Sexual Health Texting Intervention to Support Adolescent Females

NCT02419690 | Completed Results

• 1 other identifier: 13-3219
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Teen Sexual Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  6 months

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

  6 months

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

  6 months

Study Arms (2)

Usual Care

NO INTERVENTION

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).

text message intervention

ACTIVE COMPARATOR

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

Interventions

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.

text message intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health

Denver, Colorado, 80204, United States

Location

Limitations and Caveats

Data are self-report and thus may be influenced by social desirability and/or recall. Unable to assess 6-month STI and pregnancy incidence. Limited ability to detect significance due to heterogeneous sample and lack of power in stratified analyses.

Results Point of Contact

• Title: Deborah Rinehart
• Organization: Denver Health & Hospital Authority

deborah.rinehart@dhha.org

303-602-2743

Study Officials

• Deborah Rinehart, PhD

  Denver Health and Hospital Authority

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: April 17, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: November 10, 2020
• Results First Posted: November 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)