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

ConditionHuman Immunodeficiency Virus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged >= 18 years

Individuals who use MISTR services

Reside in the United States

Disqualifiers

Individuals who do not use MISTR services

Individuals who do not reside in the United States

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

223,165 Participants
are divided into 2 treatment groups
Group A: Intervention ConditionExperimental treatment 2 interventions
Group B: Control ConditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

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Emory University

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: