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

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.

• No Marginal Cost Interventions (Behavioral): The exact intervention types will be determined based on Aim 1 data analyses that seek to identify the areas that could most benefit from intervention. Possible interventions to be tested include message content, message format, message time of day, and website design.
• Low-Marginal Cost Interventions (Behavioral): The exact intervention types will be determined based on Aim 1 data analyses that seek to identify the areas that could most benefit from intervention. Possible interventions to be tested include warm handoffs, personalized messages, and enhanced remote laboratory testing.
• Standard of Care (Behavioral): MISTR users receive the current standard of care. The standard of care will be updated as impactful interventions are identified.

Primary outcomes

• Number of Participants Initiating PrEP [Through the intervention period (2 to 4 months)]: PrEP initiation is defined as a participant receiving a mailed PrEP prescription from MISTR within two months of registration.
• Number of Participants with PrEP Retention [Through the intervention period (2 to 4 months)]: PrEP retention in care is defined as a successfully renewed and mailed PrEP prescription within plus or minus one month of the scheduled date for renewal.
• Number of Participants with PrEP Re-Engagement [Through the intervention period (2 to 4 months)]: PrEP re-engagement is defined as receiving a mailed PrEP prescription within two months of a re-engagement intervention being initiated.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adults aged >= 18 years
* Individuals who use MISTR services
* Reside in the United States

Exclusion Criteria:

* Individuals who do not use MISTR services
* Individuals who do not reside in the United States

• Aaron Siegler, PhD, Principal investigator, Emory University

NIH grants: R01AI200775