Strengthening Women's Agency During Pregnancy (SWAP)

Strengthening Women's Agency in Pregnancy (SWAP): Empowerment Counselling Intervention [ECI] for Pregnant Women and Girls Affected by Intimate Partner Violence in a Refugee Camp in Tanzania

This research aims to address the feasibility and acceptability of a brief empowerment counselling intervention (ECI) among pregnant women and girls receiving antenatal care (ANC) who have experienced intimate partner violence (IPV), in humanitarian healthcare settings.

Study Overview

• Status: Not yet recruiting
• Conditions: Intimate Partner Violence
• Intervention / Treatment: Behavioral: Empowerment Counseling Intervention

Detailed Description

This research aims to address the feasibility and acceptability of a brief empowerment counseling intervention (ECI) among pregnant women and girls receiving antenatal care (ANC) who have experienced intimate partner violence (IPV), in humanitarian healthcare settings. This 3- year study will take place in two IRC-managed health posts in a refugee camp in Kigoma, Tanzania. The objectives of the study are to: 1) Adapt, as needed, for use in the context of ANC in a humanitarian setting, a brief ECI to address women's and girls' exposure to sexual and/or physical IPV during pregnancy, by improving their mental health, self-efficacy, safety, and coping strategies; 2) Test the ECI through a pilot randomized controlled trial, determining whether the intervention is feasible/acceptable and whether it improves women's self-efficacy, reduces mental distress and increases uptake of longer-term IPV services; 3) Test the feasibility of integrating such an intervention into pre-existing ANC service delivery in humanitarian settings and make recommendations for future intervention research and development, including effectively linking routine enquiry of IPV in ANC settings with support service use.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathryn Falb; Phone Number: (202) 822-0043; Email: kathryn.falb@rescue.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women or girl aged 15 years or older:
• Pregnant (any trimester);
• Attending their 2nd or later ANC visit;
• Have experienced physical and/or sexual and/or severe psychological IPV in the past 12 months;
• Consent to participate.

Exclusion Criteria:

• At their first ANC visit or accompanied by their partner (or anyone else) at the ANC visit;
• Under age 15;
• Unable to provide informed consent/assent;
• Suicidal or at risk of severe violence or of being murdered; and/or
• In a high-risk situation or medically high risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm (Empowerment Counseling Intervention); The Empowerment Counseling Intervention (ECI) entails directly linking women to on-site case managers who will provide first-line support (i.e., a brief psychosocial support session) and a safety and health assessment to women who are attending to receive ANC and disclose violence. The intervention (e.g., the initial counselling session), adapted from current case management guidelines and the Safe and Sound intervention at health facilities, will be administered directly at the health facility after a woman screens positive for IPV. In line with a survivor centered approach, as part of the initial session, the survivor participant will be invited back for further counselling sessions as part of the intervention curriculum, in addition to being supported to access other services based on her preferences, such as group psychosocial support. The intervention manual acts as a guide and support for trained social workers to support the unique needs of each survivor.	Behavioral: Empowerment Counseling Intervention; The intervention entails case managers conducting first-line support (i.e., a brief psychosocial support session), and a safety and health assessment, adapted from current case management content and the Safe and Sound intervention.
No Intervention: Standard of Care; Women in the comparison arm will receive the standard of care and be referred to support services at the nearby IRC Women's Protection and Empowerment (WPE) office.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire - 9	Depressive symptoms will be assessed via the PHQ-9 questionnaire. The range of scores is 0-27. A higher score indicates more symptoms.	3 months endline survey, past two week recall period
General Self-Efficacy Scale	Adapted measure of the GSE Scale. Possible score 10-40; higher indicating more self-efficacy.	3 months endline survey, present recall period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Checklist of Safety Behaviors	12 item index of safety behaviors; increased number of safety behaviors indicates improvement in safety behaviors	Through study completion, average length three months;
Uptake of case management services	Two items indicating whether a survivor has shared information about violence with others or has sought additional services. Higher endorsement is better uptake of case management services.	Through study completion, average length three months;
Intimate Partner violence-	Proportion of women indicating they have experienced physical, sexual, and / or psychological IPV using the WHO multi-country study instruments on IPV	Through study completion, average length three months;

Collaborators and Investigators

• Sponsor: International Rescue Committee
• Collaborators: George Washington University; World Health Organization
• Investigators: Principal Investigator: Claudia Garcia Moreno, World Health Organization; Principal Investigator: Mary Ellsberg, George Washington University; Principal Investigator: Bathsheba Mahenge, International Rescue Committee

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 15, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DF222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No