Набор скоро начнётся NCT07379658
Long-Acting Injectable HIV PrEP PROs
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Interview and survey to evaluate patient reported outcomes between the two medications..
- Кому может быть актуально
- Состояния в реестре: HIV Pre-exposure Prophylaxis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Вмешательства
- Другое Interview and survey to evaluate patient reported outcomes between the two medications.
No intervention, the two cohorts will receive the same surveys and interviews.
Первичные конечные точки
- LAI-SQ-6 Survey, Long-Acting Injectable Satisfaction Questionnaire [Срок оценки: Time of Enrollment, 6 months, 12 months]
Вторичные конечные точки (8)
- Persistence with Injectable PrEP [Срок оценки: 6 months and 12 months]
- Injection Adherence [Срок оценки: Enrollment, 6 months, 12 months]
- Injection Site Reactions [Срок оценки: Enrollment, 6 months, 12 months]
- HIV Prevention Effectiveness [Срок оценки: Baseline, 6 months, and 12 months]
- Incidence of Co-occurring STIs [Срок оценки: Enrollment, 6 months, and 12 months]
- Patient perceptions and preferences [Срок оценки: Enrollment, 6 months, and 12 months]
- Retention in Care [Срок оценки: 6 months and 12 months]
- Visit Burden Index [Срок оценки: 6 months and 12 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 3 центра
- Norton Healthcare — Louisville
- University of Louisville, School of Public Health and Information Sciences — Louisville
- University of Louisville, Kent School of Social Work — Louisville
Публикации
- 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, 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. PMID 10785582
- 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. PMID 19397800
- 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
- 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. PMID 30445896
- 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, Carte PMID 39046157
- 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. PMID 34436609
Идентификаторы
NCT: NCT07379658 · 25-N0026