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

NCT ID: NCT03842540

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1099 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-05
• Study Completion Date: 2021-06-30

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.

Detailed Description

Teen pregnancy results from under-use contraception by sexually active teens. Social networks are important influences on teen contraceptive knowledge and use. Encouraging social communication to increase knowledge and acceptability of LARC among female adolescents can increase use of contraception.

The Share Health Study is a cluster randomized control trial, randomized at the primary participant level. Primary participants will be randomized to receive either SpeakOut or a control intervention about alcohol use (PartyWise) immediately before intervention delivery. A cluster consists of primary participants and the secondary participants recruited to the study via a specialized snowball sampling procedure carried out with the assistance of the primary participant, described below.

Primary participant procedures

Adolescents ages 15-19 years old who are using an IUD or implant will be recruited through targeted social media advertisements.

After providing consent, each primary participant will complete a baseline survey collecting demographic information and asking about contraceptive knowledge, attitudes, use, and social communication as well as drug and alcohol behaviors.

Primary participants will be randomized to receive either SpeakOut or the control intervention and receive the assigned intervention immediately after randomization by phone. Each delivery session lasts about 10 minutes, and both SpeakOut and control sessions will be audio-recorded and observed for quality and fidelity measurement by UC Davis staff. Primary participants will be instructed to ask up to five social contacts if they would be willing to participate in the study and will send them a link to an online screener and survey.

The SpeakOut intervention is informed by the Theory of Diffusion of Innovation and aims to increase social communication about IUDs and implants between adolescent IUD and implant users and their peers. The intervention is comprised of four components:

1. A one-on-one communication coaching session for teen IUD and implant users. Contracted staff will deliver an educational script by phone to review effective communication strategies and encourage primary participants to share information about their contraceptive method of choice with peers, to the extent they feel comfortable.

2. Method-specific digital materials for recipients to keep and/or share with friends. Staff will provide pamphlets designed to a) deliver evidence-based information about their method, and b) facilitate communication about their choice with social contacts, including about their experience with the method and their reasons for choosing it.

3. Method-specific websites with information and resources. Staff will refer teens to a website, either SpeakOutIUD.org or SpeakOutImplant.org, which contain information about their method, including the information contained in the pamphlets, resources related to sharing their experience with their peers, and links to online information provided by the National Campaign through their online birth control support network, Bedsider.org. This includes location and contact information for clinics that provide LARC, videos featuring individuals who use these methods, and the opportunity to explore multiple methods using Bedsider's method comparison feature.

4. Method-specific 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 every week for 8 weeks following receipt of SpeakOut in clinic. These texts will provide evidence-based information about use of the method (e.g., address concerns about menstrual spotting), in order to promote accurate knowledge and facilitate ongoing use of the method, and provide reinforcement of the value of sharing their story.

The counterfactual intervention for SpeakOut - called PartyWise - 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. The approach includes an early intervention focus so that individuals with non-dependent alcohol use are identified and supported in moving towards avoidance or reduction in alcohol use and educated about ways to minimize harm. The participant will be asked two screening questions electronically, 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 study staff will guide teens in identifying personally relevant motivators for healthier behaviors, assess readiness to change, and offer educational materials. Participants who receive this intervention will have the option to sign up for text messages with additional information about alcohol consumption for 8 weeks following enrollment. Motivational Interviewing is patient-centered and utilizes the adolescent's own intrinsic motivations for change. It is based on the stages of change theoretical model in which readiness to make changes resides on a continuum and the client and counselor together explore how to help the client make the changes she is ready for or address how to help the client move towards increased readiness to make positive changes. With the participant's permission, delivery of this intervention will be audio-recorded by contracted staff.

For both experimental and control interventions, staff will offer participants the opportunity to receive text message content via email, if they have an email address and no mobile phone that receives text messages.

3 months after enrollment, contracted staff and/or research staff will contact primary participants by phone call, text, and/or e-mail and ask them to complete the first follow-up survey over the phone or online. The survey will include questions about contraceptive knowledge, attitudes, and use as well as drug and alcohol behaviors.

9 months after enrollment, contracted staff or research staff will contact primary participants by phone, text, and/or e-mail and ask them to complete the second follow-up survey over the phone or by-email. The survey will include questions about contraceptive knowledge, attitudes, and use as well as drug and alcohol behaviors.

Secondary participant procedures

Potential secondary participants will be approached by the primary participant. Primary participants will ask for potential secondary participants' to participate in the study by sending them a link to a website with study information, a screening tool to assess the secondary participants' eligibility, and a baseline survey for eligible participants.

Eligible participants will link to an electronic consent with more information about the study. If they are interested, they will indicate their consent by selecting a check box on an electronic consent form in Qualtrics, a secure survey program with electronic consent capability, on their device.

If the secondary participant consents electronically, they will be linked to the baseline survey collecting demographic information and asking about contraceptive knowledge, attitudes, use, and social communication, as well as drug and alcohol behaviors.

Three months after enrollment of their primary participant, contracted staff or research staff will contact secondary participants by phone, text, and/or e-mail and ask them to complete the first follow-up survey electronically or by phone. The survey will include questions about contraceptive knowledge, attitudes, use, and social communication as well as drug and alcohol behaviors. Contracted staff or research staff will attempt to reach primary participants for up to one month following the 3-month post-enrollment date.

Nine months after enrollment of their primary participant, contracted staff or research staff will contact secondary participants by phone call, text, and/or e-mail and ask them to complete the second follow-up survey over the phone or by-email. The survey will include questions about contraceptive knowledge, attitudes, and use as well as drug and alcohol behaviors.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SpeakOut Intervention

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.

Group Type: EXPERIMENTAL

SpeakOut

Intervention Type: 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.

PartyWise Intervention

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.

Group Type: ACTIVE_COMPARATOR

PartyWise

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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:

• 15 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.

Exclusion Criteria

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*

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Dehlendorf, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Kathleen Tebb, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Kathleen Tebb

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35230177 (View on PubMed)

Other Identifiers

IRB #16-19206 App v1.15

Identifier Type: -

Identifier Source: org_study_id