Long-Acting Injectable HIV PrEP PROs

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Anupama Raghuram MD
Study ID
NCT07379658
Status
Not Yet Recruiting

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Conditions

  • HIV Pre-exposure Prophylaxis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Interview and survey to evaluate patient reported outcomes between the two medications. — OTHER
    No intervention, the two cohorts will receive the same surveys and interviews.

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Dec 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
128 participants (estimated)

Arms

  • Arm: LEN LAI PrEP
    Those receiving or initiating LEN LAI PrEP
  • Arm: CAP LAI PrEP
    Those receiving or initiating CAB LAI PrEP

Primary Outcome Measure

LAI-SQ-6 Survey, Long-Acting Injectable Satisfaction Questionnaire [ Time Frame: Time of Enrollment, 6 months, 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Norton HealthcareLouisvilleKentucky40202
NIDI Research Clinic
University of Louisville, Kent School of Social WorkLouisvilleKentucky40292
Elana Nance
[email protected]
502-852-0418
Lesley Harris, MSW, PhD (SUB_INVESTIGATOR)
University of Louisville, School of Public Health and Information SciencesLouisvilleKentucky40202
Elana Nance
[email protected]
502-852-0418
Jelani Kerr, MSPH, PhD (SUB_INVESTIGATOR)

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Norton Healthcare· Louisville, KYUniversity of Louisville, Kent School of Social Work· Louisville, KYUniversity of Louisville, School of Public Health and Information Sciences· Louisville, KY

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