Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System (ePrEP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03729570|
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pre-exposure Prophylaxis||Other: ePrEP||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 28, 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
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.
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.
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.
- 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.
- 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.
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
|Contact: Aaron Siegler, PhDemail@example.com|
|Contact: Karen Dominguez, MPHfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Henna Budhwani 205-975-7613 email@example.com|
|United States, Georgia|
|Rollins School of Public Health||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Aaron Siegler, PhD 404-712-9733 firstname.lastname@example.org|
|Principal Investigator: Aaron Siegler, PhD|
|United States, Mississippi|
|University of Mississippi Medical Center||Recruiting|
|Jackson, Mississippi, United States, 39216|
|Contact: James B Brock, MD 601-984-5560 email@example.com|
|Principal Investigator: James Brock, MD, MS|
|Principal Investigator: Leandro Mena, MD,MPH|
|United States, North Carolina|
|University of North Carolina||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Christopher Hurt, MD 919-966-2789 firstname.lastname@example.org|
|Principal Investigator: Christopher Hurt, MD|
|Principal Investigator:||Aaron Siegler, PhD||Emory University|
|Principal Investigator:||Leandro Mena, MD MPH||University of Mississippi Medical Center|