An interventional study of Girl2Girl in Teenage Pregnancy, sponsored by Center for Innovative Public Health Research. Completed at 1 site in United States. Open to female participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-16.
Sponsored by Center for Innovative Public Health Research · Not applicable, Interventional, and Prevention
The purpose of this study is to finalize and rigorously evaluate Girl2Girl, a novel text messaging-based teenage pregnancy prevention (TPP) program designed specifically for LGB women ages 14-18 years, nation-wide. The guiding theoretical model is the Information-Motivation-Behavioral Skills (IMB) Model, which has been used extensively and is associated with increases in TPP behavior.
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. The investigators will test the intervention in a randomized control trial (RCT) of 840 LGB teenage women randomly assigned to either the intervention (n = 420) or control (n = 420) arms. Our primary efficacy outcome measures, measured at 12-months post-intervention, will be: (a) abstinence from penile-vaginal sex; (b) condom use during penile-vaginal sex, (c) use of other birth control methods during penile-vaginal sex, and (d) pregnancy.
If effective, Girl2Girl has promise to be quickly and cost-effectively implemented to scale to help to curb the spread of teenage pregnancy among women who identify as LGB.
Center for Innovative Public Health Research is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Girl2Girl is a 7-week teenage pregnancy prevention program delivered daily via text messaging to 14-18 year old females who self-identify as lesbian, bisexual, gay, or other sexual minority. In addition to program content, participants are paired with another participant (i.e., a Text Buddy) with whom they can text throughout the program to provide support; and an on-demand advice line, Girl2Genie, which shares information about sex, relationships, and the lesbian, gay, bisexual, transgender (LGBT) community.
Behavioral: Girl2Girl
The attention-matched control arm message content consists of information publicly available online related to living a healthy lifestyle. Content discussed includes: nutrition and sleep hygiene, self-esteem and body image, bullying, and drugs and alcohol. The control arm is 7-weeks in length (Week 7 is a review booster) and is delivered via text messaging. Messages are didactic and not tailored to user sexual experience. Additionally, the Text Buddy and G2Genie intervention program components are not available.
Girl2Girl is a text messaging-based teenage pregnancy prevention program specifically for 14-18 year old LGB adolescent females. Content is guided by the Information-Motivation-Behavioral Skills (IMB) model and focuses on: HIV information, motivations to engage in HIV preventive behavior, communication skills, behavioral skills (e.g., using a condom; HIV testing); and healthy/unhealthy relationships. Behavioral skills content is reinforced using brief online videos. The intervention is 7 weeks long. A "booster" is delivered 12-weeks post-intervention end and reviews the topics covered in the intervention. Girl2Girl content is tailored based upon sexual experience (i.e., whether one is abstinent or sexually active) and whether one is same-sex or dually attracted.
Number of protected penile-vaginal sex acts
The relative difference of protected penile-vaginal sex acts in the intervention versus control group at 12-months post-intervention
Time frame: Post-intervention (about 20 weeks after randomization)
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 12-months post-intervention
Time frame: Post-intervention (about 20 weeks after randomization)
Number of participants who abstained from penile-vaginal sex
The relative difference of abstinence (not engaging in vaginal sex) in the intervention versus control group at 12-months post-intervention
Time frame: Post-intervention (about 20 weeks after randomization)
Number of penile-vaginal sex acts during which a condom was used
The relative difference of protected penile-vaginal sex acts in the intervention versus control group at immediate post-intervention end, 3-, 6-, and 9-months post-intervention
Time frame: immediate post-intervention end, 3-, 6-, 9-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) during penile-vaginal sex acts in the intervention versus control group at immediate post-intervention end, 3-, 6-, and 9-months post-intervention
Time frame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
Number of participants who abstained from penile-vaginal sex
The relative difference of abstinence (not engaging vaginal sex) in the intervention versus control group at immediate post-intervention end, 3-, 6-, and 9-months post-intervention
Time frame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
Pregnancy
The percent of teens who have been pregnant since the beginning of the RCT in the intervention versus control group
Time frame: Across the 12 months post-intervention
Intentions to use condoms
The percent of teens who intend to use condoms if they have penile-vaginal sex in the next year in the intervention versus control group
Time frame: immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention
Intentions to use birth control other than condoms
The percent of teens who intend to use birth control methods other than condoms in the next year for the intervention versus control group
Time frame: immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Center for Innovative Public Health Research