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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| University of Louisville | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEN LAI PrEP | Those receiving or initiating LEN LAI PrEP |
| |
| CAP LAI PrEP | Those receiving or initiating CAB LAI PrEP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Adults aged 18 and older
Deemed eligible for HIV PrEP per healthcare provider
Receiving or initiating LAI PrEP, defined as:
Receiving PrEP services in Louisville, KY
Able to provide informed consent and complete study assessments
Exclusion Criteria:
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Participants receiving injectable PrEP in Louisville, KY.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| NIDI Research Clinic | Contact | 502-861-4646 | SystemNIDI@nortonhealthcare.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Healthcare | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 10785582 | Background | Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophr Res. 2000 May 5;42(3):241-7. doi: 10.1016/s0920-9964(99)00130-9. | |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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 |
| University of Louisville, School of Public Health and Information Sciences | Louisville | Kentucky | 40202 | United States |
|
| University of Louisville, Kent School of Social Work | Louisville | Kentucky | 40292 | United States |
|
| Background |
| Bharmal M, Payne K, Atkinson MJ, Desrosiers MP, Morisky DE, Gemmen E. Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications. Health Qual Life Outcomes. 2009 Apr 27;7:36. doi: 10.1186/1477-7525-7-36. |
| 16961550 | 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. |
| 30445896 | Background | Murray MI, Markowitz M, Frank I, Grant RM, Mayer KH, Hudson KJ, Stancil BS, Ford SL, Patel P, Rinehart AR, Spreen WR, Margolis DA. Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial. HIV Clin Trials. 2018 Aug;19(4):129-138. doi: 10.1080/15284336.2018.1511346. Epub 2018 Nov 16. |
| 39046157 | Background | Bekker LG, Das M, Abdool Karim Q, Ahmed K, Batting J, Brumskine W, Gill K, Harkoo I, Jaggernath M, Kigozi G, Kiwanuka N, Kotze P, Lebina L, Louw CE, Malahleha M, Manentsa M, Mansoor LE, Moodley D, Naicker V, Naidoo L, Naidoo M, Nair G, Ndlovu N, Palanee-Phillips T, Panchia R, Pillay S, Potloane D, Selepe P, Singh N, Singh Y, Spooner E, Ward AM, Zwane Z, Ebrahimi R, Zhao Y, Kintu A, Deaton C, Carter CC, Baeten JM, Matovu Kiweewa F; PURPOSE 1 Study Team. Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women. N Engl J Med. 2024 Oct 3;391(13):1179-1192. doi: 10.1056/NEJMoa2407001. Epub 2024 Jul 24. |
| 34436609 | Background | Hojilla JC, Hurley LB, Marcus JL, Silverberg MJ, Skarbinski J, Satre DD, Volk JE. Characterization of HIV Preexposure Prophylaxis Use Behaviors and HIV Incidence Among US Adults in an Integrated Health Care System. JAMA Netw Open. 2021 Aug 2;4(8):e2122692. doi: 10.1001/jamanetworkopen.2021.22692. |
| 28060019 | Background | Nunn AS, Brinkley-Rubinstein L, Oldenburg CE, Mayer KH, Mimiaga M, Patel R, Chan PA. Defining the HIV pre-exposure prophylaxis care continuum. AIDS. 2017 Mar 13;31(5):731-734. doi: 10.1097/QAD.0000000000001385. |
| 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 |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |