NCT03729570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

May 28, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 27, 2024

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

November 1, 2018

Results QC Date

June 3, 2024

Last Update Submit

October 16, 2024

Conditions

Pre-exposure Prophylaxis

Keywords

PrEPMSMHIVtelemedicinerandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months 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).

    6-month follow up

Secondary Outcomes (1)

  • Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 12 Months Follow-up

    12-month follow up

Study Arms (2)

ePrEP

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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.

Interventions

ePrEPOTHER

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.

ePrEP

Eligibility Criteria

Age18 Years - 29 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Rollins School of Public Health

Atlanta, Georgia, 30322, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • 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.

    PMID: 31199326DERIVED

Results Point of Contact

Title
Aaron Siegler, PhD
Organization
Emory University
asiegle@emory.edu
404-712-9733

Study Officials

  • Aaron Siegler, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 2, 2018

Study Start

May 28, 2019

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

October 18, 2024

Results First Posted

June 27, 2024

Record last verified: 2024-10

Locations

US(4)