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

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 (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. Methods 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. Results 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. Conclusions 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.

Outcomes of prevention of mother to child transmission of the human immunodeficiency virus-1 in rural Kenya—a cohort study

“…Although active follow-up was not randomized, the evidence from the subset of infants actively followed up suggests that this is a valuable intervention to improve PMTCT, as previously observed [ 42 , 43 ]. Research participation may have improved the mother’s interaction with healthcare providers, understanding and hence attitude towards PMTCT care.…”

Frequent nevirapine resistance in infants infected by HIV-1 via breastfeeding while on nevirapine prophylaxis

“…Infant plasma was unavailable at many visits due to missed visits [13] or insufficient blood volume drawn. Some of the DBS could not be amplified.…”

Development and clinical application of an evidence-based pharmaceutical care service algorithm in acute coronary syndrome

“…Therefore, it was conducted for a short period, and we were unable to observe the long‐term effects of the algorithm, including mortality and long‐term complications. Patient's loss of follow‐up often occurs in clinical trials with multiple scheduled visits . Contrary to expectations, our study incurred 34.2% follow‐up losses, which resulted in the great challenge of analysing incomplete data.…”