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

NCT03842540 | Completed

• 1 other identifier: IRB #16-19206 App v1.15
• Study Type: interventional
• Target: 1,099
• Locations: 1 country
• Sites: 1

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 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

Keywords

LARC; Contraceptive decision-making; Diffusion of Innovations

Outcome Measures

Primary Outcomes (1)

• Contraceptive use among secondary participants

  Proportion of secondary participants reporting use of any contraceptive method in follow-up surveys. Outcome is dichotomous (Yes, USING contraception/No, NOT using contraception) and based on responses to PI-authored Survey item 1: What birth control method (s) are you currently using to prevent pregnancy? (Check all that apply of the following 11 response options) "Yes, USING contraception" defined as those who check any of the following: 1. Pill (Birth control pill) 2. Patch (Birth control patch) 3. Ring ("Nuvaring") 4. Shot ("Depo") 5. Hormonal IUD (Mirena, Liletta, or Skyla) 6. Non-hormonal IUD (Paragard or "copper T") 7. Implant (Nexplanon or Implanon, rod under skin of arm) 8. Condoms "No, NOT using contraception" defined as those who do not check items 1-8 above, whether or not they check any of the following response options: 9. Withdrawal/pulling out 10. Other 11. I am not currently using a method to prevent pregnancy

  Up to 9 months

Secondary Outcomes (23)

• Implant initiation (among all secondary participants, those recently sexually active, and ever sexually active)

  Up to 9 months

• IUD initiation (ie current IUD use among those not using an IUD at baseline) among secondary participants

  Up to 9 months

• Initiation of contraceptive used by primary participant among secondary participants reporting sexual active

  Up to 9 months

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

  Up to 9 months

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

  Up to 9 months

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 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

PartyWise 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: PartyWise

Interventions

SpeakOut BEHAVIORAL

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.

SpeakOut Intervention

PartyWise BEHAVIORAL

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.

PartyWise Intervention

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Primary participants:
• Age 15 to 19
• Female
• Able to speak and read English or Spanish easily
• Uses an IUD or implant for birth control
• 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
• If minor, lives in state where they are able to consent for reproductive health services
• Secondary participants:
• to 20 years old
• Female
• 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
• If minor, lives in state where they are able to consent for reproductive health services.

You may not qualify if:

• Primary participants:
• Previous enrollment as a primary or secondary participant in the study
• Pregnant at baseline
• Secondary participants:
• Pregnant at baseline
• Previous enrollment as a primary secondary participant in the study\*

Sponsors & Collaborators

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

Study Sites (1)

Kathleen Tebb

San Francisco, California, 94118, United States

Location

Related Publications (1)

• Schwarz EB, Chatterton B, Fix M, Tebb K, Rodriguez F, Tancredi DJ, Muriki M, Satterfield J. Remotely Educating Young Women About Alcohol: A Randomized Trial of the PartyWise Intervention. J Womens Health (Larchmt). 2022 Aug;31(8):1179-1187. doi: 10.1089/jwh.2021.0285. Epub 2022 Feb 28.

  PMID: 35230177 DERIVED

Study Officials

• Christine Dehlendorf, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Kathleen Tebb, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SpeakOut: Empowering Teen to Teen Social Communication About Highly Effective Contraception (Also Known As: The Share Health Study: Teen Social Connections and Health) (Phase 2)

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: February 5, 2019
• Primary Completion: July 31, 2019
• Study Completion: June 30, 2021
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (1)