Clinical trial NCT03029962: Girl2Girl: Harnessing Text Messaging to Reduce Teenage Pregnancy Among LGB Girls
Official title: Girl2Girl: Harnessing Text Messaging to Reduce Teenage Pregnancy Among LGB Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teenage Pregnancy
Keywords: Teenage Pregnancy Prevention
LGB Girls
Text-Messaging
Information-Motivation-Behavioral Skills(IMB)Model
Lead sponsor: Center for Innovative Public Health Research
Sponsor class: OTHER
Collaborators: name: The Office of Adolescent Health, HHS
name: University of British Columbia
name: City University of New York
First posted: 2017-01-24
Enrollment: 948
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of protected penile-vaginal sex acts
timeFrame: Post-intervention (about 20 weeks after randomization)
measure: Number of participants who used other birth control methods
timeFrame: Post-intervention (about 20 weeks after randomization)
measure: Number of participants who abstained from penile-vaginal sex
timeFrame: Post-intervention (about 20 weeks after randomization)
Secondary outcomes:
measure: Number of penile-vaginal sex acts during which a condom was used
timeFrame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
measure: Number of participants who used other birth control methods
timeFrame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
measure: Number of participants who abstained from penile-vaginal sex
timeFrame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
measure: Pregnancy
timeFrame: Across the 12 months post-intervention
Other outcomes:
measure: Intentions to use condoms
timeFrame: immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention
measure: Intentions to use birth control other than condoms
timeFrame: immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention
Locations:
city: San Clemente
country: United States
facility: Center for Innovative Public Health Research
state: California
Study officials:
affiliation: Center for Innovative Public Health Research
name: Michele L Ybarra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.