NCT02592252

Brief Summary

Violence against women and girls is increasingly recognized as a major global public health and development concern. However, evidence on what forms of intervention should be prioritised is severely lacking. A cluster randomized controlled trial (The Intervention with Microfinance for AIDS \& Gender Equity - IMAGE Project) in rural South Africa combined a group-based microfinance intervention with a participatory gender and HIV training curriculum for loan participants and showed that, over a two-year period, levels of physical and/or sexual partner violence experienced by participants in the past year were reduced by 55%. The overall goal of the current study is to design and implement a cluster randomized controlled trial to assess the impact on intimate partner violence of: 1) combining participatory gender training with microfinance for women in existing microfinance loan groups, and 2) a participatory gender training programme for women (not receiving microfinance) and their male partners.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,640

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

4.8 years

First QC Date

August 13, 2015

Last Update Submit

March 23, 2018

Conditions

Maltreatment by Spouse or Partner

Outcome Measures

Primary Outcomes (1)

  • Past 12 months exposure to intimate partner violence

    Exposure to intimate partner violence will be assessed using the WHO Multi-country Study on Women's Health and Domestic Violence against Women questionnaire

    24 months post-intervention

Study Arms (4)

Microfinance + gender training

EXPERIMENTAL

Microfinance + 10 sessions of participatory gender training

Behavioral: Participatory gender trainingOther: Microfinance

Microfinance only

EXPERIMENTAL

Receive microfinance only

Other: Microfinance

Gender training only

EXPERIMENTAL

10 sessions of participatory gender training for women and their male partners

Behavioral: Participatory gender training

No intervention

NO INTERVENTION

No microfinance or participatory gender training

Interventions

Participatory gender trainingBEHAVIORAL

10 sessions of participatory gender training

Gender training onlyMicrofinance + gender training
MicrofinanceOTHER

Microfinance loan

Microfinance + gender trainingMicrofinance only

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Arms 1 and 2 - microfinance loan groups:
  • there are between 15 and 30 active members in the group
  • less than 25% of the women have been members for less than one year
  • there is a good attendance (repayment) record
  • a minimum of 70% of active members consent to take part in the study
  • Arms 3 and 4, women who:
  • are aged 20-50 years
  • are not formally employed, i.e. either self-employed or not currently working
  • have been resident in Mwanza for at least two years
  • have not been a member of a microfinance loan group in the past 12 months
  • are fluent in Swahili
  • have consented to take part in the study.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mawanza Intervention Trials Unit

Mwanza, Tanzania

RECRUITING

Related Publications (7)

  • Abramsky T, Guadarrama DS, Kapiga S, Mtolela G, Madaha F, Lees S, Harvey S. Pathways to reduced physical intimate partner violence among women in north-western Tanzania: Evidence from two cluster randomised trials of the MAISHA intervention. PLOS Glob Public Health. 2023 Nov 13;3(11):e0002497. doi: 10.1371/journal.pgph.0002497. eCollection 2023.

    PMID: 37956111DERIVED

  • Abramsky T, Harvey S, Mosha N, Mtolela G, Gibbs A, Mshana G, Lees S, Kapiga S, Stockl H. Longitudinal inconsistencies in women's self-reports of lifetime experience of physical and sexual IPV: evidence from the MAISHA trial and follow-on study in North-western Tanzania. BMC Womens Health. 2022 Apr 15;22(1):120. doi: 10.1186/s12905-022-01697-y.

    PMID: 35428296DERIVED

  • Harvey S, Abramsky T, Mshana G, Hansen CH, Mtolela GJ, Madaha F, Hashim R, Kapinga I, Watts C, Lees S, Kapiga S. A cluster randomised controlled trial to evaluate the impact of a gender transformative intervention on intimate partner violence against women in newly formed neighbourhood groups in Tanzania. BMJ Glob Health. 2021 Jul;6(7):e004555. doi: 10.1136/bmjgh-2020-004555.

    PMID: 34301673DERIVED

  • Kapiga S, Harvey S, Mshana G, Hansen CH, Mtolela GJ, Madaha F, Hashim R, Kapinga I, Mosha N, Abramsky T, Lees S, Watts C. A social empowerment intervention to prevent intimate partner violence against women in a microfinance scheme in Tanzania: findings from the MAISHA cluster randomised controlled trial. Lancet Glob Health. 2019 Oct;7(10):e1423-e1434. doi: 10.1016/S2214-109X(19)30316-X.

    PMID: 31537372DERIVED

  • Abramsky T, Lees S, Stockl H, Harvey S, Kapinga I, Ranganathan M, Mshana G, Kapiga S. Women's income and risk of intimate partner violence: secondary findings from the MAISHA cluster randomised trial in North-Western Tanzania. BMC Public Health. 2019 Aug 14;19(1):1108. doi: 10.1186/s12889-019-7454-1.

    PMID: 31412825DERIVED

  • Harvey S, Lees S, Mshana G, Pilger D, Hansen C, Kapiga S, Watts C. A cluster randomized controlled trial to assess the impact on intimate partner violence of a 10-session participatory gender training curriculum delivered to women taking part in a group-based microfinance loan scheme in Tanzania (MAISHA CRT01): study protocol. BMC Womens Health. 2018 Apr 2;18(1):55. doi: 10.1186/s12905-018-0546-8.

    PMID: 29609568DERIVED

  • Kapiga S, Harvey S, Muhammad AK, Stockl H, Mshana G, Hashim R, Hansen C, Lees S, Watts C. Prevalence of intimate partner violence and abuse and associated factors among women enrolled into a cluster randomised trial in northwestern Tanzania. BMC Public Health. 2017 Feb 14;17(1):190. doi: 10.1186/s12889-017-4119-9.

    PMID: 28193198DERIVED

Central Study Contacts

Sheila E Harvey, Ph.D

CONTACT

+44 (0)207 612 7854sheila.harvey@lshtm.ac.uk

Shelley Lees, Ph.D

CONTACT

44 (0)207 327 2586shelley.lees@lshtm.ac.uk

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

August 13, 2015

First Posted

October 30, 2015

Study Start

September 1, 2014

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

March 26, 2018

Record last verified: 2018-03

Locations

TA(1)