Long-Acting Injectable HIV PrEP PROs (IMPACT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Pre-exposure Prophylaxis
• Intervention / Treatment: Other: Interview and survey to evaluate patient reported outcomes between the two medications.

• Study Type: Observational
• Enrollment (Estimated): 128

Contacts and Locations

• Study Contact: Name: NIDI Research Clinic; Phone Number: 502-861-4646; Email: SystemNIDI@nortonhealthcare.org

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Healthcare
      • Contact: NIDI Research Clinic
    • Louisville, Kentucky, United States, 40202
      • University of Louisville, School of Public Health and Information Sciences
      • Contact: Elana Nance; Phone Number: 502-852-0418; Email: e.nance@louisville.edu
      • Sub-Investigator: Jelani Kerr, MSPH, PhD
    • Louisville, Kentucky, United States, 40292
      • University of Louisville, Kent School of Social Work
      • Contact: Elana Nance; Phone Number: 502-852-0418; Email: e.nance@louisville.edu
      • Sub-Investigator: Lesley Harris, MSW, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants receiving injectable PrEP in Louisville, KY.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LEN LAI PrEP; Those receiving or initiating LEN LAI PrEP	Other: Interview and survey to evaluate patient reported outcomes between the two medications.; No intervention, the two cohorts will receive the same surveys and interviews.
CAP LAI PrEP; Those receiving or initiating CAB LAI PrEP	Other: Interview and survey to evaluate patient reported outcomes between the two medications.; No intervention, the two cohorts will receive the same surveys and interviews.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistence with Injectable PrEP	Calculated by the proportion of days covered (PDC) and identification of gaps in treatment using medication administration data.	6 months and 12 months
Injection Adherence	Measured by the Injection Adherence Rating Scale (IARS). The IARS is a Yes/No questionnaire intended to capture valuable insight from patients using long-acting injectable medications, allowing providers to improve adherence by addressing concerns related to adherence to injection schedule, perception of the injection, and the impact of side effects. . A patient is considered adherent if they answer "No" to questions 1-5 and "Yes" to questions 7-8 (indicating consistent attendance to injections, confidence in the protective effect of the medication, and positive engagement with the regimen). A patient is considered non-adherent if they answer "Yes" to questions 1-5 (indicating missed or delayed injections due to forgetfulness or lack of consistency) or "Yes" to questions 9-10 (indicating negative feelings about the injection process, which may signal discomfort or side effects affecting adherence).	Enrollment, 6 months, 12 months
Injection Site Reactions	Injection Site Reaction Questionnaire (ISRQ) for patient-reported symptoms - DAIDS criteria for grading of infusion and injection site reactions. The ISRQ is a Yes/No questionnaire and is a tool intended to capture valuable insight from patients using long-acting injectable medications, allowing providers to assess patient perceived severity of reactions to injectable drugs. Scoring and Interpretation: Mild Injection Site Reaction (ISR): A patient is considered to have mild ISR if they respond "Yes" to 1-2 symptoms. Moderate ISR: A patient is considered to have moderate ISR if they respond "Yes" to 3 symptoms. Severe ISR: A patient is considered to have severe ISR if they respond "Yes" to ≥ 4 symptoms.	Enrollment, 6 months, 12 months
HIV Prevention Effectiveness	Reviewing HIV test results to confirm new HIV diagnoses during the study period.	Baseline, 6 months, and 12 months
Incidence of Co-occurring STIs	Reviewing routine STI testing outcomes to determine the incidence of Co-occurring STIs.	Enrollment, 6 months, and 12 months
Patient perceptions and preferences	Explored in a subset of 20 patients through the injectable PrEP Experience Interview (IPEI).	Enrollment, 6 months, and 12 months
Retention in Care	Evaluated through the proportion of appointments attended (PAA) and the proportion of patients with a scheduled end-of-study visit (PESV).	6 months and 12 months
Visit Burden Index	Evaluated through the number of PrEP-related visits per patient (i.e. provider visits, injection visits, laboratory visits, and urgent/ emergency department visits for adverse reactions to PrEP and/or additional STI screening).	6 months and 12 months

Collaborators and Investigators

• Sponsor: Anupama Raghuram MD
• Collaborators: Gilead Sciences; University of Louisville

Publications and helpful links

General Publications

• 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.
• 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
• Lee, E., et al(2010). PMS36 Injection Site Reaction Questionnaire: An Adequate Tool For Measuring Injection Site Reactions? Value in Health, 13(3), A129.
• 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.
• 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.
• 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.
• 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.
• 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.
• Nunn AS, et al. Defining the HIV pre-exposure prophylaxis care continuum. Aids. 2017 Mar 13;31(5):731-4.
• 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.
• 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
• 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
• 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
• 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

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: 25-N0026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No