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Long-Acting Injectable HIV PrEP PROs | Clinical Trials | Clareo Health

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Long-Acting Injectable HIV PrEP PROs

Improving HIV Prevention Outcomes: Insights on Long-Acting Injectable (LAI) HIV Pre-Exposure Prophylaxis (PrEP) Patient-Reported Medication Preferences, Adherence, and Clinical Outcomes (IMPACT) in a Southern US State

NCT07379658•Anupama Raghuram MD

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn about the real world effectiveness, patient satisfaction and clinical outcomes of LAI PrEP with lenacapavir (LEN) versus cabotegravir (CAB) through surveys and interviews. Participants receiving or initiating LAI PrEP part of their regular medical care will complete surveys and interviews at three study visits over the course of 12 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults aged 18 and older
•2. Deemed eligible for HIV PrEP per healthcare provider
•3. Receiving or initiating LAI PrEP, defined as:
•1. Current use of CAB or LEN LAI PrEP at study entry
•2. Initiation of either CAB or LEN LAI PrEP within 30 days of study enrollment
•4. Receiving PrEP services in Louisville, KY
•5. Able to provide informed consent and complete study assessments

Exclusion Criteria

•1. HIV diagnosis prior to enrollment
•2. Currently on oral PrEP with no plans to switch to LAI PrEP
•3. Hypersensitivities to LEN or CAB
•4. Pregnant or planning to become pregnant
•5. PI discretion

Locations (3)

Norton Healthcare

Louisville, Kentucky, United States

University of Louisville, School of Public Health and Information Sciences

Louisville, Kentucky, United States

University of Louisville, Kent School of Social Work

Louisville, Kentucky, United States

Key Dates

Start Date

January 15, 2026

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2028

Last Updated

January 30, 2026

Enrollment

128

ESTIMATED participants

Conditions

HIV Pre-exposure Prophylaxis

Interventions

Interview and survey to evaluate patient reported outcomes between the two medications.

OTHER

Contacts

NIDI Research Clinic

CONTACT

502-861-4646 SystemNIDI@nortonhealthcare.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Long-Acting Injectable HIV PrEP PROs

Inclusion Criteria

Exclusion Criteria

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