AzTrials
AzTrials

Violence, DomesticNCT06350383

Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention

A study testing WINGS+PM+ and PM+-only in people with Violence, Domestic and Psychological Distress, run by Columbia University at 2 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Violence, Domestic, Psychological Distress
What is being tested?
WINGS+PM+ and PM+-only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
2 sitesKenya
Study dates
21 May 2024to 30 Apr 2025
Phase
Interventional

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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Kenya2 sites
  • Upendo Clinic

    Nairobi, 00100

  • Kianda 42 Hospital

    Nairobi, 0100

Other trials in Kenya

About this study

Official title: Adapting a Low-cost Intimate Partner Violence (IPV) and Mental Health Response Intervention for Women in Informal Settlements in Kenya

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.

Read the 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.

Being tested
WINGS+PM+, PM+-only
Keywords
Intimate partner violence (IPV), Randomized control trial (RCT), Wings of Hope (WINGS), Problem Management Plus (PM+), Kenya, Informal settlements (slums), Women

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WINGS+PM+Behavioural

    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. The intervention is informed by social cognitive theory.

  • PM+-onlyBehavioural

    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.

Study groups in NCT06350383
Study groupRoleWhat they receive
WINGS+PM+ExperimentalWINGS+PM+ is a safety, harm reduction, and brief psychological intervention that involves seven 90-minute weekly sessions focused on exploring types and mechanisms of 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.
Receives: Behavioral: WINGS+PM+
PM+-OnlyActive comparatorPM+: 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.
Receives: Behavioral: PM+-only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experienced Psychological IPV

    A modified version of the World Health Organization Violence Against Women (WHO VAW) Questionnaire will be used to measure recent experience of intimate partner violence (IPV). The WHO IPV diagnostic tool has been used in Kenya previously. It includes four items measuring psychological IPV (e.g., insulting, humiliating, scaring or intimidating participant, or threatening); six items measuring physical IPV (e.g., slapping, pushing, throwing something at, dragging, beating up, burning, or threatening or using a weapon against participant); and three items measuring sexual IPV (e.g., forcing intercourse or other sexual acts when participant does not want to engage or forcing participant to do something sexual that they find degrading or humiliating). Participants will be asked whether or not (0=no, 1=yes) and the number of times they experienced any of these IPV items in the prior 90 days at baseline and the 3- and 6- month follow-up.

    Measured: Baseline, 3-month follow-up, 6-month follow-up

Secondary outcomes (9)
  1. Number of Participants Who Received Violence Services

    Receipt of violence-related services will be measured with an item used in prior assessments of WINGS that asks, "Have you received any services, counselling or group support for partner abuse or violence from others in the past 90 days?"

    Measured: Baseline, 3-month follow-up, 6-month follow-up

  2. General Self-Efficacy Scale (GSE) Score

    IPV self-efficacy will be assessed using a modified version of the general self-efficacy scale (GSE). The total score range is 10 to 40; higher scores indicate greater self-efficacy.

    Measured: Baseline, 3-month follow-up, 6-month follow-up

  3. Multidimensional Scale of Perceived Social Support (MSPSS) Score

    Social Support will be measured with the 12-item MSPSS, which assesses the availability of emotional and instrumental support and advice for relationship conflict or problems with intimate partners and other issues. Items are measured on a 7-point Likert scale ranging from very strongly disagree (1) to very strongly agree. The total score range is 12 to 84; higher scores indicate greater perceived social support.

    Measured: Baseline, 3-month follow-up, 6-month follow-up

  4. Safety Behavior Checklist

    Safety behaviors will be assessed using an updated version of a 7-item safety behavior checklist to determine present use of safety behaviors and to chart future adoption. The adjusted total score falls within a 0-7 range of behaviors performed, with higher scores suggesting more safety behaviors.

    Measured: Baseline, 3-month follow-up, 6-month follow-up

  5. General Anxiety Disorder Scale (GAD-7) Score

    The GAD-7 is a 7-item self-reported questionnaire used to measure anxiety severity, with total scores ranging from 0 to 21. A higher score indicates more severe anxiety.

    Measured: Baseline, 3-month follow-up, 6-month follow-up

  6. Patient Health Questionnaire (PHQ-9) Score

    Depression was assessed using the patient health questionnaire. The total score ranges from 0 to 27, with a higher score indicating greater severity of depression.

    Measured: Baseline, 3-month follow-up, 6-month follow-up

  7. WHODAS 2.0 Score

    Functional impairment will be measured using the World Health Organization Disability Assessment Schedule (WHODAS) 2.0. This 12-item instrument assesses difficulty in completing activities in the last 30 days (total score range is 0-48; higher scores indicate greater impairment severity). The WHODAS 2.0 has been used widely as a screening and outcome measure, demonstrates moderate to strong evidence of construct- and criterion-related validity, displays good sensitivity to change and has been used previously in PM+ efficacy trials in Kenya and in informal settlements in Kenya.

    Measured: Baseline, 3-month follow-up, 6-month follow-up

  8. Short Form of the Posttraumatic Stress Disorder Checklist (PCL-5) Score

    A four-item, short version of the Posttraumatic Stress Disorder Checklist (PCL) will be used to measure symptoms of PTSD. The PCL was adapted and used for an efficacy trial of PM+ in Kenya. Items are scored with a 5-point Likert ranging from 0= "not at all" to 4="extremely". The total score ranges from 0 to 16, with higher scores suggesting symptoms of PTSD.

    Measured: Baseline, 3-month follow-up, 6-month follow-up

  9. Personalized Outcomes (PSYCHLOPS Score)

    The Psychological Outcome Profiles (PSYCHLOPS) scale will be used to assess change in relation to problems that are identified by the participant. It asks respondents to nominate 2 of their main problems and to provide ratings on the magnitude of the problems and their effects on functioning and well-being in the previous week. It is sensitive to change and is internally reliable. PSYCHLOPS assesses the impact of interventions on problems that are not necessarily assessed by other standardized measures; thus, it can be useful in the context of informal settlements, where people can suffer a diverse range of problems. The total score range is 0 to 20, with a higher score indicating greater problem severity.

    Measured: Baseline, 3-month follow-up, 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start21 May 2024
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm, parallel-group design
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06350383
Sponsor's protocol ID
AAAT8527
Other IDs
K01TW011775
Status last verified
Apr 2026
First submitted
14 Mar 2024
Last updated
27 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in