Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
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ClinicalTrials.gov Identifier: NCT00996528 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 16, 2009
Last Update Posted
: May 16, 2017
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Condition or disease | Intervention/treatment | Phase |
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Fetal Alcohol Syndrome HIV Nutrition Disorders | Behavioral: Philani Intervention Program | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1239 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Neighborhood Alcohol & HIV Prevention in South African Townships (Philani) |
Study Start Date : | September 2007 |
Estimated Primary Completion Date : | September 2025 |
Estimated Study Completion Date : | September 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Philani Intervention Program |
Behavioral: 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.
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No Intervention: 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.
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- HIV-related transmission acts [ Time Frame: 18 months ]Maternal HIV transmission acts
- Baby's health status [ Time Frame: 18 months ]Children's behavioral and cognitive adjustment and school achievement
- Maternal adherence to HIV-related and general health routines [ Time Frame: 18 months ]Maternal alcohol use on the AUDIT
- Mental health [ Time Frame: 18 months ]Maternal Depression on the Edinburgh Postnatal Depression Scale (EPDS)
- Social support [ Time Frame: 18 months ]Children's peer relationships at seven and a half years

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pregnant woman
- Age 18 or older
- Informed consent
Exclusion Criteria:
- Psychosis, neurological damage, inability to communicate with interviewer
- Inability to give consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996528
South Africa | |
Philani Child Health and Nutrition Project, Khayelitsha | |
Cape Town, South Africa |
Principal Investigator: | Mary Jane Rotheram-Borus, PhD | Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mary Jane Rotheram-Borus, Professor, Semel Institute and the Department of Psychiatry, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00996528 History of Changes |
Other Study ID Numbers: |
Federal Identifier # AA017104 I R0I AA017104-01 |
First Posted: | October 16, 2009 Key Record Dates |
Last Update Posted: | May 16, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data up to the fifth year is being shared with researcher from other institutions. |
Keywords provided by Mary Jane Rotheram-Borus, University of California, Los Angeles:
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 |
Additional relevant MeSH terms:
Nutrition Disorders Fetal Alcohol Spectrum Disorders Fetal Diseases Pregnancy Complications Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders |
Chemically-Induced Disorders Ethanol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs |