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Fetal Alcohol SyndromePhase 3NCT00996528

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

A Phase 3 study testing Philani Intervention Program in people with Fetal Alcohol Syndrome and HIV, run by University of California, Los Angeles at 1 site in South Africa.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fetal Alcohol Syndrome, HIV, Nutrition Disorders
What is being tested?
Philani Intervention Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,239 participants
Where
1 siteSouth Africa
Study dates
Sep 2007to Sep 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Philani Child Health and Nutrition Project, Khayelitsha

    Cape Town

Other trials in South Africa

About this study

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.

Read the 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.

Being tested
Philani Intervention Program
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
Medical subject headings
Fetal Alcohol Spectrum Disorders, Nutrition Disorders, Alcoholism, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Philani Intervention ProgramBehavioural

    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.

Study groups in NCT00996528
Study groupRoleWhat they receive
Philani Intervention ProgramExperimentalNot described
Receives: Behavioral: Philani Intervention Program
Standard CareNo interventionNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV-related transmission acts

    Maternal HIV transmission acts

    Measured: 18 months

  2. Baby's health status

    Children's behavioral and cognitive adjustment and school achievement

    Measured: 18 months

  3. Maternal adherence to HIV-related and general health routines

    Maternal alcohol use on the AUDIT

    Measured: 18 months

  4. Mental health

    Maternal Depression on the Edinburgh Postnatal Depression Scale (EPDS)

    Measured: 18 months

  5. Social support

    Children's peer relationships at seven and a half years

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2009 (estimated)
  2. Study startSep 2007
  3. Primary completionSep 2015
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00996528
Sponsor's protocol ID
Federal Identifier # AA017104
Other IDs
I R0I AA017104-01
Status last verified
Oct 2021
First submitted
15 Oct 2009
Last updated
14 Oct 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Data up to the eighth year post birth is being shared with researcher from other institutions.

Publications

  • 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.

    PubMed 38110851

  • 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.

    PubMed 37001280

  • 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.

    PubMed 35065975

  • 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.

    PubMed 34997984

  • 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.

    PubMed 34315096

  • 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.

    PubMed 34286512

  • 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.

    PubMed 31397718

  • 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.

    PubMed 31120274

  • 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.

    PubMed 26400691

  • 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.

    PubMed 25340337

  • 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.

    PubMed 23435303

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Philani Intervention Program in people with Fetal Alcohol Syndrome and HIV, run by University of California, Los Angeles at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV-related transmission acts (time frame: 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00996528, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.

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