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

Teenage Pregnancy Clinical Trial

— Girl2Girl  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029962
• Other study ID #: 1 TP2AH000035-01-00
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: January 12, 2020

Study information

• Verified date: March 2021
• Source: Center for Innovative Public Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 948
• Est. completion date: January 12, 2020
• Est. primary completion date: January 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Teenage Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Innovative Public Health Research	San Clemente	California

Sponsors (4)

Lead Sponsor	Collaborator
Center for Innovative Public Health Research	City University of New York, The Office of Adolescent Health, HHS, University of British Columbia

Country where clinical trial is conducted

United States, 

References & Publications (2)

Doull M, Wolowic J, Saewyc E, Rosario M, Prescott T, Ybarra ML. Why Girls Choose Not to Use Barriers to Prevent Sexually Transmitted Infection During Female-to-Female Sex. J Adolesc Health. 2018 Apr;62(4):411-416. doi: 10.1016/j.jadohealth.2017.10.005. Epub 2017 Dec 28. — View Citation

Ybarra ML, Parrilla JS, Wolowic J, Rosario M, Goodenow C, Saewyc E. A National, Qualitative Study of Sexual Decision Making by Teenage Girls who are Lesbian, Gay, Bisexual, or who have Another Nonheterosexual Identity. J Pediatr. 2020 Feb;217:177-183. doi: 10.1016/j.jpeds.2019.10.038. Epub 2019 Dec 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intentions to use condoms	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
Other	Intentions to use birth control other than condoms	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
Primary	Number of protected penile-vaginal sex acts	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)
Primary	Number of participants who used other birth control methods	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)
Primary	Number of participants who abstained from penile-vaginal sex	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	Number of penile-vaginal sex acts during which a condom was used	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
Secondary	Number of participants who used other birth control methods	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
Secondary	Number of participants who abstained from penile-vaginal sex	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
Secondary	Pregnancy	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