PathToScale PERSIST: helping people stay on injectable and oral PrEP
ACCELERATING THE PATH TO SCALE FOR INJECTABLE HIV PRE-EXPOSURE PROPHYLAXIS (PrEP) in MALAWI: THE PERSIST TRIAL
This project will test whether a bundle of clinic and provider support strategies helps people in high-priority groups stay on long‑acting injectable cabotegravir or oral PrEP.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 9900 (estimated) |
| Ages | 15 Years to 110 Years |
| Sex | All |
| Sponsor | Georgetown University Academic / other |
| Locations | 1 site (Lilongwe) |
| Trial ID | NCT07221747 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal participants are people aged 15 or older from prioritized groups per Ministry of Health guidance—such as female sex workers, men who have sex with men, transgender individuals, adolescent girls and young women presenting for STI or family planning services, breastfeeding women, and men at high risk or linked to high‑risk partners—who are eligible for CAB LA or oral PrEP.
Not a fit: People who are not eligible for PrEP/CAB LA under national guidelines, who cannot attend participating clinics or drop‑in centers, or who do not want ongoing prevention services are unlikely to receive benefit from the implementation package.
Why it matters
Potential benefit: If successful, the enhanced package could increase how many people stay on injectable or oral PrEP, lowering their risk of HIV infection.
How similar studies have performed: Previous implementation work shows multi-component support can improve PrEP continuation in some settings, but large-scale evidence specifically for CAB LA rollout and its best delivery strategies remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lilongwe
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.