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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

948

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Clemente, California, United States, 92672-6745
        • Center for Innovative Public Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post-intervention (about 20 weeks after randomization)
Number of participants who used other birth control methods
Time Frame: Post-intervention (about 20 weeks after randomization)
The relative difference of teens who used birth control methods other than condoms (e.g., the pill, the patch) in the intervention versus control group at 12-months post-intervention
Post-intervention (about 20 weeks after randomization)
Number of participants who abstained from penile-vaginal sex
Time Frame: Post-intervention (about 20 weeks after randomization)
The relative difference of abstinence (not engaging in vaginal sex) in the intervention versus control group at 12-months post-intervention
Post-intervention (about 20 weeks after randomization)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of penile-vaginal sex acts during which a condom was used
Time Frame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
The relative difference of protected penile-vaginal sex acts in the intervention versus control group at immediate post-intervention end, 3-, 6-, and 9-months post-intervention
immediate post-intervention end, 3-, 6-, 9-months post-intervention
Number of participants who used other birth control methods
Time Frame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
The relative difference of teens who used birth control methods other than condoms (e.g., the pill, the patch) during penile-vaginal sex acts in the intervention versus control group at immediate post-intervention end, 3-, 6-, and 9-months post-intervention
immediate post-intervention end, 3-, 6-, 9-months post-intervention
Number of participants who abstained from penile-vaginal sex
Time Frame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
The relative difference of abstinence (not engaging vaginal sex) in the intervention versus control group at immediate post-intervention end, 3-, 6-, and 9-months post-intervention
immediate post-intervention end, 3-, 6-, 9-months post-intervention
Pregnancy
Time Frame: Across the 12 months post-intervention
The percent of teens who have been pregnant since the beginning of the RCT in the intervention versus control group
Across the 12 months post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intentions to use condoms
Time Frame: immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention
The percent of teens who intend to use condoms if they have penile-vaginal sex in the next year in the intervention versus control group
immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention
Intentions to use birth control other than condoms
Time Frame: immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention
The percent of teens who intend to use birth control methods other than condoms in the next year for the intervention versus control group
immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

January 12, 2020

Study Completion (ACTUAL)

January 12, 2020

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (ESTIMATE)

January 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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