Health TrialsbyHealthPanel

Long-Acting Injectable HIV PrEP PROs

ConditionHIV Pre-exposure Prophylaxis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnupama Raghuram MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 and older

Deemed eligible for HIV PrEP per healthcare provider

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

Disqualifiers

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

Trial population

Participants receiving injectable PrEP in Louisville, KY.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Interview and survey to evaluate patient reported outcomes between the two medications.

    Other intervention

    No intervention, the two cohorts will receive the same surveys and interviews.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: LEN LAI PrEP1 intervention
Group B: CAP LAI PrEP1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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.

Time frame
Enrollment, 6 months, 12 months
4

HIV Prevention Effectiveness

Reviewing HIV test results to confirm new HIV diagnoses during the study period.

Time frame
Baseline, 6 months, and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anupama Raghuram MD

Lead sponsor

Norton Healthcare

Sponsor institution

Gilead Sciences

Collaborator

University of Louisville

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: