HIV Pre-exposure Prophylaxis
Conditions
Brief summary
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
OTHERInterview and survey to evaluate patient reported outcomes between the two medications.
No intervention, the two cohorts will receive the same surveys and interviews.
Sponsors
Anupama Raghuram MD
Gilead Sciences
University of Louisville
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LAI-SQ-6 Survey, Long-Acting Injectable Satisfaction Questionnaire | Time of Enrollment, 6 months, 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistence with Injectable PrEP | 6 months and 12 months | Calculated by the proportion of days covered (PDC) and identification of gaps in treatment using medication administration data. |
| Injection Adherence | Enrollment, 6 months, 12 months | 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). |
| Injection Site Reactions | Enrollment, 6 months, 12 months | 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. |
| HIV Prevention Effectiveness | Baseline, 6 months, and 12 months | Reviewing HIV test results to confirm new HIV diagnoses during the study period. |
| Incidence of Co-occurring STIs | Enrollment, 6 months, and 12 months | Reviewing routine STI testing outcomes to determine the incidence of Co-occurring STIs. |
| Patient perceptions and preferences | Enrollment, 6 months, and 12 months | Explored in a subset of 20 patients through the injectable PrEP Experience Interview (IPEI). |
| Retention in Care | 6 months and 12 months | Evaluated through the proportion of appointments attended (PAA) and the proportion of patients with a scheduled end-of-study visit (PESV). |
| Visit Burden Index | 6 months and 12 months | 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). |
Countries
United States
Contacts
CONTACTNIDI Research Clinic
Outcome results
None listed