Sexual Health Texting Intervention to Support Adolescent Females

NCT ID: NCT02419690

Last Updated: 2020-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-01-31

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.

Conditions

Teen Sexual Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

text message intervention

Intervention Type: 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.

Interventions

text message intervention

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Denver Health and Hospital Authority

OTHER

Sponsor Role: lead

Responsible Party

Deborah Rinehart

Associate Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Rinehart, PhD

Role: PRINCIPAL_INVESTIGATOR

Denver Health and Hospital Authority

Locations

Denver Health

Denver, Colorado, United States

Countries

United States

Other Identifiers

13-3219

Identifier Type: -

Identifier Source: org_study_id