Girl2Girl: A Web-based Trial

Study 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.

Official Title
-----------------
A Reproductive Health Program for A Select Population

Conditions
-----------------
Pregnancy Prevention

Intervention / Treatment
-----------------
* Behavioral: Girl2Girl


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Girl2Girl<br>Girls receive text messages that address the information, motivation, and behavioral skills components need to prevent unwanted pregnancy. | Behavioral: Girl2Girl<br>* The program has a 'core' 7 weeks of daily messages and then a week 'booster' that is delivered 3 months later.<br>|
| No Intervention: Control - Healthy lifestyle<br>Girls receive text messages about a 'healthy lifestyle', including healthy social media use and self-esteem. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LGB Girls, Teenage Pregnancy Prevention, Text messaging