Skip to content

Sexual Health Texting Intervention to Support Adolescent Females

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02419690
Enrollment
244
Registered
2015-04-17
Start date
2015-04-30
Completion date
2017-01-31
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Teen Sexual Health

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.

Interventions

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.

Sponsors

Denver Health and Hospital Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Dual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.6 monthsPractice 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

MeasureTime frameDescription
Use of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)6 monthsUse of LARCs was reported at follow up surveys and reviewed in the medical record at 6 months.
Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys6 monthsSubjects 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 monthsUrinalysis 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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).
122
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. 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.
122
Total244

Baseline characteristics

CharacteristicUsual CareText Message InterventionTotal
Age, Categorical
<=18 years
122 Participants122 Participants244 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous15.9 years
STANDARD_DEVIATION 1.7
15.7 years
STANDARD_DEVIATION 1.6
15.9 years
STANDARD_DEVIATION 1.6
Race/Ethnicity, Customized
Asian
1 participants2 participants3 participants
Race/Ethnicity, Customized
Black
8 participants13 participants21 participants
Race/Ethnicity, Customized
Hispanic/Latinx
99 participants96 participants195 participants
Race/Ethnicity, Customized
White
14 participants11 participants25 participants
Region of Enrollment
United States
122 participants122 participants244 participants
Sex: Female, Male
Female
122 Participants122 Participants244 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1220 / 122
other
Total, other adverse events
0 / 1220 / 122
serious
Total, serious adverse events
0 / 1220 / 122

Outcome results

Primary

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.

Time frame: 6 months

Population: For each group, baseline, 3 and 6-month follow-up among participants with data at all points (3 and 6 month follow-up) AND who were sexually active at baseline were analyzed.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Usual CareDual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.Baseline dual protection behaviors7 Participants
Usual CareDual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.Three-month dual protection behaviors8 Participants
Usual CareDual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.Six-month dual protection behaviors7 Participants
Text Message InterventionDual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.Baseline dual protection behaviors6 Participants
Text Message InterventionDual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.Three-month dual protection behaviors8 Participants
Text Message InterventionDual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.Six-month dual protection behaviors11 Participants
Secondary

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.

Time frame: 6 months

Population: Between-group differences at baseline, 3 and 6-month follow-up among participants with data at all points were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
Usual CareKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys6-month perceived benefits birth control (0-40)26.10 score on a scaleStandard Deviation 5.69
Usual CareKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in SurveysBaseline overall knowledge (0-18)10.46 score on a scaleStandard Deviation 4.23
Usual CareKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys3-month overall knowledge (0-18)11.59 score on a scaleStandard Deviation 3.94
Usual CareKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys6-month overall knowledge (0-18)11.97 score on a scaleStandard Deviation 4.19
Usual CareKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in SurveysBaseline self-efficacy condom use (0-12)6.97 score on a scaleStandard Deviation 1.96
Usual CareKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys3-month self-efficacy condom use (0-12)6.68 score on a scaleStandard Deviation 2.08
Usual CareKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys6-month self-efficacy condom use (0-12)6.99 score on a scaleStandard Deviation 1.82
Usual CareKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in SurveysBaseline perceived benefits birth control (0-40)25.72 score on a scaleStandard Deviation 5.4
Usual CareKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys3-month perceived benefits birth control (0-40)25.59 score on a scaleStandard Deviation 5.55
Text Message InterventionKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in SurveysBaseline perceived benefits birth control (0-40)25.90 score on a scaleStandard Deviation 5.38
Text Message InterventionKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys3-month self-efficacy condom use (0-12)7.38 score on a scaleStandard Deviation 1.76
Text Message InterventionKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in SurveysBaseline overall knowledge (0-18)10.90 score on a scaleStandard Deviation 4.03
Text Message InterventionKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys6-month perceived benefits birth control (0-40)27.40 score on a scaleStandard Deviation 5.59
Text Message InterventionKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys3-month overall knowledge (0-18)13.57 score on a scaleStandard Deviation 3.63
Text Message InterventionKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys6-month self-efficacy condom use (0-12)7.39 score on a scaleStandard Deviation 1.77
Text Message InterventionKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys6-month overall knowledge (0-18)13.64 score on a scaleStandard Deviation 3.83
Text Message InterventionKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys3-month perceived benefits birth control (0-40)27.85 score on a scaleStandard Deviation 5.76
Text Message InterventionKnowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in SurveysBaseline self-efficacy condom use (0-12)7.12 score on a scaleStandard Deviation 1.75
Secondary

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.

Time frame: 6 months

Population: Between-group differences at baseline, 3 and 6-month follow-up among participants with data at all points AND were sexually active at baseline were analyzed.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Usual CareUnprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)Baseline unprotected vaginal sex23 Participants
Usual CareUnprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)3-month unprotected vaginal sex18 Participants
Usual CareUnprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)6-month unprotected vaginal sex17 Participants
Text Message InterventionUnprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)Baseline unprotected vaginal sex26 Participants
Text Message InterventionUnprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)3-month unprotected vaginal sex20 Participants
Text Message InterventionUnprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)6-month unprotected vaginal sex21 Participants
Secondary

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.

Time frame: 6 months

Population: Between-group differences at baseline, 3 and 6-month follow-up among participants with data at all points. This analysis included those who were not sexually active.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Usual CareUse of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)Baseline LARC use18 Participants
Usual CareUse of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)Three-month LARC use18 Participants
Usual CareUse of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)Six-month LARC use17 Participants
Text Message InterventionUse of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)Baseline LARC use16 Participants
Text Message InterventionUse of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)Three-month LARC use18 Participants
Text Message InterventionUse of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)Six-month LARC use17 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026