Clinical trial NCT05515094: Strengthening Women's Agency During Pregnancy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intimate Partner Violence
Lead sponsor: International Rescue Committee
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: George Washington University
First posted: 2022-08-25
Enrollment: 150
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient Health Questionnaire - 9
timeFrame: 3 months endline survey, past two week recall period
measure: General Self-Efficacy Scale
timeFrame: 3 months endline survey, present recall period
Secondary outcomes:
measure: Checklist of Safety Behaviors
timeFrame: Through study completion, average length three months;
measure: Uptake of case management services
timeFrame: Through study completion, average length three months;
measure: Intimate Partner violence-
timeFrame: Through study completion, average length three months;
Other outcomes:
Locations:
Study officials:
affiliation: World Health Organization
name: Claudia Garcia Moreno
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University
name: Mary Ellsberg
role: PRINCIPAL_INVESTIGATOR
affiliation: International Rescue Committee
name: Bathsheba Mahenge
role: PRINCIPAL_INVESTIGATOR
References: