Clinical trial NCT02419690: Sexual Health Texting Intervention to Support Adolescent Females
Official title: Effectiveness of a Patient Centered Intervention to Increase Dual Protection Against Unintended Pregnancy and Sexually Transmitted Disease Among Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Sexual Health
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 244
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Dual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.
timeFrame: 6 months
Secondary outcomes:
measure: Use of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)
timeFrame: 6 months
measure: Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys
timeFrame: 6 months
measure: Unprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)
timeFrame: 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health
state: Colorado
Study officials:
affiliation: Denver Health and Hospital Authority
name: Deborah Rinehart, PhD
role: PRINCIPAL_INVESTIGATOR
References: