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Strengthening Women's Agency During Pregnancy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05515094
Acronym
SWAP
Enrollment
150
Registered
2022-08-25
Start date
2023-01-15
Completion date
2023-12-31
Last updated
2022-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intimate Partner Violence

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.

Interventions

BEHAVIORALEmpowerment 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.

Sponsors

World Health Organization
CollaboratorOTHER
George Washington University
CollaboratorOTHER
International Rescue Committee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire - 93 months endline survey, past two week recall periodDepressive symptoms will be assessed via the PHQ-9 questionnaire. The range of scores is 0-27. A higher score indicates more symptoms.
General Self-Efficacy Scale3 months endline survey, present recall periodAdapted measure of the GSE Scale. Possible score 10-40; higher indicating more self-efficacy.

Secondary

MeasureTime frameDescription
Checklist of Safety BehaviorsThrough study completion, average length three months;12 item index of safety behaviors; increased number of safety behaviors indicates improvement in safety behaviors
Uptake of case management servicesThrough study completion, average length three months;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.
Intimate Partner violence-Through study completion, average length three months;Proportion of women indicating they have experienced physical, sexual, and / or psychological IPV using the WHO multi-country study instruments on IPV

Contacts

Primary ContactKathryn Falb
kathryn.falb@rescue.org(202) 822-0043

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026