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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00996528
• Other study ID #: Federal Identifier # AA017104
• Secondary ID: I R0I AA017104-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 2007
• Est. completion date: September 2025

Study information

• Verified date: October 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1239
• Est. completion date: September 2025
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• HIV
• Nutrition Disorders

Intervention

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.

Locations

Country	Name	City	State
South Africa	Philani Child Health and Nutrition Project, Khayelitsha	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

South Africa, 

Outcome

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