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Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)

Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00996528
Enrollment
1239
Registered
2009-10-16
Start date
2007-09-30
Completion date
2025-09-30
Last updated
2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Alcohol Syndrome, HIV, Nutrition Disorders

Keywords

fetal alcohol syndrome, alcohol abuse, HIV, malnutrition, children, mentor mother, behavioral intervention, South Africa, Maternal alcohol use, HIV-related transmission behaviors, low birth weight babies and low-weight children, HIV Seronegativity

Brief summary

The purpose of this study is to test a mother-to-mother intervention during pregnancy and after delivery with mothers in South Africa, most of whom are at risk delivering babies with fetal alcohol syndrome, babies that are underweight, or babies that are infected with HIV from an HIV-positive mother. The investigators hypothesize that the intervention will reduce the chance of these three health outcomes occurring in the babies and improve the health of the mother.

Detailed description

There are four intersecting epidemics among pregnant women in South Africa: hazardous alcohol use (30%), HIV (27%), TB (60% of HIV+), and malnutrition (24% of infants). Unless the prevention programs for these epidemics are horizontally integrated, there will never be adequate resources to address these challenges and stigma will dramatically reduce program utilization. Furthermore, while clinics are the typical sites for treating each of these health problems, this proposal will examine a home-visiting prevention program delivered by neighborhood Mentor Mothers (MM) as an alternative to clinic-based interventions to reduce the consequences of hazardous alcohol use, HIV, TB, and poor nutrition. The intervention will encourage mothers to care for their own health, parent well, maintain their mental health, and, if the mother is living with HIV (HIV+ MAR), reduce HIV transmission and/or reduce alcohol use and abuse. The results begin to inform the optimal delivery strategy for next generation of preventive interventions in order to be feasible and sustainable for broad dissemination immediately following an efficacy trial.

Interventions

BEHAVIORALPhilani Intervention Program

Offered to pregnant women / mothers through mentor mothers, i.e. mothers in community who are selected because they are doing well. They are trained to conduct home visits, 2 times a months through pregnancy. After childbirth, visits are spaced depending on the perceived need. If the baby is thriving and mother is coping well with health risks, mentor mother will visit once a month.

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Pregnant woman and their children * Age 18 or older * Informed consent

Exclusion criteria

* Psychosis, neurological damage, inability to communicate with interviewer * Inability to give consent

Design outcomes

Primary

MeasureTime frameDescription
HIV-related transmission acts18 monthsMaternal HIV transmission acts
Baby's health status18 monthsChildren's behavioral and cognitive adjustment and school achievement
Maternal adherence to HIV-related and general health routines18 monthsMaternal alcohol use on the AUDIT
Mental health18 monthsMaternal Depression on the Edinburgh Postnatal Depression Scale (EPDS)
Social support18 monthsChildren's peer relationships at seven and a half years

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026