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

Phase 3

Active, not recruiting

• Conditions: Fetal Alcohol Syndrome; HIV; Nutrition Disorders
• Interventions: Behavioral: Philani Intervention Program

• Registration Number: NCT00996528
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Primary Completion: 2015-09
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-14
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1239

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Philani Intervention Program	Philani Intervention Program	-

Primary Outcome Measures

Name	Time	Method
Social support	18 months	Children's peer relationships at seven and a half years
Maternal adherence to HIV-related and general health routines	18 months	Maternal alcohol use on the AUDIT
HIV-related transmission acts	18 months	Maternal HIV transmission acts
Baby's health status	18 months	Children's behavioral and cognitive adjustment and school achievement
Mental health	18 months	Maternal Depression on the Edinburgh Postnatal Depression Scale (EPDS)

Trial Locations

Locations (1)

Philani Child Health and Nutrition Project, Khayelitsha; 🇿🇦 Cape Town, South Africa