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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD098086-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Investigators will form community partnership with community sites that will disseminate curated educational information on Sexual and Reproductive Health/Mental Health (SRH/MH). Investigators will attend a series of outreach events hosted by community partners community and community leaders that provide/demonstrate telemedicine and the Children's Mercy Mobile Unit which is equipped to provide direct patient care. Investigators will engage up to 40 teen peer leaders to encourage healthcare-seeking behaviors and mobilize their social networks to attend outreach events. At all events, the mobile unit will be available for teens to (a) demonstrate the mobile; (b) learn about Sexual and Reproductive Health/Mental Health (SRH/MH) and local care resources; (d) acquire free over-the-counter emergency contraception, birth control, condoms, and pregnancy tests.
AccessKCTeen is a pilot clinical outreach program that uses Children Mercy's Mobile Unit and Telemedicine to demonstrate and increase access to SRH and MH.
AccessKCTeen intends to focus on these central activities:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Leader and Friend Network Participants | Experimental | All adolescents enrolled as friends of peer leaders will have access to activities and materials shared by the peer leaders. All adolescents will be asked to complete an eligibility screening survey and baseline survey online or in-person. They will complete short surveys at 2, 4 and 6 months via Twilio text, call, or email. Peer Leaders Investigators will enroll up to 40 Peer Leaders. In addition to the above activities (under intervention trial participant), if a teen is a "peer leader" they will attend a training session in-person or online with our study team to learn about sexual and mental health information and how to share information with their friends (like text or social media). The peer leaders will answer the same surveys described above and will be asked about their Peer Leader experience and how they are sharing the study health information. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Leader Model | Other | Teens will have an opportunity to interact with established peer leaders that are a part of the AccessKCTeen program. These leaders will receive a baseline training of their role, sexual and mental health. They will also receive health education and engage with a peer liaison via text messages throughout the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Healthcare Utilization From Baseline to 6 Months | Measurement of any use of healthcare utilization through trial. Healthcare utilization measured through surveys from participants at baseline, 2 months, 4 months, and 6 months. | Baseline to 6 months |
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INTERVENTION TRIAL PARTICIPANTS and Peer Leaders (ADOLECENTS) Inclusion Criteria
Aged 14-18 years and 364 days old
a. Exclusion Criteria
Younger than 14 years old or older than 18 years and 364 days at the time of enrollment
Does not speak/understand English
Not recruited from an already nominated or enrolled adolescent
Event Day Trail PARTICIPANTS (ADOLECENTS) Inclusion Criteria
Aged 14-18 years and 364 days old
a. Exclusion Criteria
Younger than 14 years old or older than 18 years and 364 days at the time of enrollment
Does not speak/understand English
Not recruited from an already nominated or enrolled adolescent
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Millerr, MD | Children's Mercy Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
In the protocol, we use the target enrollment number of 100 participants. However, our actual participants were 51 enrolled, which is reflected in our results section.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peer Leader Participants | Peer Leaders Investigators will enroll up to 40 Peer Leaders. In addition to the above activities (under intervention trial participant), if a teen is a "peer leader" they will attend a training session in-person or online with our study team to learn about sexual and mental health information and how to share information with their friends (like text or social media). The peer leaders will answer the same surveys described above and will be asked about their Peer Leader experience and how they are sharing the study health information. |
| FG001 | Friend Network Participants | Teens will have an opportunity to interact with established peer leaders that are a part of the AccessKCTeen program. These leaders will receive a baseline training of their role, sexual and mental health. They will also receive health education and engage with a peer liaison via text messages throughout the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Peer Leader Participants | Peer Leaders Investigators will enroll up to 40 Peer Leaders. In addition to the above activities (under intervention trial participant), if a teen is a "peer leader" they will attend a training session in-person or online with our study team to learn about sexual and mental health information and how to share information with their friends (like text or social media). The peer leaders will answer the same surveys described above and will be asked about their Peer Leader experience and how they are sharing the study health information. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Any Healthcare Utilization From Baseline to 6 Months | Measurement of any use of healthcare utilization through trial. Healthcare utilization measured through surveys from participants at baseline, 2 months, 4 months, and 6 months. | Posted | Count of Participants | Participants | Baseline to 6 months |
|
6 months
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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 | Peer Leader Participants | Peer Leaders Investigators will enroll up to 40 Peer Leaders. In addition to the above activities (under intervention trial participant), if a teen is a "peer leader" they will attend a training session in-person or online with our study team to learn about sexual and mental health information and how to share information with their friends (like text or social media). The peer leaders will answer the same surveys described above and will be asked about their Peer Leader experience and how they are sharing the study health information. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Miller MD | Children's Mercy Hospitals and Clinics | 816234300 | mmiller@cmh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2023 | Apr 19, 2024 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2023 | Sep 6, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 24, 2022 | Sep 11, 2023 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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Participants will enroll as a Peer Leader (THO+) or they can enroll as part of a Friend Network. Teens who enroll as a Peer Leader will attend a training session in-person or online with our study team to learn about sexual and mental health information and how to share information with their friends (like text or social media). Teens who enroll as a Friend Network will receive the shared information from the Peer Leader who invited them to be a part of the study.
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|
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| BG001 | Friend Network Participants | Teens will have an opportunity to interact with established peer leaders that are a part of the AccessKCTeen program. These leaders will receive a baseline training of their role, sexual and mental health. They will also receive health education and engage with a peer liaison via text messages throughout the study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Friend Network Participants | Teens will have an opportunity to interact with established peer leaders that are a part of the AccessKCTeen program. These leaders will receive a baseline training of their role, sexual and mental health. They will also receive health education and engage with a peer liaison via text messages throughout the study. |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Friend Network Participants | Teens will have an opportunity to interact with established peer leaders that are a part of the AccessKCTeen program. These leaders will receive a baseline training of their role, sexual and mental health. They will also receive health education and engage with a peer liaison via text messages throughout the study. | 0 | 33 | 0 | 33 | 0 | 33 |
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