Pre-exposure Prophylaxis (PrEP) at Home

Study Overview
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Brief Summary
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This study is a randomized clinical trial of PrEP@Home, a home care system for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP). Individuals entering into PrEP care at an initial in-person study visit will be randomized to the PrEP@Home system for home-based PrEP care follow-up visits or to the control standard of care for clinic-based follow-up visits. The primary aim of this study is to assess protective levels of PrEP medication for the intervention arm compared to the control arm.

Detailed Description
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Clinical guidance calls for quarterly follow-up visits for individuals taking PrEP. Yet these visits impose burdens on the healthcare system and on patients that could hinder the persistence of patients in PrEP care. Preliminary data indicate that a home-based care system for PrEP is feasible, and acceptable, and may increase patient willingness to remain in care. This study explores the effect of a home-based PrEP support system on maintenance in PrEP care. The study will enroll 396 participants in a stratified randomized, controlled trial comparing the PrEP@Home intervention arm to the standard of care control arm. The study seeks to explore intervention performance among highly impacted groups and therefore will target a sample that is 50% Black and 50% aged 18-34 years. Individuals in the intervention and control arms will have a baseline study visit, in which patients will be prescribed PrEP. Participants randomized to the intervention arm will receive home care for PrEP at months 3, 6, 9, and 12. Home care will include a mailed package with materials for HIV/sexually transmitted infection (STI)/creatinine specimen self-collection, materials for return shipping, and a link to an electronic, self-report behavioral assessment. Home care will also include access to the intervention version of the study app to facilitate patient-provider and patient-system interactions. Study clinicians will monitor participants' in-home care, and renew prescriptions as indicated. Control arm participants will be linked to a local PrEP provider, where they will be seen for quarterly clinic visits per standard of care. Control participants will have access to the control version of the study app that contains only research elements pertinent to their participation in the control arm of the study.

Official Title
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Making it Last: A Randomized, Controlled Trial of a Home Care System to Promote Persistence in PrEP Care

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: PrEP@Home System
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male at birth Report anal sex with a man in the past 6 months Are able to complete survey instruments in English Live in the metropolitan area of a study site Are willing to provide at least 2 means of alternate contact Willing to not enroll in another HIV prevention trial HIV-negative (self-reported and lab confirmed) Own and willing to use a smartphone for the duration of the study Willing to download the study app Willing to take a photo of a PrEP prescription label Behaviorally indicated for PrEP (per Centers for Disease Control and Prevention (CDC) guidance) or African American men who have sex with men (MSM) who report anal sex in the last six months PrEP naïve or < 3 months lifetime experience of PrEP use or stopped taking PrEP >6 months ago Willing to take PrEP, including adherence to daily dosing Willing to use, as needed, study-provided PrEP navigation services to obtain coverage for PrEP medication Able to work with the study site to develop a plan to cover the financial cost of PrEP if not covered through insurance or Gilead financial assistance Willing to use a home kit that will include a self-administered collection of urine, rectal and pharyngeal swabs, and finger prick blood. Exclusion Criteria: Reports having genital reassignment surgery <18 or ≥ 50 years of age Currently enrolled in another HIV prevention trial Symptoms of acute HIV infection, or being evaluated for acute infection because of recent high-risk exposure Currently taking PEP Creatinine clearance <60 ml/min Contraindications to taking tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC) History of hemophilia Unable to conduct finger prick at a study site Multiple screening attempts

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This trial will include 396 participants with 2:1 allocation for the intervention (264) and control (132) conditions. The sample of 396 will target inclusion of 50% Black and 50% younger (aged 18-34) participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrEP@Home System<br>The experimental group will be assigned to the remote care system for one year of follow-up PrEP care to include home test kits and behavioral surveillance, and telemedicine visits as needed. | Behavioral: PrEP@Home System<br>* The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit has components for self-collection of urine, rectal and pharyngeal swabs, microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up (FU) visits will be done on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of emtricitabine triphosphate (FTC-TP). The system includes a study app through which participants may track the mailing of home testing kits, access quarterly surveys, and communicate with study clinicians. The surveys will include domains that physicians assess at PrEP care quarterly FU visits (sexual risk, illicit substance use, PrEP adherence, side effects). Study Clinicians will review Lab and survey results and if the results show no contraindications for PrEP continuation, the clinician may renew a participant's PrEP prescription. Telemedicine visits will be scheduled as needed.<br>|
| Active Comparator: Standard of Care<br>The comparator group will receive active linkage to a local PrEP provider for clinic-based PrEP follow-up. Participants in this study arm will be seen quarterly by a health care provider, per standard of care when taking PrEP. | Other: Standard of Care<br>* Control participants will receive clinic-based PrEP follow-up. After the baseline assessment, control participants will receive active linkage to standard, clinic-based PrEP care for their next PrEP care follow-up visit. Participants will also download the control version of the study app, which will contain only research elements pertinent to their participation in the control arm of the study including quarterly surveys. At months 6 and 12, control arm participants will be sent materials for DBS self-collection and return shipping to allow for measurement of the study outcome, emtricitabine triphosphate (FTC-TP).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diﬀerence in emtricitabine (FTC) levels between intervention and control arms at 12-month follow-up | Measurement of FTC levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. FTC level can be translated to an interpretation that indicates the mean number of days per week PrEP is ingested over a time period of approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be FTC levels considered to be a surrogate for substantial protection: >200 femtomoles per blood spot (fmol/punch), a level indicating >4 doses/wk. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in PrEP care | Retention in PrEP care, based on assessment of a filled PrEP prescription, will be assessed by photo of dated prescription label. Participants will be prompted to use the study app to take a photo of their prescription label that identifies their name, date of prescription, and the medication name. | Up to Month 12 | 
| Diﬀerence in emtricitabine (FTC) levels between intervention and control arms at 6-month follow-up | Measurement of FTC levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. FTC level can be translated to an interpretation that indicates a mean number of days per week PrEP is ingested over a time period of approximately 1-month preceding specimen collection. The cutpoint used for the primary outcome measure will be FTC levels considered to be a surrogate for substantial protection: >700 femtomoles per blood spot (fmol/punch), a level indicating >4 doses/wk. | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-exposure prophylaxis (PrEP), Home-based monitoring