PathToScale: The PERSIST Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-110
SponsorGeorgetown University
About this trial
The purpose of this study is to identify the effectiveness of a bundle of strategies to support continuation of clients on pre-exposure prophylaxis, including long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high priority groups.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female sex workers (FSW) OR
Men who have sex with men (MSM) OR
Transgender individuals (TG) OR
Women and adolescent girls and young women (AGYW) presenting at STI services and/or family planning and/or HIV testing services OR
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Standard of Care (SoC)
BehavioralParticipants will receive the standard of care per national guidelines of PrEP counseling, national program quality improvement activities, and follow up text messages and phone calls after missed visit.
Enhanced continuation support package
BehavioralParticipants will receive the SoC and bundle of enhanced PrEP continuation support strategies with the following provider, client and structural components: 1. improving provider-client empathy and communication 2. expert client/ peer 'Dolo wa PrEP' 3. early openings of clinics
Treatment groups
9,900 Participants
are divided into 2 treatment groupsGroup A: Standard of Care (SoC)Active comparator 1 intervention
Group B: Enhanced continuation support packageActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
PrEP continuation among CAB LA PrEP users of enhanced intervention verse SoC
PrEP continuation among CAB LA PrEP users at 5-months in the enhanced continuation support arm verse SoC continuation support arm without a product interruption that requires PrEP re-initiation
Time frame
5 months of follow-up after enrollmentSecondary outcomes
1
PrEP continuation among oral PrEP users of enhanced intervention verse SoC
PrEP continuation among oral PrEP users at 5-months in the enhanced intervention verse SoC continuation support arms without product interruption requiring re-initiation
Time frame
5 months of follow-up after enrollment (window period 4-6 months based on client dosing schedule)2
PrEP continuation among CAB LA PrEP users
PrEP continuation among CAB LA PrEP users at 3-months without product interruption requiring re-initiation
Time frame
3 months after enrollment3
Assessment of PrEP use and intervention
Qualitative assessment of motivations for PrEP use, discontinuation and effectiveness of continuation support strategies
Time frame
Up to 12 months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Georgetown University
Lead sponsor
Center for the Development of People
Collaborator
Centers for Disease Control and Prevention
Collaborator
Elizabeth Glaser Pediatric AIDS Foundation
Collaborator
Healthqual
Collaborator
Johns Hopkins Research Project, Malawi
Collaborator
Johns Hopkins Bloomberg School of Public Health
Collaborator
Blantyre District Health Office, Malawi
Collaborator
Lilongwe District Health Office, Malawi
Collaborator
Lighthouse Trust
Collaborator
Ministry of Health, Malawi
Collaborator
National AIDS Commission, Malawi
Collaborator
Pakachere Institute of Health and Development Communication
Collaborator
Partners in Hope, Inc.
Collaborator
University of North Carolina, Chapel Hill
Collaborator
United States President's Emergency Plan for AIDS Relief
Collaborator
Washington University School of Medicine
Collaborator
Clinton Health Access Initiative Inc.
Collaborator
Quantitative Engineering Design
Collaborator
Source ClinicalTrials.gov