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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
ePrEP	ePrEP	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.

Primary Outcome Measures

Name	Time	Method
Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up	6-month follow up	Measurements TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. TFV-DP level can be translated to an interpretation that indicates the mean number of days per week PrEP is ingested over approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be medication levels indicating \>4 doses/wk. For participants taking emtricitabine/tenofovir disoproxil fumarate, this will be TFV-DP levels: \>1000 femtomole per blood spot (fmol/punch). For participants taking emtricitabine/tenofovir alafenamide this will be TFV-DP levels: \>140 femtomole per blood spot (fmol/punch).

Secondary Outcome Measures

Name	Time	Method
Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 12 Months Follow-up	12-month follow up	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. TFV-DP level can be translated to an interpretation that indicates the mean number of days per week PrEP is ingested over approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be medication levels indicating \>4 doses/wk. For participants taking emtricitabine/tenofovir disoproxil fumarate, this will be TFV-DP levels: \>1000 femtomole per blood spot (fmol/punch). For participants taking emtricitabine/tenofovir alafenamide this will be TFV-DP levels: \>140 femtomole per blood spot (fmol/punch).

Locations (4): University of Alabama at Birmingham
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Birmingham, Alabama, United States
University of North Carolina
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Chapel Hill, North Carolina, United States
Rollins School of Public Health
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Atlanta, Georgia, United States
University of Mississippi Medical Center
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Jackson, Mississippi, United States