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Clinical Trials/NCT05515094
NCT05515094
Unknown
Not Applicable

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

International Rescue Committee0 sites150 target enrollmentJanuary 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intimate Partner Violence
Sponsor
International Rescue Committee
Enrollment
150
Primary Endpoint
General Self-Efficacy Scale
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2023
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

General Self-Efficacy Scale

Time Frame: 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

Time Frame: 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 Outcomes

  • Intimate Partner violence-(Through study completion, average length three months;)
  • Checklist of Safety Behaviors(Through study completion, average length three months;)
  • Uptake of case management services(Through study completion, average length three months;)

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