Trial Outcomes & Findings for rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities (NCT NCT02498067)
NCT ID: NCT02498067
Last Updated: 2020-08-18
Results Overview
Reported frequency of use of condoms with another contraceptive method in past 3 months 5 option close-ended question, ranging from 1 - none of the time, to 5 - every time
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
Baseline, 3 months
Results posted on
2020-08-18
Participant Flow
Participant milestones
| Measure |
Intervention
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
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|---|---|
|
Overall Study
STARTED
|
104
|
|
Overall Study
COMPLETED
|
71
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
Intervention
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
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|---|---|
|
Overall Study
Lost to Follow-up
|
22
|
|
Overall Study
Did not meet inclusion criteria
|
11
|
Baseline Characteristics
11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline
Baseline characteristics by cohort
| Measure |
Intervention
n=104 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
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|---|---|
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Age, Categorical
<=18 years
|
30 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline
|
|
Age, Continuous
|
20.0 years
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline
|
|
Sex: Female, Male
Female
|
93 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline
|
|
Race/Ethnicity, Customized
Black or African American
|
93 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline
|
|
Relationship Status
Single
|
35 Participants
n=92 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 1 participant did not provide data for this measure.
|
|
Relationship Status
Dating/Casual partners
|
15 Participants
n=92 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 1 participant did not provide data for this measure.
|
|
Relationship Status
In relationship
|
42 Participants
n=92 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 1 participant did not provide data for this measure.
|
|
Highest Education Completed
High school diploma or less
|
37 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Highest Education Completed
Some college
|
44 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Highest Education Completed
College degree or higher
|
12 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Age at First Sexual Intercourse
|
16.1 years
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Number of Sexual Partners in Lifetime
1 partner
|
17 Participants
n=92 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 1 participant did not provide data for this measure.
|
|
Number of Sexual Partners in Lifetime
2 partners
|
17 Participants
n=92 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 1 participant did not provide data for this measure.
|
|
Number of Sexual Partners in Lifetime
3 partners
|
13 Participants
n=92 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 1 participant did not provide data for this measure.
|
|
Number of Sexual Partners in Lifetime
4 partners
|
15 Participants
n=92 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 1 participant did not provide data for this measure.
|
|
Number of Sexual Partners in Lifetime
5+ partners
|
30 Participants
n=92 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 1 participant did not provide data for this measure.
|
|
Ever Tested Positive for STI?
Yes
|
31 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Ever Tested Positive for STI?
No
|
62 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Pregnancy History
Never been pregnant
|
60 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Pregnancy History
2 pregnancies
|
21 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Pregnancy History
3+ pregnancies
|
12 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Age at First Pregnancy
|
18.1 years
n=33 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 60 participants did not provide data for this measure, as they had never been pregnant.
|
|
Number of Births
0
|
61 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Number of Births
1
|
17 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Number of Births
2+
|
15 Participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Number of Living Children
|
1.5 children
n=32 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 61 participants did not provide data for this measure.
|
|
Contraceptive Method Awareness
Withdrawal
|
74 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Contraceptive Method Awareness
Condom
|
81 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Contraceptive Method Awareness
Pill
|
71 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Contraceptive Method Awareness
Ring
|
59 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Contraceptive Method Awareness
Patch
|
54 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Contraceptive Method Awareness
Shot
|
66 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Contraceptive Method Awareness
Intrauterine device (IUD)
|
45 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Contraceptive Method Awareness
Implant
|
49 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Past Contraceptive Method Use
Never used method
|
1 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Past Contraceptive Method Use
Withdrawal
|
52 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Past Contraceptive Method Use
Condom
|
69 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Past Contraceptive Method Use
Pill
|
46 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Past Contraceptive Method Use
Ring
|
3 participants
n=104 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Past Contraceptive Method Use
Patch
|
9 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Past Contraceptive Method Use
Shot
|
37 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Past Contraceptive Method Use
IUD
|
5 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
|
Past Contraceptive Method Use
Implant
|
4 participants
n=93 Participants • 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.
Reported frequency of use of condoms with another contraceptive method in past 3 months 5 option close-ended question, ranging from 1 - none of the time, to 5 - every time
Outcome measures
| Measure |
Intervention
n=71 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
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|---|---|
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Change in Frequency of Recent Dual Method Use
Baseline, pre-app use
|
3.17 score on a scale
Interval 1.0 to 5.0
|
|
Change in Frequency of Recent Dual Method Use
3-month follow-up
|
3.45 score on a scale
Interval 1.0 to 5.0
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.
Reported frequency of use of condoms alone (without another method) in past 3 months 5 option close-ended question, ranging from 1 - none of the time, to 5 - every time
Outcome measures
| Measure |
Intervention
n=71 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
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|---|---|
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Change in Frequency of Recent Condom Use (by Itself, With no Other Method)
Baseline (pre-app use)
|
3.15 score on a scale
Interval 1.0 to 5.0
|
|
Change in Frequency of Recent Condom Use (by Itself, With no Other Method)
3-month follow-up
|
2.93 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample at baseline and the sample retained at followup. 16 of the 71 retained participants did not have sex during the 3-month time period.
Self-reported answer (yes or no) to whether participants used contraception every time they had sex in the past three months
Outcome measures
| Measure |
Intervention
n=55 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
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|---|---|
|
Change in Consistency of Recent Contraceptive Use
3-month follow-up · Yes
|
46 Participants
|
|
Change in Consistency of Recent Contraceptive Use
Baseline (pre-app use) · Yes
|
35 Participants
|
|
Change in Consistency of Recent Contraceptive Use
Baseline (pre-app use) · No
|
20 Participants
|
|
Change in Consistency of Recent Contraceptive Use
3-month follow-up · No
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. 1 participant at 3-month follow-up did not give a response.
Participants' current main method of contraception, by method type: no method or withdrawal, condom, short-term/combined hormonal (pill, patch, shot, ring), Long acting reversible contraception (LARC: IUD or implant)
Outcome measures
| Measure |
Intervention
n=71 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
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|---|---|
|
Current Main Method of Contraception
Baseline (pre-app use) · No method or withdrawal
|
24 Participants
|
|
Current Main Method of Contraception
Baseline (pre-app use) · Condom
|
13 Participants
|
|
Current Main Method of Contraception
Baseline (pre-app use) · Hormonal, short-term (pill, patch, shot, ring)
|
34 Participants
|
|
Current Main Method of Contraception
Baseline (pre-app use) · LARC (IUD or implant)
|
0 Participants
|
|
Current Main Method of Contraception
3-month follow-up · No method or withdrawal
|
15 Participants
|
|
Current Main Method of Contraception
3-month follow-up · Condom
|
5 Participants
|
|
Current Main Method of Contraception
3-month follow-up · Hormonal, short-term (pill, patch, shot, ring)
|
31 Participants
|
|
Current Main Method of Contraception
3-month follow-up · LARC (IUD or implant)
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-app use), Immediately post-app usePopulation: 1 participant did not provider data for this measure.
Participants' self-reported likelihood of using an IUD in the future, on a close-ended 5-point scale ranging from: 1 - very unlikely, to 5 - very likely
Outcome measures
| Measure |
Intervention
n=92 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
|
|---|---|
|
Change in Future Intentions to Use IUD
Baseline, pre-app use
|
2.38 score on a scale
Interval 1.0 to 5.0
|
|
Change in Future Intentions to Use IUD
Baseline, immediately post-app use
|
2.70 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline (pre-app use), Immediately post-app usePopulation: 2 participants did not provide data for this measure.
Participants' self-reported likelihood of using a contraceptive implant in the future, on a close-ended 5-point scale ranging from: 1 - very unlikely, to 5 - very likely
Outcome measures
| Measure |
Intervention
n=91 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
|
|---|---|
|
Change in Future Intentions to Use Implant
Baseline (pre-app use)
|
2.45 score on a scale
Interval 1.0 to 5.0
|
|
Change in Future Intentions to Use Implant
Immediately post-app use
|
2.66 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline (pre-app use), Immediately post-app usePopulation: 3 participants did not provide data for this measure.
Participants' self-reported likelihood of using condoms in the future, on a close-ended 5-point scale ranging from: 1 - very unlikely, to 5 - very likely
Outcome measures
| Measure |
Intervention
n=90 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
|
|---|---|
|
Change in Future Intentions to Use Condoms
Immediately post-app use
|
4.11 score on a scale
Interval 1.0 to 5.0
|
|
Change in Future Intentions to Use Condoms
Baseline (pre-app use)
|
4.22 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. 4 retained participants did not provide data for this measure.
Participants' self-reported contraceptive self-efficacy, on a close-ended 5-point scale ranging from 1 - not at all confident, to 5 - extremely confident, between baseline (pre-rPlan) and 3-month follow-up
Outcome measures
| Measure |
Intervention
n=67 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
|
|---|---|
|
Change in Self-efficacy for Contraceptive Use
Baseline (pre-rPlan)
|
3.93 score on a scale
Interval 1.0 to 5.0
|
|
Change in Self-efficacy for Contraceptive Use
3-month follow-up
|
3.71 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline (pre-rPlan), 3 monthsPopulation: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. 3 retained participants did not provide data for this measure.
Participants' self-reported condom self-efficacy, on a close-ended 5-point scale ranging from 1 - not at all confident, to 5 - extremely confident, between baseline (pre-rPlan) and 3-month follow-up
Outcome measures
| Measure |
Intervention
n=68 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
|
|---|---|
|
Change in Self-efficacy for Condom Use
Baseline (pre-rPlan)
|
3.64 score on a scale
Interval 1.0 to 5.0
|
|
Change in Self-efficacy for Condom Use
3-month follow-up
|
3.65 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsResults of sexually transmitted infection (STI) test, at baseline and 3 months
Outcome measures
| Measure |
Intervention
n=93 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
|
|---|---|
|
Results of STI Test
Baseline · Positive
|
8 Participants
|
|
Results of STI Test
Baseline · Negative
|
68 Participants
|
|
Results of STI Test
Baseline · None ordered/Missing
|
17 Participants
|
|
Results of STI Test
3-month follow-up · Positive
|
0 Participants
|
|
Results of STI Test
3-month follow-up · Negative
|
63 Participants
|
|
Results of STI Test
3-month follow-up · None ordered/Missing
|
30 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. 21 retained participants did not provide data for this measure.
Self-reported number of sexual partners in the past three months (for those who were sexually active)
Outcome measures
| Measure |
Intervention
n=50 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
|
|---|---|
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Change in Number of Recent Sexual Partners
Baseline
|
1.40 number of sexual partners
Interval 1.0 to 4.0
|
|
Change in Number of Recent Sexual Partners
3-month follow-up
|
1.24 number of sexual partners
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. 5 retained participants did not provide data for this measure.
Participants' self-reported degree to which they endorse negative condom attitudes (Brown, 1984), on a close-ended 5-point scale ranging from 1 - strongly disagree, to 5 - strongly agree, between baseline (pre-rPlan) and 3-month follow-up
Outcome measures
| Measure |
Intervention
n=66 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
|
|---|---|
|
Change in Negative Condom Attitudes
Baseline (pre-rPlan)
|
2.03 score on a scale
Interval 1.0 to 5.0
|
|
Change in Negative Condom Attitudes
3-month follow-up
|
1.99 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline (pre-rPlan), 3 monthsPopulation: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. 1 retained participant did not provide data for this measure.
Participants' self-reported degree to which they endorse positive motivators for condom use, on a close-ended 5-point scale ranging from 1 - strongly disagree, to 5 - strongly agree, between baseline (pre-rPlan) and 3-month follow-up
Outcome measures
| Measure |
Intervention
n=70 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
|
|---|---|
|
Change in Endorsement of Positive Motivators for Condom Use
Baseline (pre-rPlan)
|
4.57 score on a scale
Interval 1.0 to 5.0
|
|
Change in Endorsement of Positive Motivators for Condom Use
3-month follow-up
|
4.63 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline (pre-rPlan), 3 monthsPopulation: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. 4 retained participants did not provide data for this measure.
Participants' self-reported importance of negative contraceptive attitudes (Galavotti et al., 1995) in their decision to use contraception, on a close-ended 5-point scale ranging from 1 - not at all important, to 5 - extremely important, between baseline (pre-rPlan) and 3-month follow-up
Outcome measures
| Measure |
Intervention
n=67 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
|
|---|---|
|
Change in Negative Contraceptive Attitudes
Baseline (pre-rPlan)
|
2.20 score on a scale
Interval 1.0 to 5.0
|
|
Change in Negative Contraceptive Attitudes
3-month follow-up
|
2.20 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline (pre-rPlan), 3 monthsPopulation: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. 1 retained participant did not provide data for this measure.
Participants' self-rated importance of positive motivators for contraceptive use (Galavotti et al., 1995) in their decision to use contraception, on a close-ended 5-point scale ranging from 1 - not at all important, to 5 - extremely important, between baseline (pre-rPlan) and 3-month follow-up
Outcome measures
| Measure |
Intervention
n=70 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
|
|---|---|
|
Change in Endorsement of Positive Motivators for Contraceptive Use
Baseline (pre-rPlan)
|
4.61 score on a scale
Interval 1.0 to 5.0
|
|
Change in Endorsement of Positive Motivators for Contraceptive Use
3-month follow-up
|
4.64 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline (pre-app use), 3 monthsPopulation: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. 1 retained participant did not provide data for this measure.
Percentage of participants who correctly answered questions of which contraceptive methods were more effective at preventing pregnancy, between baseline (pre-app use) and 3-month follow-up
Outcome measures
| Measure |
Intervention
n=70 Participants
Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.
|
|---|---|
|
Change in Contraceptive Effectiveness Knowledge
Baseline (pre-rPlan): Pills vs condoms, % correct
|
31.4 percentage who answered correctly
|
|
Change in Contraceptive Effectiveness Knowledge
Baseline (pre-rPlan): IUD vs shot, % correct
|
35.7 percentage who answered correctly
|
|
Change in Contraceptive Effectiveness Knowledge
3-month follow-up: Pills vs condoms, % correct
|
16.9 percentage who answered correctly
|
|
Change in Contraceptive Effectiveness Knowledge
3-month follow-up: IUD vs shot, % correct
|
25.7 percentage who answered correctly
|
Adverse Events
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