Neighborhood Alcohol & HIV Prevention in South African Townships (Philani) - Full Text View

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)

Resource links provided by NLM:

MedlinePlus related topics: Fetal Alcohol Spectrum Disorders HIV/AIDS

Genetic and Rare Diseases Information Center resources: Fetal Alcohol Spectrum Disorders

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

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:	June 2016
Estimated Primary Completion Date:	June 2016 (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.

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)
Genders 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tomlinson M, Rotheram-Borus MJ, Harwood J, le Roux IM, O'Connor M, Worthman C. Community health workers can improve child growth of antenatally-depressed, South African mothers: a cluster randomized controlled trial. BMC Psychiatry. 2015 Sep 23;15:225. doi: 10.1186/s12888-015-0606-7.

Rotheram-Borus MJ, Tomlinson M, le Roux IM, Harwood JM, Comulada S, O'Connor MJ, Weiss RE, Worthman CM. A cluster randomised controlled effectiveness trial evaluating perinatal home visiting among South African mothers/infants. PLoS One. 2014 Oct 23;9(10):e105934. doi: 10.1371/journal.pone.0105934. eCollection 2014.

le Roux IM, Tomlinson M, Harwood JM, O'Connor MJ, Worthman CM, Mbewu N, Stewart J, Hartley M, Swendeman D, Comulada WS, Weiss RE, Rotheram-Borus MJ. Outcomes of home visits for pregnant mothers and their infants: a cluster randomized controlled trial. AIDS. 2013 Jun 1;27(9):1461-71. doi: 10.1097/QAD.0b013e3283601b53.


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:	June 8, 2015
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:


Nutrition Disorders Fetal Alcohol Spectrum Disorders Fetal Diseases Pregnancy Complications Alcohol-Induced Disorders Alcohol-Related Disorders 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 September 28, 2016