Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT00996528 |
Other study ID # |
Federal Identifier # AA017104 |
Secondary ID |
I R0I AA017104-0 |
Status |
Active, not recruiting |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
September 2007 |
Est. completion date |
September 2025 |
Study information
Verified date |
October 2021 |
Source |
University of California, Los Angeles |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.