Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT06374758
Eligibility Criteria:
PLWH Inclusion criteria: Participants must meet ALL the following inclusion criteria
1. 18 years or older at the time of obtaining the informed consent
2. Speaks English
3. Able to give consent which includes the ability to understand and comply with study requirements and instructions as judged by clinic or study staff
4. HIV-1 infection as documented by positive HIV test (positive laboratory HIV 1/2 Antibody differentiation assay or detectable HIV -1 RNA)
5. Out of care, defined as not had a medical visit with an HIV care provider with prescribing privileges for ≥6 months AND not receiving ART for ≥1 month (by self-report)
Site Staff Inclusion criteria:
Participants must meet ALL the following inclusion criteria
1. 18 years or older at the time of obtaining the informed consent
2. HIV care providers, case managers, pharmacists, or administrators involved in administrative or clinical aspects of the intervention at participating sites
3. Understand the long-term commitment to the study and be willing to participate
4. Have adequate resources to complete assessments for the duration of the study
Exclusion criteria PLWH Exclusion criteria: Participants who meet ANY of the following criteria are excluded
1. Biktarvy (B/F/TAF) contraindicated or not recommended
1. Known history of chronic kidney disease (creatinine clearance \<30 mL/min) using Cockcroft-Gault formula AND not on chronic dialysis
2. Known history of allergy to B/F/TAF components
3. Known history of intermediate-high level resistance to B/F/TAF components (score ≥30 on Stanford HIV Drug Resistance Algorithm) in the available medical record (not having a prior genotype or having M184V/I mutation is NOT an exclusion criterion)
4. Concomitant use of contraindicated medications: using drug interaction database either Lexicomp® Drug Interactions (category X Avoid combination) or Liverpool HIV Interactions Checker (category Do not Co-administer) or study drug label (USPI) as reference for list of contraindicated meds.
5. Pregnant (by self-report) or planning to become pregnant while enrolled in the study
2. HIV-2 infection
3. PLWH who are breastfeeding and are not on ART or taking ART without virologic suppression since breastfeeding will not be recommended.
4. Active opportunistic infections that would require a delay of ART as judged by the HIV care provider and based on current Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV: such as cryptococcal and Tuberculous meningitis, and CMV retinitis.16
5. Not residing in the state of Missouri at the time of the study or planning to relocate during the study period
6. Incarcerated at the time of the study enrollment.
Site Staff Exclusion criteria:
1\) Moving practice location or job relocation within 1 year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06374758
Study Brief:
Protocol Section:
NCT06374758