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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03237585
Other study ID # EC031-9/2015
Secondary ID
Status Recruiting
Phase N/A
First received July 1, 2017
Last updated July 30, 2017
Start date October 1, 2015
Est. completion date June 30, 2018

Study information

Verified date July 2017
Source Medical Research Council, South Africa
Contact Richard Adanu, PhD
Phone +233 (0) 244238556
Email rmadanu@ug.edu.gh; rmadanu@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

AIM: To assess the community level impact of the Gender Centre's Rural Response System (RRS) in reducing violence against women (VAW) in Ghana.

METHODS:

Design: An unmatched cluster randomised controlled trial with two arms i) Intervention arm- Receive Gender Centre's RRS /COMBAT package for communities as well as state agencies. Control arm - No intervention. Qualitative component Setting: Rural and urban communities in the Central Region of Ghana. i). Rural and urban communities in four (4) Districts located in the Central Region of Ghana. Two districts are along the Coast (Abura and Komenda) while the other two (Agona and Upper Denkyira) are inland districts.

ii). State Agencies (DOVVSU/Police, CHRAJ, Social Welfare, and Health Services).

Interventions: Carried out in two Districts - Agona district and Komenda district. Workings of the intervention arm will be facilitated by the Gender Studies and Human Rights Documentation Centre in Ghana.

Sample size: A total of 3280 adults (1640 women and 1640 men) from 20 clusters per trial arm (approximately 82 households per cluster) will be recruited at baseline and again at post-intervention survey. Sampling format will be a community survey with independent samples design (i.e. in each community, the people surveyed at baseline may not necessarily be the same people who are surveyed at post intervention. Clusters refer to the selected localities and their participating communities in each district.

Evaluation design: Pre-test all study participants with a standardized instrument then introduce the independent variable (intervention) to the experimental group while withholding it from the control group. After 24 months of intervention, post-test both groups with the same instrument and under the same conditions as the pretest (baseline). Compare the amount of change in dependent variable for both experimental and control groups.

Data analysis: The data will be analysed by intention to treat. The past 12 months prevalence of IPV will be compared between arms in the study.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Rural response system (RRS) intervention to reduce violence against women
The Rural Response System which uses the strategy of trained community members known as Community-based action team, COMBAT to undertake awareness-raising on gender-based violence as well as providing support to victims of violence to access justice and other relevant services.

Locations

Country Name City State
Ghana Rural and Urban Communities Abura, Komenda, Agona, Upper Denkyira Central Region

Sponsors (2)

Lead Sponsor Collaborator
Medical Research Council, South Africa University of Ghana

Country where clinical trial is conducted

Ghana, 

References & Publications (6)

1. Gender Studies and Human Rights Documentation Centre, Breaking the Silence and Challenging the Mythos of Violence against Women and Children in Ghana. Report of a national study on Violence. Edited by Dorcas Coker-Appiah and Kathy Cusack. Gender and Human Rights Documentation Centre, 1998.

2. Ghana Statistical Service (GSS). 2013. 2010. Population and Housing Census, Regional Analytical Report; Central Region, Ghana: Ghana Statistical Service, Accra.

4. Ghana Statistical Service (GSS), Ghana Health Service (GHS), and ICF Macro. 2009. Ghana Demographic and Health Survey 2008. Accra, Ghana: GSS, GHS, and ICF Macro.

Department of Health, Education, and Welfare; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research. J Am Coll Dent. 2014 Summer;81(3):4-13. — View Citation

Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. Review. — View Citation

World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Past year incidence of intimate partner violence The primary outcome indicator for this impact assessment is past year incidence of IPV (perpetration of physical and/or sexual IPV for men and experience for women). 1 year
Secondary Institutional assessment of violence against women cases Assess reported cases of violence against women 3 years
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