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Clinical Trials/NCT04809155
NCT04809155
Unknown
Not Applicable

A Reproductive Health Program for A Select Population

Center for Innovative Public Health Research1 site in 1 country574 target enrollmentJuly 7, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Prevention
Sponsor
Center for Innovative Public Health Research
Enrollment
574
Locations
1
Primary Endpoint
Number of Condom protected penile-vaginal Sex Acts
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 7, 2020
End Date
June 7, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Center for Innovative Public Health Research
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of Condom protected penile-vaginal Sex Acts

Time Frame: 3-months post-intervention

The relative difference of protected penile-vaginal sex acts in the intervention versus control group at 3-months post-intervention

Number of Participants Who Used Other Birth Control Methods

Time Frame: 3-months post-intervention

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

Secondary Outcomes

  • Testing for HIV and other sexually transmitted infections (STIs)(3-months post intervention)
  • Intentions to use condoms(3-months post intervention)
  • Intentions to Use Birth Control Other Than Condoms(3-months post intervention)
  • Pregnancy(3-months post intervention)

Study Sites (1)

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