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Brief Intervention for Teen Pregnancy Prevention (TEMPO)

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ClinicalTrials.gov Identifier: NCT02816424
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
University of New Mexico

Brief 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.

Condition or disease Intervention/treatment Phase
Teen Pregnancy Prevention Behavioral: Teens Exploring and Managing Prevention Options (TEMPO) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Teen Pregnancy Through Screening and Brief Intervention in Primary Care
Study Start Date : February 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: Brief Motivational Interviewing
Principles and skills of motivational interviewing will be used with participants assigned to brief intervention. These participants will receive feedback that they are at risk for unintended pregnancy. They will receive information on the likelihood of pregnancy given their self-reported frequency of unprotected sex. They will be given information regarding negative consequences associated with teen pregnancy. They will be provided with information on the chances of pregnancy with abstinence, condom use, oral contraceptives, and Long Acting Reversible Contraceptives (LARC). Following information exchange, participants who are high in readiness to change will engage in action planning, whereby a specific plan for reducing risk for unintended pregnancy will be collaboratively developed with the interventionist. Patients who are low in readiness to change will complete a motivational interviewing-based roadmap activity that is designed to strategically evoke motivational speech.
Behavioral: Teens Exploring and Managing Prevention Options (TEMPO)
No Intervention: Control



Primary Outcome Measures :
  1. Proportion of participants endorsing unprotected sex at 3 month follow up [ Time Frame: 3-Month Endpoint ]
    All participants

  2. Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 3 month follow up [ Time Frame: 3-Month Endpoint ]
    Among female participants


Secondary Outcome Measures :
  1. Proportion of participants endorsing unprotected sex at 9 month follow up [ Time Frame: 9-Month Endpoint ]
    All participants

  2. Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 9 month follow up [ Time Frame: 9-Month Endpoint ]
    Among female participants



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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816424


Contacts
Contact: Jennifer E Hettema, PhD 505-272-2165 jhettema@salud.unm.edu
Contact: Stephanie A Cockrell, MSW 505-697-0389 sacockrell@salud.unm.edu

Locations
United States, New Mexico
The University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Rena Vineyard    505-272-6264    HSC-Preaward@salud.unm.edu   
Contact: Virginia Chavez    505-272-3403    vchavez22@salud.unm.edu   
Principal Investigator: Jennifer E Hettema, PhD         
Sponsors and Collaborators
University of New Mexico
Department of Health and Human Services
Investigators
Principal Investigator: Jennifer E Hettema, PhD The University of New Mexico

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT02816424     History of Changes
Other Study ID Numbers: TP2AH000028
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by University of New Mexico:
Screening and Brief Intervention
Motivational Interviewing
Teen Pregnancy Prevention