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

NCT00996528 | Unknown Phase 3

• 2 other identifiers: Federal Identifier # AA017104I R0I AA017104-01
• Study Type: interventional
• Target: 1,239
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• HIV-related transmission acts

  Maternal HIV transmission acts

  18 months

• Baby's health status

  Children's behavioral and cognitive adjustment and school achievement

  18 months

• Maternal adherence to HIV-related and general health routines

  Maternal alcohol use on the AUDIT

  18 months

• Mental health

  Maternal Depression on the Edinburgh Postnatal Depression Scale (EPDS)

  18 months

• Social support

  Children's peer relationships at seven and a half years

  18 months

Study Arms (2)

Philani Intervention Program

EXPERIMENTAL

Behavioral: Philani Intervention Program

Standard Care

NO INTERVENTION

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.

Interventions

Philani Intervention Program BEHAVIORAL

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.

Philani Intervention Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant woman and their children
• Age 18 or older
• Informed consent

You may not qualify if:

• Psychosis, neurological damage, inability to communicate with interviewer
• Inability to give consent

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Philani Child Health and Nutrition Project, Khayelitsha

Cape Town, South Africa

Location

Related Publications (11)

• Asarnow LD, Norwood PP, Christodoulou J, Tomlinson M, Rotheram-Borus MJ. The Concurrent and Longitudinal Relationship between Perinatal Sleep Difficulties and Depression in a Large Sample of High-Risk Women in South Africa. Matern Child Health J. 2024 Apr;28(4):700-707. doi: 10.1007/s10995-023-03850-x. Epub 2023 Dec 19.

  PMID: 38110851 DERIVED

• Rotheram-Borus MJ, Tomlinson M, Worthman CM, Norwood P, le Roux I, O'Connor MJ. Maternal depression, alcohol use, and transient effects of perinatal paraprofessional home visiting in South Africa: Eight-year follow-up of a cluster randomized controlled trial. Soc Sci Med. 2023 May;324:115853. doi: 10.1016/j.socscimed.2023.115853. Epub 2023 Mar 23.

  PMID: 37001280 DERIVED

• 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.

  PMID: 35065975 DERIVED

• 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.

  PMID: 34997984 DERIVED

• 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.

  PMID: 34315096 DERIVED

• 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.

  PMID: 34286512 DERIVED

• 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.

  PMID: 31397718 DERIVED

• 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.

  PMID: 31120274 DERIVED

• 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.

  PMID: 26400691 DERIVED

• 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.

  PMID: 25340337 DERIVED

• 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.

  PMID: 23435303 DERIVED

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders; Nutrition Disorders; Alcoholism; Malnutrition

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Nutritional and Metabolic Diseases; Mental Disorders

Study Officials

• Mary Jane Rotheram-Borus, PhD

  Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Semel Institute and the Department of Psychiatry

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: September 1, 2007
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2025
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)