PathToScale: An Implementation Evaluation
Accelerating the Path To Scale for Injectable PrEP in Malawi: An Implementation Evaluation
Georgetown University
9,900 participants
Mar 26, 2024
OBSERVATIONAL
Conditions
Summary
The purpose of this study is to evaluate the implementation and clinical outcomes of expanded pre-exposure prophylaxis delivery modalities and service delivery points offering long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high-priority groups through diverse delivery channels.
Eligibility
Inclusion Criteria7
- 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 Criteria1
- 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.
Interventions
This hybrid observational-implementation study will observe the implementation of a choice of oral pre-exposure prophylaxis or long-acting injectable cabotegravir for pre-exposure prophylaxis for all participants.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06319105