Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Mary Jane Rotheram-Borus, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT00996528

First received: October 15, 2009

Last updated: June 15, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 15, 2009
Last Updated Date	June 15, 2012
Start Date ^ICMJE	September 2007
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 15, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00996528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Official Title ^ICMJE	Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Brief 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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Fetal Alcohol Syndrome HIV Nutrition Disorders
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Philani Intervention Program Intervention: Behavioral: Philani Intervention Program 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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	1239
Estimated Completion Date	September 2012
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Pregnant woman Age 18 or older Informed consent Exclusion Criteria: Psychosis, neurological damage, inability to communicate with interviewer Inability to give consent
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	South Africa

Administrative Information
NCT Number ^ICMJE	NCT00996528
Other Study ID Numbers ^ICMJE	Federal Identifier # AA017104, I R0 I AA0 17104-01
Has Data Monitoring Committee	No
Responsible Party	Mary Jane Rotheram-Borus, University of California, Los Angeles
Study Sponsor ^ICMJE	University of California, Los Angeles
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of California, Los Angeles
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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