This trial is active, not recruiting.

Conditions fetal alcohol syndrome, hiv, nutrition disorders
Treatment philani intervention program
Phase phase 2
Sponsor University of California, Los Angeles
Start date September 2007
End date June 2016
Trial size 1239 participants
Trial identifier NCT00996528, Federal Identifier # AA017104, I R0 I AA0 17104-01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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.
(No Intervention)
No intervention during study. Referral to clinic-based health care that is delivered by the province. Offered intervention at end of study, i.e. after 18 months.

Primary Outcomes

HIV-related transmission acts
time frame: 18 months
Baby's health status
time frame: 18 months
Maternal adherence to HIV-related and general health routines
time frame: 18 months
Mental health
time frame: 18 months
Social support
time frame: 18 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Pregnant woman - Age 18 or older - Informed consent Exclusion Criteria: - Psychosis, neurological damage, inability to communicate with interviewer - Inability to give consent

Additional Information

Official title Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.