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| Sponsor: | University of California, Los Angeles |
|---|---|
| Information provided by: | University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00996528 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Neighborhood Alcohol & HIV Prevention in South African Townships (Philani) |
| Estimated Enrollment: | 600 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Philani Intervention Program: Experimental |
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.
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|
Standard Care: No Intervention
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.
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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:
Exclusion Criteria:
Contacts and Locations| South Africa | |
| Philani Child Health and Nutrition Project, Khayelitsha | Recruiting |
| Cape Town, South Africa | |
| Contact: Ingrid M le Roux, M.D. 011-72-021-461-4514 ile@princeton.edu | |
| Contact: Mary Jane Rotheram-Borus, Ph.D. 310-794-8280 mrotheram@mednet.ucla.edu | |
| Principal Investigator: Mary Jane Rotheram-Borus, Ph.D. | |
More Information
| Responsible Party: | UCLA - Center for Community Health ( Mary Jane Rotheram-Borus, PI ) |
| Study ID Numbers: | Federal Identifier # AA017104, I R0 I AA0 17104-01 |
| Study First Received: | October 15, 2009 |
| Last Updated: | November 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00996528 History of Changes |
| Health Authority: | United States: Institutional Review Board; South Africa: Institutional Review Board |
|
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 |
|
Alcohol-Induced Disorders Fetal Diseases Fetal Alcohol Syndrome Pathologic Processes Disease Pregnancy Complications |
Syndrome Substance-Related Disorders Disorders of Environmental Origin Nutrition Disorders Alcohol-Related Disorders |
