HIV Infections, Sexually Transmitted Diseases
Conditions
Keywords
PrEP, HIV, HIV prevention, Adolescents, Young adults, Family Medicine, Residents, Physician Trainees, Training intervention, Sexual history, Sexual Health, Sexually Transmitted Infections
Brief summary
The goal of this study is to adapt evidence-based curriculum on HIV epidemiology and PrEP prescription to train family medicine physician trainees to take a thorough sexual history and discuss HIV/STI prevention and PrEP options with adolescent patients in Alabama. The primary outcomes of the study are: * Feasibility of the PrEP Pro training intervention * Acceptability of the PrEP Pro training intervention Secondary outcomes include: * Behavioral changes in sexual history taking performed by physician trainees * PrEP knowledge and prescribing practices * HIV and STI screening practices Participants will receive training on sexual history taking and HIV prevention options, including PrEP prescription and management. They will complete a pre-training survey (enrollment) and post-training survey (6 months post enrollment) to understand differences in knowledge and practice before and after receiving the training intervention. The post training survey will also assess acceptability and feasibility of the intervention. A subset of participants will complete qualitative in-depth interviews to further discuss their experiences with the program and suggestions for future adaptations.
Interventions
BEHAVIORALPrEP Pro training intervention
Training intervention adapted from evidence-based HIV epidemiology, sexual history taking, and PrEP prescription curricula.
Sponsors
National Institute of Mental Health (NIMH)
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. licensed HCP (MD, DO) trainee 2. providing medical care to AGYW in AL 3. working in a clinic setting where at least 20% of the population is Black 4. able/willing to provide informed consent
Exclusion criteria
(a) unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Implementation | 6 months | Feasibility of Intervention: 4 items, 5-point Likert scale, scale values range from 1-5 with higher score meaning more feasible to implement |
| Acceptability | 6 months | Acceptability of Intervention: 4 items, 5-point Likert scale, scale values range from 1-5 with higher score meaning the intervention is more acceptable to participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Knowledge, Willingness to Prescribe, Prescribing Practices | 6 months | measured by baseline and 6-month (pre- and post-training) surveys, qualitative interviews, EMR data. The score ranges for each subscale varied (PrEP knowledge=0-20, attitudes=0-28, and beliefs=0-8), with high values on each subscale representing good knowledge or positive attitudes toward PrEP, respectively. |
| HIV Epidemiology Knowledge Assessment | 6 months | Measured by baseline and 6-month (pre- and post-training) surveys; scores range from 0-100% based on the percentage of participants who answered all five questions related to HIV epidemiology correctly; higher percentages indicate that more participants knew the correct answer to all 5 HIV epidemiology questions. |
| HIV Screening Practices | 6 months | Percent of participants (providers) who reported they tested clients for HIV in the past week at least some of the time, by group (AGYW/ABYM). At least some of the time = answering some, many, most, or all (vs none) to questions formatted like: Among the \[AGYW/ABYM\] seen last week, for about how many did you \[test for HIV\]? measured by BL and 6-month surveys, IDIs, EMR data; BL=baseline; AGYW=adolescent girls and young women (ages 14-24); ABYM=adolescent boys and young men (ages 14-24); sex Hx=assessed for sexual history; past wk=past 7 days |
| STI Screening Practices | 6 months | Percent of participants (providers) who reported they assessed sexual history and/or tested clients for STIs in the past week at least some of the time, by group (AGYW/ABYM). At least some of the time = answering some, many, most, or all (vs none) to questions formatted like: Among the \[AGYW/ABYM\] seen last week, for about how many did you \[assess sex Hx/test for STIs\]? measured by BL and 6-month surveys, IDIs, EMR data; BL=baseline; AGYW=adolescent girls and young women (ages 14-24); ABYM=adolescent boys and young men (ages 14-24); sex Hx=assessed for sexual history; past wk=past 7 days |
| Sexual History Taking Practices | 6 months | Measured by baseline survey. Sexual history taking knowledge, attitudes, and beliefs. 23 questions split into four subscales on 3-point Likert scale; each subscale score is the mean of the scores from the questions in the scale. Subscales: Attitudes (4 items), Skills (14), Barriers (2), Training (3). Strongly agree/Somewhat agree = 3, Neither agree nor disagree = 2, Strongly disagree/Somewhat disagree = 1 Higher score on 1-3 range indicates more positive attitude towards sexual history assessment, higher skill, more barriers, and better training. |
Countries
United States
Participant flow
Recruitment details
This Alabama study involved 4 family medicine residency programs across 5 clinical sites. We contacted 10 of 11 known programs (as of 2023); 4 agreed to participate. Three others had participated in earlier phases but lacked sufficient resident turnover to participate further. Partner sites delivered the intervention training, and trained residents could opt into study participation by completing baseline/exit surveys or in-depth interviews.
Participants by arm
| Arm | Count |
|---|---|
| PrEP Pro Participants (Pilot Test) Family medicine resident trainees and PrEP Champions (residents and/or faculty) who received the PrEP Pro training intervention during the pilot test | 46 |
| Total | 46 |
Baseline characteristics
| Characteristic | PrEP Pro Participants (Pilot Test) |
|---|---|
| Age, Continuous | 29 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HIV Epidemiology knowledge assessment | 17.39 Percentage of Participants |
| HIV screening practices BL ABYM tested for HIV past wk | 21.88 Percentage of Participants |
| HIV screening practices BL AGYW tested for HIV past wk | 28.13 Percentage of Participants |
| PrEP Knowledge, Willingness to Prescribe, Prescribing Practices Baseline PrEP attitudes (score 0-28) | 24 scores on a scale |
| PrEP Knowledge, Willingness to Prescribe, Prescribing Practices Baseline PrEP beliefs (score 0-8) | 6 scores on a scale |
| PrEP Knowledge, Willingness to Prescribe, Prescribing Practices Baseline PrEP knowledge (score 0-20) | 9.5 scores on a scale |
| Race/Ethnicity, Customized Race American Indian or Alaskan Native | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 6 Participants |
| Race/Ethnicity, Customized Race Black or African American | 2 Participants |
| Race/Ethnicity, Customized Race Middle Eastern or North African | 7 Participants |
| Race/Ethnicity, Customized Race More than one race | 2 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Unknown/missing | 3 Participants |
| Race/Ethnicity, Customized Race White | 26 Participants |
| Sex/Gender, Customized Sex/gender Female | 19 Participants |
| Sex/Gender, Customized Sex/gender Gender nonconforming | 1 Participants |
| Sex/Gender, Customized Sex/gender Male | 26 Participants |
| Sexual History Taking Practices Attitudes | 2.5 Scores of a scale |
| Sexual History Taking Practices Barriers | 3.0 Scores of a scale |
| Sexual History Taking Practices Skills | 2.9 Scores of a scale |
| Sexual History Taking Practices Training | 2.7 Scores of a scale |
| STI screening practices BL ABYM sex Hx past wk | 78.13 Percent of Participants |
| STI screening practices BL ABYM tested for STI past wk | 28.13 Percent of Participants |
| STI screening practices BL AGYW sex Hx past wk | 78.13 Percent of Participants |
| STI screening practices BL AGYW tested for STI past wk | 53.13 Percent of Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
Primary
Acceptability
Acceptability of Intervention: 4 items, 5-point Likert scale, scale values range from 1-5 with higher score meaning the intervention is more acceptable to participants
Time frame: 6 months
Population: Due to a technical error in the questionnaire software, among the 32 exit questionnaire participants, 17 completed the acceptability, feasibility, and appropriateness measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PrEP Pro participants (Pilot Test) | Acceptability | 4.31 Scores on a scale | Standard Deviation 0.53 |
Primary
Feasibility of Intervention Implementation
Feasibility of Intervention: 4 items, 5-point Likert scale, scale values range from 1-5 with higher score meaning more feasible to implement
Time frame: 6 months
Population: Due to a technical error in the questionnaire software, among the 32 exit questionnaire participants, 17 completed the acceptability, feasibility, and appropriateness measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PrEP Pro participants (Pilot Test) | Feasibility of Intervention Implementation | 4.28 Scores on a scale | Standard Deviation 0.42 |
Secondary
HIV Epidemiology Knowledge Assessment
Measured by baseline and 6-month (pre- and post-training) surveys; scores range from 0-100% based on the percentage of participants who answered all five questions related to HIV epidemiology correctly; higher percentages indicate that more participants knew the correct answer to all 5 HIV epidemiology questions.
Time frame: 6 months
Population: N=32 out of 46 pilot test participants chose to take the exit questionnaire.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PrEP Pro participants (Pilot Test) | HIV Epidemiology Knowledge Assessment | 18.75 Percentage of Participants |
Secondary
HIV Screening Practices
Percent of participants (providers) who reported they tested clients for HIV in the past week at least some of the time, by group (AGYW/ABYM). At least some of the time = answering some, many, most, or all (vs none) to questions formatted like: Among the \[AGYW/ABYM\] seen last week, for about how many did you \[test for HIV\]? measured by BL and 6-month surveys, IDIs, EMR data; BL=baseline; AGYW=adolescent girls and young women (ages 14-24); ABYM=adolescent boys and young men (ages 14-24); sex Hx=assessed for sexual history; past wk=past 7 days
Time frame: 6 months
Population: N=32 out of 46 pilot test participants chose to take the exit questionnaire. Baseline and Exit questionnaires were scored looking only at participants who completed both.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PrEP Pro participants (Pilot Test) | HIV Screening Practices | Exit AGYW tested for HIV in the past week | 40.63 Percent of Participants |
| PrEP Pro participants (Pilot Test) | HIV Screening Practices | Exit ABYM tested for HIV in the past week | 28.13 Percent of Participants |
Secondary
PrEP Knowledge, Willingness to Prescribe, Prescribing Practices
measured by baseline and 6-month (pre- and post-training) surveys, qualitative interviews, EMR data. The score ranges for each subscale varied (PrEP knowledge=0-20, attitudes=0-28, and beliefs=0-8), with high values on each subscale representing good knowledge or positive attitudes toward PrEP, respectively.
Time frame: 6 months
Population: N=32 out of 46 pilot test participants chose to take the exit questionnaire. Baseline and Exit questionnaires were scored looking only at participants who completed both.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PrEP Pro participants (Pilot Test) | PrEP Knowledge, Willingness to Prescribe, Prescribing Practices | Exit Questionnaire (EQ) PrEP knowledge (score 0-20) | 16 scores on a scale |
| PrEP Pro participants (Pilot Test) | PrEP Knowledge, Willingness to Prescribe, Prescribing Practices | EQ PrEP attitudes (score 0-28) | 26 scores on a scale |
| PrEP Pro participants (Pilot Test) | PrEP Knowledge, Willingness to Prescribe, Prescribing Practices | EQ PrEP beliefs (score 0-8) | 6 scores on a scale |
Secondary
Sexual History Taking Practices
Measured by baseline survey. Sexual history taking knowledge, attitudes, and beliefs. 23 questions split into four subscales on 3-point Likert scale; each subscale score is the mean of the scores from the questions in the scale. Subscales: Attitudes (4 items), Skills (14), Barriers (2), Training (3). Strongly agree/Somewhat agree = 3, Neither agree nor disagree = 2, Strongly disagree/Somewhat disagree = 1 Higher score on 1-3 range indicates more positive attitude towards sexual history assessment, higher skill, more barriers, and better training.
Time frame: 6 months
Population: N=32 out of 46 pilot test participants chose to take the exit questionnaire. Baseline and Exit questionnaires were scored looking only at participants who completed both.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PrEP Pro participants (Pilot Test) | Sexual History Taking Practices | Attitudes | 2.5 scores on a scale |
| PrEP Pro participants (Pilot Test) | Sexual History Taking Practices | Skills | 3.0 scores on a scale |
| PrEP Pro participants (Pilot Test) | Sexual History Taking Practices | Barriers | 3 scores on a scale |
| PrEP Pro participants (Pilot Test) | Sexual History Taking Practices | Training | 2.7 scores on a scale |
Secondary
STI Screening Practices
Percent of participants (providers) who reported they assessed sexual history and/or tested clients for STIs in the past week at least some of the time, by group (AGYW/ABYM). At least some of the time = answering some, many, most, or all (vs none) to questions formatted like: Among the \[AGYW/ABYM\] seen last week, for about how many did you \[assess sex Hx/test for STIs\]? measured by BL and 6-month surveys, IDIs, EMR data; BL=baseline; AGYW=adolescent girls and young women (ages 14-24); ABYM=adolescent boys and young men (ages 14-24); sex Hx=assessed for sexual history; past wk=past 7 days
Time frame: 6 months
Population: N=32 out of 46 pilot test participants chose to take the exit questionnaire. Baseline and Exit questionnaires were scored looking only at participants who completed both.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PrEP Pro participants (Pilot Test) | STI Screening Practices | Exit AGYW assessed sexual history in the past week | 90.63 Percent of Participants |
| PrEP Pro participants (Pilot Test) | STI Screening Practices | Exit AGYW tested for STI in the past week | 56.25 Percent of Participants |
| PrEP Pro participants (Pilot Test) | STI Screening Practices | Exit Adolescent boys/young men (ABYM) assessed sexual history in the past week | 71.88 Percent of Participants |
| PrEP Pro participants (Pilot Test) | STI Screening Practices | Exit ABYM tested for STI in the past week | 34.38 Percent of Participants |