DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
This study evaluates strategies to improve access to HIV prevention through the integration of pre-exposure prophylaxis (PrEP) into existing healthcare settings, rather than limiting delivery to specialty clinics. The study addresses barriers to PrEP uptake, including limited awareness, stigma, and restricted access, and recognizes that availability alone may not ensure initiation or sustained use.
The study includes two components. First, a longitudinal cohort of current PrEP users will be followed to assess changes in access, preferences, and PrEP use over time in real-world settings. Second, a dynamic decision-support toolkit will be developed and evaluated to support patients and providers in PrEP-related decision-making. The toolkit will include patient- and provider-facing components to support clinical decision-making, improve risk understanding, and facilitate integration of PrEP into routine healthcare. The toolkit will be refined and beta-tested in selected healthcare facilities in Botswana and Alabama.
详细描述
Pre-exposure prophylaxis (PrEP) is an evidence-based and effective approach to HIV prevention, yet it has not reached its full potential due to factors such as limited awareness, constrained service resources, and stigma. Currently, most PrEP prescriptions are issued in specialty care settings, offering limited access. Therefore, achieving global implementation goals will require expanding PrEP delivery within other existing health facilities.
Making PrEP available in existing outpatient or inpatient settings alone does not guarantee its initiation or sustained use, even among individuals at risk for HIV acquisition. Appropriate decision-making regarding PrEP use requires collaboration between patients and providers, supported by an enabling clinic infrastructure. Moreover, the PrEP journey can be dynamic, with more PrEP modalities becoming available in recent years, and choices can change over time, underscoring the need for decision-support toolkits that help patients and providers navigate this evolving decision-making process. A decision support toolkit that has components that are either patient- or provider-facing, or both, could enhance patients' risk perception and increase their knowledge of PrEP, enabling them to make informed decisions about its use, as well as decrease the decision-making burden on the provider side.
As such, the investigators aim to (1) propose an implementation strategy that integrates PrEP into existing health facilities and (2) develop a dynamic choice decision support toolkit that supports PrEP integration into these existing health facilities.
Thus, our specific aims are:
- Aim 1: To conduct a prospective cohort study of existing PrEP users to better understand how their PrEP access and choices change over time in real-world settings.
- Aim 2: To conduct formative work to better understand the landscape of focal points of integration of PrEP into existing healthcare facilities (Aim 2a) and develop and beta-test a dynamic PrEP toolkit prototype needed to support this integration (Aim 2b), in parallel in Botswana and Alabama.
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
- 是
入选标准
- •Inclusion for Alabama site:
- •18 years of age or older
- •Currently using or eligible for PrEP
- •Inclusion for Botswana site:
- •18 years of age or older
- •Participated in the parent Tshireletso study in Botswana
- •Exclusion for both sites:
- •Under the age of 18
- •HIV positive
- •Inclusion for both sites:
- •18 years of age or older
- •Currently working as PrEP providers or clinic administrators at outpatient clinics
- •Exclusion for both sites:
- •Under the age of 18
- •Inclusion for both sites:
- •18 years of age or older
- •Currently working as policy makers or program leaders at outpatient clinics
- •Exclusion for both sites:
- •Under the age of 18
排除标准
- 未提供
研究组 & 干预措施
Group 1: Adults Using or Eligible for PrEP
PrEP users - Individuals aged 18 years or older who are currently using or eligible for PrEP
干预措施: Observational cohort (PrEP use in real-world settings) (Other)
Group 2: PrEP Providers and Clinic Administrators
PrEP providers and clinic administrators - Individuals aged 18 years or older who work as PrEP providers or clinic administrators at outpatient clinics or inpatient settings
干预措施: Observational cohort (PrEP use in real-world settings) (Other)
Group 3: Policy Makers and Program Leaders
Policy makers and program leaders - Individuals aged 18 years or older who work as policy makers or program leaders at outpatient clinics or inpatient settings
干预措施: Observational cohort (PrEP use in real-world settings) (Other)
研究者
Rena Patel
Principal Investigator
University of Alabama at Birmingham