Ignite Creation Date:
2025-12-18 @ 9:46 AM
Ignite Modification Date:
2025-12-23 @ 10:30 PM
Study NCT ID:
NCT03569813
Status:
None
Last Update Posted:
2024-09-26 00:00:00
First Post:
2018-06-15 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pre-exposure Prophylaxis (PrEP) at Home
Sponsor:
None
Organization:
Study Overview
Official Title:
Making it Last: A Randomized, Controlled Trial of a Home Care System to Promote Persistence in PrEP Care
Status:
None
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrEP@Home
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: