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Girl2Girl: Harnessing Text Messaging to Reduce Teenage Pregnancy Among LGB Girls (Girl2Girl)

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ClinicalTrials.gov Identifier: NCT03029962
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : September 13, 2017
Sponsor:
Collaborators:
The Office of Adolescent Health, HHS
University of British Columbia
City University of New York, School of Public Health
Information provided by (Responsible Party):
Center for Innovative Public Health Research

Brief Summary:
The purpose of this study is to finalize and rigorously evaluate Girl2Girl, a novel text messaging-based teenage pregnancy prevention (TPP) program designed specifically for LGB women ages 14-18 years, nation-wide. The guiding theoretical model is the Information-Motivation-Behavioral Skills (IMB) Model, which has been used extensively and is associated with increases in TPP behavior.

Condition or disease Intervention/treatment Phase
Teenage Pregnancy Behavioral: Girl2Girl Not Applicable

Detailed Description:

An estimated one in four teen women will become pregnant by the time she is 20 years of age. That said, significant disparity in rates exist for lesbian, gay, bisexual and other sexual minority women (LGB) versus non-LGB teen women: Research suggests that lesbian and bisexual teen women are between two and four times more likely to report having been pregnant than teen women who identified as exclusively heterosexual. Despite this compelling evidence that lesbian and bisexual adolescent women are at risk for teen pregnancy, programs tailored to the unique needs of adolescent LGB women are nonexistent. Evidence-based teen pregnancy prevention (TPP) programs targeting LGB teen women are urgently needed.

The Girl2Girl intervention text messaging-based TPP program designed specifically for LGB women ages 14-18 years, nation-wide. The investigators will test the intervention in a randomized control trial (RCT) of 840 LGB teenage women randomly assigned to either the intervention (n = 420) or control (n = 420) arms. Our primary efficacy outcome measures, measured at 12-months post-intervention, will be: (a) abstinence from penile-vaginal sex; (b) condom use during penile-vaginal sex, (c) use of other birth control methods during penile-vaginal sex, and (d) pregnancy.

If effective, Girl2Girl has promise to be quickly and cost-effectively implemented to scale to help to curb the spread of teenage pregnancy among women who identify as LGB.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Girl2Girl: Harnessing Text Messaging to Reduce Teenage Pregnancy Among LGB Girls
Actual Study Start Date : October 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: Experimental: Girl2Girl
Girl2Girl is a 7-week teenage pregnancy prevention program delivered daily via text messaging to 14-18 year old females who self-identify as lesbian, bisexual, gay, or other sexual minority. In addition to program content, participants are paired with another participant (i.e., a Text Buddy) with whom they can text throughout the program to provide support; and an on-demand advice line, Girl2Genie, which shares information about sex, relationships, and the lesbian, gay, bisexual, transgender (LGBT) community.
Behavioral: Girl2Girl
Girl2Girl is a text messaging-based teenage pregnancy prevention program specifically for 14-18 year old LGB adolescent females. Content is guided by the Information-Motivation-Behavioral Skills (IMB) model and focuses on: HIV information, motivations to engage in HIV preventive behavior, communication skills, behavioral skills (e.g., using a condom; HIV testing); and healthy/unhealthy relationships. Behavioral skills content is reinforced using brief online videos. The intervention is 7 weeks long. A "booster" is delivered 12-weeks post-intervention end and reviews the topics covered in the intervention. Girl2Girl content is tailored based upon sexual experience (i.e., whether one is abstinent or sexually active) and whether one is same-sex or dually attracted.

No Intervention: No Intervention: Health Lifestyle
The attention-matched control arm message content consists of information publicly available online related to living a healthy lifestyle. Content discussed includes: nutrition and sleep hygiene, self-esteem and body image, bullying, and drugs and alcohol. The control arm is 7-weeks in length (Week 7 is a review booster) and is delivered via text messaging. Messages are didactic and not tailored to user sexual experience. Additionally, the Text Buddy and G2Genie intervention program components are not available.



Primary Outcome Measures :
  1. Number of participants who used other birth control methods [ Time Frame: Post-intervention (about 20 weeks after randomization) ]
    The relative difference of birth control methods (e.g., the pill, the patch) during penile-vaginal sex acts in the intervention versus control group at 12-months post-intervention

  2. Number of protected penile-vaginal sex acts [ Time Frame: Post-intervention (about 20 weeks after randomization) ]
    The relative difference of protected penile-vaginal sex acts in the intervention versus control group at 12-months post-intervention

  3. Number of participants who abstained from penile-vaginal and penile-anal sex [ Time Frame: Post-intervention (about 20 weeks after randomization) ]
    The relative difference of abstinence (neither engaging in anal nor vaginal sex) in the intervention versus control group at 12-months post-intervention


Secondary Outcome Measures :
  1. Number of participants who used other birth control methods [ Time Frame: Immediate post-intervention ]
    The relative difference of birth control methods (e.g., the pill, the patch) during penile-vaginal sex acts in the intervention versus control group at immediate post-intervention end and 6-months post-intervention

  2. Number of penile-vaginal sex acts during which a condom was used [ Time Frame: Immediate post-intervention ]
    The relative difference of protected penile-vaginal sex acts in the intervention versus control group at immediate post-intervention end and 6-months post-intervention

  3. Number of participants who abstained from penile-vaginal and penile-anal sex [ Time Frame: Immediate post-intervention ]
    The relative difference of abstinence (neither engaging in anal nor vaginal sex) in the intervention versus control group at immediate post-intervention end and 6-months post-intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   cisgender / female gender identity
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • endorse a non-heterosexual sexual identity (i.e., lesbian/gay, bisexual, queer, questioning, unsure);
  • be cisgender (i.e., be assigned a female sex at birth and endorse a female gender identity);
  • be aged 14-18;
  • in high school or equivalent (including those who did not finish school/dropped out);
  • be English speaking;
  • be exclusive owners of a cell phone with an unlimited text messaging plan;
  • have used text messaging for at least six months;
  • intend to have the same cell number for the next six months; and,
  • be able to provide informed assent, including an acceptable score for "capacity to consent" and the self-safety assessment.

Exclusion Criteria:

  • not having the capacity to assent
  • not passing the self-safety assessment
  • previously participating in another study activity (with the exception of the baseline and intervention end survey pilot tests)
  • knowing someone who is already enrolled in the program
  • non-cisgender

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): NCT03029962


Contacts
Contact: Michele L Ybarra, PhD 877-302-6858 ext 801 michele@innovativepublichealth.org
Contact: Tonya L Prescott, BA 877-302-6858 ext 806 tonya@innovativepublichealth.org

Locations
United States, California
Center for Innovative Public Health Research Recruiting
San Clemente, California, United States, 92672-6745
Principal Investigator: Michele L Ybarra, PhD         
Sponsors and Collaborators
Center for Innovative Public Health Research
The Office of Adolescent Health, HHS
University of British Columbia
City University of New York, School of Public Health
Investigators
Principal Investigator: Michele L Ybarra, PhD Center for Innovative Public Health Research
Study Director: Tonya Prescott Center for Innovative Public Health Research

Responsible Party: Center for Innovative Public Health Research
ClinicalTrials.gov Identifier: NCT03029962     History of Changes
Other Study ID Numbers: 1 TP2AH000035-01-00
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Center for Innovative Public Health Research:
Teenage Pregnancy Prevention
LGB Girls
Text-Messaging
Information-Motivation-Behavioral Skills(IMB)Model