Status:
NOT_YET_RECRUITING
PathToScale: The PERSIST Trial
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Center for the Development of People
Centers for Disease Control and Prevention
Conditions:
Oral Pre-exposure Prophylaxis (PrEP)
Long-acting Injectable Cabotegravir for PrEP
Eligibility:
All Genders
15-110 years
Phase:
NA
Brief 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 o...
Detailed Description
The study will test a package of implementation strategies to support continuation on pre-exposure prophylaxis (PrEP), with a particular focus on long-acting injectable cabotegravir (CAB LA). The stud...
Eligibility Criteria
Inclusion
- •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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
9900 Patients enrolled
Trial Details
Trial ID
NCT07221747
Start Date
November 1 2025
End Date
October 1 2026
Last Update
October 28 2025
Active Locations (1)
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1
Community Health Science Unit
Lilongwe, Malawi