PrEP Demonstration Project Among Women at Risk for HIV Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened
研究概览
简要总结
The objective of this application is to increase PrEP uptake among women vulnerable to HIV acquisition in the rural South, specifically those seeking care at Federally Qualified Healthcare Centers (FQHC) in rural Alabama.
The investigators will use a mixed-methods approach to adapt and pilot test a patient-provider communication tool from the Centers for Disease Control and Prevention (CDC) PrEP toolkit that focuses on the first three steps of the PrEP cascade (e.g., recognizing HIV risk, identifying as a PrEP candidate, and interested in PrEP) to increase PrEP uptake via referrals to local PrEP clinics.
详细描述
Investigators completed formative qualitative research to explore the HIV risk perceptions of African American or Black (AA) women with recent PrEP use, AA women who are candidates for PrEP, and providers and to identify preferences around patient-provider communication about HIV risk and PrEP services (Aim 1).
The investigators then systematically adapted a patient-provider communication tool to increase PrEP uptake at federally qualified health centers in Alabama, using an iterative implementation process (Aim 2A), and assessed the feasibility, acceptability, and preliminary impact of the patient-provider communication intervention on PrEP uptake among women in a pilot pre-/post-intervention design (Aim 2B).
Provider training completion rates and satisfaction with the communication tool were assessed to evaluate implementation feasibility and intervention delivery. The study systematically documented and evaluated reasons for declining PrEP referrals, incomplete referrals, failure to initiate PrEP after successful referral, and ongoing PrEP use at 3 and 12 months post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •HIV-uninfected women
- •Age 18 years or older
- •English speaking
- •Report sexual activity or anticipate sexual activity within 6 months
研究组 & 干预措施
Patient: cultural adaptation of a patient-provider communication tool
Strengthening of the PrEP care continuum by developing and testing an intervention designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at substantial risk for HIV infection; developing and testing an intervention to reduce racial/disparities in PrEP uptake and use.
干预措施: Cultural adaptation of a patient-provider communication tool (Behavioral)
结局指标
主要结局
Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened
时间窗: Throughout recruitment period (approximately 24 months)
To determine intervention feasibility through analysis of enrollment rates (i.e., proportion of eligible patient participants who consent to participate, decline, or are lost to follow-up over the total number of eligible patient participants screened) and reasons for declining enrollment.
Intervention Feasibility: Intervention Completion Rates Among Enrolled Patients
时间窗: Throughout recruitment period (approximately 24 months)
To determine intervention feasibility through the analysis of intervention completion rates (i.e., proportion of enrolled patient participants who completed the intervention) and reasons for incomplete intervention
Intervention Feasibility: 3-month Follow-up Completion Rates Among Patients With Completed Intervention
时间窗: Throughout recruitment and follow-up period (approximately 24 months)
To determine intervention feasibility through the analysis of 3-month follow-up completion rates (i.e., proportion of enrolled patient participants with complete interventions with complete 3-month follow-up data)
Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention
时间窗: Throughout recruitment period and follow-up period (approximately 24 months)
To determine intervention feasibility through the analysis of PrEP referral acceptance rates (i.e., proportion accepting PrEP referral among those offered) and reasons for declining a referral
Intervention Acceptability: Client Satisfaction Among Patients With Completed Intervention
时间窗: On intervention day, directly after intervention delivery
To determine intervention acceptability using the Client Satisfaction Questionnaire (CSQ-8), an 8-item instrument that measures patient participants' perceived value of the intervention. The CSQ-8 generates a total score by summing individual item responses, with possible scores ranging from 8 to 32, where higher scores reflect greater treatment satisfaction.
Preliminary Effectiveness: PrEP Uptake Among Eligible Patients Post-Intervention
时间窗: Enrollment to 3 months post-intervention
To determine preliminary effectiveness through PrEP uptake (i.e., proportion of patient participants who initiated PrEP (i.e., got PrEP prescription) over the number of eligible patients referred to PrEP) in the participating clinic post-intervention.
次要结局
- PrEP Clinic Visit Adherence at 12-months: Percentage of Scheduled PrEP Visits Attended Among Patients Who Initiated Oral or Injection PrEP at Site 1(From enrollment to 12-months post-enrollment)
- PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2(3-month Follow-up)
- PrEP Medication Adherence: Self-Reported PrEP Prescription Dosage Adherence Among Participants Who Initiated Oral PrEP at Both Site 1 and Site 2(3-Month Follow-up)
- PrEP Clinic Visit Adherence at 3-months: Percentage of Scheduled PrEP Visits Attended Among Patients Who Initiated Oral or Injection PrEP at Both Site 1 and Site 2(From enrollment to 3-months post-enrollment)
研究者
Mirjam-Colette Kempf
Principle Investigator
University of Alabama at Birmingham