Clinical trial NCT02791971: The Share Health Study: Teen Social Connections and Health
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Contraception
Birth control
Social communication
Adolescent
Social network
Health education
Reproductive health
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: University of Southern California
First posted: 2016-06-07
Enrollment: 207
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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."

Eligibility criteria: 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

Primary outcomes:
measure: Initiation of a LARC method among secondary participants
timeFrame: 3 months and 9 months post-enrollment
Secondary outcomes:
measure: Initiation of cluster primary participant's LARC method among secondary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Positive social communication about LARC method between primary and secondary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Knowledge of cluster primary participant's LARC method among secondary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Positive attitudes towards cluster primary participant's LARC method among secondary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Diagnosis of sexually transmitted infection among secondary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Condom use at last sexual intercourse among sexually active secondary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Initiation of sexual activity among secondary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Pregnancy among secondary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Continuation of LARC method among primary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Initiation of social communication about LARC method among primary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Knowledge of LARC method among primary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Positive attitudes towards LARC method among primary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Pregnancy among primary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Risk of unintended pregnancy
timeFrame: 3 months and 9 months post-enrollment
measure: Alcohol use
timeFrame: 3 months and 9 months post-enrollment
measure: Knowledge of binge-drinking behaviors
timeFrame: 3 months and 9 months post-enrollment
measure: Diagnosis of an STI among primary participants
timeFrame: 3 months and 9 months post-enrollment
measure: Acceptability of SpeakOut
timeFrame: 9 months
measure: Acceptability of PartyWise [control intervention]
timeFrame: 9 months
Other outcomes:
measure: Contraceptive attitudes
timeFrame: 3 months and 9 months post-enrollment
Locations:
city: Davis
country: United States
facility: University of California, San Francisco
state: California
city: Los Angeles
country: United States
facility: University of Southern California Keck School of Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Christine Dehlendorf, MD MAS
role: PRINCIPAL_INVESTIGATOR
References: