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Clinical Trials/NCT02419690
NCT02419690
Completed
Not Applicable

Effectiveness of a Patient Centered Intervention to Increase Dual Protection Against Unintended Pregnancy and Sexually Transmitted Disease Among Adolescents

Denver Health and Hospital Authority1 site in 1 country244 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Teen Sexual Health
Sponsor
Denver Health and Hospital Authority
Enrollment
244
Locations
1
Primary Endpoint
Dual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.
Status
Completed
Last Updated
5 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
January 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deborah Rinehart

Associate Research Scientist

Denver Health and Hospital Authority

Eligibility 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys(6 months)
  • Unprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)(6 months)
  • Use of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)(6 months)

Study Sites (1)

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