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Dual Protection Project

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ClinicalTrials.gov Identifier: NCT02419690
Recruitment Status : Completed
First Posted : April 17, 2015
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Deborah Rinehart, Denver Health and Hospital Authority

Brief 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 group 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.

Condition or disease Intervention/treatment Phase
Teen Sexual Health Behavioral: text message intervention Not Applicable

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, preferably a long-acting reversible contraceptive 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 these 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Patient Centered Intervention to Increase Dual Protection Against Unintended Pregnancy and Sexually Transmitted Disease Among Adolescents
Study Start Date : April 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
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).
Active Comparator: text message intervention
Subjects in the intervention arm will receive usual care plus text messages that have been developed to promote overall teen sexual health.
Behavioral: text message intervention
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.




Primary Outcome Measures :
  1. Dual protection behaviors, reported at follow up surveys/interviews and reviewed in the medical record. [ Time Frame: 6 months ]
    Practice of protection from STDs and unintended pregnancy will be reported at follow up surveys/interviews and reviewed in the medical record.


Secondary Outcome Measures :
  1. Use of the most effective contraception methods :long acting reversable contraceptives (LARCs), reported at follow up surveys/interviews and reviewed in the medical record at 6 months. [ Time Frame: 6 months ]
    Use of LARCs will be reported at follow up surveys/interviews and reviewed in the medical record at 6 months.

  2. Knowledge, Motivation, and Attitudes toward contraception, condoms use and dual protection in follow up surveys/interviews [ Time Frame: 6 months ]
    Subjects will report their degree of knowledge, motivation, and attitudes in follow up surveys/interviews

  3. Incidence of unintended pregnancy and STDs, measured by urinalysis will be performed at 6 months to test for pregnancy, gonorrhea, and chlamydia [ Time Frame: 6 months ]
    Urinalysis will be performed at 6 months to test for pregnancy, gonorrhea, and chlamydia



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • not meeting inclusion criteria outlined above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419690


Locations
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United States, Colorado
Denver Health
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
Investigators
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Principal Investigator: Deborah Rinehart, PhD Denver Health and Hospital Authority
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Responsible Party: Deborah Rinehart, Associate Research Scientist, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT02419690    
Other Study ID Numbers: 13-3219
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No