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

Pre-exposure Prophylaxis Clinical Trial

— ePrEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03729570
• Other study ID #: IRB00103988
• Secondary ID: 3U19HD089881
• Status: Completed
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-exposure Prophylaxis

Intervention

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.

Locations

Country	Name	City	State
United States	Rollins School of Public Health	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (5)

Lead Sponsor	Collaborator
Emory University	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in tenofovir-diphosphate (TFV-DP) levels between intervention and control arms	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.	12-month follow up
Secondary	Difference in tenofovir-diphosphate (TFV-DP) levels between intervention and control arms	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.	6-month follow up