Journal article
Reducing lost to follow-up in a large clinical trial of prevention of mother-to-child transmission of HIV: The Breastfeeding, Antiretrovirals and Nutrition study experience
Clinical trials (London, England), Vol.12(2), pp.62-71
04/01/2015
DOI: 10.1177/1740774514562031
PMCID: PMC4355163
PMID: 25518956
Abstract
Background/Aims Retaining patients in prevention of mother-to-child transmission of HIV studies can be challenging in resource-limited settings, where high lost to follow-up rates have been reported. In this article, we describe the effectiveness of methods used to encourage retention in the Breastfeeding, Antiretrovirals, and Nutrition study and analyze factors associated with lost to follow-up in the study.
Methods The Breastfeeding, Antiretrovirals, and Nutrition clinical trial was designed to evaluate the efficacy of three different mother-to-child HIV transmission prevention strategies. Lower than expected participant retention prompted enhanced efforts to reduce lost to follow-up during the conduct of the trial. Following study completion, we employed regression modeling to determine predictors of perfect attendance and variables associated with being lost to follow-up.
Results During the study, intensive tracing efforts were initiated after the first 1686 mother infant pairs had been enrolled, and 327 pairs were missing. Of these pairs, 60 were located and had complete data obtained. Among the 683 participants enrolling after initiation of intensive tracing efforts, the lost to follow-up rate was 3.4%. At study's end, 290 (12.2%) of the 2369 mother infant pairs were lost to follow-up. Among successfully traced missing pairs, relocation was common and three were deceased. Log-binomial regression modeling revealed higher maternal hemoglobin and older maternal age to be significant predictors of perfect attendance. These factors and the presence of food insecurity were also significantly associated with lower rates of lost to follow-up.
Conclusion In this large HIV prevention trial, intensive tracing efforts centered on reaching study participants at their homes succeeded in finding a substantial proportion of lost to follow-up participants and were very effective in preventing further lost to follow-up during the remainder of the trial. The association between food insecurity and lower rates of lost to follow-up is likely related to the study's provision of nutritional support, including a family maize supplement, which may have contributed to patient retention.
Details
- Title: Subtitle
- Reducing lost to follow-up in a large clinical trial of prevention of mother-to-child transmission of HIV: The Breastfeeding, Antiretrovirals and Nutrition study experience
- Creators
- Christopher J. Sellers - University of North Carolina at Chapel HillHana Lee - Brown UniversityCharles Chasela - University of the WitwatersrandDumbani Kayira - UNC Project, Lilongwe, MalawiAlice Soko - UNC Project, Lilongwe, MalawiInnocent Mofolo - UNC Project, Lilongwe, MalawiSascha Ellington - Cancer Research And BiostatisticsMichael G. Hudgens - University of North Carolina at Chapel HillAthena P. Kourtis - Cancer Research And BiostatisticsCaroline C. King - Cancer Research And BiostatisticsDenise J. Jamieson - Cancer Research And BiostatisticsCharles van der Horst - University of North Carolina at Chapel HillBreastfeeding, Antiretrovirals and Nutrition (BAN) study team
- Resource Type
- Journal article
- Publication Details
- Clinical trials (London, England), Vol.12(2), pp.62-71
- DOI
- 10.1177/1740774514562031
- PMID
- 25518956
- PMCID
- PMC4355163
- NLM abbreviation
- Clin Trials
- ISSN
- 1740-7745
- eISSN
- 1740-7753
- Publisher
- Sage
- Number of pages
- 10
- Grant note
- American Recovery and Reinvestment Act Ad Astra Fellowship from University College Dublin, Ireland Gilead Foundation; Gilead Sciences Elizabeth Glaser Pediatric AIDS Foundation U.S. Agency for International Development; United States Agency for International Development (USAID) 2-D43 Tw01039-06 / National Institutes of Health Fogarty AIDS International Training and Research Program (DHHS/NIH/FIC) SIP 13-01 U48-CCU409660-09; SIP 26-04 U48-DP000059-01; SIP 22-09 U48-DP001944-01 / Prevention Research Centers Special Interest Project of the Centers for Disease Control and Prevention NIH 5T32AI070114-08 / National Institutes of Health/National Institute of Allergy and Infectious Diseases Training in Infectious Disease Epidemiology Grant R24 Tw00798 / Fogarty International Clinical Research Scholars Program; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH Fogarty International Center (FIC) Johnson Johnson; Johnson & Johnson; Johnson & Johnson USA P30-AI50410 / University of North Carolina Center for AIDS Research OPP53107 / Bill and Melinda Gates Foundation; Bill & Melinda Gates Foundation World Food Program National Institute of Allergy and Infectious Diseases; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Allergy & Infectious Diseases (NIAID) Malawi Ministry of Health and Population United Nations Children's Fund
- Language
- English
- Date published
- 04/01/2015
- Academic Unit
- Obstetrics and Gynecology; VPMA - Administration
- Record Identifier
- 9984446261402771
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