Sexual Health Texting Intervention to Support Adolescent Females

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Teen Sexual Health

Intervention / Treatment
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* Behavioral: text message intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record. | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs) | Use of LARCs was reported at follow up surveys and reviewed in the medical record at 6 months. | 6 months | 
| Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys | 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. | 6 months | 
| Unprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs) | 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. | 6 months |