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

University of California, Los Angeles (UCLA)

Status and phase: Active, not recruiting; Phase 3

Conditions: Nutrition Disorders; HIV; Fetal Alcohol Syndrome

Treatments: Behavioral: Philani Intervention Program

Study type: Interventional

Funder types: Other

Identifiers

NCT00996528

I R0I AA017104-01

Federal Identifier # AA017104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,239 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,239 participants in 2 patient groups

Philani Intervention Program

Experimental group

Treatment:

Behavioral: Philani Intervention Program

Standard Care

No Intervention group

Description:

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.