An interventional study of No Marginal Cost Interventions and Low-Marginal Cost Interventions in Human Immunodeficiency Virus, sponsored by Emory University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Emory University · Not applicable, Interventional, and Health services research
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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.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
This study's planned enrollment of 223,165 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Emory University is the lead sponsor of 1,405 studies on the registry; 223 are open to participants now.
Of its 238 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Exclusion Criteria:
Individuals using MISTR services receiving an intervention condition.
Behavioral: No Marginal Cost Interventions · Behavioral: Low-Marginal Cost Interventions
Individuals using MISTR services receiving the standard of care.
Behavioral: Standard of Care
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.
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.
MISTR users receive the current standard of care. The standard of care will be updated as impactful interventions are identified.
Number of Participants Initiating PrEP
PrEP initiation is defined as a participant receiving a mailed PrEP prescription from MISTR within two months of registration.
Time frame: 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.
Time frame: 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.
Time frame: Through the intervention period (2 to 4 months)
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for May 2031, 50 months later.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's planned 50 months is above that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →