Girl2Girl: A Web-based Trial

Pregnancy Prevention Clinical Trial

— G2G  

Official title:

A Reproductive Health Program for A Select Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04809155
• Other study ID #: R01HD095648
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: June 7, 2021

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

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 574
• Est. completion date: June 7, 2021
• Est. primary completion date: June 7, 2021
• 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) 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

Related Conditions & MeSH terms

• Pregnancy Prevention

Intervention

Behavioral:
• Girl2Girl
The program has a 'core' 7 weeks of daily messages and then a week 'booster' that is delivered 3 months later.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Center for Innovative Public Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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 3-months post-intervention	3-months post-intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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