Pregnancy PreventionG2GNCT04809155
Girl2Girl: A Web-based Trial
A study testing Girl2Girl in people with Pregnancy Prevention, run by Center for Innovative Public Health Research at 1 site in United States.
Trial summary
This is a pilot effectiveness study of Girl2Girl, a text messaging-based pregnancy prevention program for cisgender sexual minority adolescents. 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
- Pregnancy Prevention
- 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
- 574 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 7 Jun 2021
- 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) 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Innovative Public Health Research
San Clemente, California, 92672
About this study
Official title: A Reproductive Health Program for A Select Population
This is a pilot effectiveness study of Girl2Girl, a text messaging-based pregnancy prevention program for cisgender sexual minority adolescents.
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. 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.
- Conditions
- Pregnancy Prevention
- Being tested
- Girl2Girl
- Keywords
- Teenage Pregnancy Prevention, LGB Girls, Text messaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Girl2GirlBehavioural
The program has a 'core' 7 weeks of daily messages and then a week 'booster' that is delivered 3 months later.
| Study group | Role | What they receive |
|---|---|---|
| Girl2Girl | Experimental | Girls receive text messages that address the information, motivation, and behavioral skills components need to prevent unwanted pregnancy. Receives: Behavioral: Girl2Girl |
| Control - Healthy lifestyle | No intervention | Girls receive text messages about a 'healthy lifestyle', including healthy social media use and self-esteem. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3-months post-intervention
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3-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 posted22 Mar 2021
- Study start7 Jul 2020
- Primary completion7 Jun 2021 (estimated)
- Study completion7 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy PreventionStudies 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
- 574 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Innovative Public Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809155
- Sponsor's protocol ID
- R01HD095648
- Acronym
- G2G
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reproductive Health Program for A Select Population
- ClinicalTrials.gov ID
- NCT04809155
- Acronym / sponsor ID
- G2G / R01HD095648
- Conditions
- Pregnancy Prevention
- Keywords
- Teenage Pregnancy Prevention, LGB Girls, Text messaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 574 participants (estimated)
- Lead sponsor
- Center for Innovative Public Health ResearchUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 7 Jun 2021 (estimated)
- Study completion
- 7 Jun 2021 (estimated)
- First posted
- 22 Mar 2021 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Girl2Girl | Experimental | Behavioral: Girl2GirlGirls receive text messages that address the information, motivation, and behavioral skills components need to prevent unwanted pregnancy. |
| Control - Healthy lifestyle | No intervention | –Girls receive text messages about a 'healthy lifestyle', including healthy social media use and self-esteem. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Girl2GirlThe program has a 'core' 7 weeks of daily messages and then a week 'booster' that is delivered 3 months later. | Behavioural | Girl2Girl |
Primary outcome
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
4 secondary outcomes
Testing for HIV and other sexually transmitted infections (STIs)
Time frame: 3-months post intervention
Pregnancy
Time frame: 3-months post intervention
Intentions to use condoms
Time frame: 3-months post intervention
Intentions to Use Birth Control Other Than Condoms
Time frame: 3-months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Prevention
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
RecruitingPhase 3
Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
Kidney Stone, Nephrolithiasis
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Labour Dystocia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pregnancy Prevention, 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 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?
Results are not available in the source record.
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 Condom protected penile-vaginal Sex Acts (time frame: 3-months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2021.