Strengthening Women's Agency During Pregnancy

NCT ID: NCT05515094

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2023-12-31

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.

Conditions

Intimate Partner Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Empowerment Counseling Intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: collaborator

International Rescue Committee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudia Garcia Moreno

Role: PRINCIPAL_INVESTIGATOR

World Health Organization

Mary Ellsberg

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Bathsheba Mahenge

Role: PRINCIPAL_INVESTIGATOR

International Rescue Committee

Central Contacts

Kathryn Falb

Role: CONTACT

kathryn.falb@rescue.org

(202) 822-0043

Other Identifiers

DF222

Identifier Type: -

Identifier Source: org_study_id