Clinical trial NCT02816424: Brief Intervention for Teen Pregnancy Prevention
Official title: Prevention of Teen Pregnancy Through Screening and Brief Intervention in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Pregnancy Prevention
Keywords: Screening and Brief Intervention
Motivational Interviewing
Teen Pregnancy Prevention
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2016-06-28
Enrollment: 447
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Proportion of participants endorsing unprotected sex at 3 month follow up
timeFrame: 3-Month Endpoint
measure: Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 3 month follow up
timeFrame: 3-Month Endpoint
Secondary outcomes:
measure: Proportion of participants endorsing unprotected sex at 9 month follow up
timeFrame: 9-Month Endpoint
measure: Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 9 month follow up
timeFrame: 9-Month Endpoint
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: The University of New Mexico
state: New Mexico
Study officials:
affiliation: The University of New Mexico
name: Jennifer E Hettema, PhD
role: PRINCIPAL_INVESTIGATOR
References: