Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials.

K Rivet Amico,Amy Corneli,Leila E Mansoor,Kristine Torjesen,Ariane Van Der Straten

doi:10.1007/s10461-013-0429-9

Abstract

Adherence is a critical component of the success of antiretroviral-based pre-exposure prophylaxis (PrEP) in averting new HIV-infections. Ensuring drug availability at the time of potential HIV exposure relies on self-directed product use. A deeper understanding of how to best support sustained PrEP adherence remains critical to current and future PrEP efforts. This paper provides a succinct synthesis of the adherence support experiences from four pivotal PrEP trials—Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004, FEM-PrEP, Iniciativa Prophylaxis (iPrEx), and Vaginal and Oral Interventions to Control the Epidemic (VOICE). Notwithstanding variability in the design, population/cohort, formulation, drug, dosing strategy, and operationalization of adherence approaches utilized in each trial, the theoretical basis and experiences in implementation and monitoring of the approaches used by these trials provide key lessons for optimizing adherence in future research and programmatic scale-up of PrEP. Recommendations from across these trials include participant-centered approaches, separating measurement of adherence from adherence counseling, incorporating tailored strategies that go beyond education, fostering motivation, and addressing the specific context in which an individual incorporates and negotiates PrEP use.

Highlights

Efforts to reduce HIV infection through the use of topical and oral prophylactic antiretrovirals (ARVs) have recently yielded remarkable successes [1,2,3,4], with two exceptions
This paper provides a succinct synthesis of the adherence support experiences from four pivotal pre-exposure prophylaxis (PrEP) trials—Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004, FEM-PrEP, Iniciativa Prophylaxis, and Vaginal and Oral Interventions to Control the Epidemic (VOICE)
Notwithstanding variability in the design, population/cohort, formulation, drug, dosing strategy, and operationalization of adherence approaches utilized in each trial, the theoretical basis and experiences in implementation and monitoring of the approaches used by these trials provide key lessons for optimizing adherence in

Summary

Introduction

Efforts to reduce HIV infection through the use of topical and oral prophylactic antiretrovirals (ARVs) have recently yielded remarkable successes [1,2,3,4], with two exceptions. In the FEM-PrEP trial, product adherence was too low to assess the efficacy of daily tenofovir disoproxil fumarate/ emtricitabine (TDF/FTC, Truvada) in preventing HIV acquisition in the study population [5]. Even with highly effective ARVbased PrEP drugs, use of the drug is essential to confer protection, and no or low drug use results in no protection [5, 8]. In both the Iniciativa Prophylaxis (iPrEx) and Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 trials, a clear dose response could be delineated with higher levels of protection observed with higher adherence to product use. Despite clear recommendations to support or ‘counsel on’ PrEP adherence among those opting to use it [13,14,15], to date there are few publications or guidelines on how to operationally and effectively do so

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Conclusion