Sexually Transmitted InfectionsNCT01865383
Microfinance and Health Intervention Trial for Youth in Dar es Salaam, Tanzania
A study testing Microfinance and Health Leadership in people with Sexually Transmitted Infections and Domestic Violence, run by University of North Carolina, Chapel Hill at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 15 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infections, Domestic Violence
- What is being tested?
- Microfinance and Health Leadership
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,623 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwilling to provide locator information
- Unable to participate due to psychological disturbance, cognitive impairment or threatening behavior.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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.
Read the 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.
- Conditions
- Sexually Transmitted Infections, Domestic Violence
- Being tested
- Microfinance and Health Leadership
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfinance and Health LeadershipBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Microfinance and Health Leadership | Experimental | 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. Receives: Behavioral: Microfinance and Health Leadership |
| Control | No intervention | Control: Participants will receive delayed HIV prevention training at the conclusion of the intervention involving participants in the other condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of New Sexually Transmitted Infections
Measured: at 30 months
Secondary outcomes (2)
Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence
Measured: at 12 months
Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence
Measured: at 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startJul 2013
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,623 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Muhimbili University of Health and Allied Sciences, American University
- Responsible party
- Sponsor
- Investigators
- Suzanne Maman, PhD, Principal investigator, UNC Chapel HillLusajo Kajula-Maonga, MA, Principal investigator, Muhimbilit University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865383
- Sponsor's protocol ID
- 12-1111
- Other IDs
- 1R01MH098690-01
- Status last verified
- Apr 2017
- First submitted
- 24 May 2013
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be made available on request, and per NIH regulations.
Publications
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.
PubMed 26842360Mulawa 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.
PubMed 26802044Mulawa 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.
PubMed 26874081Mulawa 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.
PubMed 26880322Hill 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.
PubMed 27469516Yamanis 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.
PubMed 27506817Mulawa 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.
PubMed 28812448Mulawa 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.
PubMed 28849338
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microfinance and Health Intervention Trial for Youth in Dar es Salaam, Tanzania
- ClinicalTrials.gov ID
- NCT01865383
- Acronym / sponsor ID
- 12-1111
- Conditions
- Sexually Transmitted Infections, Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,623 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Muhimbili University of Health and Allied Sciences, American University
- Study start
- Jul 2013
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 30 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microfinance and Health Leadership | Experimental | Behavioral: Microfinance and Health LeadershipMicrofinance 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 | No intervention | –Control: Participants will receive delayed HIV prevention training at the conclusion of the intervention involving participants in the other condition. |
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling to provide locator information
- Unable to participate due to psychological disturbance, cognitive impairment or threatening behavior.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microfinance and Health LeadershipMicrofinance 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. | Behavioural | Microfinance and Health Leadership |
Primary outcome
Incidence of New Sexually Transmitted Infections
Time frame: at 30 months
2 secondary outcomes
Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence
Time frame: at 12 months
Proportion of Men Reporting Perpetration of Physical, Sexual, or Psychological Partner Violence
Time frame: at 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Background: PubMed 26842360Kajula 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 publication: PubMed 26802044Mulawa 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 publication: PubMed 26874081Mulawa 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 publication: PubMed 26880322Mulawa 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 publication: PubMed 27469516Hill 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 publication: PubMed 27506817Yamanis 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 publication: PubMed 28812448Mulawa 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 publication: PubMed 28849338Mulawa 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.
- Individual participant dataSharing planned: Yes. Data will be made available on request, and per NIH regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Maman, PhD principal investigator
UNC Chapel Hill
Lusajo Kajula-Maonga, MA principal investigator
Muhimbilit University of Health and Allied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfinance and Health Leadership in people with Sexually Transmitted Infections and Domestic Violence, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of New Sexually Transmitted Infections (time frame: at 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01865383, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.