Clinical trial NCT03842540: The Share Health Study: Teen Social Connections and Health (Phase 2)
Official title: The Share Health Study: Teens Social Connections and Health (Phase 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: LARC
Contraceptive decision-making
Diffusion of Innovations
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Davis
First posted: 2019-02-15
Enrollment: 1099
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

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\*

Primary outcomes:
measure: Contraceptive use among secondary participants
timeFrame: Up to 9 months
Secondary outcomes:
measure: Implant initiation (among all secondary participants, those recently sexually active, and ever sexually active)
timeFrame: Up to 9 months
measure: IUD initiation (ie current IUD use among those not using an IUD at baseline) among secondary participants
timeFrame: Up to 9 months
measure: Initiation of contraceptive used by primary participant among secondary participants reporting sexual active
timeFrame: Up to 9 months
measure: Positive attitudes towards cluster primary participant's LARC method among secondary participants
timeFrame: Up to 9 months
measure: Knowledge of cluster primary participant's LARC use among secondary participants
timeFrame: Up to 9 months
measure: Knowledge of LARC methods among secondary participants
timeFrame: Up to 9 months
measure: Positive social communication about LARC method between primary and secondary participants
timeFrame: Up to 9 months
measure: Negative social communication about LARC method between primary and secondary participants
timeFrame: Up to 9 months
measure: Condom use at last sexual intercourse among sexually active secondary participants
timeFrame: Up to 9 months
measure: Diagnosis of sexually transmitted infection among secondary participants
timeFrame: Up to 9 months
measure: Initiation of sexual activity among secondary participants
timeFrame: Up to 9 months
measure: Pregnancy among secondary participants
timeFrame: Up to 9 months
measure: IUD continuation among primary participants
timeFrame: Up to 9 months
measure: Implant continuation among primary participants
timeFrame: Up to 9 months
measure: Positive attitudes towards LARC method among primary participants
timeFrame: Up to 9 months
measure: Knowledge of LARC method among primary participants
timeFrame: Up to 9 months
measure: Initiation of social communication about LARC method among primary participants
timeFrame: Up to 9 months
measure: Pregnancy among primary participants
timeFrame: Up to 9 months
measure: Risk of unintended pregnancy (ie sex without contraception)
timeFrame: Up to 9 months
measure: Alcohol use
timeFrame: Up to 9 months
measure: Knowledge of binge-drinking behaviors
timeFrame: Up to 9 months
measure: Acceptability of SpeakOut
timeFrame: Up to 9 months
measure: Acceptability of PartyWise [control intervention]
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Kathleen Tebb
state: California
Study officials:
affiliation: University of California, San Francisco
name: Christine Dehlendorf, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Kathleen Tebb, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.