Strengthening Women's Agency During Pregnancy (SWAP)

December 20, 2022 updated by: International Rescue Committee

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
No 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months endline survey, past two week recall period
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.
3 months endline survey, present recall period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Checklist of Safety Behaviors
Time Frame: Through study completion, average length three months;
12 item index of safety behaviors; increased number of safety behaviors indicates improvement in safety behaviors
Through study completion, average length three months;
Uptake of case management services
Time Frame: Through 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.
Through study completion, average length three months;
Intimate Partner violence-
Time Frame: 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
Through study completion, average length three months;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Rescue Committee

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
George Washington University
World Health Organization

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claudia Garcia Moreno, World Health Organization
  • Principal Investigator: Mary Ellsberg, George Washington University
  • Principal Investigator: Bathsheba Mahenge, International Rescue Committee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DF222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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