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

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

Plain Language Summary

Simplified for easier understanding

This study is looking at how well long-acting injectable HIV prevention medicine (called cabotegravir, given as a shot every 2 months) works in real-world settings for people at higher risk of HIV. You may be eligible if: - You are 15 years or older - You are in one of the following groups considered at higher risk for HIV: - Female sex workers - Men who have sex with men - Transgender individuals - Women or young women seeking STI, family planning, or HIV testing services - Breastfeeding women - Male partners of female sex workers, or men at high risk of HIV, or men with a sexually transmitted infection You may NOT be eligible if: - You are already living with HIV or may be in the early stages of HIV infection - You have a history of hepatitis B - You have had a serious reaction to cabotegravir before - You are not able or willing to come back every 3 months for HIV testing and every 2 months for check-ins - You are currently taking medication for drug-resistant tuberculosis (MDR-TB) - You are currently on post-exposure HIV prevention medicine (PEP) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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NCT07221747


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