Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Primary Purpose
Fetal Alcohol Syndrome, HIV, Nutrition Disorders
Status
Active
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Philani Intervention Program
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Alcohol Syndrome focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- Pregnant woman and their children
- Age 18 or older
- Informed consent
Exclusion Criteria:
- Psychosis, neurological damage, inability to communicate with interviewer
- Inability to give consent
Sites / Locations
- Philani Child Health and Nutrition Project, Khayelitsha
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Philani Intervention Program
Standard Care
Arm Description
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.
Outcomes
Primary Outcome Measures
HIV-related transmission acts
Maternal HIV transmission acts
Baby's health status
Children's behavioral and cognitive adjustment and school achievement
Maternal adherence to HIV-related and general health routines
Maternal alcohol use on the AUDIT
Mental health
Maternal Depression on the Edinburgh Postnatal Depression Scale (EPDS)
Social support
Children's peer relationships at seven and a half years
Secondary Outcome Measures
Full Information
NCT ID
NCT00996528
First Posted
October 15, 2009
Last Updated
October 6, 2021
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT00996528
Brief Title
Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Official Title
Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2007 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Syndrome, HIV, Nutrition Disorders
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Philani Intervention Program
Arm Type
Experimental
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Philani Intervention Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
HIV-related transmission acts
Description
Maternal HIV transmission acts
Time Frame
18 months
Title
Baby's health status
Description
Children's behavioral and cognitive adjustment and school achievement
Time Frame
18 months
Title
Maternal adherence to HIV-related and general health routines
Description
Maternal alcohol use on the AUDIT
Time Frame
18 months
Title
Mental health
Description
Maternal Depression on the Edinburgh Postnatal Depression Scale (EPDS)
Time Frame
18 months
Title
Social support
Description
Children's peer relationships at seven and a half years
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant woman and their children
Age 18 or older
Informed consent
Exclusion Criteria:
Psychosis, neurological damage, inability to communicate with interviewer
Inability to give consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Jane Rotheram-Borus, PhD
Organizational Affiliation
Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philani Child Health and Nutrition Project, Khayelitsha
City
Cape Town
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data up to the eighth year post birth is being shared with researcher from other institutions.
Citations:
PubMed Identifier
35065975
Citation
Christodoulou J, Rotheram-Borus MJ, Hayati Rezvan P, Comulada WS, Stewart J, Almirol E, Tomlinson M. Where you live matters: Township neighborhood factors important to resilience among south African children from birth to 5 years of age. Prev Med. 2022 Apr;157:106966. doi: 10.1016/j.ypmed.2022.106966. Epub 2022 Jan 20.
Results Reference
derived
PubMed Identifier
34997984
Citation
Christodoulou J, Rotheram-Borus MJ, Hayati Rezvan P, Weiss RE, Tomlinson M. Association of early migration with child growth, cognition and behaviour in South Africa. Trop Med Int Health. 2022 Mar;27(3):218-225. doi: 10.1111/tmi.13719. Epub 2022 Jan 23.
Results Reference
derived
PubMed Identifier
34315096
Citation
Gordon S, Rotheram-Fuller E, Rezvan P, Stewart J, Christodoulou J, Tomlinson M. Maternal depressed mood and child development over the first five years of life in South Africa. J Affect Disord. 2021 Nov 1;294:346-356. doi: 10.1016/j.jad.2021.07.027. Epub 2021 Jul 16.
Results Reference
derived
PubMed Identifier
34286512
Citation
Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.
Results Reference
derived
PubMed Identifier
31397718
Citation
Rotheram-Borus MJ, Christodoulou J, Hayati Rezvan P, Comulada WS, Gordon S, Skeen S, Stewart J, Almirol E, Tomlinson M. Maternal HIV does not affect resiliency among uninfected/HIV exposed South African children from birth to 5 years of age. AIDS. 2019 Jun 1;33 Suppl 1(Suppl 1):S5-S16. doi: 10.1097/QAD.0000000000002176.
Results Reference
derived
PubMed Identifier
31120274
Citation
Rotheram-Borus MJ, Arfer KB, Christodoulou J, Comulada WS, Stewart J, Tubert JE, Tomlinson M. The association of maternal alcohol use and paraprofessional home visiting with children's health: A randomized controlled trial. J Consult Clin Psychol. 2019 Jun;87(6):551-562. doi: 10.1037/ccp0000408.
Results Reference
derived
PubMed Identifier
26400691
Citation
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.
Results Reference
derived
PubMed Identifier
25340337
Citation
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.
Results Reference
derived
PubMed Identifier
23435303
Citation
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.
Results Reference
derived
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Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
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