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 Type
OBSERVATIONAL
Enrollment
128
No intervention, the two cohorts will receive the same surveys and interviews.
Norton Healthcare
Louisville, Kentucky, United States
University of Louisville, School of Public Health and Information Sciences
Louisville, Kentucky, United States
University of Louisville, Kent School of Social Work
Louisville, Kentucky, United States
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 frame: Time of Enrollment, 6 months, 12 months
Persistence with Injectable PrEP
Calculated by the proportion of days covered (PDC) and identification of gaps in treatment using medication administration data.
Time frame: 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).
Time frame: 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.
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Time frame: Enrollment, 6 months, 12 months
HIV Prevention Effectiveness
Reviewing HIV test results to confirm new HIV diagnoses during the study period.
Time frame: Baseline, 6 months, and 12 months
Incidence of Co-occurring STIs
Reviewing routine STI testing outcomes to determine the incidence of Co-occurring STIs.
Time frame: Enrollment, 6 months, and 12 months
Patient perceptions and preferences
Explored in a subset of 20 patients through the injectable PrEP Experience Interview (IPEI).
Time frame: 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).
Time frame: 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).
Time frame: 6 months and 12 months