NCT00996528

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,239 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fetal Alcohol Syndrome
• HIV
• Nutrition Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Philani 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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2015-09-01
• Completion: 2025-09-01
• First posted: 2009-10-16
• Last updated: 2021-10-14

Locations

1 site across 1 country: South Africa