RecruitingNot ApplicableNCT07221747

PathToScale: The PERSIST Trial

ACCELERATING THE PATH TO SCALE FOR INJECTABLE HIV PRE-EXPOSURE PROPHYLAXIS (PrEP) in MALAWI: THE PERSIST TRIAL

Sponsor

Georgetown University

Enrollment

9,900 participants

Start Date

Feb 16, 2026

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 15 YearsMax Age: 110 Years

Inclusion Criteria7

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.

Exclusion Criteria1

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.

Interventions

BEHAVIORALStandard 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.

BEHAVIORALEnhanced 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

Locations(1)

Community Health Science Unit

Lilongwe, Malawi

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