Optimizing Implementation of Long Acting Injectable PrEP

NCT07649551 | Not Yet Recruiting

• 1 other identifier: R34MH135746
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Our goal is to optimize LAI-PrEP implementation within the context of other PrEP methods. Our strategy is flexible to allow pivot to include forthcoming PrEP dosing options should they become available

Conditions

HIV Infections

Keywords

PrEP; Pre-Exposure Prophylaxis

Outcome Measures

Primary Outcomes (1)

• LAI-PrEP prescribing

  Proportion of eligible patients prescribed LAI-PrEP

  3 months

Study Arms (2)

Clinic Implementation

ACTIVE COMPARATOR

We will implement changes responsive to current obstacles to LAI-PrEP care delivery with serial systematic evaluation. Preliminary impact of LAI-PrEP implementation will be evaluated using RE-AIM, assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance via electronic medical records review, survey, and exit interviews. Exit interviews will also determine feasibility, acceptability, and appropriateness of Plan-Do-Study-Act as a clinic-based implementation strategy.

Behavioral: Plan-Do-Study-Act

Control

NO INTERVENTION

Observational control period

Interventions

Plan-Do-Study-Act BEHAVIORAL

Implementation strategy of conducting cyclical small tests of change using Plan-Do-Study-Act

Clinic Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older,
• affiliated with a participating clinic, and
• be involved in prescribing or supporting PrEP care delivery.

You may not qualify if:

• years of age or younger,
• not affiliated with a participating clinic, and
• not involved in prescribing or supporting PrEP care delivery.
• years of age or older, and
• had a clinical visit for any form of PrEP care during the study period at a participating clinic site.
• years of age or younger, and
• no clinical visit for any form of PrEP care during the study period at a participating clinic site.

Sponsors & Collaborators

• University of Minnesota: lead

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Steven A John, PhD, MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven A John, PhD, MPH

CONTACT

612-625-1500; sajohn@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will pilot and evaluate an implementation strategy of conducting cyclical small tests of change using Plan-Do-Study-Act within two outpatient clinics

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 16, 2026

Record last verified: 2026-06