Girl2Girl: A Web-based Trial

NCT ID: NCT04809155

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

574 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-07

Study Completion Date

2021-06-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregnancy Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Girl2Girl

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

Group Type EXPERIMENTAL

Girl2Girl

Intervention Type BEHAVIORAL

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

Control - Healthy lifestyle

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Girl2Girl

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Center for Innovative Public Health Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Center for Innovative Public Health Research

San Clemente, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01HD095648

Identifier Type: NIH

Identifier Source: org_study_id

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