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Completed

NCT Number: NCT03569813

Pre-exposure Prophylaxis (PrEP) at Home

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, PRISM Health, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

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

    Time frame: 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 outcomes

  1. Retention in PrEP Care

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: PrEP@Home

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2018
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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