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

NCT ID: NCT00996528

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Fetal Alcohol Syndrome HIV Nutrition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Philani Intervention Program

Group Type EXPERIMENTAL

Philani Intervention Program

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Mary Jane Rotheram-Borus

Professor, Semel Institute and the Department of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Jane Rotheram-Borus, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA

Locations

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Philani Child Health and Nutrition Project, Khayelitsha

Cape Town, , South Africa

Site Status

Countries

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South Africa

References

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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.

Reference Type DERIVED
PMID: 38110851 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37001280 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35065975 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34997984 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34315096 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34286512 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31397718 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31120274 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26400691 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25340337 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23435303 (View on PubMed)

Other Identifiers

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I R0I AA017104-01

Identifier Type: -

Identifier Source: secondary_id

Federal Identifier # AA017104

Identifier Type: -

Identifier Source: org_study_id