Strengthening Women's Agency During Pregnancy

Not Applicable

• Conditions: Intimate Partner Violence

• Registration Number: NCT05515094
• Lead Sponsor: International Rescue Committee

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-05-15
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-25
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-22
• Study Start: 2023-01-15
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Intimate Partner violence-	Through study completion, average length three months;	Proportion of women indicating they have experienced physical, sexual, and / or psychological IPV using the WHO multi-country study instruments on IPV
Checklist of Safety Behaviors	Through study completion, average length three months;	12 item index of safety behaviors; increased number of safety behaviors indicates improvement in safety behaviors
Uptake of case management services	Through study completion, average length three months;	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.