The Share Health Study: Teen Social Connections and Health

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."

Primary Participant Inclusion Criteria:

- Able to speak and read English or Spanish easily

- Uses an IUD or implant for birth control, or will get one of these methods inserted at
an appointment on the day of enrollment

- 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

Primary Participant Exclusion Criteria:

- Previous enrollment as a primary or secondary participant in the study

- Pregnant at baseline

- Plan to get their IUD or implant removed at their visit and not replacing it with
another LARC

Secondary Participant Inclusion Criteria:

- 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

- Lives in California

Secondary Participant Exclusion Criteria:

- Pregnant at baseline

- Previous enrollment as a primary or secondary participant in the study