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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mary Jane Rotheram-Borus, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00996528
First received: October 15, 2009
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Fetal Alcohol Syndrome HIV Nutrition Disorders Behavioral: Philani Intervention Program Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)

Resource links provided by NLM:


Further study details as provided by Mary Jane Rotheram-Borus, University of California, Los Angeles:

Primary Outcome Measures:
  • 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


Enrollment: 1239
Study Start Date: September 2007
Estimated Study Completion Date: September 2025
Estimated Primary Completion Date: September 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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

Inclusion Criteria:

  • Pregnant woman
  • Age 18 or older
  • Informed consent

Exclusion Criteria:

  • Psychosis, neurological damage, inability to communicate with interviewer
  • Inability to give consent
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996528

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary Jane Rotheram-Borus, Professor, Semel Institute and the Department of Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00996528     History of Changes
Other Study ID Numbers: Federal Identifier # AA017104
I R0I AA017104-01
Study First Received: October 15, 2009
Last Updated: May 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data up to the fifth year 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
HIV
malnutrition
children
mentor mother
behavioral intervention
South Africa
HIV-related transmission behaviors
low birth weight babies and low-weight children
HIV Seronegativity

Additional relevant MeSH terms:
Fetal Alcohol Spectrum Disorders
Fetal Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Nutrition Disorders
Pregnancy Complications
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017