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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH128044-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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:
Secondary outcomes include:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resident Trainees | Experimental | Family medicine resident trainees who receive the PrEP Pro training intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP Pro training intervention | Behavioral | Training intervention adapted from evidence-based HIV epidemiology, sexual history taking, and PrEP prescription curricula. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
(a) unable or unwilling to provide informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Latesha E. Elopre, MD, MSPH | University of Alabama at Birmingham | Principal Investigator |
| Lynn T Matthews, MD, MPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States |
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| Label | URL |
|---|---|
| PrEP Pro Protocol Paper | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex/Gender, Customized | Sex/gender as reported by participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Due to a technical error in the questionnaire software, among the 32 exit questionnaire participants, 17 completed the acceptability, feasibility, and appropriateness measures. | Posted | Sep 2025 | Mean | Standard Deviation | Scores on a scale | 6 months |
|
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from enrollment until the end of the trial period (6 month pilot test)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 phase |
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This study is limited by small sample size, short follow-up, and sampling bias from clinics that opted in. Effectiveness in improving PrEP prescribing could not be assessed. The intervention did not address provider stigma or restrictive state laws.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lynn Matthews | University of Alabama at Birmingham | 2059348148 | lynnmatthews@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2025 | Dec 1, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 7, 2023 | Sep 3, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| 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. | 6 months |
| 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. | 6 months |
| 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 | 6 months |
| 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 | 6 months |
| Count of Participants |
| Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity as reported by participants | Count of Participants | Participants |
|
| Age, Continuous | Age in years as reported by participants | Median | Inter-Quartile Range | years |
|
| Race/Ethnicity, Customized | 8 race categories including missing and more than one race; categories are mutually exclusive -- those who reported more than one race were categorized as "more than one race" rather the individually selected races | Count of Participants | Participants |
|
| 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. | 46 pilot test participants completed the baseline questionnaire. | Number | Percentage of Participants |
|
| 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. | 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. | Median | Inter-Quartile Range | Scores of a scale |
|
| 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. | 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. | Mean | Inter-Quartile Range | scores on a scale |
|
| STI screening practices | Percent of participants who reported assessing sexual history and/or testing 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 | 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. | Number | Percent of Participants |
|
| 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 | 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. | Number | Percentage of Participants |
|
| Counts |
|---|
| Participants |
|
|
| 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 | Due to a technical error in the questionnaire software, among the 32 exit questionnaire participants, 17 completed the acceptability, feasibility, and appropriateness measures. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months |
|
|
|
| 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. | N=32 out of 46 pilot test participants chose to take the exit questionnaire. | Posted | Number | Percentage of Participants | 6 months |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | scores on a scale | 6 months |
|
|
|
| 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. | 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. | Posted | Mean | Inter-Quartile Range | scores on a scale | 6 months |
|
|
|
| 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 | 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. | Posted | Number | Percent of Participants | 6 months |
|
|
|
| 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 | 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. | Posted | Number | Percent of Participants | 6 months |
|
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| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
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| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Training |
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| Exit ABYM tested for STI in the past week |
|