A Phase 3 interventional study of Philani Intervention Program in Fetal Alcohol Syndrome, HIV and Nutrition Disorders, sponsored by University of California, Los Angeles. Active, not recruiting at 1 site in South Africa. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-14.
Sponsored by University of California, Los Angeles · Phase 3, Interventional, and Treatment
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.
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.
63 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.
This study's enrollment of 1,239 is above the median of 70 across 55 interventional studies indexed under Fetal Alcohol Spectrum Disorders.
Browse Fetal Alcohol Spectrum Disorders studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Philani Intervention Program
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.
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.
HIV-related transmission acts
Maternal HIV transmission acts
Time frame: 18 months
Baby's health status
Children's behavioral and cognitive adjustment and school achievement
Time frame: 18 months
Maternal adherence to HIV-related and general health routines
Maternal alcohol use on the AUDIT
Time frame: 18 months
Mental health
Maternal Depression on the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 18 months
Social support
Children's peer relationships at seven and a half years
Time frame: 18 months
Plan to share: Yes — Data up to the eighth year post birth is being shared with researcher from other institutions.
This study is active, not recruiting, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Fetal Alcohol Spectrum Disorders→
University of California, Los Angeles