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.
|
|---|---|---|
|
Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months
Baseline steady partner
|
121 Participants
|
103 Participants
|
|
Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months
6 mo steady partner
|
125 Participants
|
93 Participants
|
|
Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months
12 mo steady partner
|
119 Participants
|
81 Participants
|
|
Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months
Baseline casual partners
|
91 Participants
|
78 Participants
|
|
Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months
6 mo casual partners
|
60 Participants
|
58 Participants
|
|
Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months
12 mo casual partners
|
56 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months post interventionPopulation: Participants with data at baseline and at least one post-intervention assessment.
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.
Outcome measures
| Measure |
HIV/STD Risk-reduction
n=418 Participants
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.
Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it 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).
|
Health Promotion Control
n=387 Participants
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.
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.
|
|---|---|---|
|
The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months
Baseline Steady partners
|
0.524 proportion of acts
Standard Error 0.021
|
0.516 proportion of acts
Standard Error 0.022
|
|
The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months
Baseline Casual partners
|
0.713 proportion of acts
Standard Error 0.024
|
0.665 proportion of acts
Standard Error 0.028
|
|
The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months
6 mo Steady partners
|
0.585 proportion of acts
Standard Error 0.022
|
0.549 proportion of acts
Standard Error 0.023
|
|
The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months
6 mo Casual partners
|
0.712 proportion of acts
Standard Error 0.029
|
0.685 proportion of acts
Standard Error 0.029
|
|
The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months
12 mo Steady partners
|
0.613 proportion of acts
Standard Error 0.021
|
0.555 proportion of acts
Standard Error 0.022
|
|
The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months
12 mo Casual partners
|
0.678 proportion of acts
Standard Error 0.031
|
0.684 proportion of acts
Standard Error 0.030
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months post interventionPopulation: Participants with data at baseline and at least one post-intervention assessment.
The respondents' self-report of using a condom during their most recent vaginal intercourse. Calculated separately for steady and casual partners.
Outcome measures
| Measure |
HIV/STD Risk-reduction
n=418 Participants
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.
Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it 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).
|
Health Promotion Control
n=387 Participants
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.
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.
|
|---|---|---|
|
Self-reported Condom Use at Most Recent Vaginal Intercourse
Baseline Steady partners
|
193 Participants
|
175 Participants
|
|
Self-reported Condom Use at Most Recent Vaginal Intercourse
Baseline Casual partners
|
119 Participants
|
108 Participants
|
|
Self-reported Condom Use at Most Recent Vaginal Intercourse
6 mo Steady partners
|
216 Participants
|
162 Participants
|
|
Self-reported Condom Use at Most Recent Vaginal Intercourse
6 mo Casual partners
|
96 Participants
|
85 Participants
|
|
Self-reported Condom Use at Most Recent Vaginal Intercourse
12 mo Steady partners
|
204 Participants
|
176 Participants
|
|
Self-reported Condom Use at Most Recent Vaginal Intercourse
12 mo Casual partners
|
80 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months post interventionPopulation: Participants with data from baseline and at least one post-intervention assessment.
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.
Outcome measures
| Measure |
HIV/STD Risk-reduction
n=418 Participants
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.
Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it 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).
|
Health Promotion Control
n=387 Participants
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.
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.
|
|---|---|---|
|
Frequency of Condom Use in the Past 3 Months
Baseline Steady partners
|
2.991 units on a scale
Standard Error 0.078
|
3.041 units on a scale
Standard Error 0.083
|
|
Frequency of Condom Use in the Past 3 Months
Baseline Casual partners
|
3.712 units on a scale
Standard Error 0.093
|
3.603 units on a scale
Standard Error 0.109
|
|
Frequency of Condom Use in the Past 3 Months
6 mo Steady partners
|
3.309 units on a scale
Standard Error 0.079
|
2.931 units on a scale
Standard Error 0.085
|
|
Frequency of Condom Use in the Past 3 Months
6 mo Casual partners
|
3.892 units on a scale
Standard Error 0.101
|
3.594 units on a scale
Standard Error 0.110
|
|
Frequency of Condom Use in the Past 3 Months
12 mo Steady partners
|
3.238 units on a scale
Standard Error 0.077
|
3.029 units on a scale
Standard Error 0.081
|
|
Frequency of Condom Use in the Past 3 Months
12 mo Casual partners
|
3.702 units on a scale
Standard Error 0.109
|
3.649 units on a scale
Standard Error 0.111
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months post interventionPopulation: Participants with data at baseline and at least one post-intervention assessment.
A binary variable indicating whether the participants talked to partner about using condoms in the past 90 days.
Outcome measures
| Measure |
HIV/STD Risk-reduction
n=490 Participants
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.
Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it 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).
|
Health Promotion Control
n=466 Participants
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.
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.
|
|---|---|---|
|
Talked to Partner About Condom Use
Baseline Steady partners
|
318 Participants
|
269 Participants
|
|
Talked to Partner About Condom Use
Baseline Casual partners
|
145 Participants
|
124 Participants
|
|
Talked to Partner About Condom Use
6 mo Steady partners
|
310 Participants
|
243 Participants
|
|
Talked to Partner About Condom Use
6 mo Casual partners
|
122 Participants
|
100 Participants
|
|
Talked to Partner About Condom Use
12 mo Steady partners
|
294 Participants
|
245 Participants
|
|
Talked to Partner About Condom Use
12 mo Casual partners
|
105 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, and 12 months post-interventionPopulation: Participants with data at baseline and at least one post-intervention assessment.
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)
Outcome measures
| Measure |
HIV/STD Risk-reduction
n=585 Participants
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.
Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it 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).
|
Health Promotion Control
n=555 Participants
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.
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.
|
|---|---|---|
|
Condomless Vaginal Intercourse in the Past 3 Months
Baseline steady partner
|
281 Participants
|
263 Participants
|
|
Condomless Vaginal Intercourse in the Past 3 Months
6 mo steady partner
|
231 Participants
|
220 Participants
|
|
Condomless Vaginal Intercourse in the Past 3 Months
12 mo steady partner
|
231 Participants
|
230 Participants
|
|
Condomless Vaginal Intercourse in the Past 3 Months
Baseline casual partner
|
112 Participants
|
107 Participants
|
|
Condomless Vaginal Intercourse in the Past 3 Months
6 mo casual partner
|
82 Participants
|
83 Participants
|
|
Condomless Vaginal Intercourse in the Past 3 Months
12 mo casual partner
|
84 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months post interventionPopulation: Participants with data at baseline and at least one post-intervention assessment.
The report of having anal intercourse with a woman in the past 3 months
Outcome measures
| Measure |
HIV/STD Risk-reduction
n=568 Participants
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.
Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it 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).
|
Health Promotion Control
n=543 Participants
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.
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.
|
|---|---|---|
|
Heterosexual Anal Intercourse in the Past 3 Months
Baseline Steady partners
|
59 Participants
|
58 Participants
|
|
Heterosexual Anal Intercourse in the Past 3 Months
Baseline Casual partners
|
41 Participants
|
35 Participants
|
|
Heterosexual Anal Intercourse in the Past 3 Months
6 mo Steady partners
|
42 Participants
|
48 Participants
|
|
Heterosexual Anal Intercourse in the Past 3 Months
6 mo Casual partners
|
25 Participants
|
31 Participants
|
|
Heterosexual Anal Intercourse in the Past 3 Months
12 mo Steady partners
|
35 Participants
|
35 Participants
|
|
Heterosexual Anal Intercourse in the Past 3 Months
12 mo Casual partners
|
20 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months post interventionPopulation: Participants with data at baseline and at least one post-intervention assessment.
The report of having vaginal intercourse with 2 or more women in the past 3 months.
Outcome measures
| Measure |
HIV/STD Risk-reduction
n=585 Participants
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.
Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it 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).
|
Health Promotion Control
n=554 Participants
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.
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.
|
|---|---|---|
|
Multiple Vaginal Partners in the Past 3 Months
Baseline
|
256 Participants
|
220 Participants
|
|
Multiple Vaginal Partners in the Past 3 Months
6 mo
|
199 Participants
|
191 Participants
|
|
Multiple Vaginal Partners in the Past 3 Months
12 mo
|
199 Participants
|
200 Participants
|
Adverse Events
HIV/STD Risk-reduction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Promotion Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place