NCT05389358

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Witwatersrand, South Africa · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Partner Abuse
• Depression
• Adherence, Medication

Interventions

Type	Name	Description
BEHAVIORAL	Asiphephe health worker training	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).
BEHAVIORAL	Asiphephe therapeutic sessions	Asiphephe sessions are manualized using illustrated job aids, a participant workbook, session checklists, 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.
OTHER	IPV assessment	IPV intensity as measured by WHO Multicountry Study Instrument at a cut-off of any past-year physical/sexual/psychological violence exposure vs. none
OTHER	Referral for IPV or Mental Health	Study staff are trained to recognize signs or symptoms of distress and to make appropriate referrals to appropriate community-based services, if necessary. Experienced mental health professionals on the investigative can be consulted or referred to should a participant exhibit severe symptom of mental distress.

Timeline

• Start date: 2022-04-26
• Primary completion: 2024-03-31
• Completion: 2024-06-30
• First posted: 2022-05-25
• Last updated: 2022-05-25

Locations

2 sites across 1 country: South Africa