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Completed

NCT Number: NCT02816424

Brief Intervention for Teen Pregnancy Prevention

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.

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Key information

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of New Mexico

Albuquerque, New Mexico, 87131, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teens Exploring and Managing Prevention Options (TEMPO)

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

Prevention of Teen Pregnancy Through Screening and Brief Intervention in Primary Care

Acronym: TEMPO

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2016
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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