Strengthening Women's Agency During Pregnancy (SWAP)

International Rescue Committee

Status: Not yet enrolling

Conditions: Intimate Partner Violence

Treatments: Behavioral: Empowerment Counseling Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05515094

DF222

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Intervention Arm (Empowerment Counseling Intervention)

Experimental group

Description:

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.

Treatment:

Behavioral: Empowerment Counseling Intervention

Standard of Care

No Intervention group

Description:

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.