Reducing lost to follow-up in a large clinical trial of prevention of mother-to-child transmission of HIV: The Breastfeeding, Antiretrovirals and Nutrition (BAN) study experience
Published Date:Dec 17 2014
Source:Clin Trials. 12(2):156-165.
Human Immunodeficiency Virus
Infectious Disease Transmission, Vertical
Lost To Follow-Up
Lost To Follow Up
Prevention Of Mother To Child Transmission
Pubmed Central ID:PMC4355163
Funding:U48 DP001944/DP/NCCDPHP CDC HHS/United States
D43 TW001039/TW/FIC NIH HHS/United States
U48-CCU409660-09/PHS HHS/United States
R24TW00798/TW/FIC NIH HHS/United States
U48-DP000059-01/DP/NCCDPHP CDC HHS/United States
P30-AI50410/AI/NIAID NIH HHS/United States
5T32AI070114-08/AI/NIAID NIH HHS/United States
U48-DP001944-01/DP/NCCDPHP CDC HHS/United States
T32 AI070114/AI/NIAID NIH HHS/United States
P30 AI042853/AI/NIAID NIH HHS/United States
D43 TW001035/TW/FIC NIH HHS/United States
TW01039-06/TW/FIC NIH HHS/United States
U48 DP000059/DP/NCCDPHP CDC HHS/United States
P30 AI050410/AI/NIAID NIH HHS/United States
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 (LTFU) rates have been reported. In this paper, we describe the effectiveness of methods used to encourage retention in the Breastfeeding, Antiretrovirals, and Nutrition (BAN) study and analyze factors associated with LTFU in the study.
The BAN clinical trial was designed to evaluate the efficacy of 3 different mother-to-child HIV transmission prevention strategies. Lower than expected participant retention prompted enhanced efforts to reduce LTFU during the conduct of the trial. Following study completion, we employed regression modeling to determine predictors of perfect attendance and variables associated with being LTFU.
During the study, intensive tracing efforts were initiated after the first 1686 mother-infant pairs had been enrolled, and 327 pairs were missing. Sixty of these pairs were located and had complete data obtained. Among the 683 participants enrolling after initiation of intensive tracing efforts, the LTFU rate was 3.4%. At study's end, 290 (12.2%) of the 2369 mother-infant pairs were LTFU. 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 LTFU.
In this large HIV prevention trial, intensive tracing efforts centered on reaching study participants at their homes succeeded in finding a substantial proportion of LTFU participants, and were very effective in preventing further LTFU during the remainder of the trial. The association between food insecurity and lower rates of LTFU is likely related to the study's provision of nutritional support, including a family maize supplement, which may have contributed to patient retention.
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