Microfinance and Health Intervention Trial for Youth in Dar es Salaam, Tanzania

June 13, 2018 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

2623

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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
Control: Participants will receive delayed HIV prevention training at the conclusion of the intervention involving participants in the other condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of New Sexually Transmitted Infections
Time Frame: at 30 months
at 30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence
Time Frame: at 12 months
at 12 months
Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence
Time Frame: at 30 months
at 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Mental Health (NIMH)
American University
Muhimbili University of Health and Allied Sciences

Investigators

  • Principal Investigator: Suzanne Maman, PhD, UNC Chapel Hill
  • Principal Investigator: Lusajo Kajula-Maonga, MA, Muhimbilit University of Health and Allied Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (Estimate)

May 30, 2013

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1111
  • 1R01MH098690-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available on request, and per NIH regulations.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sexually Transmitted Infections

Clinical Trials on Microfinance and Health Leadership

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe