Improving TelePrEP Initiation and Retention Outcomes in the US: The MISTR+ Study

Human Immunodeficiency Virus

PrEP, Pre-exposure Prophylaxis, Telemedicine

This study uses a rapid randomized controlled trial (RCT) design to examine HIV pre-exposure prophylaxis (PrEP) delivered through telehealth. This study will develop a knowledge base of small, effective changes to digital messaging and website design to improve telemedicine PrEP (telePrEP) provision for MISTR users in the United States.

HIV pre-exposure prophylaxis (PrEP) is highly effective but levels of initiation are suboptimal. Low retention in PrEP care limits the impact of PrEP, and discontinuation is frequent among persons at continued high risk for HIV transmission. Telemedicine PrEP (telePrEP) is a promising mechanism for delivery to address challenges in PrEP initiation, retention, and reengagement. This trial is framed by a learning healthcare systems (LHS) model, introduced by the Institute of Medicine over a decade ago. The LHS aims to establish a reciprocal cycle among clinical practice, data, and knowledge to continuously improve healthcare quality. LHS continuously generates and tests new interventions, learning what works best through systematic assessments such as clinical trials, quasi-experiments, and bringing successful interventions to scale. Nudge-based interventions in healthcare have promising early results. Nudges are components of "choice architecture" that alter behavior in a predictable way and are easy to achieve. Nudges, such as text messages and other electronic prompts, have demonstrated impact on areas ranging from patient continuation in medical care and medication adherence to physician prescribing behavior. Nudges can be assessed through rapid randomized controlled trial (RCT) testing the original version against a single change (A/B testing). This approach is optimal to improve telehealth delivery because interventions can have no or very low costs and easily be tested with a rapid RCT approach. To capitalize on the promise of telePrEP by improving initiation, retention, and re-engagement, the researchers propose an implementation project that will leverage rapid RCT to optimize PrEP delivery for 1/5th of all PrEP users in the United States. Emory University has established a collaboration and data use agreement with the largest national telePrEP provider, MISTR, which provides services at no out-of-pocket cost to all users. The Emory-MISTR agreement allows for transmission of limited datasets, which will allow Emory to receive all data needed for the trial. MISTR also has agreed to modify their platform to test the proposed interventions and scale ones that are efficacious. Aim 1 will develop an evidence base to inform selection of a set of intervention candidates. Aim 2 will be rapid RCT which compare interventions that entail no marginal cost per additional user to the standard of care MISTR service. Aim 3 will be rapid RCT to assess the impact of several low-marginal cost interventions on PrEP initiation, retention, and re-engagement. The interventions in this study are all designed to be small improvements to digital messaging and website design, based on the current MISTR system. This study does not involve collecting any additional information or data on MISTR users beyond what is already collected as part of their standard care in terms of intake surveys, website use data, and PrEP prescribing data. There is no active recruitment of participants and no direct contact with participants for the study.

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United States