The Share Health Study: Teen Social Connections and Health

Contraception Clinical Trial

Official title: SpeakOut: Empowering Teen to Teen Social Communication About Highly Effective Contraception (Also Known As: The Share Health Study: Teen Social Connections and Health)

Status Completed

Clinical Trial 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.

Clinical Trial 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." ;

Related Conditions & MeSH terms

• Contraception

• NCT number: NCT02791971
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: N/A
• Start date: November 15, 2016
• Completion date: June 21, 2018