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
|Condition or disease||Intervention/treatment||Phase|
|Teen Sexual Health||Behavioral: text message intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|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|
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.
- 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.
- 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.
- 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
- 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
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
|United States, Colorado|
|Denver, Colorado, United States, 80204|
|Principal Investigator:||Deborah Rinehart, PhD||Denver Health and Hospital Authority|