Girl2Girl: A Web-based Trial

NCT04809155 | Unknown

• 1 other identifier: R01HD095648
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Prevention

Keywords

Teenage Pregnancy Prevention; LGB Girls; Text messaging

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Testing for HIV and other sexually transmitted infections (STIs)

  3-months post intervention

• Pregnancy

  3-months post intervention

• Intentions to use condoms

  3-months post intervention

• Intentions to Use Birth Control Other Than Condoms

  3-months post intervention

Study Arms (2)

Girl2Girl

EXPERIMENTAL

Girls receive text messages that address the information, motivation, and behavioral skills components need to prevent unwanted pregnancy.

Behavioral: Girl2Girl

Control - Healthy lifestyle

NO INTERVENTION

Girls receive text messages about a 'healthy lifestyle', including healthy social media use and self-esteem.

Interventions

Girl2Girl BEHAVIORAL

The program has a 'core' 7 weeks of daily messages and then a week 'booster' that is delivered 3 months later.

Girl2Girl

Eligibility Criteria

• Age: 14 Years - 18 Years
• Gender Eligibility Details: Youth self-identified as cisgender female in the screener.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Innovative Public Health Research: lead

Study Sites (1)

Center for Innovative Public Health Research

San Clemente, California, 92672, United States

Location

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: March 18, 2021
• First Posted: March 22, 2021
• Study Start: July 7, 2020
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)