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

September 9, 2026 updated by: Aaron Siegler, Emory University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

223165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Rollins School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Condition
Individuals using MISTR services receiving an intervention condition.
Behavioral: No Marginal Cost Interventions
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.
Behavioral: Low-Marginal Cost Interventions
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.
Active Comparator: Control Condition
Individuals using MISTR services receiving the standard of care.
Behavioral: Standard of Care
MISTR users receive the current standard of care. The standard of care will be updated as impactful interventions are identified.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Initiating PrEP
Time Frame: 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.
Through the intervention period (2 to 4 months)
Number of Participants with PrEP Retention
Time Frame: 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.
Through the intervention period (2 to 4 months)
Number of Participants with PrEP Re-Engagement
Time Frame: 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.
Through the intervention period (2 to 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Aaron Siegler, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

May 31, 2031

Study Completion (Estimated)

May 31, 2031

Study Registration Dates

First Submitted

September 9, 2026

First Submitted That Met QC Criteria

September 9, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026P001387
  • R01AI200775 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data are owned by a private company (MISTR). The researchers are accessing the data through a data use agreement that does not allow for sharing of individual level data. Study findings in aggregate form will be shared though publications and presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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