Trial Outcomes & Findings for WeExPAnd: PrEP Demonstration Project Among Women at Risk for HIV Infection - Preexposure Prophylaxis (PrEP) (NCT NCT04373551)
NCT ID: NCT04373551
Last Updated: 2025-12-12
Results Overview
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.
COMPLETED
NA
67 participants
Throughout recruitment period (approximately 24 months)
2025-12-12
Participant Flow
Patient participants were recruited from a Federally Qualified Health Care Center (FQHC) (Site 1) and an HIV and sexually transmitted infection (STI) clinic (Site 2) in Tuscaloosa, Alabama from March 2022-June 2024. First patient participant was enrolled March 7, 2022; last participant was enrolled in June 27, 2024.
Participant milestones
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
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|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
Intervention
|
53
|
|
Overall Study
3-month Follow-up
|
53
|
|
Overall Study
12-month Follow-up
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Did not collect 12-month data on participants enrolled in 2024 (at Site 2)
|
4
|
Baseline Characteristics
WeExPAnd: PrEP Demonstration Project Among Women at Risk for HIV Infection - Preexposure Prophylaxis (PrEP)
Baseline characteristics by cohort
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
n=67 Participants
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
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|---|---|
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Age, Continuous
|
37.6 years
STANDARD_DEVIATION 11.9 • n=9 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
65 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
67 Participants
n=9 Participants
|
|
Education
Some High School, No Diploma
|
14 Participants
n=9 Participants
|
|
Education
High School Diploma/GED
|
27 Participants
n=9 Participants
|
|
Education
Associate's/Bachelor's Degree
|
23 Participants
n=9 Participants
|
|
Education
Graduate Degree
|
3 Participants
n=9 Participants
|
|
Religion
Christian
|
56 Participants
n=9 Participants
|
|
Religion
Atheist
|
1 Participants
n=9 Participants
|
|
Religion
Other
|
2 Participants
n=9 Participants
|
|
Religion
Prefer not to answer
|
8 Participants
n=9 Participants
|
|
Household Income
Less than $30,000
|
50 Participants
n=9 Participants
|
|
Household Income
$30,000 to less than $60,000
|
11 Participants
n=9 Participants
|
|
Household Income
Prefer not to answer/Unknown
|
3 Participants
n=9 Participants
|
|
Household Income
Missing
|
3 Participants
n=9 Participants
|
|
Primary Insurance
Medicaid/Medicare
|
27 Participants
n=9 Participants
|
|
Primary Insurance
Private Insurance (e.g., Blue Cross)
|
17 Participants
n=9 Participants
|
|
Primary Insurance
None
|
19 Participants
n=9 Participants
|
|
Primary Insurance
Other
|
3 Participants
n=9 Participants
|
|
Primary Insurance
Prefer not to answer
|
1 Participants
n=9 Participants
|
|
Housing
Renting home/apartment
|
42 Participants
n=9 Participants
|
|
Housing
A friend or relative's home/apartment
|
11 Participants
n=9 Participants
|
|
Housing
Home/apartment owned by you/household member
|
10 Participants
n=9 Participants
|
|
Housing
Publicly subsidized housing
|
2 Participants
n=9 Participants
|
|
Housing
Other
|
1 Participants
n=9 Participants
|
|
Housing
Prefer not to answer
|
1 Participants
n=9 Participants
|
|
Have household members living with HIV
Yes
|
6 Participants
n=9 Participants
|
|
Have household members living with HIV
No
|
61 Participants
n=9 Participants
|
|
Relationship Status
Single/Never married
|
35 Participants
n=9 Participants
|
|
Relationship Status
Divorced/Separated
|
8 Participants
n=9 Participants
|
|
Relationship Status
Widowed
|
1 Participants
n=9 Participants
|
|
Relationship Status
Prefer not to answer
|
3 Participants
n=9 Participants
|
|
Relationship Status
Married/In a relationship
|
20 Participants
n=9 Participants
|
|
Children
Yes
|
43 Participants
n=9 Participants
|
|
Children
No
|
22 Participants
n=9 Participants
|
|
Children
Prefer not to answer
|
2 Participants
n=9 Participants
|
|
Have you heard of a daily pill that an HIV-negative person can take to prevent getting HIV?
Yes
|
22 Participants
n=9 Participants
|
|
Have you heard of a daily pill that an HIV-negative person can take to prevent getting HIV?
No/Don't Know
|
45 Participants
n=9 Participants
|
|
How likely would you be to take this HIV prevention pill if it were available to you for free?
Definitely would not take it
|
5 Participants
n=9 Participants
|
|
How likely would you be to take this HIV prevention pill if it were available to you for free?
Probably would not take it
|
10 Participants
n=9 Participants
|
|
How likely would you be to take this HIV prevention pill if it were available to you for free?
Might take it
|
19 Participants
n=9 Participants
|
|
How likely would you be to take this HIV prevention pill if it were available to you for free?
Probably would take it
|
11 Participants
n=9 Participants
|
|
How likely would you be to take this HIV prevention pill if it were available to you for free?
Definitely would take it
|
20 Participants
n=9 Participants
|
|
How likely would you be to take this HIV prevention pill if it were available to you for free?
Prefer not to answer
|
2 Participants
n=9 Participants
|
|
Do you plan to start taking PrEP as an HIV prevention method?
No, not thinking about it
|
23 Participants
n=9 Participants
|
|
Do you plan to start taking PrEP as an HIV prevention method?
Thinking about it; may start in the next 6 months
|
21 Participants
n=9 Participants
|
|
Do you plan to start taking PrEP as an HIV prevention method?
Thinking about it; intend to start in the next month
|
10 Participants
n=9 Participants
|
|
Do you plan to start taking PrEP as an HIV prevention method?
Yes, plan to start as soon as possible
|
10 Participants
n=9 Participants
|
|
Do you plan to start taking PrEP as an HIV prevention method?
Prefer not to answer
|
3 Participants
n=9 Participants
|
|
Occupation/Income Source
Working/temporarily laid off
|
37 Participants
n=9 Participants
|
|
Occupation/Income Source
Disabled (permanently or temporarily)
|
13 Participants
n=9 Participants
|
|
Occupation/Income Source
Looking for work or unemployed
|
7 Participants
n=9 Participants
|
|
Occupation/Income Source
Student
|
5 Participants
n=9 Participants
|
|
Occupation/Income Source
Other/Prefer not to answer
|
5 Participants
n=9 Participants
|
|
Have you ever taken Pre-exposure Prophylaxis (PrEP) to prevent HIV infection?
Yes
|
1 Participants
n=9 Participants
|
|
Have you ever taken Pre-exposure Prophylaxis (PrEP) to prevent HIV infection?
No
|
66 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Throughout recruitment period (approximately 24 months)Population: HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 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.
Outcome measures
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
n=215 Participants
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
|
|---|---|
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Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened
Lost to follow-up
|
12 Participants
|
|
Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened
Declined: Does not feel at risk for HIV
|
27 Participants
|
|
Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened
Declined: No time
|
37 Participants
|
|
Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened
Declined: New medication hesitancy
|
2 Participants
|
|
Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened
Declined: Other - already on PrEP
|
2 Participants
|
|
Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened
Declined: Multiple reasons
|
5 Participants
|
|
Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened
Declined: No reason provided
|
3 Participants
|
|
Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened
Enrolled
|
67 Participants
|
|
Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened
Declined: No interest in research
|
60 Participants
|
PRIMARY outcome
Timeframe: Throughout recruitment period (approximately 24 months)Population: HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 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
Outcome measures
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
n=67 Participants
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
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|---|---|
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Intervention Feasibility: Intervention Completion Rates Among Enrolled Patients
Complete intervention
|
53 Participants
|
|
Intervention Feasibility: Intervention Completion Rates Among Enrolled Patients
Incomplete intervention (i.e., lost to follow-up)
|
14 Participants
|
PRIMARY outcome
Timeframe: Throughout recruitment and follow-up period (approximately 24 months)Population: HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 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)
Outcome measures
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
n=53 Participants
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
|
|---|---|
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Intervention Feasibility: 3-month Follow-up Completion Rates Among Patients With Completed Intervention
|
53 Participants
|
PRIMARY outcome
Timeframe: Throughout recruitment period and follow-up period (approximately 24 months)Population: HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 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
Outcome measures
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
n=53 Participants
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
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|---|---|
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Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention
Accepted PrEP Referral
|
18 Participants
|
|
Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention
Declined PrEP: Low perceived HIV risk
|
12 Participants
|
|
Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention
Declined PrEP: New medication hesitancy
|
5 Participants
|
|
Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention
Declined PrEP: Need for more information/consideration time
|
5 Participants
|
|
Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention
Declined PrEP: Logistical/timing concerns
|
1 Participants
|
|
Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention
Declined PrEP: Delayed PrEP referral acceptance after intervention
|
1 Participants
|
|
Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention
Declined PrEP: Reason unknown
|
11 Participants
|
PRIMARY outcome
Timeframe: On intervention day, directly after intervention deliveryPopulation: HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months
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.
Outcome measures
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
n=53 Participants
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
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|---|---|
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Intervention Acceptability: Client Satisfaction Among Patients With Completed Intervention
|
30.45 score on a scale
Standard Deviation 1.78
|
PRIMARY outcome
Timeframe: Enrollment to 3 months post-interventionPopulation: The overall number of participants analyzed for this outcome measure includes the number of eligible patients referred to PrEP at our primary partnering clinic site (i.e., Site 1) after the intervention as part of the study (n = 17). Data from our secondary clinic site (Site 2) were excluded from the pre-post comparison due to insufficient sample size.
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.
Outcome measures
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
n=17 Participants
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
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|---|---|
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Preliminary Effectiveness: PrEP Uptake Among Eligible Patients Post-Intervention
|
41.18 percentage of patients initiating PrEP
Interval 21.56 to 64.05
|
SECONDARY outcome
Timeframe: 3-month Follow-upPopulation: HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months; specifically, the Number of Participants Analyzed for this measure is a subset of the total number of participants who completed 3-month follow-up (n=53) and both accepted a PrEP referral and initiated oral PrEP medication after the intervention at both Site 1 and Site 2 (n=7).
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.
Outcome measures
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
n=7 Participants
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
|
|---|---|
|
PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2
Excellent
|
1 Participants
|
|
PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2
Very Good
|
2 Participants
|
|
PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2
Good
|
2 Participants
|
|
PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2
Fair
|
2 Participants
|
|
PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2
Poor
|
0 Participants
|
|
PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2
Very Poor
|
0 Participants
|
SECONDARY outcome
Timeframe: 3-Month Follow-upPopulation: HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months; specifically, the Number of Participants Analyzed for this measure is a subset of the total number of participants who completed 3-month follow-up (n=53) and both accepted a PrEP referral and initiated oral PrEP medication after the intervention at both Site 1 and Site 2 (n=7).
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.
Outcome measures
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
n=7 Participants
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
|
|---|---|
|
PrEP Medication Adherence: Self-Reported PrEP Prescription Dosage Adherence Among Participants Who Initiated Oral PrEP at Both Site 1 and Site 2
|
72.14 percentage of medication taken
Standard Deviation 22.33
|
SECONDARY outcome
Timeframe: From enrollment to 3-months post-enrollmentPopulation: HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months; specifically, the Number of Participants Analyzed for this measure is a subset of the total number of participants who completed 3-month follow-up (n=53) and both accepted a PrEP referral and initiated oral or injection PrEP medication after the intervention (n=8) 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.
Outcome measures
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
n=8 Participants
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
|
|---|---|
|
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
|
95.83 percentage of PrEP visits attended
Standard Deviation 11.78
|
SECONDARY outcome
Timeframe: From enrollment to 12-months post-enrollmentPopulation: HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months; specifically, the Number of Participants Analyzed for this measure is a subset of the total number of participants who completed 12-month follow-up (n=48) and both accepted a PrEP referral and initiated oral or injection PrEP medication after the intervention at Site 1 (n=7). No 12-month data was collected from Site 2.
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.
Outcome measures
| Measure |
Patient: Cultural Adaptation of a Patient-Provider Communication Tool
n=7 Participants
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool.
|
|---|---|
|
PrEP Clinic Visit Adherence at 12-months: Percentage of Scheduled PrEP Visits Attended Among Patients Who Initiated Oral or Injection PrEP at Site 1
|
85.24 percentage of PrEP visits attended
Standard Deviation 20.35
|
Adverse Events
Cultural Adaptation of a Client-Provider Communication Tool
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mirjam-Colette Kempf
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place