Strengthening Women's Agency During Pregnancy

Intimate Partner Violence Clinical Trial

— SWAP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05515094
• Other study ID #: DF222
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: International Rescue Committee
• Contact: Kathryn Falb
• Phone: (202) 822-0043
• Email: kathryn.falb[@]rescue.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intimate Partner Violence

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
International Rescue Committee	George Washington University, World Health Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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;
Secondary	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;
Secondary	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;