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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02592252
Other study ID # QA430
Secondary ID
Status Recruiting
Phase N/A
First received August 13, 2015
Last updated March 23, 2018
Start date September 2014
Est. completion date December 2019

Study information

Verified date March 2018
Source London School of Hygiene and Tropical Medicine
Contact Sheila E Harvey, Ph.D
Phone +44 (0)207 612 7854
Email sheila.harvey@lshtm.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2640
Est. completion date December 2019
Est. primary completion date July 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

Arms 1 and 2 - microfinance loan groups:

1. there are between 15 and 30 active members in the group

2. less than 25% of the women have been members for less than one year

3. there is a good attendance (repayment) record

4. a minimum of 70% of active members consent to take part in the study

Arms 3 and 4, women who:

1. are aged 20-50 years

2. are not formally employed, i.e. either self-employed or not currently working

3. have been resident in Mwanza for at least two years

4. have not been a member of a microfinance loan group in the past 12 months

5. are fluent in Swahili

6. have consented to take part in the study.

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms

  • Maltreatment by Spouse or Partner

Intervention

Behavioral:
Participatory gender training
10 sessions of participatory gender training
Other:
Microfinance
Microfinance loan

Locations

Country Name City State
Tanzania Mawanza Intervention Trials Unit Mwanza

Sponsors (5)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine Bangladesh Rural Advancement Committee, EngenderHealth, Mwanza Intervention Trials Unit, National Institute for Medical Research, Tanzania

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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