Phase 4 HIV and AIDS Trial, Recruiting NCT06374758 Sponsor: University of Missouri-Columbia Condition: HIV and AIDS
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Phase 4 HIV and AIDS Trial, Recruiting

NCT06374758
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

People living with HIV (PLWH):

  • People who are 18 years of age or older at the time of signing the consent form
  • People who speak English
  • People who are able to understand and follow the study requirements, as assessed by the clinic or study team
  • People who have a confirmed HIV-1 diagnosis, shown by a positive HIV test or detectable HIV in the blood
  • People who have been out of HIV care, meaning they have not seen an HIV care provider in 6 months or more, and have not been taking HIV treatment for at least 1 month (based on what they report themselves)

Site staff (healthcare and administrative workers):

  • People who are 18 years of age or older at the time of signing the consent form
  • People who work at a participating site as HIV care providers, case managers, pharmacists, or administrators involved in the study's clinical or administrative activities
  • People who understand the long-term commitment the study requires and are willing to take part
  • People who have enough time and resources to complete study assessments for the full duration of the study

Who may not be able to join:

People living with HIV (PLWH):

  • People for whom the study medication Biktarvy (B/F/TAF) is not recommended or is not safe, including:
    • People with a known history of significant kidney disease (with kidney function below a certain level) who are not on dialysis
    • People with a known allergy to any ingredient in Biktarvy
    • People whose medical records show a significant level of resistance to Biktarvy's components based on a drug resistance test (note: not having had a resistance test before, or having a specific common mutation called M184V/I, does not automatically exclude someone — confirm with trial site)
    • People currently taking other medications that are known to interact dangerously with Biktarvy, as determined by recognised drug interaction references
    • People who are pregnant (by their own report) or planning to become pregnant during the study
  • People who have HIV-2 (rather than HIV-1)
  • People who are breastfeeding and are either not on HIV treatment, or are on HIV treatment but the virus is not fully suppressed
  • People who have a serious active infection that, according to their HIV care provider and current medical guidelines, would mean HIV treatment needs to be delayed — examples include certain types of meningitis or a specific eye infection called CMV retinitis
  • People who do not live in the state of Missouri at the time of the study, or who are planning to move away during the study period
  • People who are incarcerated at the time of enrolling in the study

Site staff:

  • People who are planning to move their place of work or change jobs within one year

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Dima Dandachi, MD, MPH, University of Missouri-Columbia

Phone: (573) 882-7746

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
University of Missouri-Columbia
Registry
ClinicalTrials.gov
Start date
29 April 2024
Est. completion
1 May 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24.; To study the change over time in the acceptability of the ACCELERATE model of care in patient and staff participants.; To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants; To study the change over time in feasibility of the ACCELERATE model of care in staff participants; To study the change over time in sustainability of the ACCELERATE model of care in staff participants; Qualitative data

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov