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Completed

NCT Number: NCT03729570

Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System

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.

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Key information

Conditions

Pre-exposure Prophylaxis

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ePrEP

Other

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.

Primary outcomes

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

    Time frame: 6-month 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).

Secondary outcomes

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

    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 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).

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)
  • University of Mississippi Medical Center
  • University of North Carolina, Chapel Hill

Registry information

Official study 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

Acronym: ePrEP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 2, 2018
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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