RECRUITING

Accelerated ART Initiation for PWHIV Who Are Out of Care

Conditions

HIV Infections ART Noncompliance, Patient

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. The ACCELERATE model combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved HIV regimen, a free 30-day medication starter supply, and re-linkage to medical care.

Official Title

ACCELERATE a Multisite Prospective Hybrid (Effectiveness-implementation) Type 2 Design, Single-arm, Mixed-methods Study of a Simplified Accelerated ART Initiation Protocol for People With HIV Who Are Out of Care.

Quick Facts

Study Start:2024-04-29

Study Completion:2025-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06374758

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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.

Inclusion Criteria

Exclusion 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)

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.

Contacts and Locations

Study Contact

Dima Dandachi, MD, MPH

CONTACT

(573) 882-7746

dandachid@health.missouri.edu

Hilal Abdessamad, MD

CONTACT

5735303333

hilal.abdessamad@health.missouri.edu

Principal Investigator

Dima Dandachi, MD, MPH

PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Study Locations (Sites)

University of Missouri-Columbia

Columbia, Missouri, 65212

United States

KC Care Health Center

Kansas City, Missouri, 64124

United States

NOVUS Health

Saint Louis, Missouri, 63111

United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

Dima Dandachi, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Missouri-Columbia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-29

Study Completion Date2025-11-01

Study Record Updates

Study Start Date2024-04-29

Study Completion Date2025-11-01

Terms related to this study

Additional Relevant MeSH Terms

HIV Infections
ART
Noncompliance, Patient