Contraception BehaviorNCT04578093
Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy
A study testing LARC peer-based curriculum in people with Contraception Behavior, run by The University of Texas Medical Branch, Galveston.
Trial summary
Previously studied peer-based educational videos on LARC (long-acting reversible contraceptive) devices will be incorporated into a high school health curriculum. This will then be administered to the intervention high school. Read more about this study
- Who is it for?
- Ages 13 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception Behavior
- What is being tested?
- LARC peer-based curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 8 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- female, never used LARC, attending high school, less than 20 yo
Who cannot join
- used LARC
About this study
Official title: Investigating an Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy
Previously studied peer-based educational videos on LARC (long-acting reversible contraceptive) devices will be incorporated into a high school health curriculum. This will then be administered to the intervention high school. Outcomes including LARC knowledge, attitudes and uptake will be compared to a control high school.
- Conditions
- Contraception Behavior
- Being tested
- LARC peer-based curriculum
- Keywords
- teen pregnancy, adolescent contraception
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LARC peer-based curriculumBehavioural
Peer-based educational videos and supplemental activities
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Will receive adjusts curriculum Receives: Behavioral: LARC peer-based curriculum |
| Control | No intervention | Will receive unadjusted curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inquiries made of provider
Incidence of teenagers initiating LARC discussion or asking provider questions about LARC when visiting the school-based healthcare clinic provider.
Measured: 6 months
Secondary outcomes (1)
LARC uptake
Incidence of teenager using IUD or subnormal implant.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Jan 2021
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Why it stopped: PI No Longer at Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraception BehaviorStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- case-control
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pooja R Patel, MD, MPH, MMS, Principal investigator, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578093
- Sponsor's protocol ID
- IRB 20-0250
- Status last verified
- Mar 2023
- First submitted
- 5 Oct 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating an Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy
- ClinicalTrials.gov ID
- NCT04578093
- Acronym / sponsor ID
- IRB 20-0250
- Conditions
- Contraception Behavior
- Keywords
- teen pregnancy, adolescent contraception
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI No Longer at Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previously studied peer-based educational videos on LARC (long-acting reversible contraceptive) devices will be incorporated into a high school health curriculum. This will then be administered to the intervention high school. Outcomes including LARC knowledge, attitudes and uptake will be compared to a control high school.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- case-control
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: LARC peer-based curriculumWill receive adjusts curriculum |
| Control | No intervention | –Will receive unadjusted curriculum |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- female, never used LARC, attending high school, less than 20 yo
Key exclusion criteria (1 listed)
- used LARC
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 |
|---|---|---|
| LARC peer-based curriculumPeer-based educational videos and supplemental activities | Behavioural | Intervention |
Primary outcome
Inquiries made of provider
Time frame: 6 months
Incidence of teenagers initiating LARC discussion or asking provider questions about LARC when visiting the school-based healthcare clinic provider.
1 secondary outcome
LARC uptake
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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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.
Pooja R Patel, MD, MPH, MMS principal investigator
UTMB
Questions about this trial
What is this clinical trial studying?
A study testing LARC peer-based curriculum in people with Contraception Behavior, run by The University of Texas Medical Branch, Galveston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Inquiries made of provider (time frame: 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 7 Mar 2023; AzTrials last refreshed its copy on 28 Oct 2026.