Making it Last: A Randomized, Controlled Trial of a Home Care System to Promote Persistence in PrEP Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 10
- 主要终点
- Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up
研究概览
简要总结
This study is a randomized clinical trial of PrEP@Home, a home care system for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP). Individuals entering into PrEP care at an initial in-person study visit will be randomized to the PrEP@Home system for home-based PrEP care follow-up visits or to the control standard of care for clinic-based follow-up visits. The primary aim of this study is to assess protective levels of PrEP medication for the intervention arm compared to the control arm.
详细描述
Clinical guidance calls for quarterly follow-up visits for individuals taking PrEP. Yet these visits impose burdens on the healthcare system and on patients that could hinder the persistence of patients in PrEP care. Preliminary data indicate that a home-based care system for PrEP is feasible, and acceptable, and may increase patient willingness to remain in care.
This study explores the effect of a home-based PrEP support system on maintenance in PrEP care. The study will enroll 396 participants in a stratified randomized, controlled trial comparing the PrEP@Home intervention arm to the standard of care control arm. The study seeks to explore intervention performance among highly impacted groups and therefore will target a sample that is 50% Black and 50% aged 18-34 years.
Individuals in the intervention and control arms will have a baseline study visit, in which patients will be prescribed PrEP. Participants randomized to the intervention arm will receive home care for PrEP at months 3, 6, 9, and 12. Home care will include a mailed package with materials for HIV/sexually transmitted infection (STI)/creatinine specimen self-collection, materials for return shipping, and a link to an electronic, self-report behavioral assessment. Home care will also include access to the intervention version of the study app to facilitate patient-provider and patient-system interactions. Study clinicians will monitor participants' in-home care, and renew prescriptions as indicated. Control arm participants will be linked to a local PrEP provider, where they will be seen for quarterly clinic visits per standard of care. Control participants will have access to the control version of the study app that contains only research elements pertinent to their participation in the control arm of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male at birth
- •Report anal sex with a man in the past 6 months
- •Are able to complete survey instruments in English
- •Live in the metropolitan area of a study site
- •Are willing to provide at least 2 means of alternate contact
- •Willing to not enroll in another HIV prevention trial
- •HIV-negative (self-reported and lab confirmed)
- •Own and willing to use a smartphone for the duration of the study
- •Willing to download the study app
- •Willing to take a photo of a PrEP prescription label
- •Behaviorally indicated for PrEP (per Centers for Disease Control and Prevention (CDC) guidance) or African American men who have sex with men (MSM) who report anal sex in the last six months
- •PrEP naïve or < 3 months lifetime experience of PrEP use or stopped taking PrEP >6 months ago
- •Willing to take PrEP, including adherence to daily dosing
- •Willing to use, as needed, study-provided PrEP navigation services to obtain coverage for PrEP medication
- •Able to work with the study site to develop a plan to cover the financial cost of PrEP if not covered through insurance or Gilead financial assistance
- •Willing to use a home kit that will include a self-administered collection of urine, rectal and pharyngeal swabs, and finger prick blood.
排除标准
- •Reports having genital reassignment surgery
- •<18 or ≥ 50 years of age
- •Currently enrolled in another HIV prevention trial
- •Symptoms of acute HIV infection, or being evaluated for acute infection because of recent high-risk exposure
- •Currently taking PEP
- •Creatinine clearance <60 ml/min
- •Contraindications to taking tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC)
- •History of hemophilia
- •Unable to conduct finger prick at a study site
- •Multiple screening attempts
结局指标
主要结局
Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up
时间窗: Month 6
Adherence to study medications was measured using blood TFV-DP levels. For participants taking emtricitabine/tenofovir disoproxil fumarate, TFV-DP levels \>1000 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. For those taking emtricitabine/tenofovir alafenamide, TFV-DP levels \>140 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. Participants achieving these levels were considered to have adhered appropriately (\>4 doses per week). Researchers used decision rules to determine adherence for participants who either reported using both medications in the period or did not report which medication they used. For instance, if a participant had a TFV-DP level above both cut points, they would be considered adherent to treatment.
次要结局
- Retention in PrEP Care(Up to Month 6)
- Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 12-month Follow-up(Month 12)
研究者
Aaron Siegler
Associate Professor
Emory University