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Trial record 1 of 1 for:    NCT03729570
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Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System (ePrEP)

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ClinicalTrials.gov Identifier: NCT03729570
Recruitment Status : Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : March 22, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of North Carolina, Chapel Hill
University of Mississippi Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Aaron Siegler, Emory University

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.

Condition or disease Intervention/treatment Phase
Pre-exposure Prophylaxis Other: ePrEP Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
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 (visit) consists of surveys, specimen collection, and 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.



Primary Outcome Measures :
  1. Difference in tenofovir-diphosphate (TFV-DP) levels between intervention and control arms [ Time Frame: 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 dried blood spot (DBS) samples. TFV-DP level can be translated to an interpretation that indicates the mean number of days per week PrEP was ingested over a time period of approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be TFV-DP levels considered to be a surrogate for substantial protection: >700 fmol per DBS punch - a level of drug that corresponds to ingestion of at least 4 FTC/TDF tablets per week.


Secondary Outcome Measures :
  1. Difference in tenofovir-diphosphate (TFV-DP) levels between intervention and control arms [ Time Frame: 6-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. The cutpoint used for the secondary outcome measure will be TFV-DP levels considered to be a surrogate for substantial protection: >700 fmol per DBS punch - a level of drug that corresponds to ingestion of at least 4 FTC/TDF tablets per week.



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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Assigned male at birth
  • Age 18-24 (inclusive)
  • Live in a rural or small town Zone Improvement Plan (ZIP) Code based on urbanicity classification
  • 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
  • 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
  • Willing to take daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as PrEP
  • Willing to use study-provided PrEP navigation services

Exclusion Criteria:

  • HIV positive (self-report or laboratory confirmed)
  • Chronic Hepatitis B
  • Currently enrolled in any HIV prevention trial (behavioral or biomedical)
  • Currently taking emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as 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 taking emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
  • Personal diagnosis or family history of hemophilia
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729570


Contacts
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Contact: Aaron Siegler, PhD 404-712-9733 asiegle@emory.edu
Contact: Karen Dominguez, MPH 404-727-9788 kjdomin@emory.edu

Locations
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United States, Georgia
Rollins School of Public Health Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Aaron Siegler, PhD    404-712-9733    asiegle@emory.edu   
Principal Investigator: Aaron Siegler, PhD         
United States, Mississippi
University of Mississippi Medical Center Not yet recruiting
Jackson, Mississippi, United States, 39216
Contact: James B Brock, MD    601-984-5560    jbbrock@umc.edu   
Principal Investigator: James Brock, MD, MS         
Principal Investigator: Leandro Mena, MD,MPH         
United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Christopher Hurt, MD    919-966-2789    churt@med.unc.edu   
Principal Investigator: Christopher Hurt, MD         
Sponsors and Collaborators
Emory University
National Institutes of Health (NIH)
University of North Carolina, Chapel Hill
University of Mississippi Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Aaron Siegler, PhD Emory University
Principal Investigator: Leandro Mena, MD MPH University of Mississippi Medical Center

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Responsible Party: Aaron Siegler, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03729570     History of Changes
Other Study ID Numbers: IRB00103988
3U19HD089881 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aaron Siegler, Emory University:
PrEP
MSM
HIV
telemedicine
randomized controlled trial