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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02816424
Other study ID # TP2AH000028
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2015
Est. completion date August 20, 2021

Study information

Verified date April 2020
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine recommend that teen health providers screen for sexual risk behaviors and provide education and counseling to those at risk, there are currently no specific guidelines or protocols available to guide such practices, nor have there been any rigorous evaluations of efficacy. Preventing teen pregnancy through brief intervention in primary care holds the promise to have a significant public health impact and reduce health disparities by engaging, educating, and motivating the majority of teens who visit a primary care setting each year. In the current study, we seek to rigorously evaluate the impact of brief intervention vs. informational control on unprotected sexual intercourse among teens with past year unprotected sex at two primary care clinics serving predominately underserved, minority populations in New Mexico. The target population for the current study will be 1350 male and female teens, aged 13-19, from the Atrisco Center for Family and Community Health and the Albuquerque Job Corps Wellness Center. Extensive formative work involving the study population will be conducted prior to the trial to refine the motivational interviewing-based brief intervention. Eligible youth will be randomly assigned to brief intervention or an informational control condition, in addition to regularly offered medically-based contraception consultation and prescription services. Follow-ups at 3- and 9- months will compare rates of unprotected sex and acceptance of long-acting reversible contraceptives. Brief education and counseling interventions could be feasibly implemented during the greater than eight preventive and acute primary care visits that the average US adolescent attends during their teen years. Such an approach could conserve valuable resources required by more intensive interventions for nonresponsive teens with greater need. Furthermore, social determinants of health, such as poverty and race, that may reduce access to more extensive psychosocial interventions, are less likely to prevent access to primary care, increasing health equity.


Recruitment information / eligibility

Status Completed
Enrollment 447
Est. completion date August 20, 2021
Est. primary completion date August 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 19 Years
Eligibility Inclusion Criteria: - Aged 13-19 - Self-reported past year unprotected sex - Can read and speak English - Willing to be contacted for follow-up Exclusion Criteria: - Current use of long-acting reversible contraceptives - Self-reported pregnancy or pregnancy discovered during optional medical contraception consultation - Expressed suicidality - Obvious cognitive impairment - Inability to provide informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Teens Exploring and Managing Prevention Options (TEMPO)


Locations

Country Name City State
United States The University of New Mexico Albuquerque New Mexico

Sponsors (2)

Lead Sponsor Collaborator
University of New Mexico Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants endorsing unprotected sex at 3 month follow up All participants 3-Month Endpoint
Primary Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 3 month follow up Among female participants 3-Month Endpoint
Secondary Proportion of participants endorsing unprotected sex at 9 month follow up All participants 9-Month Endpoint
Secondary Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 9 month follow up Among female participants 9-Month Endpoint
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