Pre-exposure Prophylaxis (PrEP) at Home

Not Applicable

Completed

• Conditions: HIV/AIDS
• Interventions: Behavioral: PrEP@Home System; Other: Standard of Care

• Registration Number: NCT03569813
• Lead Sponsor: Emory University

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-26
• Study Start: 2019-04-26
• Primary Completion: 2023-04-15
• Study Completion: 2023-04-15
• Disposition First Posted: 2023-09-01
• Disposition First Submitted: 2024-04-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 318

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PrEP@Home System	PrEP@Home System	The experimental group will be assigned to the remote care system for one year of follow-up PrEP care to include home test kits, behavioral surveillance, and telemedicine visits as needed.
Standard of Care	Standard of Care	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up	Month 6	Adherence to study medications was measured using blood TFV-DP levels. For participants taking emtricitabine/tenofovir disoproxil fumarate, TFV-DP levels \>1000 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. For those taking emtricitabine/tenofovir alafenamide, TFV-DP levels \>140 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. Participants achieving these levels were considered to have adhered appropriately (\>4 doses per week). Researchers used decision rules to determine adherence for participants who either reported using both medications in the period or did not report which medication they used. For instance, if a participant had a TFV-DP level above both cut points, they would be considered adherent to treatment.

Secondary Outcome Measures

Name	Time	Method
Retention in PrEP Care	Up to Month 6	Retention in PrEP care is based on participant self-report of taking PrEP at least 4 days per week in the last week as measured at the 6 months.
Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 12-month Follow-up	Month 12	Adherence to study medications was measured using blood TFV-DP levels. For participants taking emtricitabine/tenofovir disoproxil fumarate, TFV-DP levels \>1000 femtomole per blood spot (fmol/punch) indicated adherence \>4 doses per week. For those taking emtricitabine/tenofovir alafenamide, TFV-DP levels \>140 femtomole per blood spot (fmol/punch) indicated adherence \>4 doses per week. Participants achieving these levels were considered to have adhered appropriately (\>4 doses per week). For participants who either reported using both medications in the period or did not report which medication they used, the researchers used decision rules to determine adherence. For instance, if a participant had a TDF-DP level above both cutpoints, they would be considered adherent to treatment.

Trial Locations

Locations (5)

Washington University AIDS Clinical Trial Unit; 🇺🇸 Saint Louis, Missouri, United States

Emory University, PRISM Health; 🇺🇸 Atlanta, Georgia, United States

Open Arms Health Care Center; 🇺🇸 Jackson, Mississippi, United States

MetroHealth; 🇺🇸 Cleveland, Ohio, United States

The Fenway Institute; 🇺🇸 Boston, Massachusetts, United States