Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 24 Years
Eligible Genders
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Assigned male at birth - Age 18-24 (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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Other: ePrEP
    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.
No Intervention
Standard of care
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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Henna Budhwani
205-975-7613
budhwani@uab.edu

More Details

Status
Recruiting
Sponsor
Emory University

Study Contact

Aaron Siegler, PhD
404-712-9733
asiegle@emory.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.