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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fetal Alcohol Syndrome, HIV, Nutrition Disorders

Intervention / Treatment
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* Behavioral: Philani Intervention Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Philani Intervention Program<br> | Behavioral: Philani Intervention Program<br>* 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.<br>|
| No Intervention: Standard Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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