The Share Health Study: Teen Social Connections and Health
Condition: Contraception
Study type: Interventional

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.
    

Detailed description: 
      Teen pregnancy results from sexually active adolescents' under-use of effective
      contraception. The most effective reversible methods - intrauterine devices (IUDs) and
      subdermal contraceptive implants, collectively referred to as long-acting reversible
      contraception (LARC) - have low rates of use among adolescents. 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
      these methods.

      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 immediately before intervention delivery on the day of
      their clinic appointment. 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.

      The design of SpeakOut was initially motivated by a qualitative study performed by Dr.
      Dehlendorf's team that found that adolescent IUD users report that a lack of social
      communication about this method is a barrier to IUD use. Dr. Dehlendorf's team then performed
      further qualitative work designed to understand the transmission of information about
      contraception within social networks, with the goal of informing a social-network-based
      intervention. The investigators confirmed that social communication is an influential factor
      in contraceptive decision making, and that it is considered particularly important to speak
      to individuals who have personal experience with specific methods. However, participants
      reported often hearing negative information about these methods, particularly IUDs, through
      their social network.

      Primary participant procedures

        -  Partner clinic and affiliate staff will notify research staff of appointment times for
           female patients aged 15 to 19 who are using or are planning to initiate use of LARC.

        -  Research staff will approach patients in the clinic waiting room or other clinic area
           before or after their appointment with approval of clinic staff and invite them to learn
           more about the study in a private room and be screened for eligibility.

        -  After being screened and providing written 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, and will provide a list of first names of female social contacts age
           15 to 19 with whom they feel comfortable talking about personal issues. These people
           will be potential secondary participants for the study. Research staff will ask that in
           the two weeks after enrollment, primary participants ask potential secondary
           participants if they are interested in being contacted by research staff, and if they
           are, to share their contact information with research staff.

        -  Participants will be randomized to receive either SpeakOut or a control intervention and
           receive the assigned intervention immediately after randomization.

        -  Research staff will randomize and deliver the assigned intervention before or after the
           clinic visit, depending on clinic flow.

        -  Once randomized, research staff will deliver either SpeakOut or the control intervention
           to the participant. Each delivery session lasts about 15 minutes, and sessions will be
           audio-recorded and observed for quality and fidelity measurement by UC Davis staff. As
           indicated the consent form for primary participants, primary participants may verbally
           indicate that they do not wish for the session to be recorded, and research staff will
           not record their session.

        -  Research staff will complete a fidelity checklist indicating which intervention
           components the primary participant received.

        -  Research staff will send primary participants an email and/or text reminder about
           secondary participant recruitment one week after their enrollment.

        -  In the period two to four weeks following primary participant enrollment, research staff
           will contact primary participants so that primary participants may share with research
           staff which potential secondary participants from their lists are willing to be
           contacted, as well as potential secondary participants contact information including
           phone number and/or email.

        -  Three months after enrollment, 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. Research staff will attempt to
           reach primary participants for up to one month following the 3-month post-enrollment
           date.

        -  Nine months after enrollment, research staff will contact primary 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. Research staff will attempt to
           reach primary participants for up to one month following the 9-month post-enrollment
           date.

      In addition to the above procedures, research staff at UC Davis will seek to obtain
      publically available claims data related to primary participants' reproductive health care
      over the 9-month study period. If available, Family PACT (Family Planning Access, Care, and
      Treatment) and Medi-Cal data will be obtained on pregnancy and removal of IUD or implant over
      the 9-month study period. This data will validate primary participant self-report of
      pregnancy and method removal at follow-up, or substitute for missing follow-up data. The
      California Department of Health Care Services (DHCS) has a standardized application process
      for the evaluation, review and potential approval of requests for protected data for research
      purposes. To obtain Family PACT and Medi-Cal administrative data from DHCS, researchers must
      submit an application for approval from the Data and Research Committee (DRC), which oversees
      DHCS' data request evaluation process, and from the Committee for the Protection of Human
      Subjects under the California Health and Human Services Agency (CHHSA). The DRC assesses the
      appropriateness of requests for protected data, assigns a priority status to each request,
      and recommends potential approval/denial action to DHCS Executive management. As a part of
      accessing DHCS data, researchers are required to provide a presentation of their findings to
      DHCS staff. In addition, requests can only be approved if they have a clear and strong
      argument that the proposed research request will result in information that benefits the
      Medi-Cal program (Section 1902(a) of the federal Social Security Act (42 U.S.C. 1396a(7)).
      Linkages to external data sources must be performed by DHCS staff, therefore SpeakOut will
      need to provide identifiable participant data to DHCS in order to obtain linked
      administrative data from participants' claims history.

      Information about the above process is included in the primary participant consent form, and
      primary participants may verbally inform the consenting researcher that they opt out of
      having their data accessed.

      Secondary participant procedures

        -  Potential secondary participants, identified by primary participants at baseline, will
           initially be approached by the primary participant who listed them. Primary participants
           will ask for potential secondary participants' permission to be contacted by research
           staff. Primary participants will report permission to research staff, who will then
           obtain secondary contact information from primary participants and contact potential
           secondary participants by phone call, text, and/or e-mail to ask if they would like to
           screen for eligibility as a secondary participant over the phone. Research staff will
           attempt to reach potential secondary participants for up to four weeks following primary
           participant enrollment.

        -  Eligibility screening will take place over the phone and verbal consent will be
           obtained.

        -  Secondary participants 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.

        -  Three months after enrollment of their primary participant, research staff will contact
           secondary participants by phone call, text, and/or e-mail and ask them to complete the
           first follow-up survey over the phone or by-email. The survey will include questions
           about contraceptive knowledge, attitudes, use, and social communication as well as drug
           and alcohol behaviors. 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, 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.
           Research staff will attempt to reach primary participants for up to one month following
           the 9-month post-enrollment date.

      Please note that our sample size of 2500 is based on an estimate of cluster sizes of 4
      secondary participants per 1 primary participant. As per our initial grant application,
      "During the course of the study, the distribution of initial cluster sizes (i.e. enrolled
      eligible secondary participants per primary participant) will be monitored for gross
      departures from our planning assumptions. In case of discrepancies, the targeted enrollment
      will be adjusted to achieve the necessary effective sample size. To preserve the integrity of
      the trial, this monitoring will only concern enrollment information, not study outcomes."
    

Intervention name(s): SpeakOut; Alcohol Control Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): Partywise, Partysafe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Contraception; Birth control; Social communication; Adolescent; Social network; Health education; Reproductive health