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

University of Witwatersrand

Status: Enrolling

Conditions: Adherence, Medication; Partner Abuse; Depression

Treatments: Behavioral: Asiphephe health worker training; Other: IPV assessment; Other: Referral for IPV or Mental Health; Behavioral: Asiphephe therapeutic sessions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05389358

5K01MH121185 (U.S. NIH Grant/Contract)

K01MH12118501 M210216;

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Asiphephe therapeutic sessions

Other: Referral for IPV or Mental Health

Other: IPV assessment

Behavioral: Asiphephe health worker training

Enhanced standard of care

Active Comparator group

Description:

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.

Treatment:

Other: Referral for IPV or Mental Health

Other: IPV assessment