PathToScale: The PERSIST Trial
Recruiting · NCT07221747 · Interventional (participants receive a specific treatment) · Lead sponsor: Georgetown University
View the official record on ClinicalTrials.gov →Interventions studied
Enhanced continuation support packageStandard of Care (SoC)
What this trial is about
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.
Who can take part
Age range
15 Years to 110 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- 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 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 is running
1 location listed.
- Community Health Science Unit - Lilongwe, Malawi