An interventional study of Pharmacy-technician based model in HIV, sponsored by University of Chicago. Not yet recruiting. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University of Chicago · Not applicable, Interventional, and Health services research
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.
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.
University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
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Exclusion Criteria:
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.
LA-CAB/RPV Initiation Rate
Number of LA-CAB/RPV initiations per number of HIV provider visits per month
Time frame: Baseline through 42 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of Chicago