Clinical trial NCT04809155: Girl2Girl: A Web-based Trial
Official title: A Reproductive Health Program for A Select Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Prevention
Keywords: Teenage Pregnancy Prevention
LGB Girls
Text messaging
Lead sponsor: Center for Innovative Public Health Research
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 574
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Condom protected penile-vaginal Sex Acts
timeFrame: 3-months post-intervention
measure: Number of Participants Who Used Other Birth Control Methods
timeFrame: 3-months post-intervention
Secondary outcomes:
measure: Testing for HIV and other sexually transmitted infections (STIs)
timeFrame: 3-months post intervention
measure: Pregnancy
timeFrame: 3-months post intervention
measure: Intentions to use condoms
timeFrame: 3-months post intervention
measure: Intentions to Use Birth Control Other Than Condoms
timeFrame: 3-months post intervention
Other outcomes:
Locations:
city: San Clemente
country: United States
facility: Center for Innovative Public Health Research
state: California
Study officials:
References: