Girl2Girl: A Web-based Trial (G2G)

A Reproductive Health Program for A Select Population

This is a pilot effectiveness study of Girl2Girl, a text messaging-based pregnancy prevention program for cisgender sexual minority adolescents.

Study Overview

• Status: Unknown
• Conditions: Pregnancy Prevention
• Intervention / Treatment: Behavioral: Girl2Girl

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. This is an extension of a previous randomized controlled trial. Here, the cohort was recruited using an effectiveness strategy: Girls were allowed to register and enroll themselves without needing to talk to research staff. All eligible and interested youth were allowed to enroll; no diversity targets were applied.

• Study Type: Interventional
• Enrollment (Anticipated): 574
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• 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) on the screener;
• Be cisgender (i.e., be assigned a female sex at birth and endorse a female gender identity) on the screener;
• Be aged 14-18;
• Be English speaking;
• Be able to provide informed assent, including the self-directed self-safety assessment.

Exclusion Criteria:

• Not passing the self-directed self-safety assessment
• Knowing someone who is already enrolled in the program (added part-way through the recruitment period)
• Non-cisgender identity in the screener

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Girl2Girl; Girls receive text messages that address the information, motivation, and behavioral skills components need to prevent unwanted pregnancy.	Behavioral: Girl2Girl; The program has a 'core' 7 weeks of daily messages and then a week 'booster' that is delivered 3 months later.
No Intervention: Control - Healthy lifestyle; Girls receive text messages about a 'healthy lifestyle', including healthy social media use and self-esteem.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Condom protected penile-vaginal Sex Acts	The relative difference of protected penile-vaginal sex acts in the intervention versus control group at 3-months post-intervention	3-months post-intervention
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 3-months post-intervention	3-months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testing for HIV and other sexually transmitted infections (STIs)	The relative odds of reporting an HIV or other STI test during the observation period for those in the intervention versus control	3-months post intervention
Pregnancy	The percent of teens who have been pregnant since the beginning of the observation period in the intervention versus control group	3-months post intervention
Intentions to use condoms	The percent of teens who intend to use condoms if they have penile-vaginal sex in the future	3-months post intervention
Intentions to Use Birth Control Other Than Condoms	The percent of teens who intend to use birth control other than condoms if they have penile-vaginal sex in the future	3-months post intervention

Collaborators and Investigators

• Sponsor: Center for Innovative Public Health Research

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Anticipated): June 7, 2021
• Study Completion (Anticipated): June 7, 2021

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Text messaging; Teenage Pregnancy Prevention; LGB Girls
• Other Study ID Numbers: R01HD095648 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No