The Share Health Study: Teen Social Connections and Health

NCT02791971 | Completed

• 1 other identifier: TP2AH000045-01-01
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 2

Brief 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 uptake of LARC methods 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 who attend appointments at participating clinics will be invited to enroll in the evaluation study as "primary" participants and receive either SpeakOut or a control intervention about alcohol use. 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 initiate use of a LARC method within 9 months of study enrollment.

Conditions

Contraception

Keywords

Contraception; Birth control; Social communication; Adolescent; Social network; Health education; Reproductive health

Outcome Measures

Primary Outcomes (1)

• Initiation of a LARC method among secondary participants

  Self-reported measure of current contraceptive use in secondary participants not using IUD or implant at baseline. Will be examined among sexually active secondary participants, as well as all secondary participants regardless of sexual activity.

  3 months and 9 months post-enrollment

Secondary Outcomes (19)

• Initiation of cluster primary participant's LARC method among secondary participants

  3 months and 9 months post-enrollment

• Positive social communication about LARC method between primary and secondary participants

  3 months and 9 months post-enrollment

• Knowledge of cluster primary participant's LARC method among secondary participants

  3 months and 9 months post-enrollment

• Positive attitudes towards cluster primary participant's LARC method among secondary participants

  3 months and 9 months post-enrollment

• Diagnosis of sexually transmitted infection among secondary participants

  3 months and 9 months post-enrollment

Other Outcomes (1)

• Contraceptive attitudes

  3 months and 9 months post-enrollment

Study Arms (2)

SpeakOut Intervention

EXPERIMENTAL

Primary participants will be randomized to this arm or the Alcohol Control Arm at the time of enrollment. Secondary participants will be assigned to this arm if the primary participant whom initially told them about the study is in this arm. Primary participants in this arm will receive the SpeakOut intervention on the day of enrollment, and will complete surveys on their contraceptive knowledge, attitudes, behaviors, and social communication at baseline, three months, and nine months. Secondary participants in this arm will complete similar surveys at baseline, three months, and nine months. Note: Secondary participants will not receive intervention, but will be assessed on outcomes that may have been affected as a result of social communication with primary participants.

Behavioral: SpeakOut

Alcohol Control Intervention

ACTIVE COMPARATOR

Primary participants will be randomized to this arm or the SpeakOut Intervention Arm at the time of enrollment. Secondary participants will be assigned to this arm if the primary participant whom initially told them about the study is in this arm. Primary participants in this arm will receive the Alcohol Control Intervention on the day of enrollment, and will complete surveys on their contraceptive knowledge, attitudes, behaviors, and social communication at baseline, three months, and nine months. Secondary participants in this arm will complete similar surveys at baseline, three months, and nine months. Note: Secondary participants will receive an intervention, but will be assessed on outcomes that may have been affected as a result of social communication with primary participants.

Behavioral: Alcohol Control Intervention

Interventions

SpeakOut BEHAVIORAL

SpeakOut aims to increase social communication about IUDs and implants between adolescent IUD and implant users and their peers. SpeakOut has four components: * Coaching session. Research staff will deliver a script to encourage recipients to share information about their contraceptive method with peers. * Printed materials for recipients to keep and/or share with friends. * Websites with information and resources. Staff will refer recipients to a website, either SpeakOutIUD.org or SpeakOutImplant.org, which contain information about their method. * 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 in clinic.

SpeakOut Intervention

Alcohol Control Intervention BEHAVIORAL

The active comparator intervention is an alcohol assessment and education intervention using an SBIRT (Screening, Brief Intervention, and Referral to Treatment) framework. SBIRT is an evidence-based practice model aimed at preventing problematic use and identifying potential abuse and dependency issues. Research 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 research staff will guide teens in identifying personally relevant motivators for healthier behaviors, assess readiness to change, and offer educational materials and referrals.

Also known as: Partywise, Partysafe

Alcohol Control Intervention

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Able to speak and read English or Spanish easily
• Uses an IUD or implant for birth control, or will get one of these methods inserted at an appointment on the day of enrollment
• Is comfortable with close friend knowing that they use an IUD or implant
• Can think of at least one friend or family member they would be comfortable asking to join a study about health topics like birth control and alcohol use

You may not qualify if:

• Previous enrollment as a primary or secondary participant in the study
• Pregnant at baseline
• Plan to get their IUD or implant removed at their visit and not replacing it with another LARC
• Able to speak and read English or Spanish easily
• Was listed as a social contact by a primary participant at enrollment, and can name that primary participant at screening
• Lives in California
• Pregnant at baseline
• Previous enrollment as a primary or secondary participant in the study

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Davis: collaborator
• University of Southern California: collaborator

Study Sites (2)

University of California, San Francisco

Davis, California, 94110, United States

Location

University of Southern California Keck School of Medicine

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Communication; Health Education

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Christine Dehlendorf, MD MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 7, 2016
• Study Start: November 15, 2016
• Primary Completion: June 21, 2018
• Study Completion: June 21, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

US (2)