Electronic Health Record, HIV Infections, Primary Health Care
Conditions
Brief summary
This study is being conducted to investigate a strategy that may improve knowledge and uptake of pre-exposure prophylaxis for HIV prevention (PrEP) among cisgender women in primary care.
Detailed description
Members of the study team previously developed and evaluated the Electronic health record Medication Complete Communication (EMC2) strategy to 'hardwire' provider/patient communication & surveillance of select prescription (Rx) medications. EMC2 PrEP will adapt from the previous strategy to * educate cisgender women in primary care who have increased vulnerability to HIV about PrEP using an interactive, health literacy-appropriate educational tool securely delivered via the patient portal * facilitate, for those who express interest, the rapid and discrete scheduling of a dedicated PrEP clinic visit with a primary care clinician trained in PrEP delivery The current study aims are to: Aim 1: Refine and implement an electronic health record (EHR)-based strategy as a potential quality improvement activity that supports informed decision-making and PrEP uptake among women with increased HIV vulnerability in primary care (the EMC2 PrEP strategy). Aim 2: Pilot-test the EMC2 PrEP strategy in primary care to determine its feasibility, acceptability, and preliminary efficacy among women with increased vulnerability to HIV. Aim 3: Develop a standard operating protocol (SOP) for disseminating the EMC2 PrEP strategy to a national network of federally qualified health centers.
Interventions
BEHAVIORALEMC2 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.
BEHAVIORALDiscrete 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.
Sponsors
Merck Sharp & Dohme LLC
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* female * HIV negative * have received 2 or more tests in the past 12 months for chlamydia, gonorrhea and/or syphilis * and/or have received a positive diagnosis for at least one of those sexually transmitted infections in the past 6 months * currently engaged in primary care * not currently using PrEP
Exclusion criteria
* severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Uptake (Use) | 6 months | PrEP uptake will be measured during the intervention period between study arms to investigate the effects of the EMC2 PrEP strategy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Attitudes | 2-6 weeks | A 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. |
| PrEP Knowledge | 2-6 weeks | A 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. |
| Health Literacy | 2-6 weeks | CHEW 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. |
| Perceived Risk of HIV | 2-6 weeks | The 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. |
| Process Measure | 2-6 weeks | 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. |
| Acceptability of the Strategy | 2-6 weeks | 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. |
| Health Activation | 2-6 weeks | A 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| 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. | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Total | Usual Care | The EMC2 PrEP Strategy |
|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 10.3 | 36.1 years STANDARD_DEVIATION 9.3 | 36.3 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 17 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 169 Participants | 83 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Household Income $100,000 or more | 93 Participants | 44 Participants | 49 Participants |
| Household Income < $25,000 | 10 Participants | 7 Participants | 3 Participants |
| Household Income $25,000-$49,999 | 30 Participants | 16 Participants | 14 Participants |
| Household Income $50,000-$74,999 | 41 Participants | 20 Participants | 21 Participants |
| Household Income $75,000-$99,999 | 25 Participants | 13 Participants | 12 Participants |
| Insurance Status Medicaid | 15 Participants | 11 Participants | 4 Participants |
| Insurance Status Medicare | 4 Participants | 2 Participants | 2 Participants |
| Insurance Status Multiple | 12 Participants | 5 Participants | 7 Participants |
| Insurance Status Other | 12 Participants | 5 Participants | 7 Participants |
| Insurance Status Private or HMO | 154 Participants | 75 Participants | 79 Participants |
| Insurance Status Self-pay/No insurance | 3 Participants | 2 Participants | 1 Participants |
| Marital Status Divorced | 16 Participants | 9 Participants | 7 Participants |
| Marital Status Living with a partner | 18 Participants | 11 Participants | 7 Participants |
| Marital Status Married | 58 Participants | 26 Participants | 32 Participants |
| Marital Status Other | 4 Participants | 0 Participants | 4 Participants |
| Marital Status Separated | 6 Participants | 1 Participants | 5 Participants |
| Marital Status Single | 96 Participants | 51 Participants | 45 Participants |
| Marital Status Widowed | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 14 Participants | 8 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Black/African American | 66 Participants | 31 Participants | 35 Participants |
| Race/Ethnicity, Customized Race Multiple | 8 Participants | 7 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 23 Participants | 10 Participants | 13 Participants |
| Race/Ethnicity, Customized Race White/Caucasian | 89 Participants | 44 Participants | 45 Participants |
| Sex: Female, Male Female | 200 Participants | 100 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
PrEP Uptake (Use)
PrEP uptake will be measured during the intervention period between study arms to investigate the effects of the EMC2 PrEP strategy.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | PrEP Uptake (Use) | 0 Participants |
| The EMC2 PrEP Strategy | PrEP Uptake (Use) | 0 Participants |
Secondary
Acceptability of the Strategy
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.
Time frame: 2-6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The EMC2 PrEP Strategy | Acceptability of the Strategy | Satisfaction of the appearance of the guide | 7.7 score on a scale | Standard Deviation 1.7 |
| The EMC2 PrEP Strategy | Acceptability of the Strategy | Satisfaction of the quality of the guide | 8.3 score on a scale | Standard Deviation 1.8 |
Secondary
Health Activation
A 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).
Time frame: 2-6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Health Activation | Low | 61 Participants |
| Usual Care | Health Activation | Moderate | 30 Participants |
| Usual Care | Health Activation | High | 9 Participants |
| The EMC2 PrEP Strategy | Health Activation | Low | 64 Participants |
| The EMC2 PrEP Strategy | Health Activation | Moderate | 30 Participants |
| The EMC2 PrEP Strategy | Health Activation | High | 6 Participants |
Secondary
Health Literacy
CHEW 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.
Time frame: 2-6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Health Literacy | Limited | 22 Participants |
| Usual Care | Health Literacy | Adequate | 78 Participants |
| The EMC2 PrEP Strategy | Health Literacy | Limited | 20 Participants |
| The EMC2 PrEP Strategy | Health Literacy | Adequate | 80 Participants |
Secondary
Perceived Risk of HIV
The 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.
Time frame: 2-6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Perceived Risk of HIV | 19.2 score on a scale | Standard Deviation 5.2 |
| The EMC2 PrEP Strategy | Perceived Risk of HIV | 19.1 score on a scale | Standard Deviation 4.6 |
Secondary
PrEP Attitudes
A 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.
Time frame: 2-6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | PrEP Attitudes | 11.2 score on a scale | Standard Deviation 4.4 |
| The EMC2 PrEP Strategy | PrEP Attitudes | 10.5 score on a scale | Standard Deviation 3.9 |
Secondary
PrEP Knowledge
A 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.
Time frame: 2-6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | PrEP Knowledge | 5.6 score on a scale | Standard Deviation 2.2 |
| The EMC2 PrEP Strategy | PrEP Knowledge | 7.5 score on a scale | Standard Deviation 2.5 |
Secondary
Process Measure
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.
Time frame: 2-6 weeks
Population: Only participants in the intervention group were asked the questions. 43 participants have missing process measure data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The EMC2 PrEP Strategy | Process Measure | Received PrEP decision guide in patient portal | 20 Participants |
| The EMC2 PrEP Strategy | Process Measure | Reviewed the material after received | 10 Participants |