NCT07221747Recruiting
PathToScale: The PERSIST Trial
ACCELERATING THE PATH TO SCALE FOR INJECTABLE HIV PRE-EXPOSURE PROPHYLAXIS (PrEP) in MALAWI: THE PERSIST TRIAL
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 9900 (estimated)
- First submitted
- 25 Oct 2025
- Start date
- 16 Feb 2026
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Georgetown University
- Diseases
- HIV
- NCT number
- NCT07221747
What you commit to
- Study type: Interventional
- Planned participants: 9900
- From 16 Feb 2026 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- •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
- 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.
Age in the registry: 15 years to 110 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Community Health Science Unit Coordinator of this site? Confirm its status | Lilongwe | Malawi | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.