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The Share Health Study: Teen Social Connections and Health

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ClinicalTrials.gov Identifier: NCT02791971
Recruitment Status : Recruiting
First Posted : June 7, 2016
Last Update Posted : March 14, 2017
Sponsor:
Collaborators:
University of California, Davis
University of Southern California
Information provided by (Responsible Party):
University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Contraception Behavioral: SpeakOut Behavioral: Alcohol Control Intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: SpeakOut Intervention

Primary participants will be randomized to this arm or the Alcohol Control Arm at the time of enrollment. Secondary participants will be assigned to this arm if the primary participant whom initially told them about the study is in this arm. Primary participants in this arm will receive the SpeakOut intervention on the day of enrollment, and will complete surveys on their contraceptive knowledge, attitudes, behaviors, and social communication at baseline, three months, and nine months. Secondary participants in this arm will complete similar surveys at baseline, three months, and nine months.

Note: Secondary participants will not receive intervention, but will be assessed on outcomes that may have been affected as a result of social communication with primary participants.

Behavioral: SpeakOut

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.

Active Comparator: Alcohol Control Intervention

Primary participants will be randomized to this arm or the SpeakOut Intervention Arm at the time of enrollment. Secondary participants will be assigned to this arm if the primary participant whom initially told them about the study is in this arm. Primary participants in this arm will receive the Alcohol Control Intervention on the day of enrollment, and will complete surveys on their contraceptive knowledge, attitudes, behaviors, and social communication at baseline, three months, and nine months. Secondary participants in this arm will complete similar surveys at baseline, three months, and nine months.

Note: Secondary participants will receive an intervention, but will be assessed on outcomes that may have been affected as a result of social communication with primary participants.

Behavioral: Alcohol Control Intervention
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 Name: Partywise, Partysafe




Primary Outcome Measures :
  1. Initiation of a LARC method among secondary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Self-reported measure of current contraceptive use in secondary participants not using IUD or implant at baseline. Will be examined among sexually active secondary participants, as well as all secondary participants regardless of sexual activity.


Secondary Outcome Measures :
  1. Initiation of cluster primary participant's LARC method among secondary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Self-reported measure of current contraceptive use in secondary participants not using IUD or implant at baseline. Will be examined among sexually active secondary participants, as well as all secondary participants regardless of sexual activity. Outcome will also be examined separately by LARC method, i.e. implant initiation among all secondary participants not using an implant at baseline (even if they used an IUD at baseline) if the primary participant was an implant user, as well as IUD initiation among all secondary participants not using an IUD at baseline (even if they used an implant) if the primary participant was an IUD user.

  2. Positive social communication about LARC method between primary and secondary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Self-reported measures of discussion about contraceptive methods with primary participant, in secondary participant follow-up surveys, and 5-point likert scale measures of agreement/disagreement with statements of positive and negative content of discussion.

  3. Knowledge of cluster primary participant's LARC method among secondary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Secondary participants' accurate knowledge of features of their cluster primary participant's LARC method. In baseline and follow-up surveys, secondary participants will be asked to report whether or not they have ever heard of the method. If they have heard of the method in follow-up surveys, they will be asked to report on a 4-point Likert scale their self-perceived knowledge of the method. They will also be asked to answer a set of true/false/don't know knowledge items on the method's features derived from the Guttmacher Institute's Survey of Young Adults ("Fogzone" survey) and National Survey of Reproductive and Contraceptive Knowledge, as well as an item on the relative effectiveness of the method in relation to birth control pills.

  4. Positive attitudes towards cluster primary participant's LARC method among secondary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Self-reported global attitudinal scales of contraceptive methods in secondary participant baseline and follow-up surveys, scored from 0-10.

  5. Diagnosis of sexually transmitted infection among secondary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Diagnosis of a sexually transmitted infection (chlamydia, gonorrhea, trichomoniasis [or trich], or other). Measured via self-report in secondary participant follow-up surveys (binary yes/no measure of diagnosis, and measure regarding which STI they were diagnosed with).

  6. Condom use at last sexual intercourse among sexually active secondary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Self-reported in secondary participant baseline and follow-up surveys with standardized question from the Office of Adolescent Health in the Department of Health and Human Services.

  7. Initiation of sexual activity among secondary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Self-reported measure of ever having had sexual intercourse (standardized OAH measure) in secondary participant baseline and follow-up surveys among those who had not had sexual intercourse prior to enrollment.

  8. Pregnancy among secondary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Self-reported measure of interval pregnancy (standardized OAH measure) in secondary participant follow-up surveys.

  9. Continuation of LARC method among primary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Self-reported measure of current contraceptive method use in primary participant follow-up surveys. Also assessed using claims data.

  10. Initiation of social communication about LARC method among primary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Primary participants' report of social communication about their LARC method, as well as the number of social contacts they talked to about their LARC method. Self-reported in measures assessing discussion about contraceptive methods with people they know generally and social contacts they listed at baseline specifically in primary participant surveys.

  11. Knowledge of LARC method among primary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Primary participants' accurate knowledge of their chosen LARC method. In follow-up surveys, they will be asked to report on a 4-point Likert scale their self-perceived knowledge of the method. They will also be asked to answer a set of true/false/don't know knowledge items on the method's features derived from the Guttmacher Institute's Survey of Young Adults ("Fogzone" survey) and National Survey of Reproductive and Contraceptive Knowledge, as well as an item on the relative effectiveness of the method in relation to birth control pills.

  12. Positive attitudes towards LARC method among primary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Self-reported global attitudinal scales in primary participant baseline and follow-up surveys, scored from 0-10.

  13. Pregnancy among primary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Self-reported measure of interval pregnancy (standardized OAH measure) in primary participant follow-up surveys.

  14. Risk of unintended pregnancy [ Time Frame: 3 months and 9 months post-enrollment ]
    Participants' risky sexual activity, defined as reporting sex without a contraceptive method in the past 3 months. Self-reported in primary and secondary participants' baseline and follow-up surveys. Will include sub-analysis of both primary and secondary participants.

  15. Alcohol use [ Time Frame: 3 months and 9 months post-enrollment ]
    Participants' days of alcohol use as reported in surveys, measured via self-report in measure derived from the Youth Risk Behavior Survey.

  16. Knowledge of binge-drinking behaviors [ Time Frame: 3 months and 9 months post-enrollment ]
    Participants' knowledge of what constitutes binge drinking, including sex differences in binge drinking. Knowledge measures on follow-up surveys will are derived from the youth Risk Behavior survey.

  17. Diagnosis of an STI among primary participants [ Time Frame: 3 months and 9 months post-enrollment ]
    Diagnosis of a sexually transmitted infection (chlamydia, gonorrhea, trichomoniasis [or trich], or other). Measured via self-report in primary participant follow-up surveys (binary yes/no measure of diagnosis, and measure regarding which STI they were diagnosed with). Also assessed via claims data.

  18. Acceptability of SpeakOut [ Time Frame: 9 months ]
    Measured using items developed by the researchers to understand participants' experience with and opinion of different intervention components of SpeakOut.. Will be examined among both primary and secondary participants.

  19. Acceptability of PartyWise [control intervention] [ Time Frame: 9 months ]
    Measured using items developed by the researchers to understand participants' experience with and opinion of different intervention components of Party Wise. Will be examined among both primary and secondary participants.


Other Outcome Measures:
  1. Contraceptive attitudes [ Time Frame: 3 months and 9 months post-enrollment ]
    Participants' attitudes towards various contraceptive methods, reported in global attitudinal scales in surveys, scored from 0-10.



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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791971


Contacts
Contact: Christine Dehlendorf, MD MAS 415-206-8712 christine.dehlendorf@ucsf.edu
Contact: Edith Fox 415-206-2544 edith.fox@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
Davis, California, United States, 94110
Contact: Edith E Fox, MPH    415-206-2544    edith.fox@ucsf.edu   
Contact: Reiley D Reed, MPH    4152068699    reiley.reed@ucsf.edu   
Principal Investigator: Christine E Dehlendorf, MD MAS         
University of Southern California Keck School of Medicine Recruiting
Los Angeles, California, United States, 90033
Contact: Thomas Valente, PhD         
Contact: Maribel Morales         
Principal Investigator: Thomas Valente, PhD         
Sponsors and Collaborators
University of California, San Francisco
University of California, Davis
University of Southern California
Investigators
Principal Investigator: Christine Dehlendorf, MD MAS University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02791971     History of Changes
Other Study ID Numbers: TP2AH000045-01-01
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of California, San Francisco:
Contraception
Birth control
Social communication
Adolescent
Social network
Health education
Reproductive health

Additional relevant MeSH terms:
Ethanol
Contraceptive Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Reproductive Control Agents