Clinical trial NCT00996528: Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Official title: Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
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
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2009-10-16
Enrollment: 1239
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HIV-related transmission acts
timeFrame: 18 months
measure: Baby's health status
timeFrame: 18 months
measure: Maternal adherence to HIV-related and general health routines
timeFrame: 18 months
measure: Mental health
timeFrame: 18 months
measure: Social support
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Philani Child Health and Nutrition Project, Khayelitsha
Study officials:
affiliation: Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA
name: Mary Jane Rotheram-Borus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.