Sexual Health Texting Intervention to Support Adolescent Females

Not Applicable

Completed

Conditions: Teen Sexual Health

Interventions: Behavioral: text message intervention

Registration Number: NCT02419690

Lead Sponsor: Denver Health and Hospital Authority

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 244

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
text message intervention	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.

Primary Outcome Measures

Name	Time	Method
Dual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.	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 Outcome Measures

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