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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
67
Adaptation of a patient-provider communication tool for PrEP uptake utilized among women and their providers in a pilot pre/post-intervention design.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened
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.
Time frame: Throughout recruitment period (approximately 24 months)
Intervention Feasibility: Intervention Completion Rates Among Enrolled Patients
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
Time frame: Throughout recruitment period (approximately 24 months)
Intervention Feasibility: 3-month Follow-up Completion Rates Among Patients With Completed Intervention
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)
Time frame: Throughout recruitment and follow-up period (approximately 24 months)
Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention
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
Time frame: Throughout recruitment period and follow-up period (approximately 24 months)
Intervention Acceptability: Client Satisfaction Among Patients With Completed Intervention
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.
Time frame: On intervention day, directly after intervention delivery
Preliminary Effectiveness: PrEP Uptake Among Eligible Patients 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.
Time frame: Enrollment to 3 months post-intervention
PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2
To determine PrEP medication regimen adherence, patient participants completed an adherence questionnaire using a 6-point Likert scale to self-report their perceived ability to take their PrEP medication as prescribed over the last 4 weeks. The scale ranged from excellent to very poor.
Time frame: 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
To determine PrEP medication dosage adherence, patients completed an adherence questionnaire to self-report the percentage of PrEP medication they have taken in the last 4 weeks.
Time frame: 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
To determine PrEP clinic visit adherence, we calculated the average percentage of PrEP visits attended among patient participants who initiate PrEP, compared to the number of PrEP visits scheduled. Visit data was extracted from patients' electronic medical records.
Time frame: From enrollment to 3-months post-enrollment
PrEP Clinic Visit Adherence at 12-months: Percentage of Scheduled PrEP Visits Attended Among Patients Who Initiated Oral or Injection PrEP at Site 1
To determine PrEP clinic visit adherence, we calculated the average percentage of PrEP visits attended among patient participants who initiated PrEP, compared to the number of PrEP visits scheduled. Visit data was extracted from patients' electronic medical records.
Time frame: From enrollment to 12-months post-enrollment
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