NCT07821671

Brief 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 the United States.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223,165

participants targeted

Target at P75+ for not_applicable

Timeline
52mo left

Started Mar 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2031

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

4.3 years

First QC Date

September 9, 2026

Last Update Submit

September 9, 2026

Conditions

Human Immunodeficiency Virus

Keywords

PrEPPre-exposure ProphylaxisTelemedicine

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Initiating PrEP

    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

    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

    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)

Study Arms (2)

Intervention Condition

EXPERIMENTAL

Individuals using MISTR services receiving an intervention condition.

Behavioral: No Marginal Cost InterventionsBehavioral: Low-Marginal Cost Interventions

Control Condition

ACTIVE COMPARATOR

Individuals using MISTR services receiving the standard of care.

Behavioral: Standard of Care

Interventions

No Marginal Cost InterventionsBEHAVIORAL

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.

Intervention Condition
Low-Marginal Cost InterventionsBEHAVIORAL

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.

Intervention Condition
Standard of CareBEHAVIORAL

MISTR users receive the current standard of care. The standard of care will be updated as impactful interventions are identified.

Control Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Rollins School of Public Health

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Aaron Siegler, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Siegler, PhD

CONTACT

404-712-9733asiegle@emory.edu

Rebecca Moges-Banks, MPH

CONTACT

Rebecca.moges-banks@emory.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 16, 2026

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

May 31, 2031

Study Completion (Estimated)

May 31, 2031

Last Updated

September 16, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)