Pre-exposure Prophylaxis (PrEP) at Home

NCT03569813 | Completed Results DMC

• 2 other identifiers: IRB00096594R01MH114692
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 5

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.

Conditions

HIV/AIDS

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up

  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.

  Month 6

Secondary Outcomes (2)

• Retention in PrEP Care

  Up to Month 6

• Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 12-month Follow-up

  Month 12

Study Arms (2)

PrEP@Home System

EXPERIMENTAL

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.

Behavioral: PrEP@Home System

Standard of Care

ACTIVE COMPARATOR

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

Interventions

PrEP@Home System BEHAVIORAL

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.

PrEP@Home System

Standard of Care OTHER

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).

Standard of Care

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

Emory University, PRISM Health

Atlanta, Georgia, 30322, United States

Location

The Fenway Institute

Boston, Massachusetts, 02215, United States

Location

Open Arms Health Care Center

Jackson, Mississippi, 39202, United States

Location

Washington University AIDS Clinical Trial Unit

St Louis, Missouri, 63110, United States

Location

MetroHealth

Cleveland, Ohio, 44109, United States

Location

Related Publications (1)

• Gonzalez J, Rebolledo PA, Siegler AJ, Huang W, Mayer KH, Cantos VD. Development of a home-based pre-exposure prophylaxis care delivery system for long-acting injectable cabotegravir: a formative exploration of patient preferences. AIDS Care. 2024 Dec;36(12):1882-1890. doi: 10.1080/09540121.2024.2397128. Epub 2024 Sep 8.

  PMID: 39245031 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Aaron Siegler, PhD
• Organization: Emory University

asiegle@emory.edu

404-712-9733

Study Officials

• Aaron Siegler, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Kenneth Mayer, MD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 26, 2018
• Study Start: April 26, 2019
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-09

Locations

US (5)