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

NCT ID: NCT01865383

Last Updated: 2018-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2623 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sexually Transmitted Infections Domestic Violence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Microfinance and Health Leadership

Intervention Type BEHAVIORAL

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

American University

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suzanne Maman, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Lusajo Kajula-Maonga, MA

Role: PRINCIPAL_INVESTIGATOR

Muhimbilit University of Health and Allied Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26842360 (View on PubMed)

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.

Reference Type RESULT
PMID: 26802044 (View on PubMed)

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.

Reference Type RESULT
PMID: 26874081 (View on PubMed)

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.

Reference Type RESULT
PMID: 26880322 (View on PubMed)

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.

Reference Type RESULT
PMID: 27469516 (View on PubMed)

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.

Reference Type RESULT
PMID: 27506817 (View on PubMed)

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.

Reference Type RESULT
PMID: 28812448 (View on PubMed)

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.

Reference Type RESULT
PMID: 28849338 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01MH098690-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-1111

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.