Trial Outcomes & Findings for Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention (NCT NCT06350383)

260 women from two clinics were recruited from two public health clinics in Nairobi informal settlements between May and August 2024. The clinics were Upendo in Mathare and Kianda 42 in Kibera.

Randomization occurred at the participant level. No units other than participants were randomized.

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

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.

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?"

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.

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.

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.

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.

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.

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.

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.

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.

Using monitoring systems from previous studies (adherence to activities and delivery quality checklists), investigators will assess intervention protocol fidelity. Investigators will audiotape all intervention sessions and randomly select and review 20% in order to assess quality control and implementation fidelity. Fidelity levels below 80% will trigger retraining and closer supervision.

Facilitator satisfaction and ease of intervention delivery will be assessed with a shortened version of the Evidence-Based Practice Attitude Scale (EBPAS-36). Responses are given on a 5-point Likert scale ranging from 0="not at all" to 4="to a very great extent." With high scores indicating satisfaction.

Safety will be assessed through adverse event reporting by CHVs/Research Assistant (RA)/clinic staff and exit interviews with CHVs asking about negative intervention experiences.

Participants will be asked to rate their satisfaction with the session at the end of each intervention session. Participant satisfaction was assessed using a four-point Likert scale ranging from not at all satisfied (1) to very satisfied (4). The number of participants who scored 3 or above (representing satisfied or very satisfied) is reported.

Attendance rate will be reported as the percent of participants who completed all sessions of the study intervention.

Number of participants who completed the 3-month assessment and the 6 month-assessment after receiving the study intervention.