Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System

Study Overview
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Brief Summary
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The premise for the study is that a tailored approach for rural young men who have sex with men (YMSM), addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of Pre-exposure Prophylaxis (PrEP) initiation and persistence in care.

Detailed Description
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The premise for the study is that a tailored approach for YMSM from rural and small town areas, addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of PrEP initiation and persistence in care. The study sites are Alabama, Georgia, North Carolina, and Mississippi. Using a smartphone application (app), participants assigned to the intervention will receive and maintain a PrEP prescription without needing to leave their home (excepting pharmacy pick-up in some cases) - achieved through app-based surveys/screenings, telemedicine consultations, and home specimen self-collection.

Official Title
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Testing an Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System to Promote PrEP Among Adolescent Men Who Have Sex With Men (MSM) in Rural and Small Town Areas

Conditions
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Pre-exposure Prophylaxis

Intervention / Treatment
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* Other: ePrEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Assigned male at birth Age 18-29 (inclusive) Live in a study state (Georgia, Mississippi, North Carolina, Alabama) Able to provide informed consent and complete survey instruments in English Willing to provide complete contact information (including 2 alternate contacts) Able and willing to provide identification verification for viewing confirmation only Laboratory confirmed HIV negative Owns a smartphone capable of running the study app Male sex partners in past 6 months or clinician discretion of epidemiologic context of HIV risk Behavioral/epidemiological indication for PrEP : History of inconsistent or no condom use with more than one partner History of inconsistent or no condom use with one partner who is not mutually monogamous HIV-positive sexual partner Any sexually transmitted infection (STI) diagnosed in past 6 months Commercial sex work African American MSM reporting anal sex in the past 6 months Clinician discretion based on epidemiologic context of HIV risk Willing to take FDA-approved daily oral PrEP Willing to use study-provided PrEP navigation services Willing to self-collect specimens Exclusion Criteria: HIV positive (self-report or laboratory confirmed) Chronic Hepatitis B or no verification of hepatitis B vaccination Currently enrolled in any HIV prevention trial (biomedical) Currently taking oral PrEP based on self-report Creatinine clearance <60 ml/min based on the Cockcroft-Gault equation Symptoms of acute HIV infection within the prior 30 days Contraindications to oral PrEP Personal diagnosis or family history of hemophilia Health insurance with Kaiser Permanente (unable to prescribe PrEP through the study) Investigator discretion to exclude anyone whose best interest is not to participate Evidence of fraudulent participation, such as duplicate Internet Protocol (IP) address, multiple screening attempts, duplicate emails, etc

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ePrEP<br>Participants will receive the ePrEP home care system for telemedicine PrEP, permitting initiation and persistence in PrEP care. The ePrEP home care system consists of: a smartphone application (app) for video-based telemedicine PrEP consultations with a clinician; secure messaging; a system to track shipments to & from participants; and behavioral risk surveys that are complemented by home specimen kits. Self-collected specimens will be mailed to laboratories for routine, guideline-based testing for PrEP care. Home specimen collection will be used to determine the primary study outcome of tenofovir-diphosphate levels. | Other: ePrEP<br>* Participants will have a baseline teleconsultation with a site study clinician who will be responsible for prescribing PrEP as indicated. They will be offered a 1-month check-in and telemedicine consultations at 3, 6, 9 and 12 months. Participants will complete home specimen collection for laboratory tests for each consultation. The virtual study visit consists of surveys, specimen collection, and a telemedicine consultation.<br>|
| No Intervention: Standard of care<br>Participants will be referred to a publicly available website that geolocates the nearest PrEP provider. They will receive standard of care, defined as what a member of the general public would be able to access for PrEP services. Home specimen self-collection will be used to determine the primary study outcome of tenofovir-diphosphate levels. Additional research assessments will include quarterly surveys. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in tenofovir-diphosphate (TFV-DP) levels between intervention and control arms | Measurement of TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected dried blood spot (DBS) samples. TFV-DP level can be translated to an interpretation that indicates the mean number of days per week PrEP was ingested over a time period of approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be TFV-DP levels considered to be a surrogate for substantial protection: >700 fmol per DBS punch - a level of drug that corresponds to ingestion of at least 4 emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets per week. | 12-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in tenofovir-diphosphate (TFV-DP) levels between intervention and control arms | Measurement of TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. The cutpoint used for the secondary outcome measure will be TFV-DP levels considered to be a surrogate for substantial protection: >700 fmol per DBS punch - a level of drug that corresponds to ingestion of at least 4 FTC/TDF tablets per week. | 6-month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MSM, PrEP, HIV, telemedicine, randomized controlled trial