Overview

This trial is active, not recruiting.

Condition teen sexual health
Treatment text message intervention
Sponsor Denver Health and Hospital Authority
Start date April 2015
End date January 2017
Trial size 250 participants
Trial identifier NCT02419690, 13-3219

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(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).
(Active Comparator)
Subjects in the intervention arm will receive usual care plus text messages that have been developed to promote overall teen sexual health.
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 Outcomes

Measure
Dual protection behaviors, reported at follow up surveys/interviews and reviewed in the medical record.
time frame: 6 months

Secondary Outcomes

Measure
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
Knowledge, Motivation, and Attitudes toward contraception, condoms use and dual protection in follow up surveys/interviews
time frame: 6 months
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

Eligibility Criteria

Female participants from 13 years up to 18 years old.

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

Additional Information

Official title Effectiveness of a Patient Centered Intervention to Increase Dual Protection Against Unintended Pregnancy and Sexually Transmitted Disease Among Adolescents
Principal investigator Deborah Rinehart, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Denver Health and Hospital Authority.