Intimate Partner ViolenceSWAPNCT05515094
Strengthening Women's Agency During Pregnancy
A study testing Empowerment Counseling Intervention in people with Intimate Partner Violence, run by International Rescue Committee.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Empowerment Counseling Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- Empowerment Counseling Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment Counseling InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (Empowerment Counseling Intervention) | Experimental | 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. Receives: Behavioral: Empowerment Counseling Intervention |
| Standard of Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire - 9
Depressive symptoms will be assessed via the PHQ-9 questionnaire. The range of scores is 0-27. A higher score indicates more symptoms.
Measured: 3 months endline survey, past two week recall period
General Self-Efficacy Scale
Adapted measure of the GSE Scale. Possible score 10-40; higher indicating more self-efficacy.
Measured: 3 months endline survey, present recall period
Secondary outcomes (3)
Checklist of Safety Behaviors
12 item index of safety behaviors; increased number of safety behaviors indicates improvement in safety behaviors
Measured: Through study completion, average length three months;
Uptake of case management services
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.
Measured: Through study completion, average length three months;
Intimate Partner violence-
Proportion of women indicating they have experienced physical, sexual, and / or psychological IPV using the WHO multi-country study instruments on IPV
Measured: Through study completion, average length three months;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start15 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Rescue Committee
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, George Washington University
- Responsible party
- Sponsor
- Investigators
- Claudia Garcia Moreno, Principal investigator, World Health OrganizationMary Ellsberg, Principal investigator, George Washington UniversityBathsheba Mahenge, Principal investigator, International Rescue Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515094
- Sponsor's protocol ID
- DF222
- Acronym
- SWAP
- Status last verified
- Aug 2022
- First submitted
- 15 May 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05515094
- Acronym / sponsor ID
- SWAP / DF222
- Conditions
- Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- International Rescue CommitteeUniversity, hospital or other
- Collaborators
- World Health Organization, George Washington University
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (Empowerment Counseling Intervention) | Experimental | Behavioral: Empowerment Counseling InterventionThe 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. |
| Standard of Care | No intervention | –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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowerment Counseling InterventionThe 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. | Behavioural | Intervention Arm (Empowerment Counseling Intervention) |
Primary outcome
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.
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 secondary outcomes
Checklist of Safety Behaviors
Time frame: Through study completion, average length three months;
Uptake of case management services
Time frame: Through study completion, average length three months;
Intimate Partner violence-
Time frame: Through study completion, average length three months;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Garcia Moreno principal investigator
World Health Organization
Mary Ellsberg principal investigator
George Washington University
Bathsheba Mahenge principal investigator
International Rescue Committee
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment Counseling Intervention in people with Intimate Partner Violence, run by International Rescue Committee.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Falb ((202) 822-0043, kathryn.falb@rescue.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire - 9 (time frame: 3 months endline survey, past two week recall period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.