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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: May 20, 2013
Last verified: May 2013

October 15, 2009
May 20, 2013
September 2007
September 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00996528 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Fetal Alcohol Syndrome
  • HIV
  • Nutrition Disorders
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.
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1239
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant woman
  • Age 18 or older
  • Informed consent

Exclusion Criteria:

  • Psychosis, neurological damage, inability to communicate with interviewer
  • Inability to give consent
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00996528
Federal Identifier # AA017104, I R0 I AA0 17104-01
No
Mary Jane Rotheram-Borus, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Not Provided
University of California, Los Angeles
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP