Trial Outcomes & Findings for An Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy (NCT NCT05709860)
NCT ID: NCT05709860
Last Updated: 2025-05-30
Results Overview
PrEP uptake will be measured during the intervention period between study arms to investigate the effects of the EMC2 PrEP strategy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
6 months
Results posted on
2025-05-30
Participant Flow
Participant milestones
| Measure |
Usual Care
Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.
|
The EMC2 PrEP Strategy
The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.
EMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.
Discrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 participant in the intervention group has missing income data.
Baseline characteristics by cohort
| Measure |
Usual Care
n=100 Participants
Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.
|
The EMC2 PrEP Strategy
n=100 Participants
The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.
EMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.
Discrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.1 years
STANDARD_DEVIATION 9.3 • n=100 Participants
|
36.3 years
STANDARD_DEVIATION 11.2 • n=100 Participants
|
36.2 years
STANDARD_DEVIATION 10.3 • n=200 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=100 Participants
|
100 Participants
n=100 Participants
|
200 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=200 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=100 Participants
|
14 Participants
n=100 Participants
|
31 Participants
n=200 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=100 Participants
|
86 Participants
n=100 Participants
|
169 Participants
n=200 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=200 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
44 Participants
n=100 Participants
|
45 Participants
n=100 Participants
|
89 Participants
n=200 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
31 Participants
n=100 Participants
|
35 Participants
n=100 Participants
|
66 Participants
n=200 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
8 Participants
n=100 Participants
|
6 Participants
n=100 Participants
|
14 Participants
n=200 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
10 Participants
n=100 Participants
|
13 Participants
n=100 Participants
|
23 Participants
n=200 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple
|
7 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
8 Participants
n=200 Participants
|
|
Marital Status
Married
|
26 Participants
n=100 Participants
|
32 Participants
n=100 Participants
|
58 Participants
n=200 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=200 Participants
|
|
Marital Status
Divorced
|
9 Participants
n=100 Participants
|
7 Participants
n=100 Participants
|
16 Participants
n=200 Participants
|
|
Marital Status
Separated
|
1 Participants
n=100 Participants
|
5 Participants
n=100 Participants
|
6 Participants
n=200 Participants
|
|
Marital Status
Single
|
51 Participants
n=100 Participants
|
45 Participants
n=100 Participants
|
96 Participants
n=200 Participants
|
|
Marital Status
Living with a partner
|
11 Participants
n=100 Participants
|
7 Participants
n=100 Participants
|
18 Participants
n=200 Participants
|
|
Marital Status
Other
|
0 Participants
n=100 Participants
|
4 Participants
n=100 Participants
|
4 Participants
n=200 Participants
|
|
Household Income
< $25,000
|
7 Participants
n=100 Participants • 1 participant in the intervention group has missing income data.
|
3 Participants
n=99 Participants • 1 participant in the intervention group has missing income data.
|
10 Participants
n=199 Participants • 1 participant in the intervention group has missing income data.
|
|
Household Income
$25,000-$49,999
|
16 Participants
n=100 Participants • 1 participant in the intervention group has missing income data.
|
14 Participants
n=99 Participants • 1 participant in the intervention group has missing income data.
|
30 Participants
n=199 Participants • 1 participant in the intervention group has missing income data.
|
|
Household Income
$50,000-$74,999
|
20 Participants
n=100 Participants • 1 participant in the intervention group has missing income data.
|
21 Participants
n=99 Participants • 1 participant in the intervention group has missing income data.
|
41 Participants
n=199 Participants • 1 participant in the intervention group has missing income data.
|
|
Household Income
$75,000-$99,999
|
13 Participants
n=100 Participants • 1 participant in the intervention group has missing income data.
|
12 Participants
n=99 Participants • 1 participant in the intervention group has missing income data.
|
25 Participants
n=199 Participants • 1 participant in the intervention group has missing income data.
|
|
Household Income
$100,000 or more
|
44 Participants
n=100 Participants • 1 participant in the intervention group has missing income data.
|
49 Participants
n=99 Participants • 1 participant in the intervention group has missing income data.
|
93 Participants
n=199 Participants • 1 participant in the intervention group has missing income data.
|
|
Insurance Status
Private or HMO
|
75 Participants
n=100 Participants
|
79 Participants
n=100 Participants
|
154 Participants
n=200 Participants
|
|
Insurance Status
Medicaid
|
11 Participants
n=100 Participants
|
4 Participants
n=100 Participants
|
15 Participants
n=200 Participants
|
|
Insurance Status
Medicare
|
2 Participants
n=100 Participants
|
2 Participants
n=100 Participants
|
4 Participants
n=200 Participants
|
|
Insurance Status
Self-pay/No insurance
|
2 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
3 Participants
n=200 Participants
|
|
Insurance Status
Other
|
5 Participants
n=100 Participants
|
7 Participants
n=100 Participants
|
12 Participants
n=200 Participants
|
|
Insurance Status
Multiple
|
5 Participants
n=100 Participants
|
7 Participants
n=100 Participants
|
12 Participants
n=200 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPrEP uptake will be measured during the intervention period between study arms to investigate the effects of the EMC2 PrEP strategy.
Outcome measures
| Measure |
Usual Care
n=100 Participants
Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.
|
The EMC2 PrEP Strategy
n=100 Participants
The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.
EMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.
Discrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.
|
|---|---|---|
|
PrEP Uptake (Use)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2-6 weeksA 10-item questionnaire, developed by the study team and the scientific literature, will be used to evaluate knowledge of pre-exposure prophylaxis among study participants. Correctly answered questions will be summed (0 to 10) for a total score. Higher scores will indicate greater PrEP knowledge.
Outcome measures
| Measure |
Usual Care
n=100 Participants
Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.
|
The EMC2 PrEP Strategy
n=100 Participants
The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.
EMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.
Discrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.
|
|---|---|---|
|
PrEP Knowledge
|
5.6 score on a scale
Standard Deviation 2.2
|
7.5 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 2-6 weeksThe 8-item Perceived Risk of HIV scale is used to assess how vulnerable an individual feels to HIV. The scale was developed in the United States and attention was paid to health literacy. Response options vary for each item, though they are measured on a 4-point Likert scale. Total score of 8 items is calculated and range from 10 to 40. Higher scores mean higher perceived risk of HIV.
Outcome measures
| Measure |
Usual Care
n=100 Participants
Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.
|
The EMC2 PrEP Strategy
n=100 Participants
The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.
EMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.
Discrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.
|
|---|---|---|
|
Perceived Risk of HIV
|
19.2 score on a scale
Standard Deviation 5.2
|
19.1 score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 2-6 weeksA PrEP Attitudes 5-items scale (Walsh, 2019) is used to assess attitudes toward PrEP, each item is measured on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). A total score is calculated and range from 5 to 25. Higher scores mean more stigma towards PrEP use.
Outcome measures
| Measure |
Usual Care
n=100 Participants
Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.
|
The EMC2 PrEP Strategy
n=100 Participants
The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.
EMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.
Discrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.
|
|---|---|---|
|
PrEP Attitudes
|
11.2 score on a scale
Standard Deviation 4.4
|
10.5 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 2-6 weeksCHEW health literacy is used to assess participant's health literacy level. Participants were asked three questions about difficulty in understanding medical materials and information, the options range from all of the time to none of the time. The responses of the three questions are then categorized into limited and adequate health literacy level. We used CHEW health literacy because the measure can be conducted over phone calls.
Outcome measures
| Measure |
Usual Care
n=100 Participants
Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.
|
The EMC2 PrEP Strategy
n=100 Participants
The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.
EMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.
Discrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.
|
|---|---|---|
|
Health Literacy
Limited
|
22 Participants
|
20 Participants
|
|
Health Literacy
Adequate
|
78 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: 2-6 weeksA modified version of our team's 10-item Consumer Health Activation Index (CHAI) is used to assess participant's engagement in healthcare. Response options are a Likert scale; linear transformation is used to put total scores onto a 0-100 scale, with higher numbers indicating greater activation. The total scores are then categorized into 3 categories: Low (0-79), Moderate (80-94), and High (\>94).
Outcome measures
| Measure |
Usual Care
n=100 Participants
Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.
|
The EMC2 PrEP Strategy
n=100 Participants
The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.
EMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.
Discrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.
|
|---|---|---|
|
Health Activation
Low
|
61 Participants
|
64 Participants
|
|
Health Activation
Moderate
|
30 Participants
|
30 Participants
|
|
Health Activation
High
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 2-6 weeksPopulation: Only participants in the intervention group were asked the questions. 43 participants have missing process measure data.
The participants in the intervention group were asked two questions about 1) whether they received a PrEP decision guide, and 2) did they read or review it, to assess the acceptability of the intervention material.
Outcome measures
| Measure |
Usual Care
Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.
|
The EMC2 PrEP Strategy
n=57 Participants
The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.
EMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.
Discrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.
|
|---|---|---|
|
Process Measure
Received PrEP decision guide in patient portal
|
—
|
20 Participants
|
|
Process Measure
Reviewed the material after received
|
—
|
10 Participants
|
SECONDARY outcome
Timeframe: 2-6 weeksPopulation: Only the participants in the intervention group are asked to rate their satisfaction with the intervention materials. And 10 participants in the intervention group who read or view the material were asked about the satisfaction with the material.
Using 10-point Likert scale response options (1=very unsatisfied to 10=very satisfied), participants in the intervention group are asked to rate their satisfaction with the materials.
Outcome measures
| Measure |
Usual Care
Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.
|
The EMC2 PrEP Strategy
n=10 Participants
The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.
EMC2 PrEP Educational Tool: Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.
Discrete Scheduling of a Dedicated PrEP Visit: Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.
|
|---|---|---|
|
Acceptability of the Strategy
Satisfaction of the appearance of the guide
|
—
|
7.7 score on a scale
Standard Deviation 1.7
|
|
Acceptability of the Strategy
Satisfaction of the quality of the guide
|
—
|
8.3 score on a scale
Standard Deviation 1.8
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
The EMC2 PrEP Strategy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place