Health Care UtilizationNCT05444855
Increasing Teen Access to Sexual and Mental Health Care
A study testing Peer Leader Model in people with Health Care Utilization, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
Investigators will form community partnership with community sites that will disseminate curated educational information on Sexual and Reproductive Health/Mental Health (SRH/MH). Read more about this study
- Who is it for?
- Ages 14 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization
- What is being tested?
- Peer Leader Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2022to 1 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Increasing Teen Access to Care Using Peer Social Networks and Mobile Health Services
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.
Read the 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.
- Conditions
- Health Care Utilization
- Being tested
- Peer Leader Model
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Leader ModelOther
Also called THO+
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Peer Leader Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start8 Jun 2022
- Primary completion30 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Melissa Miller, Children's Mercy Hospital Kansas City
- Investigators
- Melissa Millerr, MD, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444855
- Sponsor's protocol ID
- 00002100
- Other IDs
- R21HD098086-02S1
- Status last verified
- Sep 2024
- First submitted
- 17 Feb 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Teen Access to Care Using Peer Social Networks and Mobile Health Services
- ClinicalTrials.gov ID
- NCT05444855
- Acronym / sponsor ID
- 00002100
- Conditions
- Health Care Utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Peer Leader and Friend Network Participants | Experimental | Other: Peer Leader ModelAll 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. |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Leader ModelAlso: THO+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 | Peer Leader and Friend Network Participants |
Primary outcome
Number of Participants With Any Healthcare Utilization From Baseline to 6 Months
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Millerr, MD principal investigator
Children's Mercy Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Leader Model in people with Health Care Utilization, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any Healthcare Utilization From Baseline to 6 Months (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.