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Pre-exposure Prophylaxis (PrEP) at Home (PrEP@Home)

Primary Purpose

HIV/AIDS

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PrEP@Home System

Standard of Care

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring Pre-exposure prophylaxis (PrEP), Home-based monitoring

Eligibility Criteria

18 Years - 49 Years (Adult)MaleAccepts Healthy Volunteers

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 smart phone for the duration of the study
Willing to download 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 has initiated PrEP within the last three months
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 study site to develop a plan to cover financial cost of PrEP if not covered through insurance or Gilead financial assistance
Willing to use a home kit that will include 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
Has taken Post Exposure Prophylaxis (PEP) in the last 3 months
Has ever taken PrEP for ≥ 3 months
Creatinine clearance <60 ml/min
Hepatitis B surface antigen (HBsAg) positive
Contraindications to taking tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)
History of hemophilia
Unable to conduct finger prick at study site

Sites / Locations

Emory University, PRISM Health
The Fenway Institute
Open Arms Health Care Center
Washington University AIDS Clinical Trial Unit
MetroHealth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PrEP@Home System

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03569813

First Posted

June 15, 2018

Last Updated

August 29, 2023

Sponsor

Emory University

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT03569813

Brief Title

Pre-exposure Prophylaxis (PrEP) at Home

Acronym

PrEP@Home

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

April 26, 2019 (Actual)

Primary Completion Date

April 15, 2023 (Actual)

Study Completion Date

April 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV/AIDS

Keywords

Pre-exposure prophylaxis (PrEP), Home-based monitoring

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

318 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PrEP@Home System

Arm Type

Experimental

Arm Description

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.

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

PrEP@Home System

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

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).

Primary Outcome Measure Information:

Title

Diﬀerence in emtricitabine (FTC) levels between intervention and control arms at 12-month follow-up

Description

Time Frame

Month 12

Secondary Outcome Measure Information:

Title

Retention in PrEP care

Description

Time Frame

Up to Month 12

Title

Diﬀerence in emtricitabine (FTC) levels between intervention and control arms at 6-month follow-up

Description

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.

Time Frame

Month 6

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aaron Siegler, PhD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kenneth Mayer, MD

Organizational Affiliation

Harvard Medical School (HMS and HSDM)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University, PRISM Health

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

The Fenway Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Open Arms Health Care Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

Washington University AIDS Clinical Trial Unit

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

MetroHealth

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

12. IPD Sharing Statement

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Pre-exposure Prophylaxis (PrEP) at Home

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