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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00996528
Recruitment Status : Active, not recruiting
First Posted : October 16, 2009
Last Update Posted : February 17, 2020
Information provided by (Responsible Party):
Mary Jane Rotheram-Borus, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Fetal Alcohol Syndrome HIV Nutrition Disorders Behavioral: Philani Intervention Program Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Study Start Date : September 2007
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Philani Intervention Program 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.

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.

Primary Outcome Measures :
  1. HIV-related transmission acts [ Time Frame: 18 months ]
    Maternal HIV transmission acts

  2. Baby's health status [ Time Frame: 18 months ]
    Children's behavioral and cognitive adjustment and school achievement

  3. Maternal adherence to HIV-related and general health routines [ Time Frame: 18 months ]
    Maternal alcohol use on the AUDIT

  4. Mental health [ Time Frame: 18 months ]
    Maternal Depression on the Edinburgh Postnatal Depression Scale (EPDS)

  5. Social support [ Time Frame: 18 months ]
    Children's peer relationships at seven and a half years

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00996528

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South Africa
Philani Child Health and Nutrition Project, Khayelitsha
Cape Town, South Africa
Sponsors and Collaborators
University of California, Los Angeles
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Principal Investigator: Mary Jane Rotheram-Borus, PhD Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Mary Jane Rotheram-Borus, Professor, Semel Institute and the Department of Psychiatry, University of California, Los Angeles Identifier: NCT00996528    
Other Study ID Numbers: Federal Identifier # AA017104
I R0I AA017104-01
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data up to the eighth year post birth is being shared with researcher from other institutions.
Keywords provided by Mary Jane Rotheram-Borus, University of California, Los Angeles:
fetal alcohol syndrome
alcohol abuse
Maternal alcohol use
low birth weight babies and low-weight children
mentor mother
behavioral intervention
South Africa
HIV-related transmission behaviors
HIV Seronegativity
Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Fetal Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Nutrition Disorders
Pregnancy Complications
Substance-Related Disorders
Chemically-Induced Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs