Trial Outcomes & Findings for Sexual Health Texting Intervention to Support Adolescent Females (NCT NCT02419690)
NCT ID: NCT02419690
Last Updated: 2020-11-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
244 participants
Primary outcome timeframe
6 months
Results posted on
2020-11-10
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
122
|
|
Overall Study
COMPLETED
|
122
|
122
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sexual Health Texting Intervention to Support Adolescent Females
Baseline characteristics by cohort
| Measure |
Usual Care
n=122 Participants
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
n=122 Participants
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.
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
122 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.9 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
15.7 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
15.9 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latinx
|
99 participants
n=5 Participants
|
96 participants
n=7 Participants
|
195 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 participants
n=5 Participants
|
13 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
122 participants
n=5 Participants
|
122 participants
n=7 Participants
|
244 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Usual Care
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|
|
Dual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.
Baseline dual protection behaviors
|
7 Participants
|
6 Participants
|
|
Dual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.
Three-month dual protection behaviors
|
8 Participants
|
8 Participants
|
|
Dual Protection Behaviors, Reported in Surveys and Reviewed in the Medical Record.
Six-month dual protection behaviors
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Use of LARCs was reported at follow up surveys and reviewed in the medical record at 6 months.
Outcome measures
| Measure |
Usual Care
n=69 Participants
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
n=67 Participants
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.
|
|---|---|---|
|
Use of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)
Baseline LARC use
|
18 Participants
|
16 Participants
|
|
Use of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)
Three-month LARC use
|
18 Participants
|
18 Participants
|
|
Use of the Most Effective Contraception Methods: Long Acting Reversible Contraceptives (LARCs)
Six-month LARC use
|
17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Between-group differences at baseline, 3 and 6-month follow-up among participants with data at all points were analyzed.
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.
Outcome measures
| Measure |
Usual Care
n=69 Participants
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
n=67 Participants
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.
|
|---|---|---|
|
Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys
Baseline overall knowledge (0-18)
|
10.46 score on a scale
Standard Deviation 4.23
|
10.90 score on a scale
Standard Deviation 4.03
|
|
Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys
3-month overall knowledge (0-18)
|
11.59 score on a scale
Standard Deviation 3.94
|
13.57 score on a scale
Standard Deviation 3.63
|
|
Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys
6-month overall knowledge (0-18)
|
11.97 score on a scale
Standard Deviation 4.19
|
13.64 score on a scale
Standard Deviation 3.83
|
|
Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys
Baseline self-efficacy condom use (0-12)
|
6.97 score on a scale
Standard Deviation 1.96
|
7.12 score on a scale
Standard Deviation 1.75
|
|
Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys
3-month self-efficacy condom use (0-12)
|
6.68 score on a scale
Standard Deviation 2.08
|
7.38 score on a scale
Standard Deviation 1.76
|
|
Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys
6-month self-efficacy condom use (0-12)
|
6.99 score on a scale
Standard Deviation 1.82
|
7.39 score on a scale
Standard Deviation 1.77
|
|
Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys
Baseline perceived benefits birth control (0-40)
|
25.72 score on a scale
Standard Deviation 5.40
|
25.90 score on a scale
Standard Deviation 5.38
|
|
Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys
3-month perceived benefits birth control (0-40)
|
25.59 score on a scale
Standard Deviation 5.55
|
27.85 score on a scale
Standard Deviation 5.76
|
|
Knowledge, Motivation, and Attitudes Toward Contraception, Condom Use and Dual Protection in Surveys
6-month perceived benefits birth control (0-40)
|
26.10 score on a scale
Standard Deviation 5.69
|
27.40 score on a scale
Standard Deviation 5.59
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Usual Care
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|
|
Unprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)
Baseline unprotected vaginal sex
|
23 Participants
|
26 Participants
|
|
Unprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)
3-month unprotected vaginal sex
|
18 Participants
|
20 Participants
|
|
Unprotected Vaginal Sex at Baseline, 3 and 6 Months Post-baseline (Formerly Incidence of Unintended Pregnancy and STIs)
6-month unprotected vaginal sex
|
17 Participants
|
21 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Text Message Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place