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临床试验/NCT05909176
NCT05909176已完成不适用

Start the Conversation: Evaluating Implementation of a Multi-level PrEP Initiative for Black Cisgender Women in New Orleans, Louisiana

Duke University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2023年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
1
主要终点
Number of Women Engaged in Conversation

研究概览

简要总结

The study objectives are to:

  • Evaluate implementation outcomes from piloting the Start the Conversation Initiative
  • Assess initial indicators of clinical effectiveness among patients engaged in the Start the Conversation Initiative

These outcomes will be assessed qualitatively through in-depth interviews (IDIs), debriefing sessions with GYN residents and leadership, medical chart reviews and/or de-identified Epic queries, training records, discussions with the Black Women and PrEP (BWAP) Task Force, and social media metrics.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •LSU GYN residents
  • •Women eligible for PrEP per CDC guidelines including Black cisgender women

排除标准

  • •Not meeting above criteria

研究组 & 干预措施

Combined Care Model Only

Experimental

The pre-intervention phase will last for 4 months (months 1-4). The only study activity during the pre-intervention phase is the collection of routine PrEP uptake data to establish a baseline for PrEP prescribing at the GYN residency clinics and local PrEP clinics. The implementation of the combined-care model at the LSU GYN residency clinic at UMCNO for 10 months (months 5-14). Then we will add implementation of the social media campaign in the NOLA area for 8 months (months 15-22); implementation of the combined-care model at LSU GYN residency clinic at UMCNO will continue. The layered approach allows for an opportunity to assess the effect of the combined-care model, and subsequently, to what extent the social media campaign additionally engages Black women and builds demand for PrEP.

干预措施: GYN Residency Training (Behavioral)

Combined Care Model + Social Media

Experimental

The pre-intervention phase will last for 4 months (months 1-4). The only study activity during the pre-intervention phase is the collection of routine PrEP uptake data to establish a baseline for PrEP prescribing at the GYN residency clinics and local PrEP clinics. The implementation of the combined-care model at the LSU GYN residency clinic at UMCNO for 10 months (months 5-14). Then we will add implementation of the social media campaign in the NOLA area for 8 months (months 15-22); implementation of the combined-care model at LSU GYN residency clinic at UMCNO will continue. The layered approach allows for an opportunity to assess the effect of the combined-care model, and subsequently, to what extent the social media campaign additionally engages Black women and builds demand for PrEP.

干预措施: GYN Residency Training (Behavioral)

Combined Care Model + Social Media

Experimental

The pre-intervention phase will last for 4 months (months 1-4). The only study activity during the pre-intervention phase is the collection of routine PrEP uptake data to establish a baseline for PrEP prescribing at the GYN residency clinics and local PrEP clinics. The implementation of the combined-care model at the LSU GYN residency clinic at UMCNO for 10 months (months 5-14). Then we will add implementation of the social media campaign in the NOLA area for 8 months (months 15-22); implementation of the combined-care model at LSU GYN residency clinic at UMCNO will continue. The layered approach allows for an opportunity to assess the effect of the combined-care model, and subsequently, to what extent the social media campaign additionally engages Black women and builds demand for PrEP.

干预措施: Social Media Campaign (Behavioral)

结局指标

主要结局

Number of Women Engaged in Conversation

时间窗: Up to 18 months (from month 5 to month 22)

Total number of women overall and number of Black cisgender women with whom GYN residents start the conversation about PrEP (pre-exposure prophylaxis)

Total Number of Women Initiating PrEP

时间窗: Up to 18 months (from month 5 to month 22)

Total number of women initiating PrEP (Pre-exposure Prophylaxis) at the LSU (Louisiana State University) GYN clinic (or after referral to a PrEP clinic).

次要结局

  • Number of Women Choosing Follow-up Care at the LSU (Louisiana State University) GYN Resident Clinic Versus Transition to a Local PrEP (Pre-exposure Prophylaxis) Provider(Up to 18 months (from month 5 to month 22))
  • Overall Number of Women Who Initiated PrEP and Completed a Follow-up Appointment(Up to 18 months (from month 5 to month 22))
  • Total Number of Contacts With the LaHub Website(Up to 8 months (from month 15 to month 22))

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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