Trial record 13 of 38 for:    teen AND (violence OR aggression) | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01865383
First received: May 24, 2013
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Sexually Transmitted Infections
Gender Based Violence Perpetration
Behavioral: Microfinance and Health Leadership

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Microfinance and Health Intervention Trial for Youth in Dar es Salaam, Tanzania

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Incidence of New Sexually Transmitted Infections [ Time Frame: at 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence [ Time Frame: at 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2623
Study Start Date: July 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microfinance and Health Leadership
Microfinance and Health Leadership: Participants will receive small loans and business training as part of the microfinance component. Camp leaders will receive health leadership training and then pass on knowledge to camp members.
Behavioral: Microfinance and Health Leadership
No Intervention: Control

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01865383

Contacts
Contact: Suzanne Maman, PhD 919-966-3901 maman@email.unc.edu

Locations
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Suzanne Maman       maman@email.unc.edu   
Principal Investigator: Suzanne Maman, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Suzanne Maman, PhD UNC Chapel Hill
Principal Investigator: Lusajo Kajula-Maonga, MA Muhimbilit University of Health and Allied Sciences
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01865383     History of Changes
Other Study ID Numbers: 12-1111, 1R01MH098690-01
Study First Received: May 24, 2013
Last Updated: April 21, 2014
Health Authority: Tanzania: National Institute for Medical Research
United States: Institutional Review Board

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 01, 2014