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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    HIV/STD Risk-reduction   Health Promotion Control
STARTED   609   572 
Followed-up at 6 mo   558   535 
Followed-up at 12 mo   569   537 
COMPLETED   585   555 
NOT COMPLETED   24   17 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   HIV/STD Risk-reduction   Health Promotion Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 609   572   1181 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      609 100.0%      572 100.0%      1181 100.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Black South African   609   572   1181 
Not Black South African   0   0   0 
Region of Enrollment 
[Units: Participants]
     
South Africa   609   572   1181 
Married 
[Units: Participants]
     
Married   27   41   68 
Not Married   582   531   1113 
Employment Status 
[Units: Participants]
     
Not employed   425   368   793 
Employed   184   204   388 
Completed high school 
[Units: Participants]
     
Completed high school   279   239   518 
Less than high school   330   333   663 
Alcohol dependent 
[Units: Participants]
     
Alcohol dependent   377   330   707 
Not alcohol dependent   232   242   474 


  Outcome Measures

1.  Primary:   Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months   [ Time Frame: Baseline, 6 months, 12 months post-intervention ]

2.  Secondary:   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 ]

3.  Secondary:   Self-reported Condom Use at Most Recent Vaginal Intercourse   [ Time Frame: Baseline, 6 months, 12 months post intervention ]

4.  Secondary:   Frequency of Condom Use in the Past 3 Months   [ Time Frame: Baseline, 6 months, 12 months post intervention ]

5.  Secondary:   Talked to Partner About Condom Use   [ Time Frame: Baseline, 6 months, 12 months post intervention ]

6.  Secondary:   Condomless Vaginal Intercourse in the Past 3 Months   [ Time Frame: Baseline, 6 months, and 12 months post-intervention ]

7.  Secondary:   Heterosexual Anal Intercourse in the Past 3 Months   [ Time Frame: Baseline, 6 months, 12 months post intervention ]

8.  Secondary:   Multiple Vaginal Partners in the Past 3 Months   [ Time Frame: Baseline, 6 months, 12 months post intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: jjemmott@asc.upenn.edu


Publications of Results:
Other Publications:

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