Trial Outcomes & Findings for Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM (PrEParate) (NCT NCT04048382)
NCT ID: NCT04048382
Last Updated: 2022-07-08
Results Overview
Participants will be asked if they have scheduled an appointment for PrEP consultation on a follow up questionnaire. It will be confirmed by reviewing their medical records.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
3 months
Results posted on
2022-07-08
Participant Flow
Participant milestones
| Measure |
Patient Navigation (PN)
This intervention consists of standardized health educational materials and manualized sessions that can be implemented based on a participant's stage in the PrEP continuum. The intervention will utilize bilingual peer lay navigators and also consist of barrier reduction strategies to assist individuals with implementing HIV prevention, including the use of PrEP.
Patient Navigation: Spanish-English bilingual peer lay navigators hired by Family Health Centers of San Diego will provide the PN intervention during the study, trained using manuals developed in formative research and via the Patient Navigation Research Program training approach. Services will generally focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing PrEP-related healthcare; 2) increasing each patient's knowledge, attitudes, and self-efficacy for initiating and adhering to PrEP; 3) improving communication between the patient and healthcare team through appointment scheduling and reminders; and 4) sexual risk reduction counseling.
|
Usual Care (UC)
Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish).
Usual Care: The booklet given is a 2-page booklet including the following information: 1) overview of PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and adhering to PrEP. Participants will also be provided with both verbal and written information regarding available sexual health and HIV prevention services, including PrEP, at Family Health Centers of San Diego (FHCSD). Comprehensive HIV-prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal cost. If a UC participant is diagnosed with a sexually transmitted infection, including HIV, treatment and follow-up will be coordinated by FHCSD staff as per usual care procedures.
|
|---|---|---|
|
3-Month Follow Up
STARTED
|
28
|
29
|
|
3-Month Follow Up
COMPLETED
|
26
|
28
|
|
3-Month Follow Up
NOT COMPLETED
|
2
|
1
|
|
6-Month Follow up
STARTED
|
28
|
28
|
|
6-Month Follow up
COMPLETED
|
26
|
28
|
|
6-Month Follow up
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Patient Navigation (PN)
This intervention consists of standardized health educational materials and manualized sessions that can be implemented based on a participant's stage in the PrEP continuum. The intervention will utilize bilingual peer lay navigators and also consist of barrier reduction strategies to assist individuals with implementing HIV prevention, including the use of PrEP.
Patient Navigation: Spanish-English bilingual peer lay navigators hired by Family Health Centers of San Diego will provide the PN intervention during the study, trained using manuals developed in formative research and via the Patient Navigation Research Program training approach. Services will generally focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing PrEP-related healthcare; 2) increasing each patient's knowledge, attitudes, and self-efficacy for initiating and adhering to PrEP; 3) improving communication between the patient and healthcare team through appointment scheduling and reminders; and 4) sexual risk reduction counseling.
|
Usual Care (UC)
Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish).
Usual Care: The booklet given is a 2-page booklet including the following information: 1) overview of PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and adhering to PrEP. Participants will also be provided with both verbal and written information regarding available sexual health and HIV prevention services, including PrEP, at Family Health Centers of San Diego (FHCSD). Comprehensive HIV-prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal cost. If a UC participant is diagnosed with a sexually transmitted infection, including HIV, treatment and follow-up will be coordinated by FHCSD staff as per usual care procedures.
|
|---|---|---|
|
3-Month Follow Up
Enrolled but did not complete survey
|
2
|
0
|
|
3-Month Follow Up
Withdrawal by Subject
|
0
|
1
|
|
6-Month Follow up
Enrolled but did not complete survey
|
2
|
0
|
Baseline Characteristics
Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM (PrEParate)
Baseline characteristics by cohort
| Measure |
Patient Navigation (PN)
n=28 Participants
This intervention consists of standardized health educational materials and manualized sessions that can be implemented based on a participant's stage in the PrEP continuum. The intervention will utilize bilingual peer lay navigators and also consist of barrier reduction strategies to assist individuals with implementing HIV prevention, including the use of PrEP.
Patient Navigation: Spanish-English bilingual peer lay navigators hired by Family Health Centers of San Diego will provide the PN intervention during the study, trained using manuals developed in formative research and via the Patient Navigation Research Program training approach. Services will generally focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing PrEP-related healthcare; 2) increasing each patient's knowledge, attitudes, and self-efficacy for initiating and adhering to PrEP; 3) improving communication between the patient and healthcare team through appointment scheduling and reminders; and 4) sexual risk reduction counseling.
|
Usual Care (UC)
n=29 Participants
Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish).
Usual Care: The booklet given is a 2-page booklet including the following information: 1) overview of PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and adhering to PrEP. Participants will also be provided with both verbal and written information regarding available sexual health and HIV prevention services, including PrEP, at Family Health Centers of San Diego (FHCSD). Comprehensive HIV-prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal cost. If a UC participant is diagnosed with a sexually transmitted infection, including HIV, treatment and follow-up will be coordinated by FHCSD staff as per usual care procedures.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.07 years
STANDARD_DEVIATION 2.45 • n=99 Participants
|
25.59 years
STANDARD_DEVIATION 3.01 • n=107 Participants
|
25.33 years
STANDARD_DEVIATION 2.73 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
24 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Non-binary
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Transgender
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Number of participants analyzed= 53 due to missing data. This question was displayed contingent on answering "Yes" to "Before this study, had you ever heard of PrEP?"
Participants will be asked if they have scheduled an appointment for PrEP consultation on a follow up questionnaire. It will be confirmed by reviewing their medical records.
Outcome measures
| Measure |
Patient Navigation (PN)
n=26 Participants
This intervention consists of standardized health educational materials and manualized sessions that can be implemented based on a participant's stage in the PrEP continuum. The intervention will utilize bilingual peer lay navigators and also consist of barrier reduction strategies to assist individuals with implementing HIV prevention, including the use of PrEP.
Patient Navigation: Spanish-English bilingual peer lay navigators hired by Family Health Centers of San Diego will provide the PN intervention during the study, trained using manuals developed in formative research and via the Patient Navigation Research Program training approach. Services will generally focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing PrEP-related healthcare; 2) increasing each patient's knowledge, attitudes, and self-efficacy for initiating and adhering to PrEP; 3) improving communication between the patient and healthcare team through appointment scheduling and reminders; and 4) sexual risk reduction counseling.
|
Usual Care (UC)
n=27 Participants
Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish).
Usual Care: The booklet given is a 2-page booklet including the following information: 1) overview of PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and adhering to PrEP. Participants will also be provided with both verbal and written information regarding available sexual health and HIV prevention services, including PrEP, at Family Health Centers of San Diego (FHCSD). Comprehensive HIV-prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal cost. If a UC participant is diagnosed with a sexually transmitted infection, including HIV, treatment and follow-up will be coordinated by FHCSD staff as per usual care procedures.
|
|---|---|---|
|
Percent of Participants That Scheduled an Appointment for PrEP Consultation.
|
10 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Number of participants analyzed= 53 due to missing data. This question was displayed contingent on answering "Yes" to "Before this study, had you ever heard of PrEP?"
Participants will be asked if they have attended an appointment for PrEP consultation on a follow up questionnaire. It will be confirmed by reviewing their medical records.
Outcome measures
| Measure |
Patient Navigation (PN)
n=26 Participants
This intervention consists of standardized health educational materials and manualized sessions that can be implemented based on a participant's stage in the PrEP continuum. The intervention will utilize bilingual peer lay navigators and also consist of barrier reduction strategies to assist individuals with implementing HIV prevention, including the use of PrEP.
Patient Navigation: Spanish-English bilingual peer lay navigators hired by Family Health Centers of San Diego will provide the PN intervention during the study, trained using manuals developed in formative research and via the Patient Navigation Research Program training approach. Services will generally focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing PrEP-related healthcare; 2) increasing each patient's knowledge, attitudes, and self-efficacy for initiating and adhering to PrEP; 3) improving communication between the patient and healthcare team through appointment scheduling and reminders; and 4) sexual risk reduction counseling.
|
Usual Care (UC)
n=27 Participants
Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish).
Usual Care: The booklet given is a 2-page booklet including the following information: 1) overview of PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and adhering to PrEP. Participants will also be provided with both verbal and written information regarding available sexual health and HIV prevention services, including PrEP, at Family Health Centers of San Diego (FHCSD). Comprehensive HIV-prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal cost. If a UC participant is diagnosed with a sexually transmitted infection, including HIV, treatment and follow-up will be coordinated by FHCSD staff as per usual care procedures.
|
|---|---|---|
|
Percent of Participants That Attended an Appointment for PrEP Consultation.
|
10 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Number of participants analyzed= 53 due to missing data. This question was displayed contingent on answering "Yes" to "Before this study, had you ever heard of PrEP?"
Participants will be asked if they have received a PrEP prescription on a follow up questionnaire. It will be confirmed by reviewing their medical records.
Outcome measures
| Measure |
Patient Navigation (PN)
n=26 Participants
This intervention consists of standardized health educational materials and manualized sessions that can be implemented based on a participant's stage in the PrEP continuum. The intervention will utilize bilingual peer lay navigators and also consist of barrier reduction strategies to assist individuals with implementing HIV prevention, including the use of PrEP.
Patient Navigation: Spanish-English bilingual peer lay navigators hired by Family Health Centers of San Diego will provide the PN intervention during the study, trained using manuals developed in formative research and via the Patient Navigation Research Program training approach. Services will generally focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing PrEP-related healthcare; 2) increasing each patient's knowledge, attitudes, and self-efficacy for initiating and adhering to PrEP; 3) improving communication between the patient and healthcare team through appointment scheduling and reminders; and 4) sexual risk reduction counseling.
|
Usual Care (UC)
n=27 Participants
Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish).
Usual Care: The booklet given is a 2-page booklet including the following information: 1) overview of PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and adhering to PrEP. Participants will also be provided with both verbal and written information regarding available sexual health and HIV prevention services, including PrEP, at Family Health Centers of San Diego (FHCSD). Comprehensive HIV-prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal cost. If a UC participant is diagnosed with a sexually transmitted infection, including HIV, treatment and follow-up will be coordinated by FHCSD staff as per usual care procedures.
|
|---|---|---|
|
Percent of Participants That Received a PrEP Prescription.
|
12 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Number of participants analyzed= 54 due to missing data. This question was displayed if answer to "Before this study, had you ever heard of PrEP?" was "Yes." Some participants obtained a PrEP prescription outside of the 3-month follow up timeframe (i.e., prior to their previous assessment), but did not fill their prescription at that time. These participants responded "No" to obtaining a PrEP prescription in the last 3-months, but "Yes" to filling their prescription in the last 3 months.
Participants will be asked if they have filled their PrEP prescription on a follow up questionnaire. It will be confirmed by reviewing their medical records.
Outcome measures
| Measure |
Patient Navigation (PN)
n=26 Participants
This intervention consists of standardized health educational materials and manualized sessions that can be implemented based on a participant's stage in the PrEP continuum. The intervention will utilize bilingual peer lay navigators and also consist of barrier reduction strategies to assist individuals with implementing HIV prevention, including the use of PrEP.
Patient Navigation: Spanish-English bilingual peer lay navigators hired by Family Health Centers of San Diego will provide the PN intervention during the study, trained using manuals developed in formative research and via the Patient Navigation Research Program training approach. Services will generally focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing PrEP-related healthcare; 2) increasing each patient's knowledge, attitudes, and self-efficacy for initiating and adhering to PrEP; 3) improving communication between the patient and healthcare team through appointment scheduling and reminders; and 4) sexual risk reduction counseling.
|
Usual Care (UC)
n=28 Participants
Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish).
Usual Care: The booklet given is a 2-page booklet including the following information: 1) overview of PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and adhering to PrEP. Participants will also be provided with both verbal and written information regarding available sexual health and HIV prevention services, including PrEP, at Family Health Centers of San Diego (FHCSD). Comprehensive HIV-prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal cost. If a UC participant is diagnosed with a sexually transmitted infection, including HIV, treatment and follow-up will be coordinated by FHCSD staff as per usual care procedures.
|
|---|---|---|
|
Percent of Participants That Filled Their PrEP Prescription.
|
11 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: This question was displayed contingent on answering "Yes" to "Before this study, had you ever heard of PrEP?" Number of participants analyzed= 35. Some participants obtained and/or filled a PrEP prescription outside of the 3-month follow up timeframe (i.e., prior to their previous assessment), but did not initiate PrEP use at that time. These participants responded "No" to obtaining or filling a PrEP prescription in the last 3-months, but "Yes" to initiating PrEP in the last 3 months.
Participants will be asked to self-report their PrEP initiation on a follow up questionnaire.
Outcome measures
| Measure |
Patient Navigation (PN)
n=18 Participants
This intervention consists of standardized health educational materials and manualized sessions that can be implemented based on a participant's stage in the PrEP continuum. The intervention will utilize bilingual peer lay navigators and also consist of barrier reduction strategies to assist individuals with implementing HIV prevention, including the use of PrEP.
Patient Navigation: Spanish-English bilingual peer lay navigators hired by Family Health Centers of San Diego will provide the PN intervention during the study, trained using manuals developed in formative research and via the Patient Navigation Research Program training approach. Services will generally focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing PrEP-related healthcare; 2) increasing each patient's knowledge, attitudes, and self-efficacy for initiating and adhering to PrEP; 3) improving communication between the patient and healthcare team through appointment scheduling and reminders; and 4) sexual risk reduction counseling.
|
Usual Care (UC)
n=17 Participants
Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish).
Usual Care: The booklet given is a 2-page booklet including the following information: 1) overview of PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and adhering to PrEP. Participants will also be provided with both verbal and written information regarding available sexual health and HIV prevention services, including PrEP, at Family Health Centers of San Diego (FHCSD). Comprehensive HIV-prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal cost. If a UC participant is diagnosed with a sexually transmitted infection, including HIV, treatment and follow-up will be coordinated by FHCSD staff as per usual care procedures.
|
|---|---|---|
|
Percent of Participants That Initiated PrEP Use.
|
11 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: This question was displayed if "Before this study, had you ever heard of PrEP?" was "Yes." Number of participants analyzed= 34. Some participants obtained and/or filled a PrEP prescription outside of the 3-month follow up timeframe (i.e., prior to their previous assessment), but did not initiate PrEP use at that time. These participants responded "No" to obtaining/filling a PrEP prescription in the last 3-months, but "Yes" to initiating PrEP in the last 3 months, and had adherence to report.
Participants will be asked to self-report their PrEP use over the past seven days on a follow up questionnaire.
Outcome measures
| Measure |
Patient Navigation (PN)
n=18 Participants
This intervention consists of standardized health educational materials and manualized sessions that can be implemented based on a participant's stage in the PrEP continuum. The intervention will utilize bilingual peer lay navigators and also consist of barrier reduction strategies to assist individuals with implementing HIV prevention, including the use of PrEP.
Patient Navigation: Spanish-English bilingual peer lay navigators hired by Family Health Centers of San Diego will provide the PN intervention during the study, trained using manuals developed in formative research and via the Patient Navigation Research Program training approach. Services will generally focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing PrEP-related healthcare; 2) increasing each patient's knowledge, attitudes, and self-efficacy for initiating and adhering to PrEP; 3) improving communication between the patient and healthcare team through appointment scheduling and reminders; and 4) sexual risk reduction counseling.
|
Usual Care (UC)
n=16 Participants
Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish).
Usual Care: The booklet given is a 2-page booklet including the following information: 1) overview of PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and adhering to PrEP. Participants will also be provided with both verbal and written information regarding available sexual health and HIV prevention services, including PrEP, at Family Health Centers of San Diego (FHCSD). Comprehensive HIV-prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal cost. If a UC participant is diagnosed with a sexually transmitted infection, including HIV, treatment and follow-up will be coordinated by FHCSD staff as per usual care procedures.
|
|---|---|---|
|
Percent of Participants That Adhered to PrEP Over the Past Seven Days for Participants That Initiated PrEP
|
8 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Data was not collected due to a coding error, thus the number of participants analyzed was zero.
Participants will be asked if they have attended a PrEP follow-up appointment on a follow up questionnaire. It will be confirmed by reviewing their medical records.
Outcome measures
Outcome data not reported
Adverse Events
Patient Navigation (PN)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care (UC)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patient Navigation (PN)
n=28 participants at risk
This intervention consists of standardized health educational materials and manualized sessions that can be implemented based on a participant's stage in the PrEP continuum. The intervention will utilize bilingual peer lay navigators and also consist of barrier reduction strategies to assist individuals with implementing HIV prevention, including the use of PrEP.
Patient Navigation: Spanish-English bilingual peer lay navigators hired by Family Health Centers of San Diego will provide the PN intervention during the study, trained using manuals developed in formative research and via the Patient Navigation Research Program training approach. Services will generally focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing PrEP-related healthcare; 2) increasing each patient's knowledge, attitudes, and self-efficacy for initiating and adhering to PrEP; 3) improving communication between the patient and healthcare team through appointment scheduling and reminders; and 4) sexual risk reduction counseling.
|
Usual Care (UC)
n=29 participants at risk
Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish).
Usual Care: The booklet given is a 2-page booklet including the following information: 1) overview of PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and adhering to PrEP. Participants will also be provided with both verbal and written information regarding available sexual health and HIV prevention services, including PrEP, at Family Health Centers of San Diego (FHCSD). Comprehensive HIV-prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal cost. If a UC participant is diagnosed with a sexually transmitted infection, including HIV, treatment and follow-up will be coordinated by FHCSD staff as per usual care procedures.
|
|---|---|---|
|
Immune system disorders
Serious Adverse Event
|
0.00%
0/28 • March 12, 2020 through study completion, an average of 2 months
A participant notified the study team that he was diagnosed with HIV and would like to discontinue participation in the study. The study team is uncertain of the exposure or diagnosis date. This information is Protected Health Information and the participant does not wish to continue participating, thus we will not have access to medical records for the exact date of the adverse event. All-cause mortality and other (not including serious) adverse events were not monitored/assessed.
|
3.4%
1/29 • Number of events 1 • March 12, 2020 through study completion, an average of 2 months
A participant notified the study team that he was diagnosed with HIV and would like to discontinue participation in the study. The study team is uncertain of the exposure or diagnosis date. This information is Protected Health Information and the participant does not wish to continue participating, thus we will not have access to medical records for the exact date of the adverse event. All-cause mortality and other (not including serious) adverse events were not monitored/assessed.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place