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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

Brief Summary:
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. An alternative approach to addressing women's risk of heterosexual transmission of HIV, one that would be an important complement to the predominant approach, is focusing on men. By reducing sexual risk behavior of men, it should be possible to reduce rates of HIV in both men and women. The rates in men would decline because they are the recipients of the intervention; rates in women 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 controlled 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. We hypothesized that men who receive a culturally appropriate theory-based HIV/STD risk-reduction intervention will be more likely to report consistently using condoms during intercourse in the 12-month post intervention period than will men who receive an attention-control intervention, adjusting for baseline condom use.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participants were masked to intervention arm at time of recruitment.
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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)

  6. 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

  7. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Pennsylvania
University of Fort Hare
Temple University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: John B Jemmott III, PhD Trustees of the University of Pennsylvania

Publications of Results:
Other Publications:
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 )
First Posted: December 13, 2011    Key Record Dates
Results First Posted: December 19, 2017
Last Update Posted: December 19, 2017
Last Verified: November 2017

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:
Genital Diseases, Female
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