Overview

This trial is active, not recruiting.

Conditions sexually transmitted infections, domestic violence
Treatment microfinance and health leadership
Sponsor University of North Carolina, Chapel Hill
Collaborator National Institute of Mental Health (NIMH)
Start date July 2013
End date September 2016
Trial size 2623 participants
Trial identifier NCT01865383, 12-1111, 1R01MH098690-01

Summary

Young men who are members of the camps randomized to receive a microfinance and health leadership intervention will have a lower incidence of sexually transmitted infections (Neisseria gonorrhea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) and report perpetrating less physical or sexual violence against sexual partners as compared to young men who are members of camps not randomized to receive the intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Microfinance and Health Leadership: Participants will be eligible to receive small loans and business training as part of the microfinance component. Nominated leaders in camps will receive health leadership training on prevention of HIV risk behaviors and gender based violence perpetration, and then pass on knowledge to camp members.
microfinance and health leadership
Microfinance and Health Leadership: Participants will be eligible to receive small loans and business training as part of the microfinance component. Nominated leaders in camps will receive health leadership training on prevention of HIV risk behaviors and gender based violence perpetration, and then pass on knowledge to camp members.
(No Intervention)
Control: Participants will receive delayed HIV prevention training at the conclusion of the intervention involving participants in the other condition.

Primary Outcomes

Measure
Incidence of New Sexually Transmitted Infections
time frame: at 30 months

Secondary Outcomes

Measure
Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence
time frame: at 12 months
Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence
time frame: at 30 months

Eligibility Criteria

Male or female participants from 15 years up to 99 years old.

Inclusion Criteria: - Must be registered camp member for at least the last 3 months - Must be at least 15 years old - Must plan to reside in Dar es Salaam, Tanzania for the next 30 months - Must visit primary camp at least 1 time per week - Must provide contact information of friend or family member Exclusion Criteria: - Unwilling to provide locator information - Unable to participate due to psychological disturbance, cognitive impairment or threatening behavior.

Additional Information

Official title Microfinance and Health Intervention Trial for Youth in Dar es Salaam, Tanzania
Principal investigator Suzanne Maman, PhD
Description Finding effective strategies to reach out to young men and mobilize them to reduce their HIV risk is critical, given men's control over the terms and conditions of most sexual partnerships. Unequal power distribution in relationships has a devastating impact on women, leading to HIV prevalence among young women in some sub-Saharan African countries four to seven times higher than among young men the same age. Gender power differentials have negative consequences for men as well, leading to increased risk of physical and mental health problems, substance use, and low uptake of health-related services. We need innovative approaches to address the structural and social determinant of young men's risk. Lack of economic opportunity is a key structural determinant of risk that has negative consequences for men, and has been linked to poor health outcomes. The influence of social network members is a social determinant of risk for both HIV and gender-based violence that can be addressed through interventions designed to change network norms. For the past 12 years our group has conducted research in Dar es Salaam, Tanzania on HIV and gender-based violence. With support from the National Institute of Mental Health (NIMH) we identified networks of young men who socialize in what are called "camps" and we successfully piloted a microfinance and health leadership intervention with men in camps like the one proposed in this application (R21 MH080577). Camps are enduring social groups of mostly men that have elected leadership, paid membership fees, and physical space to meet. The equivalent of a camp in US culture may be a cross between a club and a gang. Camps appear to be an urban phenomenon in Tanzania and our group is the first to have published data describing them. Men in camps engage in HIV risk behavior and in gender-based violence that put them and their partners at risk for HIV. Research suggests that microfinance combined with health promotion can lead to improvement in health outcomes, including reductions in HIV risk and gender-based violence. However, few, if any well designed evaluations of microfinance and health programs with young men have been reported.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.