Pre-exposure Prophylaxis (PrEP) at Home (PrEP@Home)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03569813 |
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Recruitment Status :
Not yet recruiting
First Posted : June 26, 2018
Last Update Posted : June 26, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV/AIDS | Behavioral: PrEP@Home System Other: Standard of Care | Not Applicable |
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 persistence of patients in PrEP care. Preliminary data indicate that a home-based care system for PrEP is feasible, 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 into 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 patients 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.
At months 6 and 12, all participants will be mailed materials for dried blood spot (DBS) self-collection to allow for measurement of tenofovir diphosphate (TFV-DP) levels. The primary outcome is a comparison of the levels of TFV-DP, a measure that provides information regarding protective levels of PrEP, for the intervention relative to the control arm.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 396 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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) |
| Primary Purpose: | Prevention |
| Official Title: | Making it Last: A Randomized, Controlled Trial of a Home Care System to Promote Persistence in PrEP Care |
| Estimated Study Start Date : | September 2018 |
| Estimated Primary Completion Date : | May 2022 |
| Estimated Study Completion Date : | May 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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 and behavioral surveillance, and telemedicine visits as needed.
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Behavioral: PrEP@Home System
The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit includes components for self-collection of urine, rectal swab, pharyngeal swab and microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up visits will be conducted on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of TFV-DP. 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 follow-up visits (sexual risk, illicit substance use, PrEP adherence, side effects). Lab and survey results will be sent to study clinicians 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 necessary. |
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Active Comparator: 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.
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Other: Standard of Care
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, TFV-DP levels. |
- Difference in tenofovir-diphosphate (TFV-DP) levels between intervention and control arms at 12 month follow-up [ Time Frame: Month 12 ]Measurement of TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. TFV-DP level can be translated to an interpretation that indicates 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 TFV-DP levels considered to be a surrogate for substantial protection: >700 femtomole per blood spot (fmol/punch), a level indicating >4 doses/wk.
- Retention in PrEP care [ Time Frame: Up to Month 12 ]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 tenofovir-diphosphate (TFV-DP) levels between intervention and control arms at 6 month follow-up [ Time Frame: Month 6 ]Measurement of TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. TFV-DP level can be translated to an interpretation that indicates 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 TFV-DP levels considered to be a surrogate for substantial protection: >700 femtomole per blood spot (fmol/punch), a level indicating >4 doses/wk.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569813
| Contact: Aaron Siegler, PhD | 404-712-9733 | asiegle@emory.edu | |
| Contact: Karen Dominguez | 404-727-9788 | karen.dominguez@emory.edu |
| United States, Georgia | |
| Emory University, PRISM Health | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Aaron Siegler, PhD 404-712-9733 asiegle@emory.edu | |
| Contact: Karen Dominguez 404-727-9788 karen.dominguez@emory.edu | |
| United States, Massachusetts | |
| The Fenway Institute | Not yet recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Kenneth Mayer, MD 617-267-0900 | |
| United States, Mississippi | |
| Open Arms Health Care Center | Not yet recruiting |
| Jackson, Mississippi, United States, 39202 | |
| Contact: Leandro Mena, MD, MPH 601-500-7660 | |
| United States, Missouri | |
| Washington University AIDS Clinical Trial Unit | Not yet recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Rupa Patel, MD, MPH 314-454-0058 | |
| Principal Investigator: | Aaron Siegler, PhD | Emory University | |
| Principal Investigator: | Kenneth Mayer, MD | Harvard Medical School |
| Responsible Party: | Aaron Siegler, Associate Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT03569813 History of Changes |
| Other Study ID Numbers: |
IRB00096594 R01MH114692 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 26, 2018 Key Record Dates |
| Last Update Posted: | June 26, 2018 |
| Last Verified: | June 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Aaron Siegler, Emory University:
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Pre-exposure prophylaxis (PrEP) Home-based monitoring |