Project Tara: Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility of CDTM+
研究概览
简要总结
This study addresses real-world use of long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) by evaluating implementation and clinical outcomes of a pharmacist-led collaborative drug therapy management model (CDTM+) that will be expanded for telehealth outreach to women with health-related social needs (HRSN).
详细描述
The purpose of this study is to evaluate the implementation and delivery of CAB/RPV LA to women with HRSN by adopting a pharmacist-led CDTM. The project primarily addresses the real-world use of CAB + RPV LA among women who are under-represented in clinical trials and assesses the feasibility and acceptability of CDTM+, and adoption of CAB/RPV LA among participants receiving the CDTM+ model.
Investigators will enhance the existing CDTM to reduce important social and structural barriers to CAB/RPV LA for women with HRSN, by increasing accessibility- using telehealth to deliver CDTM outreach to clinical and community sites without a clinician referral (CDTM+), which is highly scalable. In addition to assessing engagement with the CDTM+ intervention and impact on key implementation (reach, feasibility, acceptability, uptake) and clinical outcomes (CAB/RPV LA initiation), investigators will also assess impact on patient engagement in non-HIV related care and psychological, sexual, and social well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Living with diagnosed HIV
- •Receiving HIV care-related services from Yale New Haven Health (YNHH)
- •Currently on oral ART and virally suppressed for at least 6 months (from electronic health review).
- •Have experienced at least one HRSN: a) homelessness or housing insecurity; b) food insecurity; c) criminal legal system involvement; OR d) substance use in the past 3 years (from self-report at screening).
- •Able to converse comfortably in English or Spanish
排除标准
- •Unable or unwilling to complete informed consent (e.g., have a conservator of person)
- •Have initiated CAB/RPV oral lead-in prior to enrollment.
- •Have a contraindication to CAB/RPV LA per label.
- •Have known or suspected resistance to CAB/RPV
- •Pregnant or breast-feeding
研究组 & 干预措施
Pharmacist lead CDTM+
Participants will meet with a clinic-based pharmacist via telehealth for an introductory visit to discuss CAB/RPV LA and possible switch from oral to injectable therapy. The tele-visit can occur by phone or video visit.
干预措施: Collaborative drug therapy management model (Behavioral)
Pharmacist lead CDTM+
Participants will meet with a clinic-based pharmacist via telehealth for an introductory visit to discuss CAB/RPV LA and possible switch from oral to injectable therapy. The tele-visit can occur by phone or video visit.
干预措施: Cabotegravir/Rilpivirine (Drug)
结局指标
主要结局
Feasibility of CDTM+
时间窗: Baseline, Month 12
Feasibility of CDTM+ assessed using the Intervention Measure: 4-item Likert scale, each item scored 1 (completely disagree) to 5 (completely agree) and averaged. Score range 4-20, higher scores reflect higher feasibility.
Evaluate the adoption of CAB/RPV LA in the population receiving CDTM+
时间窗: Month 12
Assessed by the percentage of patients who have a documented 1st injection visit
Acceptability of CDTM+
时间窗: Baseline, Month 12
Assessed using the Theoretical Framework of Acceptability Questionnaire: 7-items, each scored on Likert scale 1 to 5 and averaged. Score range 7-35, higher scores reflect higher acceptability.
次要结局
- Barriers and facilitators to CAB/RPV LA initiation(Baseline, Month 6, Month 12)
- Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA adherence(Month 12)
- Uptake/adoption of the CDTM+ intervention(Baseline, Month 12)
- Evaluate the effectiveness of the CDTM+ intervention on intention to switch to CAB/RPV LA(Baseline, immediately following CDTM+)
- Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA maintenance of virologic suppression(Month 12)
- Reach/penetration of the CDTM+ intervention(Baseline, Month 12)