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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 : Recruiting
First Posted : November 2, 2018
Last Update Posted : June 4, 2020
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

Tracking Information
First Submitted Date  ICMJE November 1, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE May 28, 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
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 emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets per week.
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pre-exposure Prophylaxis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: ePrEP
  • 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 24 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Aaron Siegler, PhD 404-712-9733 asiegle@emory.edu
Contact: Karen Dominguez, MPH 404-727-9788 kjdomin@emory.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729570
Other Study ID Numbers  ICMJE IRB00103988
3U19HD089881 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aaron Siegler, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Aaron Siegler, PhD Emory University
Principal Investigator: Leandro Mena, MD MPH University of Mississippi Medical Center
PRS Account Emory University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP