Randomized Controlled Trial of Daily Text Messages To Support Adherence to PrEP In At-Risk for HIV Individuals: The TAPIR Study

Abstract

Background

Adherence is critical for efficacy of tenofovir disoproxil fumarate/emtricitabine as pre-exposure prophylaxis (PrEP).

Methods

Between 02/2013 and 02/2016, 398 men who have sex with men and transgender women were randomized 1:1 to receive individualized Texting for Adherence Building (iTAB) or standard care (SoC) for 48 weeks. The primary endpoint was dried blood spot (DBS) tenofovir (TFV-DP) concentrations at both week 12 and week 48 (or the last on-drug visit) of >719 fmol/punch consistent with ≥4 doses per week (i.e. adequate adherence). Secondary outcomes included DBS TFV-DP concentrations of >1246 fmol/punch consistent with 7 doses per week (i.e. near perfect adherence) and plasma FTC >350 ng/mL (consistent with dosing within the past 24 hours).

Results

Concentrations >719 fmol/punch of TFV-DP were found in 88.6% of participants at week 12 and 82.5% at week 48. For the primary endpoint the study arms did not differ (72.0% in iTAB and 69.2% in SoC, p>0.05). For the secondary composite endpoint of >1246 fmol/punch the iTAB arm was superior to SoC (33.5% vs 24.8%, p=0.06), reaching statistical significance when adjusting for age [Odds Ratio=1.56 (95% CI 1.00–2.42 p<0.05)]. At week 48, iTAB was superior to SoC for near-perfect adherence (51.0% vs. 37.4%, p=0.02). At week 12, iTAB was superior to SoC for dosing in past 24 hours by plasma FTC (47.5% versus 33.3%, p=0.007), but not at weeks 24, 36 and 48 (all P>0.05).

Conclusions

Automated text messaging is a low-burden tool that improves durability of near-perfect PrEP adherence.

Trial Registration

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