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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: University of California, Los Angeles

Current Primary Outcome:

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


Original Primary Outcome:

  • 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 ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, Los Angeles

Dates:
Date Received: October 15, 2009
Date Started: September 2007
Date Completion: September 2025
Last Updated: May 12, 2017
Last Verified: May 2017