Actively Recruiting

Phase Not Applicable
Age: 15Years - 110Years
All Genders
Healthy Volunteers
NCT07221747

PathToScale: The PERSIST Trial

Led by Georgetown University · Updated on 2026-03-04

9900

Participants Needed

1

Research Sites

36 weeks

Total Duration

On this page

Sponsors

G

Georgetown University

Lead Sponsor

C

Center for the Development of People

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

PathToScale: The PERSIST Trial

Who Can Participate

Age: 15Years - 110Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 15 years or older
  • Female sex workers
  • Men who have sex with men
  • Transgender individuals
  • Women, adolescent girls, and young women attending STI, family planning, or HIV testing services
  • Breastfeeding women
  • Male partners of female sex workers, men at high risk for HIV, or men with syndromic or lab-confirmed sexually transmitted infections
  • Individuals initiated on long-acting injectable cabotegravir for PrEP aged 15 years or above
Not Eligible

You will not qualify if you...

  • Living with HIV-1 or showing signs of possible acute HIV infection
  • Prior diagnosis of Hepatitis B
  • Known severe side effects to long-acting cabotegravir
  • Unwilling or unable to return for 3-monthly HIV testing or 2-monthly counseling and safety monitoring visits
  • Currently on multi-drug resistant tuberculosis medications
  • Currently taking post-exposure prophylaxis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Community Health Science Unit

Lilongwe, Malawi

Actively Recruiting

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Research Team

C

Charles Holmes, MD, MPH

CONTACT

D

Deborah Hoege, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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