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
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Anupama Raghuram MD
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- LAI-SQ-6 Survey, Long-Acting Injectable Satisfaction Questionnaire
概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
LEN LAI PrEP
Those receiving or initiating LEN LAI PrEP
干预措施: Interview and survey to evaluate patient reported outcomes between the two medications. (Other)
CAP LAI PrEP
Those receiving or initiating CAB LAI PrEP
干预措施: Interview and survey to evaluate patient reported outcomes between the two medications. (Other)
结局指标
主要结局
LAI-SQ-6 Survey, Long-Acting Injectable Satisfaction Questionnaire
时间窗: 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.
次要结局
- Persistence with Injectable PrEP(6 months and 12 months)
- Injection Adherence(Enrollment, 6 months, 12 months)
- Injection Site Reactions(Enrollment, 6 months, 12 months)
- HIV Prevention Effectiveness(Baseline, 6 months, and 12 months)
- Incidence of Co-occurring STIs(Enrollment, 6 months, and 12 months)
- Patient perceptions and preferences(Enrollment, 6 months, and 12 months)
- Retention in Care(6 months and 12 months)
- Visit Burden Index(6 months and 12 months)
研究者
Anupama Raghuram MD
Chief Research Scientist
Norton Healthcare