Human Immunodeficiency VirusNCT07821671
Improving TelePrEP Initiation and Retention Outcomes in the US: The MISTR+ Study
A study testing No Marginal Cost Interventions and Low-Marginal Cost Interventions in people with Human Immunodeficiency Virus, run by Emory University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- No Marginal Cost Interventions and Low-Marginal Cost Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223,165 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 31 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged >= 18 years
- Individuals who use MISTR services
- Reside in the United States
Who cannot join
- Individuals who do not use MISTR services
- Individuals who do not reside in the United States
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rebecca Moges-Banks, MPH contact
United States1 site
Emory University Rollins School of Public Health
Atlanta, Georgia, 30322
About this study
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- No Marginal Cost Interventions, Low-Marginal Cost Interventions, Standard of Care
- Keywords
- PrEP, Pre-exposure Prophylaxis, Telemedicine
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Marginal Cost InterventionsBehavioural
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 InterventionsBehavioural
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 CareBehavioural
MISTR users receive the current standard of care. The standard of care will be updated as impactful interventions are identified.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | Individuals using MISTR services receiving an intervention condition. Receives: Behavioral: No Marginal Cost Interventions; Behavioral: Low-Marginal Cost Interventions |
| Control Condition | Active comparator | Individuals using MISTR services receiving the standard of care. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Initiating PrEP
PrEP initiation is defined as a participant receiving a mailed PrEP prescription from MISTR within two months of registration.
Measured: Through the intervention period (2 to 4 months)
Number of Participants with PrEP Retention
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.
Measured: Through the intervention period (2 to 4 months)
Number of Participants with PrEP Re-Engagement
PrEP re-engagement is defined as receiving a mailed PrEP prescription within two months of a re-engagement intervention being initiated.
Measured: Through the intervention period (2 to 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Mar 2027 (estimated)
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Each intervention will be tested compared to a control condition; it is expected that each MISTR user will receive an average of two or three interventions.
- Masking
- None (open label)
- Enrolment
- 223,165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Siegler, Emory University
- Investigators
- Aaron Siegler, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821671
- Sponsor's protocol ID
- 2026P001387
- Other IDs
- R01AI200775
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving TelePrEP Initiation and Retention Outcomes in the US: The MISTR+ Study
- ClinicalTrials.gov ID
- NCT07821671
- Acronym / sponsor ID
- 2026P001387
- Conditions
- Human Immunodeficiency Virus
- Keywords
- PrEP, Pre-exposure Prophylaxis, Telemedicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 223,165 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each intervention will be tested compared to a control condition; it is expected that each MISTR user will receive an average of two or three interventions.
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: No Marginal Cost Interventions, Behavioral: Low-Marginal Cost InterventionsIndividuals using MISTR services receiving an intervention condition. |
| Control Condition | Active comparator | Behavioral: Standard of CareIndividuals using MISTR services receiving the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged >= 18 years
- Individuals who use MISTR services
- Reside in the United States
Key exclusion criteria (2 listed)
- Individuals who do not use MISTR services
- Individuals who do not reside in the United States
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Marginal Cost InterventionsThe 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. | Behavioural | Intervention Condition |
| Low-Marginal Cost InterventionsThe 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. | Behavioural | Intervention Condition |
| Standard of CareMISTR users receive the current standard of care. The standard of care will be updated as impactful interventions are identified. | Behavioural | Control Condition |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Moges-Banks, MPH contact
Aaron Siegler, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Marginal Cost Interventions and Low-Marginal Cost Interventions in people with Human Immunodeficiency Virus, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Siegler, PhD (404-712-9733, asiegle@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Initiating PrEP (time frame: Through the intervention period (2 to 4 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.