Clinical trial NCT06350383: Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention
Official title: Adapting a Low-cost Intimate Partner Violence (IPV) and Mental Health Response Intervention for Women in Informal Settlements in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence, Domestic
Psychological Distress
Keywords: Intimate partner violence (IPV)
Randomized control trial (RCT)
Wings of Hope (WINGS)
Problem Management Plus (PM+)
Kenya
Informal settlements (slums)
Women
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Drexel University
name: Africa Mental Health Research and Training Foundation
name: Fogarty International Center of the National Institute of Health
First posted: 2024-04-05
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel-group design
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this feasibility study (clinical trial) is to test a low-cost, combined, adapted intimate partner violence (IPV) and mental health intervention (Wings of Hope: WINGS + Problem Management Plus: PM+) that can be carried out by lay community health workers as a foundation for a potential low-cost essential services package for women experiencing IPV and related mental health challenges in informal settlements in Kenya. The main aims of the study are to (1) assess the safety, feasibility, and acceptability of WINGS+PM+ among women experiencing IPV in informal settlements in Kenya; (2) to test preliminary efficacy of program mediating outcomes in addition to the distal outcome (incidence/severity of IPV), while closely monitoring fidelity or process measures, including attendance/retention, adherence, quality of delivery, participant satisfaction, safety and quality improvement and adaptation modifications; and (3) generate data on distributions of study outcomes to calculate the power to detect a meaningful effect size in a future efficacy trial. Women experiencing IPV (n=260) will be recruited from the outpatient walk-in departments at the Kianda 42 Hospital in Kibera informal settlement (n=130) and Upendo Clinic in Mathare informal settlement (n=130). Consenting women will be screened for experiences of recent IPV (last 3 months). Subsequently 130 eligible IPV survivors from the Kianda 42 Hospital and 130 from the Upendo Clinic will be randomized to either receive the combined WINGS+PM+ intervention (n=65) or the PM+-only intervention (control/comparison arm) (n=65) at each clinic.

Detailed description: Women experiencing IPV (n=260) will be recruited from the outpatient walk-in departments at Kianda 42 Clinic in Kibera informal settlement (n=130) and Upendo Clinic in Mathare informal settlement (n=130). Consenting patients will be screened for recent experiences of IPV (past 3 months) by nurses or staff using an adapted version of the World Health Organization (WHO) IPV Brief Self-screener (IPV-BSS) and asked several mental health and functioning questions.

Informational scripts about the study will be shared and posted at the two clinics and also shared by community health volunteers (CHVs) with clinic patients during routine household visits. Every CHV who is attached to a clinic is responsible for doing routine visits with clinic patients in up to 100 households each month in the informal settlement in which the clinic is located. The purpose of these routine household visits is to check-in on patients, let households know about new or relevant clinic programs, and carry out relevant health-related trainings (e.g., how to treat water during a cholera outbreak or how to practice proper hygiene during COVID). The informational script will let patients in the clinics and broader community know that, if they are interested in the program, they can come to the clinic to be screened for eligibility.

Eligibility/IPV screens will be collected by trained non-specialist in-take staff in a private in-take room at the Kianda 42 Clinic in Kibera and Upendo in Mathare. Screening is anonymous. No identifying information will be collected as part of the screen. Answers to the screening questions will be recorded on digitally on study tablets. Verbal consent for eligibility screens will be collected. In-take staff will note on the informed consent document that the participant verbally consented to the screening, and sign their own names to attest to participants' consent.

If women screen positive for IPV in the past three months and meet the rest of the eligibility criteria, they will be asked if they are interested in participating in the feasibility trial. If they express interest, they will be referred to a trained CHV who will take them through the a digital Informed Consent Process for the feasibility trial.

Consenting participants will be guided through a baseline assessment by a CHV and then randomized to either the combined WINGS+PM+ (n=130; 65 at Kianda 42 and 65 at Upendo) or the psychological-only (PM+) arm (n=130; 65 at Kianda 42 and 65 at Upendo). Block randomization with random block sizes will be used to "force" a balance between study arms with respect to the number of women per arm per clinic.

WINGS+PM+ and PM+-only sessions will be delivered by trained CHVs at Kianda 42 and Upendo. WINGS+PM+ is a safety, harm reduction, and brief psychological intervention combined and adapted by community members from informal settlements in Kenya (IPV survivors, health clinic staff, and CHVs) from two evidence-based interventions: Wings of Hope (WINGS) and Problem Management Plus (PM+). This intervention was designed to be facilitated by non-specialists (e.g., CHVs). It involves seven 90-minute weekly sessions focused on exploring types and mechanisms of IPV (e.g., the role of household economics in IPV); building motivation to address IPV; safety planning and revision; enhancing social support to address IPV; goal setting and revision; identifying IPV-related services and needs; linkage and referral to services; self-care planning; learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention. PM+: is a brief psychological intervention also designed to be facilitated by non-specialists (e.g. CHVs) and focused on problem management and evidence-based behavioral strategies to enhance one's capacity to adaptively manage psychological distress. It has been shown to be effective at reducing psychological distress among women who have experienced gender-based violence in informal settlements in Nairobi, Kenya. PM+ involves five 90-minute, weekly individual sessions focused on learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention.

Intervention outcomes will be assessed at four time points: baseline, immediately post intervention (IPI), 3-month, and 6-month follow-up.

To reduce contamination, CHVs will either carry out assessment or facilitate the intervention. Some CHVs will deliver PM+-only while others will deliver the WINGS+PM+ intervention. Project staff will meet regularly with CHVs providing PM+ only to establish the types of support and counselling they offered to participants and check that there was no contamination of the WINGS+PM+ strategies in the PM+-only arm. All intervention sessions will be audio-recorded for quality assurance.

Eligibility criteria: Inclusion Criteria:

* Reports experiencing IPV in the past 3 months using the WHO IPV-BSS screener
* Reports feeling safe participating in the study
* Able to provide informed consent and follow study procedures
* Fluent in English and/or Swahili
* At least 18 years of age

Exclusion Criteria:

* Does not report IPV in the past 3 months,
* Does not feel safe participating in study,
* Unable to provide informed consent and/or follow study procedures,
* Cannot communicate in English or Swahili,
* Under the age of 18 years

Primary outcomes:
measure: World Health Organization (WHO) Violence Against Women (VAW) diagnostic instrument
timeFrame: Baseline, immediately post intervention, 3-month follow-up, 6-month follow-up
Secondary outcomes:
measure: Receipt of violence services
timeFrame: Baseline, immediately post intervention, 3-month follow-up, 6-month follow-up
measure: Domestic Violence Coping Self-efficacy Scale (DVCSE)
timeFrame: Baseline, immediately post intervention, 3-month follow-up, 6-month follow-up
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline, immediately post intervention, 3-month follow-up, 6-month follow-up
measure: Safety Behavior Checklist
timeFrame: Baseline, immediately post intervention, 3-month follow-up, 6-month follow-up
measure: Psychological distress (GHQ-12)
timeFrame: Baseline, immediately post intervention, 3-month follow-up, 6-month follow-up
measure: Functioning (WHODAS 2.0)
timeFrame: Baseline, immediately post intervention, 3-month follow-up, 6-month follow-up
measure: Short form of the Posttraumatic Stress Disorder Checklist (PCL-5)
timeFrame: Baseline, immediately post intervention, 3-month follow-up, 6-month follow-up
measure: Personalized outcomes (PSYCHLOPS)
timeFrame: Baseline, immediately post intervention, 3-month follow-up, 6-month follow-up
Other outcomes:
measure: Quality control/intervention fidelity
timeFrame: Through study completion, an average of 8 months
measure: Facilitator Satisfaction and ease of intervention delivery (EBPAS-36)
timeFrame: Through study completion, an average of 8 months
measure: Adverse events
timeFrame: Through study completion, an average of 8 months
measure: Participant satisfaction with intervention
timeFrame: Through study completion, an average of 8 months
measure: Number of participants in attendance at sessions
timeFrame: Through study completion, an average of 8 months
measure: Retention Rate
timeFrame: Baseline, immediately post intervention, 3-month follow-up, 6-month follow-up
Locations:
city: Nairobi
country: Kenya
facility: Upendo Clinic
city: Nairobi
country: Kenya
facility: Kianda 42 Hospital
Study officials:
References: