Loss to follow-up among infants in a study of isoniazid prophylaxis (P1041) in South Africa

Document Abstract / Summary Overview

Abstract Objective—To assess risk factors for loss to follow-up (LFU) from the IMPAACT P1041 study, an isoniazid (INH) prophylaxis study conducted in southern Africa. Design—Infants in two cohorts, human immunodeficiency virus-infected (HIV+) and HIVexposed but non-infected (HIV−), were randomized to INH or placebo for 96 weeks. LFU was evaluated at week 96. Results—Of 1351 infants, 12.9% were LFU (10.4% HIV+, 14.7% HIV−); 65% of the HIV+ cohort was asymptomatic. Among HIV+ infants, large household size (>6 vs. <4 members, P = 0.035) and presence of an elder (≥55 years, P = 0.05) were associated with better retention. Although attenuated in adjusted analysis, these associations held among HIV− infants. Among HIV− infants, having a younger mother increased the risk (P = 0.008) and maternal history of TB reduced the risk of LFU, the latter by nearly 70% (P = 0.048 univariate, 0.09 adjusted). LFU was largely due to inability to contact the participant (58% HIV+, 30% HIV−), and inability to attend the clinic and withdrawal of consent (HIV−). Conclusions—Household support was an important factor in participant retention, particularly for the non-HIV-infected cohort, as young maternal age was a risk factor for LFU. Retaining study participants from this mobile population can be challenging and may warrant additional support.