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Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men

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ClinicalTrials.gov Identifier: NCT01490359
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborators:
University of Fort Hare
Temple University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
John Jemmott, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Human Immunodeficiency Virus Infection
Sexually Transmitted Diseases
Interventions Behavioral: Men Making a Difference HIV/STD Risk Reduction Intervention
Behavioral: Health Promotion Control
Enrollment 1181
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV/STD Risk-reduction Health Promotion Control
Hide Arm/Group 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.

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 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.

Period Title: Overall Study
Started 609 572
Followed-up at 6 mo 558 535
Followed-up at 12 mo 569 537
Completed 585 555
Not Completed 24 17
Arm/Group Title HIV/STD Risk-reduction Health Promotion Control Total
Hide Arm/Group 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.

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 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 of all reporting groups
Overall Number of Baseline Participants 609 572 1181
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 609 participants 572 participants 1181 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
609
 100.0%
572
 100.0%
1181
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 609 participants 572 participants 1181 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
609
 100.0%
572
 100.0%
1181
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 609 participants 572 participants 1181 participants
Black South African 609 572 1181
Not Black South African 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Africa Number Analyzed 609 participants 572 participants 1181 participants
609 572 1181
Married  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 609 participants 572 participants 1181 participants
Married 27 41 68
Not Married 582 531 1113
Employment Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 609 participants 572 participants 1181 participants
Not employed 425 368 793
Employed 184 204 388
Completed high school  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 609 participants 572 participants 1181 participants
Completed high school 279 239 518
Less than high school 330 333 663
Alcohol dependent  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 609 participants 572 participants 1181 participants
Alcohol dependent 377 330 707
Not alcohol dependent 232 242 474
1.Primary Outcome
Title Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months
Hide Description 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.
Time Frame Baseline, 6 months, 12 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with data at baseline and at least one follow-up.
Arm/Group Title HIV/STD Risk-reduction Health Promotion Control
Hide Arm/Group 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.

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 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 Number of Participants Analyzed 418 387
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline steady partner Number Analyzed 365 participants 325 participants
121
  33.2%
103
  31.7%
6 mo steady partner Number Analyzed 311 participants 273 participants
125
  40.2%
93
  34.1%
12 mo steady partner Number Analyzed 299 participants 274 participants
119
  39.8%
81
  29.6%
Baseline casual partners Number Analyzed 151 participants 142 participants
91
  60.3%
78
  54.9%
6 mo casual partners Number Analyzed 109 participants 104 participants
60
  55.0%
58
  55.8%
12 mo casual partners Number Analyzed 104 participants 96 participants
56
  53.8%
48
  50.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV/STD Risk-reduction, Health Promotion Control
Comments Assuming alpha = 0.05, a 2-tailed test, ICC = 0.01, 15% attrition at 12-month follow-up, and N = 1,152 men in the trial from 44 neighborhoods with an average of 26 men in each neighborhood, the trial was estimated to have 81% power to detect a 10% increase in consistent condom use from 32% to 42% in the HIV/STI intervention group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .008
Comments The GEE model included baseline measure of consistent condom use, intervention condition, time (6- vs. 12-mo follow-up), and type of partner (steady vs casual partners) with robust standard errors and an independent working correlation matrix.
Method generalized estimating equations (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
1.03 to 1.71
Estimation Comments Estimate is odds ratio (intervention vs. health control).
2.Secondary Outcome
Title The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months
Hide Description 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.
Time Frame Baseline, 6 months, 12 months post intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with data at baseline and at least one post-intervention assessment.
Arm/Group Title HIV/STD Risk-reduction Health Promotion Control
Hide Arm/Group 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.

Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the 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).

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 Number of Participants Analyzed 418 387
Mean (Standard Error)
Unit of Measure: proportion of acts
Baseline Steady partners Number Analyzed 365 participants 325 participants
0.524  (0.021) 0.516  (0.022)
Baseline Casual partners Number Analyzed 151 participants 142 participants
0.713  (0.024) 0.665  (0.028)
6 mo Steady partners Number Analyzed 311 participants 273 participants
0.585  (0.022) 0.549  (0.023)
6 mo Casual partners Number Analyzed 109 participants 104 participants
0.712  (0.029) 0.685  (0.029)
12 mo Steady partners Number Analyzed 299 participants 274 participants
0.613  (0.021) 0.555  (0.022)
12 mo Casual partners Number Analyzed 104 participants 96 participants
0.678  (0.031) 0.684  (0.030)
3.Secondary Outcome
Title Self-reported Condom Use at Most Recent Vaginal Intercourse
Hide Description The respondents' self-report of using a condom during their most recent vaginal intercourse. Calculated separately for steady and casual partners.
Time Frame Baseline, 6 months, 12 months post intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with data at baseline and at least one post-intervention assessment.
Arm/Group Title HIV/STD Risk-reduction Health Promotion Control
Hide Arm/Group 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.

Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the 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).

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 Number of Participants Analyzed 418 387
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Steady partners Number Analyzed 365 participants 325 participants
193
  52.9%
175
  53.8%
Baseline Casual partners Number Analyzed 151 participants 143 participants
119
  78.8%
108
  75.5%
6 mo Steady partners Number Analyzed 311 participants 273 participants
216
  69.5%
162
  59.3%
6 mo Casual partners Number Analyzed 109 participants 105 participants
96
  88.1%
85
  81.0%
12 mo Steady partners Number Analyzed 299 participants 274 participants
204
  68.2%
176
  64.2%
12 mo Casual partners Number Analyzed 104 participants 96 participants
80
  76.9%
75
  78.1%
4.Secondary Outcome
Title Frequency of Condom Use in the Past 3 Months
Hide Description 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.
Time Frame Baseline, 6 months, 12 months post intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with data from baseline and at least one post-intervention assessment.
Arm/Group Title HIV/STD Risk-reduction Health Promotion Control
Hide Arm/Group 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.

Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the 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).

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 Number of Participants Analyzed 418 387
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Steady partners Number Analyzed 365 participants 325 participants
2.991  (0.078) 3.041  (0.083)
Baseline Casual partners Number Analyzed 151 participants 142 participants
3.712  (0.093) 3.603  (0.109)
6 mo Steady partners Number Analyzed 311 participants 273 participants
3.309  (0.079) 2.931  (0.085)
6 mo Casual partners Number Analyzed 109 participants 104 participants
3.892  (0.101) 3.594  (0.110)
12 mo Steady partners Number Analyzed 418 participants 387 participants
3.238  (0.077) 3.029  (0.081)
12 mo Casual partners Number Analyzed 104 participants 96 participants
3.702  (0.109) 3.649  (0.111)
5.Secondary Outcome
Title Talked to Partner About Condom Use
Hide Description A binary variable indicating whether the participants talked to partner about using condoms in the past 90 days.
Time Frame Baseline, 6 months, 12 months post intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with data at baseline and at least one post-intervention assessment.
Arm/Group Title HIV/STD Risk-reduction Health Promotion Control
Hide Arm/Group 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.

Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the 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).

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 Number of Participants Analyzed 490 466
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Steady partners Number Analyzed 425 participants 390 participants
318
  74.8%
269
  69.0%
Baseline Casual partners Number Analyzed 220 participants 192 participants
145
  65.9%
124
  64.6%
6 mo Steady partners Number Analyzed 369 participants 329 participants
310
  84.0%
243
  73.9%
6 mo Casual partners Number Analyzed 163 participants 149 participants
122
  74.8%
100
  67.1%
12 mo Steady partners Number Analyzed 360 participants 335 participants
294
  81.7%
245
  73.1%
12 mo Casual partners Number Analyzed 150 participants 130 participants
105
  70.0%
90
  69.2%
6.Secondary Outcome
Title Condomless Vaginal Intercourse in the Past 3 Months
Hide Description 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)
Time Frame Baseline, 6 months, and 12 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with data at baseline and at least one post-intervention assessment.
Arm/Group Title HIV/STD Risk-reduction Health Promotion Control
Hide Arm/Group 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.

Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the 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).

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 Number of Participants Analyzed 585 555
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline steady partner Number Analyzed 585 participants 555 participants
281
  48.0%
263
  47.4%
6 mo steady partner Number Analyzed 558 participants 535 participants
231
  41.4%
220
  41.1%
12 mo steady partner Number Analyzed 566 participants 537 participants
231
  40.8%
230
  42.8%
Baseline casual partner Number Analyzed 585 participants 554 participants
112
  19.1%
107
  19.3%
6 mo casual partner Number Analyzed 558 participants 534 participants
82
  14.7%
83
  15.5%
12 mo casual partner Number Analyzed 567 participants 535 participants
84
  14.8%
83
  15.5%
7.Secondary Outcome
Title Heterosexual Anal Intercourse in the Past 3 Months
Hide Description The report of having anal intercourse with a woman in the past 3 months
Time Frame Baseline, 6 months, 12 months post intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with data at baseline and at least one post-intervention assessment.
Arm/Group Title HIV/STD Risk-reduction Health Promotion Control
Hide Arm/Group 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.

Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the 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).

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 Number of Participants Analyzed 568 543
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Steady partners Number Analyzed 547 participants 527 participants
59
  10.8%
58
  11.0%
Baseline Casual partners Number Analyzed 517 participants 482 participants
41
   7.9%
35
   7.3%
6 mo Steady partners Number Analyzed 512 participants 493 participants
42
   8.2%
48
   9.7%
6 mo Casual partners Number Analyzed 463 participants 444 participants
25
   5.4%
31
   7.0%
12 mo Steady partners Number Analyzed 520 participants 503 participants
35
   6.7%
35
   7.0%
12 mo Casual partners Number Analyzed 484 participants 453 participants
20
   4.1%
18
   4.0%
8.Secondary Outcome
Title Multiple Vaginal Partners in the Past 3 Months
Hide Description The report of having vaginal intercourse with 2 or more women in the past 3 months.
Time Frame Baseline, 6 months, 12 months post intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with data at baseline and at least one post-intervention assessment.
Arm/Group Title HIV/STD Risk-reduction Health Promotion Control
Hide Arm/Group 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.

Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the 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).

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 Number of Participants Analyzed 585 554
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 585 participants 554 participants
256
  43.8%
220
  39.7%
6 mo Number Analyzed 558 participants 534 participants
199
  35.7%
191
  35.8%
12 mo Number Analyzed 567 participants 536 participants
199
  35.1%
200
  37.3%
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HIV/STD Risk-reduction Health Promotion Control
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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 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.

All-Cause Mortality
HIV/STD Risk-reduction Health Promotion Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HIV/STD Risk-reduction Health Promotion Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/609 (0.00%)   0/572 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HIV/STD Risk-reduction Health Promotion Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/609 (0.00%)   0/572 (0.00%) 
A limitation of the study is the reliance on self-reports of behavior. In addition, the results may not generalize to all South African men.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. John B. Jemmott III
Organization: University of Pennsylvania
Phone: 215-573-9366
Responsible Party: John Jemmott, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01490359     History of Changes
Other Study ID Numbers: 806038
1R01HD053270 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2011
First Posted: December 13, 2011
Results First Submitted: September 23, 2015
Results First Posted: December 19, 2017
Last Update Posted: December 19, 2017