NCT02434796

Brief Summary

Women in Tanzania suffer alarming rates of intimate partner violence (IPV) that has detrimental effects on mental and physical health including an increased risk of HIV infection. The investigators will use a cluster randomized control study design to conduct a preliminary evaluation study of TEVAW, an intervention that aims to improve gender equitable attitudes and to decrease tolerance of IPV among men and women in rural Tanzania. Nine villages will be randomly assigned into one of three study arms, each comprised of 150 partnered women and their co-resident male partners. Women in the comparison arm are currently exposed to World Education's savings and lending group intervention (known as LIMCA), in which they receive training on business skills, literacy, child nutrition and health, child protection, intimate partner violence (IPV) and HIV prevention. Women in Intervention Arm 1 will be exposed to LIMCA, while their male partners will participate in male peer group workshops that explore gender norms, IPV and HIV prevention issues. In Intervention Arm 2, men and women will receive the same treatment as Intervention Arm 1 and participate in community dialogues with community leaders to explore similar topics as the male peer groups. Our hypothesis is that study participants in Arm 2 will report improved gender equitable attitudes and lower intolerance of intimate partner violence than participants in Arm 1 and participants in the control group. Data will be collected at baseline and endline using a structured questionnaire with questions from three validated instruments that measure gender equitable attitudes and attitudes about IPV.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

April 30, 2015

Last Update Submit

March 16, 2017

Conditions

Keywords

Intimate Partner ViolenceGender-Based ViolenceGenderHIV

Outcome Measures

Primary Outcomes (1)

  • Difference in proportion of men who report a husband is justified in beating his wife

    For attitudes on IPV, men get the value of 1, if they agree that a husband is justified in hitting or beating his wife if she (a) burns the food; (b) argues with him; (c) goes out without telling him; (d) neglects the children; or (e) refuses to have sexual intercourse with him; men get a 0 if they do not agree with any of these statements.

    4 months

Secondary Outcomes (1)

  • Difference in proportion of men who report gender-inequitable attitudes

    4 months

Study Arms (2)

Arm 1 Male Peer Groups (MPG)

EXPERIMENTAL

Women participate in savings groups and male partners participate in male peer group workshops on gender norms, IPV and HIV prevention. This intervention aims to improve knowledge and attitudes about the harms of IPV on women, men and children; the confidence to internalize positive masculine ideals (e.g. caring for one's family) and to challenge gender stereotypes (e.g. women are not equal to men); and the ability to formulate positive outcome expectations regarding IPV (intolerance of violence perpetrated by themselves or others) and healthy relationships with their spouses and communities.

Behavioral: Male Peer Groups

Arm 2 MPG & Community Dialogues

EXPERIMENTAL

This arm will include women participants in savings groups, male peer groups and community dialogues. Village community leaders will engage in community dialogues on gender norms, IPV and HIV prevention.

Behavioral: Male Peer Groups and Community Dialogues

Interventions

In Intervention Arm 1, male partners participate in male peer group workshops on gender norms, IPV and HIV prevention. Men's peer groups address gender inequality and transformation of gender power relations, positive masculinities and accountability of men in the perpetration of violence against women. This intervention aims to improve knowledge and attitudes among men about the harms of IPV on women, men and children; the confidence to internalize positive masculine ideals and to challenge gender stereotypes; and the ability to formulate positive outcome expectations regarding IPV and healthy relationships with their spouses and communities. Male peer group workshops will be conducted as a series of four workshops for a total of 24 hours spread out over a 5-month period.

Arm 1 Male Peer Groups (MPG)

Men participate in male peer group workshops as in Intervention Arm 1. In addition, village level community leaders engage in community mobilization/sensitization activities that include women members of savings groups and their male partners who participate male peer groups. Community dialogues focus on gender norms, IPV and HIV prevention. First, a one-day workshop for community leaders on topics similar to those raised in male peer group sessions. Second, trained community leaders facilitate community dialogues on IPV, HIV prevention, and gender norms with savings groups members and their male partners who participate in male peer groups. Each workshop will be a day-long event.

Arm 2 MPG & Community Dialogues

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Married women, aged 18 and older, who live in Karatu District in Northern Tanzania with their male partners, who participate in the LIMCA program, are willing to participate, and provide informed consent.
  • Male partners of women LIMCA members named above, aged 18 and older who live in Karatu District in Northern Tanzania, are willing to participate, and provide informed consent.

You may not qualify if:

  • Women who are not partnered, who do not live in the study catchment area, who do not participate in the LIMCA program, and who do not provide informed consent
  • Men who are not married or partnered, who do not live in the study catchment area; whose wives/partners do not participate in the LIMCA program, and who do not provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Halim N, Steven Mzilangwe E, Reich N, Badi L, Simmons E, Servidone M, Bingham Holmes N 2nd, Kawemama P, Messersmith LJ. Together to end violence against women in Tanzania: Results of a pilot cluster randomized controlled trial to evaluate preliminary effectiveness of interpersonal and community level interventions to address intimate partner violence. Glob Public Health. 2019 Dec;14(12):1653-1668. doi: 10.1080/17441692.2019.1609062. Epub 2019 May 13.

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Lisa Messersmith, PhD, MPH

    Boston University Center for Global Health and Development

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 5, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2016

Study Completion

January 1, 2017

Last Updated

March 17, 2017

Record last verified: 2017-03