CClinicalTrials.gg
Status unknownNCT04809155G2GUpdated Mar 22, 2021

Girl2Girl: A Web-based Trial

An interventional study of Girl2Girl in Pregnancy Prevention, sponsored by Center for Innovative Public Health Research. Status unknown at 1 site in United States. Open to female participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-22.

Sponsored by Center for Innovative Public Health Research · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
574
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pregnancy Prevention

Keywords

  • Teenage Pregnancy Prevention
  • LGB Girls
  • Text messaging
03

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
574 participants (estimated)

Study arms

  • Experimental
    Girl2Girl

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

    Behavioral: Girl2Girl

  • No intervention
    Control - Healthy lifestyle

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

Interventions

  • BehavioralGirl2Girl

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3-months post-intervention

  2. 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

    Time frame: 3-months post-intervention

Secondary outcomes

  1. 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

    Time frame: 3-months post intervention

  2. Pregnancy

    The percent of teens who have been pregnant since the beginning of the observation period in the intervention versus control group

    Time frame: 3-months post intervention

  3. Intentions to use condoms

    The percent of teens who intend to use condoms if they have penile-vaginal sex in the future

    Time frame: 3-months post intervention

  4. 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

    Time frame: 3-months post intervention

06

Study locations

1 site
  • Center for Innovative Public Health Research
    San Clemente, California 92672, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04809155
Lead sponsor
Center for Innovative Public Health Research
Responsible party
Sponsor
First posted
Mar 22, 2021
Start date
Jul 7, 2020
Primary completion
Jun 7, 2021 (estimated)
Completion
Jun 7, 2021 (estimated)
Last update
Mar 22, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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