The Share Health Study: Teen Social Connections and Health (Phase 2)

Summary

The purpose of this study is to determine whether delivery of SpeakOut, a behavioral intervention to increase social communication about long-acting reversible contraceptive (LARC) methods among adolescents, is associated with increased contraceptive use among the social contacts of SpeakOut recipients.

The investigators will conduct a cluster randomized controlled trial of SpeakOut with adolescent LARC users and their female peers. Over three years, SpeakOut will be implemented in eight partner clinics. IUD and implant users aged 15 to 19 will be recruited online and invited to enroll in the evaluation study as "primary" participants and receive either SpeakOut or a control intervention about alcohol use called PartyWise. The social contacts of primary participants will be asked to enroll in the study as "secondary" participants. The study's primary outcome will be the proportion of sexually-active secondary participants who are using any contraceptive method at 9-month follow-up.

Conditions

• Contraception

Interventions

BEHAVIORAL

SpeakOut

SpeakOut aims to increase social communication about contraception between adolescent IUD and implant users and their peers. SpeakOut has four components: 1. Coaching session. Research staff will deliver a script to encourage recipients to share information about their contraceptive method with peers. 2. Digital materials for recipients to keep and/or share with friends. 3. Websites with information and resources. Staff will refer recipients to a website, either SpeakOutIUD.org or SpeakOutImplant.org, which contain information about their method. 4. Text messages with information about recipients' method and about how to share their experience. Recipients will be given the opportunity to sign up for text messages that will be sent for 8 weeks following receipt of SpeakOut.

BEHAVIORAL

PartyWise

The active comparator intervention is an alcohol assessment and education intervention using an SBIRT (Screening, Brief Intervention, and Referral to Treatment) framework. Staff will ask two screening questions developed by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the American Academy of Pediatrics to screen for adolescents potentially at risk. Using a script based on tenets of motivational interviewing to assess alcohol related consequences, the staff will guide teens in identifying personally relevant motivators for healthier behaviors, assess readiness to change, and offer educational materials and referrals.

Sponsors & Collaborators

• University of California, Davis

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Christine Dehlendorf, MD, MAS · University of California, San Francisco

• Kathleen Tebb, PhD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

20 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-02-05

Primary Completion

2019-07-31

Completion

2021-06-30

Countries

• United States

Study Locations