Teenage PregnancyGirl2GirlNCT03029962
Girl2Girl: Harnessing Text Messaging to Reduce Teenage Pregnancy Among LGB Girls
A study testing Girl2Girl in people with Teenage Pregnancy, run by Center for Innovative Public Health Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Teenage Pregnancy
- What is being tested?
- Girl2Girl
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 948 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 12 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- endorse a non-heterosexual sexual identity (i.e., lesbian/gay, bisexual, queer, questioning, unsure);
- be cisgender (i.e., be assigned a female sex at birth and endorse a female gender identity);
- be aged 14-18;
- in high school or equivalent (including those who did not finish school/dropped out);
- be English speaking;
- be exclusive owners of a cell phone with an unlimited text messaging plan;
Show all 9Show fewer
- have used text messaging for at least six months;
- intend to have the same cell number for the next six months; and,
- be able to provide informed assent, including an acceptable score for "capacity to consent" and the self-safety assessment.
Who cannot join
- not having the capacity to assent
- not passing the self-safety assessment
- previously participating in another study activity (with the exception of the baseline and intervention end survey pilot tests)
- knowing someone who is already enrolled in the program
- non-cisgender
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Innovative Public Health Research
San Clemente, California, 92672-6745
About this study
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.
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. 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.
- Conditions
- Teenage Pregnancy
- Being tested
- Girl2Girl
- Keywords
- Teenage Pregnancy Prevention, LGB Girls, Text-Messaging, Information-Motivation-Behavioral Skills(IMB)Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Girl2GirlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Girl2Girl | Experimental | 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. Receives: Behavioral: Girl2Girl |
| No Intervention: Health Lifestyle | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Post-intervention (about 20 weeks after randomization)
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Across the 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startOct 2016
- Primary completion12 Jan 2020
- Study completion12 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Teenage PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 948 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Innovative Public Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS, University of British Columbia, City University of New York
- Responsible party
- Sponsor
- Investigators
- Michele L Ybarra, PhD, Principal investigator, Center for Innovative Public Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029962
- Sponsor's protocol ID
- 1 TP2AH000035-01-00
- Acronym
- Girl2Girl
- Status last verified
- Mar 2021
- First submitted
- 17 Jan 2017
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ybarra ML, Parrilla JS, Wolowic J, Rosario M, Goodenow C, Saewyc E. A National, Qualitative Study of Sexual Decision Making by Teenage Girls who are Lesbian, Gay, Bisexual, or who have Another Nonheterosexual Identity. J Pediatr. 2020 Feb;217:177-183. doi: 10.1016/j.jpeds.2019.10.038. Epub 2019 Dec 13.
PubMed 31843216Doull M, Wolowic J, Saewyc E, Rosario M, Prescott T, Ybarra ML. Why Girls Choose Not to Use Barriers to Prevent Sexually Transmitted Infection During Female-to-Female Sex. J Adolesc Health. 2018 Apr;62(4):411-416. doi: 10.1016/j.jadohealth.2017.10.005. Epub 2017 Dec 28.
PubMed 29290373Ybarra ML, Saewyc E, Rosario M, Dunsiger S. Subgroup Analyses of Girl2Girl, a Text Messaging-Based Teen Pregnancy Prevention Program for Sexual Minority Girls: Results from a National RCT. Prev Sci. 2023 Dec;24(Suppl 2):292-299. doi: 10.1007/s11121-023-01493-6. Epub 2023 Feb 8.
PubMed 36753043
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Girl2Girl: Harnessing Text Messaging to Reduce Teenage Pregnancy Among LGB Girls
- ClinicalTrials.gov ID
- NCT03029962
- Acronym / sponsor ID
- Girl2Girl / 1 TP2AH000035-01-00
- Conditions
- Teenage Pregnancy
- Keywords
- Teenage Pregnancy Prevention, LGB Girls, Text-Messaging, Information-Motivation-Behavioral Skills(IMB)Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 948 participants (actual)
- Lead sponsor
- Center for Innovative Public Health ResearchUniversity, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS, University of British Columbia, City University of New York
- Study start
- Oct 2016 (actual)
- Primary completion
- 12 Jan 2020 (actual)
- Study completion
- 12 Jan 2020 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Girl2Girl | Experimental | Behavioral: Girl2GirlGirl2Girl 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. |
| No Intervention: Health Lifestyle | No intervention | –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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- endorse a non-heterosexual sexual identity (i.e., lesbian/gay, bisexual, queer, questioning, unsure);
- be cisgender (i.e., be assigned a female sex at birth and endorse a female gender identity);
- be aged 14-18;
- in high school or equivalent (including those who did not finish school/dropped out);
- be English speaking;
Key exclusion criteria (5 listed)
- not having the capacity to assent
- not passing the self-safety assessment
- previously participating in another study activity (with the exception of the baseline and intervention end survey pilot tests)
- knowing someone who is already enrolled in the program
- non-cisgender
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Girl2GirlGirl2Girl 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. | Behavioural | Experimental: Girl2Girl |
Primary outcome
Number of protected penile-vaginal sex acts
Time frame: Post-intervention (about 20 weeks after randomization)
The relative difference of protected penile-vaginal sex acts in the intervention versus control group at 12-months post-intervention
Number of participants who used other birth control methods
Time frame: Post-intervention (about 20 weeks after randomization)
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
Number of participants who abstained from penile-vaginal sex
Time frame: Post-intervention (about 20 weeks after randomization)
The relative difference of abstinence (not engaging in vaginal sex) in the intervention versus control group at 12-months post-intervention
4 secondary outcomes
Number of penile-vaginal sex acts during which a condom was used
Time frame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
Number of participants who used other birth control methods
Time frame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
Number of participants who abstained from penile-vaginal sex
Time frame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
Pregnancy
Time frame: Across the 12 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Background: PubMed 31843216Ybarra ML, Parrilla JS, Wolowic J, Rosario M, Goodenow C, Saewyc E. A National, Qualitative Study of Sexual Decision Making by Teenage Girls who are Lesbian, Gay, Bisexual, or who have Another Nonheterosexual Identity. J Pediatr. 2020 Feb;217:177-183. doi: 10.1016/j.jpeds.2019.10.038. Epub 2019 Dec 13.
- Background: PubMed 29290373Doull M, Wolowic J, Saewyc E, Rosario M, Prescott T, Ybarra ML. Why Girls Choose Not to Use Barriers to Prevent Sexually Transmitted Infection During Female-to-Female Sex. J Adolesc Health. 2018 Apr;62(4):411-416. doi: 10.1016/j.jadohealth.2017.10.005. Epub 2017 Dec 28.
- Derived from this study: PubMed 36753043Ybarra ML, Saewyc E, Rosario M, Dunsiger S. Subgroup Analyses of Girl2Girl, a Text Messaging-Based Teen Pregnancy Prevention Program for Sexual Minority Girls: Results from a National RCT. Prev Sci. 2023 Dec;24(Suppl 2):292-299. doi: 10.1007/s11121-023-01493-6. Epub 2023 Feb 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele L Ybarra, PhD principal investigator
Center for Innovative Public Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Girl2Girl in people with Teenage Pregnancy, run by Center for Innovative Public Health Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of protected penile-vaginal sex acts (time frame: Post-intervention (about 20 weeks after randomization)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03029962, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.