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

NCT01490359 | Completed Results

• 2 other identifiers: 8060381R01HD053270
• Study Type: interventional
• Target: 1,181
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Human Immunodeficiency Virus Infection; Sexually Transmitted Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months

  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.

  Baseline, 6 months, 12 months post-intervention

Secondary Outcomes (7)

• The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months

  Baseline, 6 months, 12 months post intervention

• Self-reported Condom Use at Most Recent Vaginal Intercourse

  Baseline, 6 months, 12 months post intervention

• Frequency of Condom Use in the Past 3 Months

  Baseline, 6 months, 12 months post intervention

• Talked to Partner About Condom Use

  Baseline, 6 months, 12 months post intervention

• Condomless Vaginal Intercourse in the Past 3 Months

  Baseline, 6 months, and 12 months post-intervention

Study Arms (2)

HIV/STD risk-reduction

EXPERIMENTAL

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

Health Promotion Control

ACTIVE COMPARATOR

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

Interventions

Men Making a Difference HIV/STD Risk Reduction Intervention BEHAVIORAL

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).

Also known as: HIV/STD Risk Reduction Intervention

HIV/STD risk-reduction

Health Promotion Control BEHAVIORAL

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.

Also known as: Attention-Control

Health Promotion Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men ages 18 to 45 years
• Reside in a randomly selected neighborhoods
• Report vaginal intercourse in the previous 3 months
• Have a photo identification

You may not qualify if:

• Plan to relocate from the area within the next 15 months

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of Fort Hare: collaborator
• Temple University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Related Publications (6)

• Icard LD, Jemmott JB 3rd, Teitelman A, O'Leary A, Heeren GA. Mediation effects of problem drinking and marijuana use on HIV sexual risk behaviors among childhood sexually abused South African heterosexual men. Child Abuse Negl. 2014 Feb;38(2):234-42. doi: 10.1016/j.chiabu.2013.08.002. Epub 2013 Sep 13.

  PMID: 24041455 BACKGROUND

• Heeren GA, Icard LD, O'Leary A, Jemmott JB 3rd, Ngwane Z, Mtose X. Protective factors and HIV risk behavior among South African men. AIDS Behav. 2014 Oct;18(10):1991-7. doi: 10.1007/s10461-014-0767-2.

  PMID: 24722765 BACKGROUND

• Jemmott JB 3rd, Jemmott LS, O'Leary A, Ngwane Z, Icard LD, Heeren GA, Mtose X, Carty C. Cluster-randomized controlled trial of an HIV/sexually transmitted infection risk-reduction intervention for South African men. Am J Public Health. 2014 Mar;104(3):467-73. doi: 10.2105/AJPH.2013.301578. Epub 2014 Jan 16.

  PMID: 24432923 RESULT

• O'Leary A, Jemmott JB 3rd, Jemmott LS, Bellamy S, Icard LD, Ngwane Z. Mediation of an efficacious HIV risk reduction intervention for South African men. AIDS Behav. 2015 Oct;19(10):1842-9. doi: 10.1007/s10461-015-1042-x.

  PMID: 25969177 RESULT

• 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.

  PMID: 24736094 RESULT

• Jemmott JB 3rd, Stephens-Shields A, O'Leary A, Jemmott LS, Teitelman A, Ngwane Z, Mtose X. Mediation of effects of a theory-based behavioral intervention on self-reported physical activity in South African men. Prev Med. 2015 Mar;72:1-7. doi: 10.1016/j.ypmed.2014.12.022. Epub 2015 Jan 4.

  PMID: 25565482 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. John B. Jemmott III
• Organization: University of Pennsylvania

jjemmott@asc.upenn.edu

215-573-9366

Study Officials

• John B Jemmott III, PhD

  Trustees of the University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were masked to intervention arm at time of recruitment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kenneth B. Clark Professor of Communication in Psychiatry

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 13, 2011
• Study Start: November 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2011
• Last Updated: December 19, 2017
• Results First Posted: December 19, 2017

Record last verified: 2017-11