PathToScale PERSIST: helping people stay on injectable and oral PrEP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The program uses a hybrid type 3 pragmatic cluster randomized design where delivery sites (primary health centers, private clinics, and drop-in/community centers) are randomized to standard Ministry of Health care versus an enhanced continuation support package for PrEP users, with emphasis on long‑acting injectable cabotegravir (CAB LA). The primary outcome is PrEP continuation at five months, with secondary outcomes including alternative continuation timepoints, acceptability, feasibility, appropriateness, and fidelity of the implementation strategies among CAB LA users and providers. Clusters are balanced by facility type and clinic/PrEP volume using constrained randomization, and most PrEP users are passively enrolled with a subset actively enrolled for targeted research activities. The approach tests real-world implementation strategies to improve sustained PrEP use in prioritized populations such as female sex workers, men who have sex with men, transgender people, adolescent girls and young women, and other high-risk groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

•Inclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis will be applied per Ministry of Health guidelines. Per Ministry of Health guidelines, the following populations will be prioritized for long-acting injectable cabotegravir for pre-exposure prophylaxis distribution, following individual risk assessment:

Individuals who are 15+ years old AND either

1. Female sex workers (FSW) OR
2. Men who have sex with men (MSM) OR
3. Transgender individuals (TG) OR
4. Women and adolescent girls and young women (AGYW) presenting at STI services and/or family planning and/or HIV testing services OR
5. Breastfeeding women (BFW) OR
6. 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 Criteria:

* Per Ministry of Health guidelines, exclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis includes:

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.

Where it's running

• Community Health Science Unit
  Lilongwe, Malawi Recruiting

Study contacts

• Principal investigator: Charles Holmes, MD, MPH — Georgetown University
• Study coordinator: Charles Holmes, MD, MPH
• Email: charles.holmes@georgetown.edu
• Phone: +1 (202) 662-9000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.