PathToScale: The PERSIST Trial

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

Interventions

BEHAVIORAL

Standard of Care (SoC)

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.

BEHAVIORAL

Enhanced continuation support package

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

Sponsors & Collaborators

• Center for the Development of People

  collaborator UNKNOWN

• Centers for Disease Control and Prevention

  collaborator FED

• Elizabeth Glaser Pediatric AIDS Foundation

  collaborator OTHER

• Healthqual

  collaborator UNKNOWN

• Johns Hopkins Research Project, Malawi

  collaborator UNKNOWN

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• Blantyre District Health Office, Malawi

  collaborator UNKNOWN

• Lilongwe District Health Office, Malawi

  collaborator UNKNOWN

• Lighthouse Trust

  collaborator OTHER

• Ministry of Health, Malawi

  collaborator OTHER_GOV

• National AIDS Commission, Malawi

  collaborator UNKNOWN

• Pakachere Institute of Health and Development Communication

  collaborator UNKNOWN

• Partners in Hope, Inc.

  collaborator INDUSTRY

• University of North Carolina, Chapel Hill

  collaborator OTHER

• United States President's Emergency Plan for AIDS Relief

  collaborator FED

• Washington University School of Medicine

  collaborator OTHER

• Clinton Health Access Initiative Inc.

  collaborator OTHER

• Quantitative Engineering Design

  collaborator UNKNOWN

• Georgetown University

  lead OTHER

Principal Investigators

• Charles Holmes, MD, MPH · Georgetown University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-16

Primary Completion

2026-08-31

Completion

2026-11-30

Countries

• Malawi

Study Locations