NCT03237585

Brief 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.

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
3,280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

August 2, 2017

Status Verified

July 1, 2017

Enrollment Period

2.7 years

First QC Date

July 1, 2017

Last Update Submit

July 30, 2017

Conditions

Keywords

gender based violenceviolence against womenintimate partner violenceimpact assessmentrural response systemcluster randomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Institutional assessment of violence against women cases

    3 years

Study Arms (2)

i) Intervention arm- Receive Gender Centre's RRS package

EXPERIMENTAL
Behavioral: Rural response system (RRS) intervention to reduce violence against women

No intervention

NO INTERVENTION

Interventions

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.

i) Intervention arm- Receive Gender Centre's RRS package

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult women (ages 18 to 49 years) and adult men (≥ 18 years) in the Central Region of Ghana
  • Usually live (sleep and eat) in the household, have lived in the community for at least a year

You may not qualify if:

  • Minor
  • Not able to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rural and Urban Communities

Abura, Komenda, Agona, Upper Denkyira, Central Region, Ghana

RECRUITING

Related 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.

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

    BACKGROUND
  • Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. doi: 10.1093/ije/28.2.319.

    PMID: 10342698BACKGROUND
  • 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.

    BACKGROUND
  • 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. No abstract available.

    PMID: 24141714BACKGROUND
  • 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.

    PMID: 25951677BACKGROUND

Study Officials

  • Richard Adanu, PhD

    University of Ghana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adolphina Addo-Lartey, PhD

CONTACT

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

July 1, 2017

First Posted

August 2, 2017

Study Start

October 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 30, 2018

Last Updated

August 2, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share

Study protocol will be published.

Shared Documents
STUDY PROTOCOL
Time Frame
2017
Access Criteria
Published in Open Access Journal

Locations