NCT01865383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,623

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 15, 2018

Status Verified

April 1, 2017

Enrollment Period

3.7 years

First QC Date

May 24, 2013

Last Update Submit

June 13, 2018

Conditions

Sexually Transmitted InfectionsDomestic Violence

Outcome Measures

Primary Outcomes (1)

  • Incidence of New Sexually Transmitted Infections

    at 30 months

Secondary Outcomes (2)

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

    at 12 months

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

    at 30 months

Study Arms (2)

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.

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.

Interventions

Microfinance and Health LeadershipBEHAVIORAL

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.

Microfinance and Health Leadership

Eligibility Criteria

Age15 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unwilling to provide locator information
  • Unable to participate due to psychological disturbance, cognitive impairment or threatening behavior.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (8)

  • 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.

    PMID: 26842360BACKGROUND

  • 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.

    PMID: 26802044RESULT

  • 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.

    PMID: 26874081RESULT

  • 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.

    PMID: 26880322RESULT

  • 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.

    PMID: 27469516RESULT

  • 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.

    PMID: 27506817RESULT

  • 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.

    PMID: 28812448RESULT

  • 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.

    PMID: 28849338RESULT

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Suzanne Maman, PhD

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Lusajo Kajula-Maonga, MA

    Muhimbilit University of Health and Allied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2013

First Posted

May 30, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

June 15, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Data will be made available on request, and per NIH regulations.

Locations

US(1)