Trial Outcomes & Findings for Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South (NCT NCT06487390)
NCT ID: NCT06487390
Last Updated: 2025-12-09
Results Overview
Feasibility of Intervention: 4 items, 5-point Likert scale, scale values range from 1-5 with higher score meaning more feasible to implement
COMPLETED
NA
46 participants
6 months
2025-12-09
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
46 pilot test participants completed the baseline questionnaire.
Baseline characteristics by cohort
| Measure |
PrEP Pro Participants (Pilot Test)
n=46 Participants
Family medicine resident trainees and PrEP Champions (residents and/or faculty) who received the PrEP Pro training intervention during the pilot test
|
|---|---|
|
Sex/Gender, Customized
Sex/gender · Female
|
19 Participants
n=46 Participants
|
|
Sex/Gender, Customized
Sex/gender · Male
|
26 Participants
n=46 Participants
|
|
Sex/Gender, Customized
Sex/gender · Gender nonconforming
|
1 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=46 Participants
|
|
Age, Continuous
|
29 years
n=46 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaskan Native
|
0 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
6 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
26 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
2 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown/missing
|
3 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Race · Middle Eastern or North African
|
7 Participants
n=46 Participants
|
|
HIV Epidemiology knowledge assessment
|
17.39 Percentage of Participants
n=46 Participants • 46 pilot test participants completed the baseline questionnaire.
|
|
Sexual History Taking Practices
Attitudes
|
2.5 Scores of a scale
n=32 Participants • 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.
|
|
Sexual History Taking Practices
Skills
|
2.9 Scores of a scale
n=32 Participants • 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.
|
|
Sexual History Taking Practices
Barriers
|
3.0 Scores of a scale
n=32 Participants • 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.
|
|
Sexual History Taking Practices
Training
|
2.7 Scores of a scale
n=32 Participants • 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.
|
|
PrEP Knowledge, Willingness to Prescribe, Prescribing Practices
Baseline PrEP knowledge (score 0-20)
|
9.5 scores on a scale
n=32 Participants • 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.
|
|
PrEP Knowledge, Willingness to Prescribe, Prescribing Practices
Baseline PrEP attitudes (score 0-28)
|
24 scores on a scale
n=32 Participants • 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.
|
|
PrEP Knowledge, Willingness to Prescribe, Prescribing Practices
Baseline PrEP beliefs (score 0-8)
|
6 scores on a scale
n=32 Participants • 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.
|
|
STI screening practices
BL AGYW sex Hx past wk
|
78.13 Percent of Participants
n=32 Participants • 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.
|
|
STI screening practices
BL AGYW tested for STI past wk
|
53.13 Percent of Participants
n=32 Participants • 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.
|
|
STI screening practices
BL ABYM sex Hx past wk
|
78.13 Percent of Participants
n=32 Participants • 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.
|
|
STI screening practices
BL ABYM tested for STI past wk
|
28.13 Percent of Participants
n=32 Participants • 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.
|
|
HIV screening practices
BL AGYW tested for HIV past wk
|
28.13 Percentage of Participants
n=32 Participants • 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.
|
|
HIV screening practices
BL ABYM tested for HIV past wk
|
21.88 Percentage of Participants
n=32 Participants • 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.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Due to a technical error in the questionnaire software, among the 32 exit questionnaire participants, 17 completed the acceptability, feasibility, and appropriateness measures.
Feasibility of Intervention: 4 items, 5-point Likert scale, scale values range from 1-5 with higher score meaning more feasible to implement
Outcome measures
| Measure |
PrEP Pro participants (Pilot Test)
n=17 Participants
Family medicine resident trainees and PrEP Champions (residents and/or faculty) who received the PrEP Pro training intervention during the pilot test phase
|
|---|---|
|
Feasibility of Intervention Implementation
|
4.28 Scores on a scale
Standard Deviation 0.42
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Due to a technical error in the questionnaire software, among the 32 exit questionnaire participants, 17 completed the acceptability, feasibility, and appropriateness measures.
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
Outcome measures
| Measure |
PrEP Pro participants (Pilot Test)
n=17 Participants
Family medicine resident trainees and PrEP Champions (residents and/or faculty) who received the PrEP Pro training intervention during the pilot test phase
|
|---|---|
|
Acceptability
|
4.31 Scores on a scale
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: N=32 out of 46 pilot test participants chose to take the exit questionnaire.
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.
Outcome measures
| Measure |
PrEP Pro participants (Pilot Test)
n=32 Participants
Family medicine resident trainees and PrEP Champions (residents and/or faculty) who received the PrEP Pro training intervention during the pilot test phase
|
|---|---|
|
HIV Epidemiology Knowledge Assessment
|
18.75 Percentage of Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
PrEP Pro participants (Pilot Test)
n=32 Participants
Family medicine resident trainees and PrEP Champions (residents and/or faculty) who received the PrEP Pro training intervention during the pilot test phase
|
|---|---|
|
Sexual History Taking Practices
Attitudes
|
2.5 scores on a scale
Interval 2.5 to 2.8
|
|
Sexual History Taking Practices
Skills
|
3.0 scores on a scale
Interval 2.9 to 3.0
|
|
Sexual History Taking Practices
Barriers
|
3 scores on a scale
Interval 2.5 to 3.0
|
|
Sexual History Taking Practices
Training
|
2.7 scores on a scale
Interval 2.3 to 3.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
PrEP Pro participants (Pilot Test)
n=32 Participants
Family medicine resident trainees and PrEP Champions (residents and/or faculty) who received the PrEP Pro training intervention during the pilot test phase
|
|---|---|
|
PrEP Knowledge, Willingness to Prescribe, Prescribing Practices
Exit Questionnaire (EQ) PrEP knowledge (score 0-20)
|
16 scores on a scale
Interval 13.0 to 19.0
|
|
PrEP Knowledge, Willingness to Prescribe, Prescribing Practices
EQ PrEP attitudes (score 0-28)
|
26 scores on a scale
Interval 23.0 to 28.0
|
|
PrEP Knowledge, Willingness to Prescribe, Prescribing Practices
EQ PrEP beliefs (score 0-8)
|
6 scores on a scale
Interval 5.0 to 7.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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
Outcome measures
| Measure |
PrEP Pro participants (Pilot Test)
n=32 Participants
Family medicine resident trainees and PrEP Champions (residents and/or faculty) who received the PrEP Pro training intervention during the pilot test phase
|
|---|---|
|
STI Screening Practices
Exit AGYW assessed sexual history in the past week
|
90.63 Percent of Participants
|
|
STI Screening Practices
Exit AGYW tested for STI in the past week
|
56.25 Percent of Participants
|
|
STI Screening Practices
Exit Adolescent boys/young men (ABYM) assessed sexual history in the past week
|
71.88 Percent of Participants
|
|
STI Screening Practices
Exit ABYM tested for STI in the past week
|
34.38 Percent of Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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
Outcome measures
| Measure |
PrEP Pro participants (Pilot Test)
n=32 Participants
Family medicine resident trainees and PrEP Champions (residents and/or faculty) who received the PrEP Pro training intervention during the pilot test phase
|
|---|---|
|
HIV Screening Practices
Exit AGYW tested for HIV in the past week
|
40.63 Percent of Participants
|
|
HIV Screening Practices
Exit ABYM tested for HIV in the past week
|
28.13 Percent of Participants
|
Adverse Events
PrEP Pro Participants (Pilot Test)
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