Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care

Not Applicable

• Conditions: Depression; Partner Abuse; Adherence, Medication
• Interventions: Behavioral: Asiphephe health worker training; Other: Referral for IPV or Mental Health; Behavioral: Asiphephe therapeutic sessions; Other: IPV assessment

• Registration Number: NCT05389358
• Lead Sponsor: University of Witwatersrand, South Africa

Brief Summary

This quasi-experimental feasibility study recruit n=40 participants from each of two public antenatal clinics in Johannesburg, South Africa. Using the Bowen et al. approach, key feasibility study questions will be those around acceptability, implementation, and promising effects on intermediate variable. While this pilot trial is not powered to determine efficacy, it can help establish whether intervention targets the appropriate intermediate mechanisms (i.e. primary endpoints of IPV exposure and depressive symptoms) and moves intended outcomes in the right direction (i.e. towards better adherence as measured by self-reported adherence).

Detailed Description

Prevention of mother-to-child transmission (PMTCT) programs are effective if women take medication regularly, yet many perinatal women in sub-Saharan Africa have sup-optimal adherence. Intimate partner violence (IPV) worsens women's ability to adhere to antiretroviral therapy (ART), and leads to higher rates of depression. In a quasi-experimental feasibility study in South Africa, 2 inner-city Johannesburg clinics will be assigned to intervention or enhanced standard of care conditions. Intervention consists of training health workers to deliver one-on-one sessions in pregnancy (4 sessions) and postpartum (2 sessions) using problem-solving therapy and safety planning. Following n=80 women in a prospective cohort will allow for preliminarily assessment of intervention effects on: perinatal depression, IPV exposure, and ART adherence at 6 months postpartum. Additional qualitative research with 10 providers and 15 beneficiaries will help us qualitatively assess acceptability of intervention content, measures, and study conditions. This pilot trial can establish acceptability of intervention and control conditions and provide preliminary point estimates to inform future trial design.

Study Timeline

• Study Start: 2022-04-26
• Status Verified: 2022-05
• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-19
• Last Update Submitted: 2022-05-19
• Study First Posted: 2022-05-25
• Last Update Posted: 2022-05-25
• Primary Completion: 2024-03-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• 18 years or older (the age of research consent in South Africa)
• currently pregnant and less than 30 weeks gestation (from antenatal green card)
• speak a study language (English, isiZulu, Sesotho)
• living with HIV (self-reported and confirmed on green card)
• report past-year IPV (score of ≥1 on WHO multicountry study instrument)
• are willing to provide informed consent

Exclusion Criteria

• fail to meet all of the inclusion criteria
• at risk of immediate danger (current suicidality, homicidality, or risk to child safety)
• planning to terminate the pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Asiphephe health worker training	The Asiphephe (meaning "Let us stay safe") intervention is a problem-solving therapy manual delivered in a one-on-one setting by lay health workers during routine antenatal care. Lay health workers are already employed by the Department of Health and are trained in-service (30 hours) and receive monthly supervision (total of approximately 6 one-on-one hours; 15 group hours). Asiphephe includes illustrated job aids, participant workbook, intervention checklist, and an intervention manual. The model is informed by problem-solving therapy (Lund, 2018), trauma-informed coping (Sikkema, 2018) and safety planning (Garcia-Moreno, forthcoming) and was piloted with 12 health workers with input from 3 global mental health experts.
Intervention	IPV assessment	The Asiphephe (meaning "Let us stay safe") intervention is a problem-solving therapy manual delivered in a one-on-one setting by lay health workers during routine antenatal care. Lay health workers are already employed by the Department of Health and are trained in-service (30 hours) and receive monthly supervision (total of approximately 6 one-on-one hours; 15 group hours). Asiphephe includes illustrated job aids, participant workbook, intervention checklist, and an intervention manual. The model is informed by problem-solving therapy (Lund, 2018), trauma-informed coping (Sikkema, 2018) and safety planning (Garcia-Moreno, forthcoming) and was piloted with 12 health workers with input from 3 global mental health experts.
Enhanced standard of care	Referral for IPV or Mental Health	The enhanced standard of care condition will entail a clinic-wide training (5 hours) on IPV, mental health, and HIV care in order to sensitize staff to the nature of the research. The clinic will receive access to established referral network to which participants can gain additional help with violence exposure or mental ill health. Participants in this arm will also be observed for adverse events and social harms, with referrals made appropriately by study staff.
Intervention	Asiphephe therapeutic sessions	The Asiphephe (meaning "Let us stay safe") intervention is a problem-solving therapy manual delivered in a one-on-one setting by lay health workers during routine antenatal care. Lay health workers are already employed by the Department of Health and are trained in-service (30 hours) and receive monthly supervision (total of approximately 6 one-on-one hours; 15 group hours). Asiphephe includes illustrated job aids, participant workbook, intervention checklist, and an intervention manual. The model is informed by problem-solving therapy (Lund, 2018), trauma-informed coping (Sikkema, 2018) and safety planning (Garcia-Moreno, forthcoming) and was piloted with 12 health workers with input from 3 global mental health experts.
Intervention	Referral for IPV or Mental Health	The Asiphephe (meaning "Let us stay safe") intervention is a problem-solving therapy manual delivered in a one-on-one setting by lay health workers during routine antenatal care. Lay health workers are already employed by the Department of Health and are trained in-service (30 hours) and receive monthly supervision (total of approximately 6 one-on-one hours; 15 group hours). Asiphephe includes illustrated job aids, participant workbook, intervention checklist, and an intervention manual. The model is informed by problem-solving therapy (Lund, 2018), trauma-informed coping (Sikkema, 2018) and safety planning (Garcia-Moreno, forthcoming) and was piloted with 12 health workers with input from 3 global mental health experts.
Enhanced standard of care	IPV assessment	The enhanced standard of care condition will entail a clinic-wide training (5 hours) on IPV, mental health, and HIV care in order to sensitize staff to the nature of the research. The clinic will receive access to established referral network to which participants can gain additional help with violence exposure or mental ill health. Participants in this arm will also be observed for adverse events and social harms, with referrals made appropriately by study staff.

Primary Outcome Measures

Name	Time	Method
Intimate partner violence	6 months postpartum	IPV exposure will be measured using the World Health Organization multicountry study instrument of behaviorally-specific likert-type items about frequency of physical, sexual, or psychological violence from a partner. Any IPV will be defined as an affirmative response to any physical, sexual, or psychological violence question. For primary outcome assessment, the WHO instrument will be examined as a continuous measure summing all standardized response items as a marker of IPV intensity (Tsai, 2016).
Depression	6 months postpartum	Depressive symptoms using Patient Health Questionnaire-9 will be assessed as a continuous marker of symptomology (with ≥13 indicating probable depression)

Secondary Outcome Measures

Name	Time	Method
ART adherence	6 months postpartum	Self-reported ART adherence will be collected using a multi-item measure (Wilson et al, 2014).

Trial Locations

Locations (2)

Malvern Clinic; 🇿🇦 Johannesburg, Gauteng, South Africa

Yeoville Clinic; 🇿🇦 Johannesburg, Gauteng, South Africa