Clinical trial NCT05389358: Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care
Official title: Pilot Intervention for Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Partner Abuse
Depression
Adherence, Medication
Keywords: intimate partner violence
perinatal depression
ART adherence
HIV
antenatal care
prevention of mother-to-child transmission
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: National Institute of Mental Health (NIMH)
First posted: 2022-05-25
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 primary health clinics offering antenatal care services in inner-city Johannesburg, South Africa will be randomized to receive intervention or enhanced standard of care. Within each clinic n=40 participants will take part in baseline, midline, and endline assessments.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression
timeFrame: 6 months postpartum
measure: Intimate partner violence
timeFrame: 6 months postpartum
Secondary outcomes:
measure: ART adherence
timeFrame: 6 months postpartum
Other outcomes:
measure: Viral suppression
timeFrame: 6 months postpartum
measure: Anxiety
timeFrame: 6 months postpartum
measure: PTSD
timeFrame: 6 months postpartum
Locations:
city: Johannesburg
country: South Africa
facility: Malvern Clinic
state: Gauteng
city: Johannesburg
country: South Africa
facility: Yeoville Clinic
state: Gauteng
Study officials:
References: