Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT05389358
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:
NCT05389358
Study Brief:
Protocol Section:
NCT05389358