Leveraging Pharmacy Technicians to Advance the Reach of Modern Antiretroviral Therapy (PHARM ART) in Community Clinics (PHARM ART)

April 20, 2026 updated by: University of Chicago

Long-acting injectable HIV medication is an important new innovation in HIV treatment, but complex delivery logistics have resulted in limited access for people with HIV (PWH). The goal of this study is to use clinic-based pharmacy technicians to improve delivery of long-acting injectable HIV medication at federally qualified health centers in Chicago.

Participants at the community clinics may be invited to take part in study surveys or interviews. Participants at the community clinics will be part of an observational cohort.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The overarching goal of this proposal is to integrate a pharmacy technician-based model for delivering long-acting injectable cabotegravir-rilpivirine (LA-CAB/RPV) into community-based federally qualified health centers (FQHCs) that care for underserved people with HIV (PWH). LA-CAB/RPV, given every 4 or 8 weeks, is a novel HIV treatment option that positively impacts quality of life and has been shown to improve viral suppression in PWH with adherence challenges. However, rollout has been slow due to complex delivery logistics such as navigating insurance coverage and procuring medication from designated specialty pharmacies. Despite strong interest from PWH and providers, this complexity has prevented many FQHCs, which provide HIV care regardless of ability to pay or insurance, from being able to offer LA-CAB/RPV. Preliminary data from academic HIV clinics demonstrate that a LA-CAB/RPV delivery model which places a pharmacy technician in a key role, along with multidisciplinary case conferences (coalition-building), robust relationships with the specialty pharmacies that supply LA-CAB/RPV (network weaving), and tools for quality monitoring, allows programs to effectively initiate and maintain PWH on treatment. In this study, guided by two implementation science frameworks, the Consolidated Framework of Implementation Research (CFIR 2.0) and Proctor's implementation outcomes, the study will adapt and test the pharm-tech based model in five FQHC clinics in Chicago, assessing cost and equity impacts. Aim 1 will consist of formative work to adapt and refine the pharm tech-based model for the FQHC setting via rapid ethnography and implementation mapping. Aim 2 involves a hybrid Type III implementation-effectiveness study. To evaluate the effect of the PHARM ART model, the study will compare the LA-CAB/RPV initiation rate in implementation clinics vs. a group of contemporaneous control clinics using a controlled interrupted time series design over three phases: before the PHARM ART model (pre-implementation phase - 24 months prior to initiation of PHARM ART), during active facilitation by the study team (implementation phase - 21 months), and with cessation of active facilitation (sustainment phase - 21 months). Using electronic medical record data and iterative qualitative and survey research, the study will delineate mechanisms by which the PHARM ART model works in the FQHC setting, assess the quality of implementation, and evaluate clinical effectiveness outcomes. In Aim 3 the study will estimate cost, budgetary impact and cost-effectiveness of PHARM ART and associated strategies. The study will adapt an existing mathematical model to evaluate epidemiologic and economic impact across populations, applying distributional cost-effectiveness analysis (DCEA) to assess health equity impacts, including scenarios with varying levels of baseline viral suppression. The proposed work will provide important information on implementation strategies and cost/equity considerations to guide decisions by clinics and funders to invest in capacity-building.

Study Type

Interventional

Enrollment (Estimated)

465

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with HIV at implementation sites
  • English or Spanish speaking
  • Age 15 year and older
  • Able to provide informed consent

Exclusion Criteria:

  • Inability to provide informed consent due to cognitive deficits, active psychosis, or acute intoxication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The primary intervention is the integration of a pharmacy technician into the HIV care team. In addition, several other implementation strategies will be used to support programs in effectively initiating and maintaining people living with HIV on long-acting injectable treatment, including multidisciplinary case conferences, robust relationships with the specialty pharmacies that supply LA-CAB/RPV, and tools for quality monitoring.
Other: Pharmacy-technician based model
The pharmacy technician will be integrated into the HIV care team, taking referrals, documenting contact information for patients, assessing patient-level barriers to receipt of LA CAB/RPV (social determinants) for discussion with the care team, ensuring drug coverage, coordinating medication delivery and storage, tracking injections, scheduling injections, and completing clinical documentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LA-CAB/RPV Initiation Rate
Time Frame: Baseline through 42 months
Number of LA-CAB/RPV initiations per number of HIV provider visits per month
Baseline through 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute of Mental Health (NIMH)
University of California, San Francisco
Lawndale Christian Health Center
Chicago Family Health Center

Investigators

  • Principal Investigator: Moira McNulty, University of Chicago

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 Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB25-0456
  • 1R01MH140440 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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