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Completed

NCT Number: NCT02419690

Sexual Health Texting Intervention to Support Adolescent Females

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.

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Key information

Conditions

Age range

13 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health

Denver, Colorado, 80204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text Message Intervention

Behavioral

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

  1. 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

  1. Use of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)

    Time frame: 6 months

    Use of LARCs was reported at follow up surveys and reviewed in the medical record at 6 months.

  2. Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys

    Time frame: 6 months

    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.

  3. Unprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 17, 2015
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.