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

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ClinicalTrials.gov Identifier: NCT00996528
Recruitment Status : Active, not recruiting
First Posted : October 16, 2009
Last Update Posted : May 16, 2017
Information provided by (Responsible Party):

October 15, 2009
October 16, 2009
May 16, 2017
September 2007
September 2025   (Final data collection date for primary outcome measure)
  • 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
  • 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 ]
Complete list of historical versions of study NCT00996528 on ClinicalTrials.gov Archive Site
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Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Fetal Alcohol Syndrome
  • HIV
  • Nutrition Disorders
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.
  • Experimental: Philani Intervention Program
    Intervention: Behavioral: Philani Intervention Program
  • No Intervention: Standard Care
    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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
September 2025
September 2025   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant woman
  • Age 18 or older
  • Informed consent

Exclusion Criteria:

  • Psychosis, neurological damage, inability to communicate with interviewer
  • Inability to give consent
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
South Africa
Federal Identifier # AA017104
I R0I AA017104-01
Not Provided
Plan to Share IPD: Yes
Plan Description: Data up to the fifth year is being shared with researcher from other institutions.
Mary Jane Rotheram-Borus, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Mary Jane Rotheram-Borus, PhD Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA
University of California, Los Angeles
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP