NCT03029962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
948

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2020

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

3.3 years

First QC Date

January 17, 2017

Last Update Submit

March 12, 2021

Conditions

Keywords

Teenage Pregnancy PreventionLGB GirlsText-MessagingInformation-Motivation-Behavioral Skills(IMB)Model

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (4)

  • Number of penile-vaginal sex acts during which a condom was used

    immediate post-intervention end, 3-, 6-, 9-months post-intervention

  • Number of participants who used other birth control methods

    immediate post-intervention end, 3-, 6-, 9-months post-intervention

  • Number of participants who abstained from penile-vaginal sex

    immediate post-intervention end, 3-, 6-, 9-months post-intervention

  • Pregnancy

    Across the 12 months post-intervention

Other Outcomes (2)

  • Intentions to use condoms

    immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention

  • Intentions to use birth control other than condoms

    immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention

Study Arms (2)

Experimental: Girl2Girl

EXPERIMENTAL

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

No Intervention: Health Lifestyle

NO INTERVENTION

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.

Interventions

Girl2GirlBEHAVIORAL

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.

Experimental: Girl2Girl

Eligibility Criteria

Age14 Years - 18 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailscisgender / female gender identity
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Innovative Public Health Research

San Clemente, California, 92672-6745, United States

Location

Related Publications (3)

  • 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.

    PMID: 31843216BACKGROUND
  • 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.

    PMID: 29290373BACKGROUND
  • Ybarra ML, Saewyc E, Rosario M, Dunsiger S. Subgroup Analyses of Girl2Girl, a Text Messaging-Based Teen Pregnancy Prevention Program for Sexual Minority Girls: Results from a National RCT. Prev Sci. 2023 Dec;24(Suppl 2):292-299. doi: 10.1007/s11121-023-01493-6. Epub 2023 Feb 8.

Study Officials

  • Michele L Ybarra, PhD

    Center for Innovative Public Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 24, 2017

Study Start

October 1, 2016

Primary Completion

January 12, 2020

Study Completion

January 12, 2020

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations