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

NCT05389358 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-05-25

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • University of Witwatersrand, South Africa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-26
Primary Completion
2024-03-31
Completion
2024-06-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05389358 on ClinicalTrials.gov