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

Emory University

Status: Completed

Conditions: Pre-exposure Prophylaxis

Treatments: Other: ePrEP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03729570

IRB00103988

3U19HD089881 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 217 patients

Sex: Male

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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217 participants in 2 patient groups

ePrEP

Experimental group

Description:

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.

Treatment:

Other: ePrEP

Standard of care

No Intervention group

Description:

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.