AccessKCTeen2: Increasing Teen Access to Care

Sponsor

Children's Mercy Hospital Kansas City (Other)

Overall Status

Recruiting

CT.gov ID

NCT05444855

Collaborator

(none)

250

Enrollment

Location

Arms

14.3

Anticipated Duration (Months)

17.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Health Care Utilization	Other: Peer Leader Model	N/A

Detailed Description

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:

Education based on a peer-leader model: In collaboration with community-based partners, investigators will identify and train approximately 40 peer leaders in disseminating information and resources for Sexual and Reproductive Health/Mental Health (SRH/MH) MH/SRH to their social networks. Peer leaders may disseminate information in the form of sharing curated online resources or mobilizing friends to attend live educational events. Peer leaders will also help connect their friends to resources by spreading information and encouraging friends to attend CM mobile unit demonstrations. Investigators will use text messaging to engage peers in these educational events and share general health resources.
Mobile Unit and Telemedicine Demonstration Events: The mobile unit will be present at community events to demonstrate how in-person care could work on the unit as well as how telemedicine works. Investigators will answer questions and help adolescents get registered for telemedicine.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will enroll as a Peer Leader (THO+) , they can enroll apart of a Friend Network, or enroll in the study as an Event Day participant. 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 apart of the study. Teens who enroll as an Event Day participant will not have received information from a Peer Leader. They will enroll in the study from attending an event were AccessKCTeen is attending. They will receive education or clinical care from healthcare professionals.Participants will enroll as a Peer Leader (THO+) , they can enroll apart of a Friend Network, or enroll in the study as an Event Day participant. 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 apart of the study. Teens who enroll as an Event Day participant will not have received information from a Peer Leader. They will enroll in the study from attending an event were AccessKCTeen is attending. They will receive education or clinical care from healthcare professionals.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Increasing Teen Access to Care Using Peer Social Networks and Mobile Health Services

Actual Study Start Date :

Apr 22, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Trial Participants All adolescents will have access to THO+ 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.	Other: Peer Leader Model 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. Other Names: THO+
No Intervention: Adult Stakeholders Adults Involved with teens (e.g., parent of teen, member of community, works at community partner organization) that will help promote community based events and provide feedback on events.
Experimental: Event Day Participants Adolescents not already in the trial who attend demonstration and clinical care events must enroll as research participants if they want to receive study medications or testing. This again is all optional to teens. This survey will ask for contact information which is required to track study medications and provide testing results, all other survey questions will be optional.	Other: Peer Leader Model 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. Other Names: THO+

Arm

Intervention/Treatment

Experimental: Intervention Trial Participants

All adolescents will have access to THO+ 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.

Other: Peer Leader Model

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.

Other Names:

THO+

No Intervention: Adult Stakeholders

Adults Involved with teens (e.g., parent of teen, member of community, works at community partner organization) that will help promote community based events and provide feedback on events.

Experimental: Event Day Participants

Adolescents not already in the trial who attend demonstration and clinical care events must enroll as research participants if they want to receive study medications or testing. This again is all optional to teens. This survey will ask for contact information which is required to track study medications and provide testing results, all other survey questions will be optional.

Other: Peer Leader Model

Other Names:

THO+

Outcome Measures

Primary Outcome Measures

Healthcare Utilization from Baseline to 6 months via Participant Survey. [Baseline to 6 months]
Measurement of participant use of healthcare utilization through trial. Healthcare utilization measured through surveys from participants at baseline, 2 months, 4 months, and 6 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INTERVENTION TRIAL PARTICIPANTS and Peer Leaders (ADOLECENTS) Inclusion Criteria

Aged 14-18 years and 364 days old

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

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

ADULT STAKEHOLDERS Inclusion Criteria

Aged 18 years and older
Involved with teens as trusted adults (e.g., parent of teen, member of community, works at community partner organization)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Mercy Hospital	Kansas City	Missouri	United States	64108

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

Investigators

Principal Investigator: Melissa Millerr, MD, Children's Mercy Kansas City

Study Documents (Full-Text)

Study Protocol - Nov 27, 2021

More Information

Publications

None provided.

Responsible Party:

Children's Mercy Hospital Kansas City

ClinicalTrials.gov Identifier:

NCT05444855

Other Study ID Numbers:

00002100

First Posted:

Jul 6, 2022

Last Update Posted:

Jul 6, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 6, 2022