Long-Acting Injectable HIV PrEP PROs

NCT07379658 | Not Yet Recruiting

• 1 other identifier: 25-N0026
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HIV Pre-exposure Prophylaxis

Outcome Measures

Primary Outcomes (1)

• LAI-SQ-6 Survey, Long-Acting Injectable Satisfaction Questionnaire

  The primary endpoint of this study is to compare treatment satisfaction of CAB and LEN LAI PrEP, as measured by the Long-Acting Injectable Satisfaction Questionnaire (LAI-SQ-6), adapted for LAI therapy from the Treatment Satisfaction Questionnaire for Medication- 9 (TSQM-9) \[12\]. The minimum score possible on this questionnaire is 0 and the maximum score possible on this questionnaire is 36. Higher scores indicate a higher satisfaction, while lower scores suggest areas for improvement in patient experience with injectable medication.

  Time of Enrollment, 6 months, 12 months

Secondary Outcomes (8)

• Persistence with Injectable PrEP

  6 months and 12 months

• Injection Adherence

  Enrollment, 6 months, 12 months

• Injection Site Reactions

  Enrollment, 6 months, 12 months

• HIV Prevention Effectiveness

  Baseline, 6 months, and 12 months

• Incidence of Co-occurring STIs

  Enrollment, 6 months, and 12 months

Study Arms (2)

LEN LAI PrEP

Those receiving or initiating LEN LAI PrEP

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

CAP LAI PrEP

Those receiving or initiating CAB LAI PrEP

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

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.

CAP LAI PrEP; LEN LAI PrEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants receiving injectable PrEP in Louisville, KY.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Louisville: collaborator
• Anupama Raghuram MD: lead
• Gilead Sciences: collaborator

Study Sites (3)

Norton Healthcare

Louisville, Kentucky, 40202, United States

Location

University of Louisville, School of Public Health and Information Sciences

Louisville, Kentucky, 40202, United States

Location

University of Louisville, Kent School of Social Work

Louisville, Kentucky, 40292, United States

Location

Related Publications (14)

• U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse, Corrected version 2.1. [July 2017]. Available from https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf

  BACKGROUND

• Lee, E., et al(2010). PMS36 Injection Site Reaction Questionnaire: An Adequate Tool For Measuring Injection Site Reactions? Value in Health, 13(3), A129.

  BACKGROUND

• Thompson, K, et al. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia research. 42. 241-7. 10.1016/S0920-9964(99)00130-9.

  BACKGROUND

• Bharmal M, et al. Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications. Health Qual Life Outcomes. 2009;7:36.

  BACKGROUND

• Woodcock A, Bradley C. Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version. Value Health. 2006 Sep-Oct;9(5):320-33. doi: 10.1111/j.1524-4733.2006.00121.x.

  PMID: 16961550 BACKGROUND

• Kelley CF, et al.Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons. N Engl J Med. 2024 Nov 27. 10. Murray MI, et al. Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial. HIV Clin Trials. 2018;19(4):129-138.

  BACKGROUND

• Bekker LG, et al. Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women. N Engl J Med. 2024 Oct 3;391(13):1179-1192.

  BACKGROUND

• Hojilla JC, et al. Characterization of HIV Preexposure Prophylaxis Use Behaviors and HIV Incidence Among US Adults in an Integrated Health Care System. JAMA Netw Open. 2021;4(8):e2122692.

  BACKGROUND

• Nunn AS, et al. Defining the HIV pre-exposure prophylaxis care continuum. Aids. 2017 Mar 13;31(5):731-4.

  BACKGROUND

• CDC. Core indicators for monitoring the Ending the HIV Epidemic initiative: National HIV Surveillance System data reported through September 2023; and PrEP data reported through June 2023. https://www.cdc.gov/hiv/library/reports/surveillance-data-tables. Published December 2023. Accessed March 28, 2025.

  BACKGROUND

• Singh, S., et al. Estimating Lifetime Risk of a Diagnosis of HIV Infection Among MSM: United States, 2017-2021. Conference on Retroviruses and Opportunistic Infections, Denver, Colorado, March 3-6 2024 https://www.natap.org/2024/CROI/croi_243.htm

  BACKGROUND

• HIV/AIDS Reporting and Statistics - Cabinet for Health and Family Services. HIV/AIDS Annual Surveillance Report 2024. Ky.gov. https://www.chfs.ky.gov/agencies/dph/dehp/hab/Pages/reportsstats.aspx, accessed March 14, 2025

  BACKGROUND

• Centers for Disease Control and Prevention. (2024, April 22). Fast Facts: HIV in the United States. CDC.gov. https://www.cdc.gov/hiv/data-research/facts-stats/index.html, accessed March 14, 2025

  BACKGROUND

• CDC. (2024). Expanding PrEP Coverage in the United States to Achieve EHE Goals. National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention. https://www.cdc.gov/nchhstp/director-letters/expanding-prep-coverage.html, accessed March 14, 2025

  BACKGROUND

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

NIDI Research Clinic

CONTACT

502-861-4646; SystemNIDI@nortonhealthcare.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Research Scientist

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 30, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 30, 2026

Record last verified: 2025-12

Locations

US (3)