NCT07553949

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
465

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
41mo left

Started Jan 2027

Typical duration for not_applicable hiv

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 14, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

  • LA-CAB/RPV Initiation Rate

    Number of LA-CAB/RPV initiations per number of HIV provider visits per month

    Baseline through 42 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

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.

Intervention

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Moira McNulty

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 28, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

April 28, 2026

Record last verified: 2026-04