Clinical trial NCT03729570: Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-exposure Prophylaxis
Keywords: PrEP
MSM
HIV
telemedicine
randomized controlled trial
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of North Carolina, Chapel Hill
name: University of Mississippi Medical Center
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-11-02
Enrollment: 217
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up
timeFrame: 6-month follow up
Secondary outcomes:
measure: Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 12 Months Follow-up
timeFrame: 12-month follow up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Atlanta
country: United States
facility: Rollins School of Public Health
state: Georgia
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: Emory University
name: Aaron Siegler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siegler AJ, Brock JB, Hurt CB, Ahlschlager L, Dominguez K, Kelley CF, Jenness SM, Wilde G, Jameson SB, Bailey-Herring G, Mena LA. An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jun 10;8(6):e13982. doi: 10.2196/13982.