Teen Sexual HealthNCT02419690
Sexual Health Texting Intervention to Support Adolescent Females
A study testing text message intervention in people with Teen Sexual Health, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
This study aims to use a text messaging intervention to prevent unintended teen pregnancy and transmission of sexually transmitted disease. The study will be informed by a formative qualitative phase (February 2014 - January 2015) which will include individual qualitative interviews and focus groups with teens to… Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Teen Sexual Health
- What is being tested?
- text message intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- biologically female;
- between 13 and 18 years of age;
- not currently pregnant or trying to become pregnant;
- have texting capability; and
- able to read/write/speak in English.
Who cannot join
- not meeting inclusion criteria outlined above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Patient Centered Intervention to Increase Dual Protection Against Unintended Pregnancy and Sexually Transmitted Disease Among Adolescents
This study aims to use a text messaging intervention to prevent unintended teen pregnancy and transmission of sexually transmitted disease. The study will be informed by a formative qualitative phase (February 2014 - January 2015) which will include individual qualitative interviews and focus groups with teens to elucidate and explore the barriers to effective contraceptive use and sexually transmitted disease (STD) prevention and to obtain feedback on the developed intervention. The second efficacy phase will randomize subjects to the texting intervention or to usual care.
Read the detailed description
Adolescents, particularly those from disadvantaged backgrounds, are disproportionally affected by both unintended pregnancies and STDs. While youth only represent a quarter of the sexually active population in the US, they account for almost half of all new STDs and the rate of unintended pregnancies among sexually active teens is almost double the rate of all sexually active women. Teen mothers experience higher rates of negative social outcomes including school dropout and children of teens are more likely to have low birth weight, lower academic achievement and more likely to perpetuate the cycle of teen pregnancy themselves. Both unintended pregnancies and STDs are much higher among racial/ethnic minority populations. Contraceptive methods considered most effective for pregnancy prevention do not protect against STDs and HIV transmission. Dual protection methods include being on an effective and consistent form of contraception and having an effective STD prevention method in place, preferably consistent condom use. Non-penetrative sexual practices can be substituted.
There are many barriers to providing sexual health education and services in the context of primary care visits. A recent study of pediatricians found that 61% of pediatricians reported discussing contraception, use of condoms and/or STDs with patients at preventive care visits. Most providers (76%), however, believed they did not have sufficient time to provide such counseling in the visit. The problems are even more acute in resource-limited safety net settings. Therefore, a two-tiered approach may prove to be useful, where providers initially address reproductive health issues in the visit but where additional support outside the visit provides additional information, support, motivation and connection to services. An innovative intervention using texting technology may prove to be a cost effective method of providing support between visits.
- Conditions
- Teen Sexual Health
- Being tested
- text message intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text message interventionBehavioural
Subjects will be sent 58 messages (3-5 per week) over 12 weeks, plus reminder messages for follow up interviews. The content of these messages will focus on contraception methods and effectiveness, sexually transmitted infection (STI) transmission, condom use, partner and parental communication, and healthy relationships. There will also be several text messages asking the participant if they would like to have a health educator contact them. The format will include facts, quizzes, true/false and some will have links to videos/pictures and websites, and some will request a response.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | The current standard of care in the clinic is a preventive care physical examination every 1-2 years and/or treatment for presenting medical conditions. The frequency and content of reproductive health is not standardized between clinicians, but it is expected that all clinicians will address sexuality during routine visits. Additionally, sexually active teens are encouraged to have urine screening tests for chlamydia, gonorrhea and pregnancy as indicated. Teens may also see a reproductive health educator at the clinic as well. Available contraceptive methods are oral contraceptive pills, contraceptive patches, Depo-Provera, diaphragms, condoms, implants and intrauterine devices (IUDs). |
| text message intervention | Active comparator | Subjects in the intervention arm will receive usual care plus text messages that have been developed to promote overall teen sexual health. Receives: Behavioral: text message intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.
Practice of protection from STIs and unintended pregnancy were reported at baseline and follow up surveys. Between-group differences at baseline, 3 and 6-month follow-up among participants with data at all points AND who were sexually active at baseline were analyzed.
Measured: 6 months
Secondary outcomes (3)
Use of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)
Use of LARCs was reported at follow up surveys and reviewed in the medical record at 6 months.
Measured: 6 months
Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys
Subjects reported their degree of knowledge (0-18, higher score = higher knowledge), motivation (0-12, higher score = higher self-efficacy for condom use), and attitudes (0-40, higher score = more perceived benefits of birth control use) in baseline and follow-up surveys.
Measured: 6 months
Unprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)
Urinalysis was to be performed at 6 months post-baseline to test for pregnancy, gonorrhea, and chlamydia. However, the researchers were unable to obtain urinalyses at 6 months from all participants due to logistical challenges and participant attrition. We instead analyzed self-reported unprotected sex (i.e., did not use condoms 100% of the time) at each of the study time points to assess potential risk for unintended pregnancy and/or STI.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Teen Sexual HealthStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Rinehart, Denver Health and Hospital Authority
- Investigators
- Deborah Rinehart, PhD, Principal investigator, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419690
- Sponsor's protocol ID
- 13-3219
- Status last verified
- Sep 2020
- First submitted
- 13 Jan 2015
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Patient Centered Intervention to Increase Dual Protection Against Unintended Pregnancy and Sexually Transmitted Disease Among Adolescents
- ClinicalTrials.gov ID
- NCT02419690
- Acronym / sponsor ID
- 13-3219
- Conditions
- Teen Sexual Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Posted 10 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to use a text messaging intervention to prevent unintended teen pregnancy and transmission of sexually transmitted disease. The study will be informed by a formative qualitative phase (February 2014 - January 2015) which will include individual qualitative interviews and focus groups with teens to elucidate and explore the barriers to effective contraceptive use and sexually transmitted disease (STD) prevention and to obtain feedback on the developed intervention. The second efficacy phase will randomize subjects to the texting intervention or to usual care.
Detailed description
Adolescents, particularly those from disadvantaged backgrounds, are disproportionally affected by both unintended pregnancies and STDs. While youth only represent a quarter of the sexually active population in the US, they account for almost half of all new STDs and the rate of unintended pregnancies among sexually active teens is almost double the rate of all sexually active women. Teen mothers experience higher rates of negative social outcomes including school dropout and children of teens are more likely to have low birth weight, lower academic achievement and more likely to perpetuate the cycle of teen pregnancy themselves. Both unintended pregnancies and STDs are much higher among racial/ethnic minority populations. Contraceptive methods considered most effective for pregnancy prevention do not protect against STDs and HIV transmission. Dual protection methods include being on an effective and consistent form of contraception and having an effective STD prevention method in place, preferably consistent condom use. Non-penetrative sexual practices can be substituted.
There are many barriers to providing sexual health education and services in the context of primary care visits. A recent study of pediatricians found that 61% of pediatricians reported discussing contraception, use of condoms and/or STDs with patients at preventive care visits. Most providers (76%), however, believed they did not have sufficient time to provide such counseling in the visit. The problems are even more acute in resource-limited safety net settings. Therefore, a two-tiered approach may prove to be useful, where providers initially address reproductive health issues in the visit but where additional support outside the visit provides additional information, support, motivation and connection to services. An innovative intervention using texting technology may prove to be a cost effective method of providing support between visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –The current standard of care in the clinic is a preventive care physical examination every 1-2 years and/or treatment for presenting medical conditions. The frequency and content of reproductive health is not standardized between clinicians, but it is expected that all clinicians will address sexuality during routine visits. Additionally, sexually active teens are encouraged to have urine screening tests for chlamydia, gonorrhea and pregnancy as indicated. Teens may also see a reproductive health educator at the clinic as well. Available contraceptive methods are oral contraceptive pills, contraceptive patches, Depo-Provera, diaphragms, condoms, implants and intrauterine devices (IUDs). |
| text message intervention | Active comparator | Behavioral: text message interventionSubjects in the intervention arm will receive usual care plus text messages that have been developed to promote overall teen sexual health. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- biologically female;
- between 13 and 18 years of age;
- not currently pregnant or trying to become pregnant;
- have texting capability; and
- able to read/write/speak in English.
Key exclusion criteria (1 listed)
- not meeting inclusion criteria outlined above
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 |
|---|---|---|
| text message interventionSubjects will be sent 58 messages (3-5 per week) over 12 weeks, plus reminder messages for follow up interviews. The content of these messages will focus on contraception methods and effectiveness, sexually transmitted infection (STI) transmission, condom use, partner and parental communication, and healthy relationships. There will also be several text messages asking the participant if they would like to have a health educator contact them. The format will include facts, quizzes, true/false and some will have links to videos/pictures and websites, and some will request a response. | Behavioural | text message intervention |
Primary outcome
Dual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.
Time frame: 6 months
Practice of protection from STIs and unintended pregnancy were reported at baseline and follow up surveys. Between-group differences at baseline, 3 and 6-month follow-up among participants with data at all points AND who were sexually active at baseline were analyzed.
3 secondary outcomes
Use of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)
Time frame: 6 months
Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys
Time frame: 6 months
Unprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Deborah Rinehart, PhD principal investigator
Denver Health and Hospital Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing text message intervention in people with Teen Sexual Health, run by Denver Health and Hospital Authority 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 1 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 10 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 10 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record. (time frame: 6 months). 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 10 Nov 2020.