Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men - Full Text View

Purpose

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.

To be sure, there is an alternative approach to addressing women's risk of heterosexual transmission of HIV, one that would be an important complement to the predominant approach: namely, focusing on men. By reducing men's sexual risk behavior, it should be possible to reduce rates of HIV in both men and women. Men's rates would decline because they are the recipients of the intervention; women's rates 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 control 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.

The primary hypothesis is that men who receive a culturally appropriate theory-based HIV/STD risk-reduction intervention will be more likely to report consistently using condoms during vaginal intercourse in the 12-month post intervention period than will men who receive an attention-control intervention, controlling for baseline condom use.

Condition	Intervention	Phase
Human Immunodeficiency Virus Infection Sexually Transmitted Diseases	Behavioral: Men Making a Difference HIV/STD Risk Reduction Intervention Behavioral: Health Promotion Control	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	South African Men Health Promotion Project

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Sexually Transmitted Diseases

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Self-reported consistent condom use during vaginal intercourse in the past 3 months [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
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.
Self-reported consistent condom use during vaginal intercourse in the past 3 months [ Time Frame: 12 months post intervention ] [ Designated as safety issue: No ]
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:

The self-reported proportion of condom-protected acts of vaginal intercourse in the past 3 months [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
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: 6 months post intervention ] [ Designated as safety issue: No ]
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: 6 months post intervention ] [ Designated as safety issue: No ]
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.
Multiple vaginal partners in the past 3 months [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
The report of having vaginal intercourse with 2 or more women in the past 3 months.
Heterosexual anal intercourse in the past 3 months [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
The report of having anal intercourse with a woman in the past 3 months
Health promotion behaviors in the past 30 days [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
Behaviors targeted by the control intervention, including 5 a day diet, physical activity, alcohol and drug use.
The self-reported proportion of condom-protected acts of vaginal intercourse in the past 3 months [ Time Frame: 12 months post intervention ] [ Designated as safety issue: No ]
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: 12 months post intervention ] [ Designated as safety issue: No ]
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: 12 months post intervention ] [ Designated as safety issue: No ]
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.
Multiple vaginal partners in the past 3 months [ Time Frame: 12 months post intervention ] [ Designated as safety issue: No ]
The report of having vaginal intercourse with 2 or more women in the past 3 months.
Heterosexual anal intercourse in the past 3 months [ Time Frame: 12 months post intervention ] [ Designated as safety issue: No ]
The report of having anal intercourse with a woman in the past 3 months
Health promotion behaviors in the past 30 days [ Time Frame: 12 months post intervention ] [ Designated as safety issue: No ]
Behaviors targeted by the control intervention, including 5 a day diet, physical activity, alcohol and drug use.


Enrollment:	1181
Study Start Date:	November 2007
Study Completion Date:	April 2011
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: HIV/STD risk-reduction	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	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

Arms

Assigned Interventions

Experimental: HIV/STD risk-reduction

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

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

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Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Genders 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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jemmott JB 3rd, Jemmott LS, Ngwane Z, Zhang J, Heeren GA, Icard LD, O'Leary A, Mtose X, Teitelman A, Carty C. Theory-based behavioral intervention increases self-reported physical activity in South African men: a cluster-randomized controlled trial. Prev Med. 2014 Jul;64:114-20. doi: 10.1016/j.ypmed.2014.04.012. Epub 2014 Apr 13.


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
Study First Received:	December 7, 2011
Last Updated:	December 8, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:


human immunodeficiency virus randomized controlled trial intervention studies South Africa	men sexually behavior social cognitive theory

Additional relevant MeSH terms:


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 Genital Diseases, Female

ClinicalTrials.gov processed this record on September 23, 2016