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Completed

NCT Number: NCT03029962

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

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.

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Key information

Conditions

Age range

14 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Innovative Public Health Research

San Clemente, California, 92672-6745, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Girl2Girl

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Center for Innovative Public Health Research

Other

Collaborators

  • City University of New York
  • The Office of Adolescent Health, HHS
  • University of British Columbia

Registry information

Acronym: Girl2Girl

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 24, 2017
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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