NCT05444855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 8, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

February 17, 2022

Results QC Date

April 19, 2024

Last Update Submit

September 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Other: Peer Leader Model

Interventions

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.

Also known as: THO+
Peer Leader and Friend Network Participants

Eligibility Criteria

Age14 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 14-18 years and 364 days old

You may not qualify if:

  • 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
  • Aged 14-18 years and 364 days old
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Melissa Miller MD
Organization
Children's Mercy Hospitals and Clinics

Study Officials

  • Melissa Millerr, MD

    Children's Mercy Kansas City

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

February 17, 2022

First Posted

July 6, 2022

Study Start

June 8, 2022

Primary Completion

April 30, 2023

Study Completion

May 1, 2023

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-09

Locations