Acceptability and Feasibility of long-acting INjectable ART in Adolescents and Young Adults.
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202402700796695
- Lead Sponsor
- Desmond Tutu Health Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 200
•Known HIV-1 positive.
•Aged 12 - 24 years inclusive.
•Clinically well (no current HIV-related illnesses).
•Weight = 35 kg.
•Willing to switch to a long-acting injectable ART regimen for a 48-week period.
•Be virally suppressed (<50 copies/ml) at time of switch.
•Willing to be followed by the study team for 96 weeks after switch.
•Able to understand and comply with protocol requirements and sign full informed assent / consent.
•For women and adolescents of childbearing potential, be willing to use effective contraception for the duration of the study (including the post-trial access period and the 48-week follow-up phase). This includes the use of oral or injectable hormonal contraceptives, a contraceptive implant or an intrauterine device (IUD).
In addition, for cohort 1 (n=75):
•Currently receiving standard of care first-line ART.
•Suppressed viral load at the last 2 SOC measurements, with the most recent viral load drawn within 12 months of screening date (so indicating >1 year of viral suppression). Note: SOC viral load are drawn every 12 months.
•No evidence of recent poor adherence (e.g. missed clinic visits or missed pharmacy collection).
In addition, for cohort 2 (n=50):
•Currently receiving standard of care first-line ART.
•Most recent clinic viral load =50 copies/ml (but previous viral load suppressed) OR other evidence of poor adherence in past year (e.g. a missed pharmacy collection or missed clinic visits).
•Willing to receive enhanced adherence support prior to switch.
In addition, for cohort 3 (n=75)
•ART-naïve, by self-report.
•About to commence SOC first-line ART;
•Adolescent or caregiver unwilling to participate in an ART switch study.
•History of hypersensitivity to any of the study drugs or their components.
•Known HIV-1 resistance to any of the study ART drug groups (NNRTIs or INSTIs).
•History of seizures or people at risk of seizures.
•Abnormal liver function (>2.5 x ULN ALT or AST).
•Evidence of Hepatitis B infection (positive Hep B surface antigen or anti-core AB).
•Severe hepatic impairment and those with advanced hepatitis C, or those expected to need the introduction of new treatment for hepatitis C during the course of the study.
•People who are at high risk of suicide.
•Women who are pregnant or breastfeeding.
•Participant is acutely ill with COVID-19 infection.
•Use of prohibited medication (e.g. rifampicin).
•Coagulopathy or use of anticoagulants which would preclude IM injections.
•Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant’s ability to comply with the dosing schedule or which may compromise the safety of the participant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acceptability and tolerability of injectable method of ART delivery by adolescents (drawn from adverse event data as well as qualitative data from IDIs).;Feasibility of delivering injectable ART in a community setting (drawn from adherence to injection schedule by each cohort, and from key informant interviews).;Adherence to study visits and to injectable product over the study period
- Secondary Outcome Measures
Name Time Method Efficacy of long-acting injection regimen in each cohort (drawn from rate of ongoing viral suppression at end of injection period);To assess viral resistance in participants experiencing Viral load = 50 copies/ml at any visit beyond week 0 (explored at any raised viral load, not only if meets viral failure criteria).