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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01865383
Other study ID # 12-1111
Secondary ID 1R01MH098690-01
Status Completed
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date March 1, 2017

Study information

Verified date April 2017
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2623
Est. completion date March 1, 2017
Est. primary completion date March 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 99 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (4)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill American University, Muhimbili University of Health and Allied Sciences, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Epub 2016 Jul 28. — View 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. — View 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. 2016 Jan 21. pii: 0886260515625910. [Epub ahead of pri — View 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. — View 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 — View 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. — View 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 — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of New Sexually Transmitted Infections at 30 months
Secondary Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence at 12 months
Secondary Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence at 30 months
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