Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neighborhood Alcohol & HIV Prevention in South African Townships (Philani) |
- HIV-related transmission acts [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Baby's health status [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Maternal adherence to HIV-related and general health routines [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Mental health [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Social support [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Enrollment: | 1239 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (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 |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00996528
| South Africa | |
| Philani Child Health and Nutrition Project, Khayelitsha | |
| Cape Town, South Africa | |
More Information
No publications provided by University of California, Los Angeles
Additional 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 R0 I AA0 17104-01 |
| Study First Received: | October 15, 2009 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Institutional Review Board South Africa: Human Research Ethics Committee |
Keywords provided by University of California, Los Angeles:
|
fetal alcohol syndrome alcohol abuse HIV malnutrition children mentor mother |
behavioral intervention South Africa Maternal alcohol use HIV-related transmission behaviors low birth weight babies and low-weight children HIV Seronegativity |
Additional relevant MeSH terms:
|
Fetal Alcohol Spectrum Disorders Nutrition Disorders Alcohol-Induced Disorders Alcohol-Related Disorders |
Chemically-Induced Disorders Fetal Diseases Pregnancy Complications Substance-Related Disorders |
ClinicalTrials.gov processed this record on March 02, 2015