PathToScale: The PERSIST Trial

NCT07221747 | Recruiting

• 1 other identifier: STUDY00009615
• Study Type: interventional
• Target: 9,900
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Pre-exposure Prophylaxis (PrEP); Long-acting Injectable Cabotegravir for PrEP

Outcome Measures

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

  5 months of follow-up after enrollment

Secondary Outcomes (3)

• PrEP continuation among oral PrEP users of enhanced intervention verse SoC

  5 months of follow-up after enrollment (window period 4-6 months based on client dosing schedule)

• PrEP continuation among CAB LA PrEP users

  3 months after enrollment

• Assessment of PrEP use and intervention

  Up to 12 months after enrollment

Study Arms (2)

Standard of Care (SoC)

ACTIVE COMPARATOR

Receive the standard of care (SoC) per Ministry of Health guidelines for PrEP continuation.

Behavioral: Standard of Care (SoC)

Enhanced continuation support package

ACTIVE COMPARATOR

Enhanced bundle of clinical support and provider focused intervention package to promote sustained PrEP use.

Behavioral: Standard of Care (SoC); Behavioral: Enhanced continuation support package

Interventions

Standard of Care (SoC) BEHAVIORAL

Participants 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; Standard of Care (SoC)

Enhanced continuation support package BEHAVIORAL

Participants 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

Enhanced continuation support package

Eligibility Criteria

• Age: 15 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are 15+ years old AND either
• 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
• Breastfeeding women (BFW) OR
• Male partners of female sex workers and/or Men at high risk for HIV and/or men presenting with a syndromic or lab-confirmed sexually transmitted infections. All individuals initiated on long-acting injectable cabotegravir for pre-exposure prophylaxis 15 years or above will be included in the passively enrolled sample.

You may not qualify if:

• Those living with HIV-1 or evidence of possible acute HIV infection OR Those with a prior Hepatitis B diagnosis OR Those with a known history of severe side effects to Cabotegravir Long Acting OR Those unwilling or unable to return for 3-monthly HIV testing or 2-monthly counseling and safety monitoring visits OR Clients currently on multi-drug resistance tuberculosis (MDR-TB) medications OR Clients currently taking post-exposure prophylaxis.

Sponsors & Collaborators

• Georgetown University: lead
• Centers for Disease Control and Prevention: collaborator
• Elizabeth Glaser Pediatric AIDS Foundation: collaborator
• Healthqual: collaborator
• Center for the Development of People: 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

Study Sites (1)

Community Health Science Unit

Lilongwe, Malawi

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

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

Study Officials

• Charles Holmes, MD, MPH

  Georgetown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Holmes, MD, MPH

CONTACT

+1 (202) 662-9000; charles.holmes@georgetown.edu

Deborah Hoege, MPH

CONTACT

+1 (202) 662-9000; dh1107@georgetown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel design with all intervention facilities implementing the enhanced continuation package of strategies or standard of care (SoC) simultaneously.

Study Record Dates

• First Submitted: October 25, 2025
• First Posted: October 28, 2025
• Study Start: February 16, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)