Not yet recruiting NCT07379658
Long-Acting Injectable HIV PrEP PROs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interview and survey to evaluate patient reported outcomes between the two medications..
- Who it may be relevant to
- Registry conditions: HIV Pre-exposure Prophylaxis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- LAI-SQ-6 Survey, Long-Acting Injectable Satisfaction Questionnaire [Time frame: Time of Enrollment, 6 months, 12 months]
Secondary outcome measures (8)
- Persistence with Injectable PrEP [Time frame: 6 months and 12 months]
- Injection Adherence [Time frame: Enrollment, 6 months, 12 months]
- Injection Site Reactions [Time frame: Enrollment, 6 months, 12 months]
- HIV Prevention Effectiveness [Time frame: Baseline, 6 months, and 12 months]
- Incidence of Co-occurring STIs [Time frame: Enrollment, 6 months, and 12 months]
- Patient perceptions and preferences [Time frame: Enrollment, 6 months, and 12 months]
- Retention in Care [Time frame: 6 months and 12 months]
- Visit Burden Index [Time frame: 6 months and 12 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Norton Healthcare — Louisville
- University of Louisville, School of Public Health and Information Sciences — Louisville
- University of Louisville, Kent School of Social Work — Louisville
Publications
- 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
Identifiers
NCT: NCT07379658 · 25-N0026