Virtual PrEP: Rendering PrEP Delivery More Efficient Using an mHealth Intervention and TAF/FTC
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 5
- 主要终点
- 'Final Visit Questionnaire' will be used to determine participants' stated preference for either the standard of care or the mHealth-based model of care.
研究概览
简要总结
Gay, bisexual and other men who have sex with men (GBM) account for over half of new HIV infections in Canada each year, and have a 131-fold higher risk of HIV than other Canadian men. HIV pre-exposure prophylaxis (PrEP) using regular oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC) is an effective and safe HIV prevention option.
Despite growing interest, awareness and willingness to use PrEP there has been numerous challenges to the broader rollout of PrEP. This study will address some of these challenges by assessing participant satisfaction,feasibility and clinical outcomes associated with a web-based mobile health (mHealth) model of care for daily oral TAF/FTC PrEP compared to standard of care delivery of TAF/FTC PrEP in Canadian GBM/TGW, in the era of COVID-19.
The ultimate goal of this study is to provide a scalable model for remote PrEP delivery that minimizes the need for in-person interactions; respects guideline recommendations regarding how to optimally monitor patients; and is attractive to both patients and providers.
This study is a 1:1 open-label, pragmatic randomized controlled trial using a AB:BA crossover design, comparing the standard of care to an mHealth based model of care (Freddie® ) for TAF/FTC PrEP delivery over 72 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Self-reported gay, bisexual or other man who has sex with men (inclusive of transgender men) or transgender woman
- •HIV seronegative, as documented by a 4th generation HIV antigen/antibody combination test performed within 14 days of baseline
- •No symptoms of acute HIV seroconversion (fever, myalgias, arthralgias, malaise, headache, rash, pharyngitis and/or diarrhea that is otherwise unexplained)
- •Meets clinical criteria for PrEP according to the prescribing clinician. Patients can be enrolled into the study regardless of whether they will be newly initiating PrEP, or are already receiving PrEP; those already receiving PrEP can be using any regimen (eg. daily TDF/FTC, on-demand TDF/FTC, daily TAF/FTC) as long as they are willing to transition to the study regimen of daily, oral TAF/FTC.
- •eGFR >30ml/min
- •Has adequate access to the internet to permit use of the mHealth platform
- •Adequate facility in English to communicate with their provider
排除标准
- •Known hypersensitivity/allergy to TAF/FTC
- •Actively participating in another interventional trial related to the delivery of PrEP or sexual health-related care
- •Being unwilling or unable to perform self-collected pharyngeal and/or rectal swabs as part of routine PrEP care
- •Potential to become pregnant
- •Currently living in, or planning to move to a location that would render standard of care or ad hoc in-person visits to the study site impractical during the study period.
研究组 & 干预措施
Standard model of care
Delivery of PrEP care through the local standard of care.
干预措施: PrEP (Drug)
Standard model of care
Delivery of PrEP care through the local standard of care.
干预措施: Standard of Care (Other)
mHealth model of care
Delivery of PrEP care through the Freddie® mobile Health (mHealth) platform.
干预措施: PrEP (Drug)
mHealth model of care
Delivery of PrEP care through the Freddie® mobile Health (mHealth) platform.
干预措施: mHealth Model of Care (Other)
结局指标
主要结局
'Final Visit Questionnaire' will be used to determine participants' stated preference for either the standard of care or the mHealth-based model of care.
时间窗: 72 weeks
The primary outcome will be defined using the response to the following question: "During this study, your PrEP care was provided through the Freddie platform for part of the study period, and through your clinic's standard procedures for part of the study period. Which of these did you prefer?"
次要结局
- Quantity of missing laboratory questionnaires will be used to compare the number of missed laboratory evaluations by model of care.(72 weeks)
- Interview administered questionnaires will be used to comparison of the average amount of participant time required for PrEP follow-up activities by model of care(72 weeks)
- Questionnaires administered to clinicians will be used to compare of the average amount of clinician time required for PrEP follow-up by activities per model of care(72 weeks)
- Study visit attendance will be followed to compare of the total number of participant visits by model of care(72 weeks)
- PrEP adherence questionnaire administered at week 36 and 72 will be used to determine PrEP adherence.(72 weeks)
- Dried blood spot will be collected at week 36 and 72 will be used to determine PrEP adherence.(72 weeks)
- Hair Samples will be collected at week 36 and 72 will be used to determine PrEP adherence.(72 weeks)
- Satisfaction questionnaires will be used to compare participant satisfaction with their PrEP care by model of care.(72 weeks)
- Study visit attendance will be used to compare the number of missed visits by model of care(72 weeks)
- Participant visit logs will be used to assess retention in PrEP care by model of care.(72 weeks)
- Interview administered questionnaires will be used to qualitatively learn about the preferences of patients and providers about the mHealth model of care.(72 weeks)