search
Back to results

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

Primary Purpose

Sexually Transmitted Infections, Domestic Violence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microfinance and Health Leadership
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Infections

Eligibility Criteria

15 Years - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Microfinance and Health Leadership

Control

Arm Description

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.

Control: Participants will receive delayed HIV prevention training at the conclusion of the intervention involving participants in the other condition.

Outcomes

Primary Outcome Measures

Incidence of New Sexually Transmitted Infections

Secondary Outcome Measures

Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence
Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence

Full Information

First Posted
May 24, 2013
Last Updated
June 13, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH), Muhimbili University of Health and Allied Sciences, American University
search

1. Study Identification

Unique Protocol Identification Number
NCT01865383
Brief Title
Microfinance and Health Intervention Trial for Youth in Dar es Salaam, Tanzania
Official Title
Microfinance and Health Intervention Trial for Youth in Dar es Salaam, Tanzania
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH), Muhimbili University of Health and Allied Sciences, American University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infections, Domestic Violence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2623 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microfinance and Health Leadership
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control: Participants will receive delayed HIV prevention training at the conclusion of the intervention involving participants in the other condition.
Intervention Type
Behavioral
Intervention Name(s)
Microfinance and Health Leadership
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of New Sexually Transmitted Infections
Time Frame
at 30 months
Secondary Outcome Measure Information:
Title
Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence
Time Frame
at 12 months
Title
Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence
Time Frame
at 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Maman, PhD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lusajo Kajula-Maonga, MA
Organizational Affiliation
Muhimbilit University of Health and Allied Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available on request, and per NIH regulations.
Citations:
PubMed Identifier
26842360
Citation
Kajula L, Balvanz P, Kilonzo MN, Mwikoko G, Yamanis T, Mulawa M, Kajuna D, Hill L, Conserve D, Reyes HL, Leatherman S, Singh B, Maman S. Vijana Vijiweni II: a cluster-randomized trial to evaluate the efficacy of a microfinance and peer health leadership intervention for HIV and intimate partner violence prevention among social networks of young men in Dar es Salaam. BMC Public Health. 2016 Feb 3;16:113. doi: 10.1186/s12889-016-2774-x.
Results Reference
background
PubMed Identifier
26802044
Citation
Mulawa M, Kajula LJ, Yamanis TJ, Balvanz P, Kilonzo MN, Maman S. Perpetration and Victimization of Intimate Partner Violence Among Young Men and Women in Dar es Salaam, Tanzania. J Interpers Violence. 2018 Aug;33(16):2486-2511. doi: 10.1177/0886260515625910. Epub 2016 Jan 21.
Results Reference
result
PubMed Identifier
26874081
Citation
Mulawa M, Yamanis TJ, Hill LM, Balvanz P, Kajula LJ, Maman S. Evidence of social network influence on multiple HIV risk behaviors and normative beliefs among young Tanzanian men. Soc Sci Med. 2016 Mar;153:35-43. doi: 10.1016/j.socscimed.2016.02.002. Epub 2016 Feb 2.
Results Reference
result
PubMed Identifier
26880322
Citation
Mulawa M, Yamanis TJ, Balvanz P, Kajula LJ, Maman S. Comparing Perceptions with Actual Reports of Close Friend's HIV Testing Behavior Among Urban Tanzanian Men. AIDS Behav. 2016 Sep;20(9):2014-22. doi: 10.1007/s10461-016-1335-8.
Results Reference
result
PubMed Identifier
27469516
Citation
Hill LM, Maman S, Kilonzo MN, Kajula LJ. Anxiety and depression strongly associated with sexual risk behaviors among networks of young men in Dar es Salaam, Tanzania. AIDS Care. 2017 Feb;29(2):252-258. doi: 10.1080/09540121.2016.1210075. Epub 2016 Jul 28.
Results Reference
result
PubMed Identifier
27506817
Citation
Yamanis TJ, Dervisevic E, Mulawa M, Conserve DF, Barrington C, Kajula LJ, Maman S. Social Network Influence on HIV Testing Among Urban Men in Tanzania. AIDS Behav. 2017 Apr;21(4):1171-1182. doi: 10.1007/s10461-016-1513-8.
Results Reference
result
PubMed Identifier
28812448
Citation
Mulawa MI, Kajula LJ, Maman S. Peer network influence on intimate partner violence perpetration among urban Tanzanian men. Cult Health Sex. 2018 Apr;20(4):474-488. doi: 10.1080/13691058.2017.1357193. Epub 2017 Aug 16.
Results Reference
result
PubMed Identifier
28849338
Citation
Mulawa MI, Reyes HLM, Foshee VA, Halpern CT, Martin SL, Kajula LJ, Maman S. Associations Between Peer Network Gender Norms and the Perpetration of Intimate Partner Violence Among Urban Tanzanian Men: a Multilevel Analysis. Prev Sci. 2018 May;19(4):427-436. doi: 10.1007/s11121-017-0835-8.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs