Trial Outcomes & Findings for Online Peer Influence on IUD Behaviors and Attitudes (NCT NCT02279043)
NCT ID: NCT02279043
Last Updated: 2019-03-19
Results Overview
Self-reported use of IUC in post-survey
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
630 participants
Primary outcome timeframe
12 days post-baseline
Results posted on
2019-03-19
Participant Flow
Participant milestones
| Measure |
Intervention
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
Control
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
IUC Users
IUC users will be recruited to populate intervention groups. Interaction with IUC users will be the intervention for non-IUC users randomized to the intervention arm. IUC users will receive no intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
175
|
315
|
140
|
|
Overall Study
COMPLETED
|
128
|
226
|
140
|
|
Overall Study
NOT COMPLETED
|
47
|
89
|
0
|
Reasons for withdrawal
| Measure |
Intervention
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
Control
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
IUC Users
IUC users will be recruited to populate intervention groups. Interaction with IUC users will be the intervention for non-IUC users randomized to the intervention arm. IUC users will receive no intervention.
|
|---|---|---|---|
|
Overall Study
Post-rand. exclusion - not eligible
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
46
|
88
|
0
|
Baseline Characteristics
Online Peer Influence on IUD Behaviors and Attitudes
Baseline characteristics by cohort
| Measure |
Intervention
n=174 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
Control
n=314 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
IUC Users
IUC users will be recruited to populate intervention groups. Interaction with IUC users will be the intervention for non-IUC users randomized to the intervention arm. IUC users will receive no intervention.
|
Total
n=488 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-24
|
90 Participants
n=99 Participants
|
159 Participants
n=107 Participants
|
—
|
249 Participants
n=7 Participants
|
|
Age, Customized
25-34
|
79 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
—
|
216 Participants
n=7 Participants
|
|
Age, Customized
35-45
|
5 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
—
|
22 Participants
n=7 Participants
|
|
Age, Customized
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
—
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
174 Participants
n=99 Participants
|
314 Participants
n=107 Participants
|
—
|
488 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
—
|
36 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
22 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
—
|
60 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latina
|
11 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
—
|
47 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
116 Participants
n=99 Participants
|
185 Participants
n=107 Participants
|
—
|
301 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
—
|
27 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Missing
|
4 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
—
|
17 Participants
n=7 Participants
|
|
Number of pregnancies
0 pregnancies
|
82 Participants
n=99 Participants
|
159 Participants
n=107 Participants
|
—
|
241 Participants
n=7 Participants
|
|
Number of pregnancies
1 or more pregnancies
|
21 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
—
|
50 Participants
n=7 Participants
|
|
Number of pregnancies
Missing
|
71 Participants
n=99 Participants
|
126 Participants
n=107 Participants
|
—
|
197 Participants
n=7 Participants
|
|
Number of children
0 children
|
154 Participants
n=99 Participants
|
282 Participants
n=107 Participants
|
—
|
436 Participants
n=7 Participants
|
|
Number of children
1 or more children
|
20 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
—
|
51 Participants
n=7 Participants
|
|
Number of children
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
—
|
1 Participants
n=7 Participants
|
|
Birth control method used at baseline
Pill
|
95 Participants
n=99 Participants
|
171 Participants
n=107 Participants
|
—
|
266 Participants
n=7 Participants
|
|
Birth control method used at baseline
Patch
|
2 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
—
|
13 Participants
n=7 Participants
|
|
Birth control method used at baseline
Ring
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
—
|
23 Participants
n=7 Participants
|
|
Birth control method used at baseline
Shot
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
—
|
24 Participants
n=7 Participants
|
|
Birth control method used at baseline
Arm implant
|
17 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
—
|
46 Participants
n=7 Participants
|
|
Birth control method used at baseline
Condoms
|
64 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
—
|
174 Participants
n=7 Participants
|
|
Birth control method used at baseline
Withdrawal
|
37 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
—
|
107 Participants
n=7 Participants
|
|
Birth control method used at baseline
Female sterilization
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
—
|
8 Participants
n=7 Participants
|
|
Birth control method used at baseline
Male sterilization
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
—
|
9 Participants
n=7 Participants
|
|
Birth control method used at baseline
Other
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
—
|
8 Participants
n=7 Participants
|
|
Birth control method used at baseline
None
|
7 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
—
|
23 Participants
n=7 Participants
|
|
Parental education
High school graduate or less
|
31 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
—
|
82 Participants
n=7 Participants
|
|
Parental education
Some college or 4-year college graduate
|
56 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
—
|
178 Participants
n=7 Participants
|
|
Parental education
More than 4-year college graduate
|
41 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
—
|
94 Participants
n=7 Participants
|
|
Parental education
Missing
|
46 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
—
|
134 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 days post-baselineSelf-reported use of IUC in post-survey
Outcome measures
| Measure |
Control
n=226 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=128 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Number of Participants Reporting IUC Use
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 days post-baselinePopulation: Number analyzed is less than what is pictured in participant flow diagram because analysis for this outcome only includes those participants who have complete pre-survey and post-survey data pertaining to this outcome.
Mean difference of responses to scale in pre- and post-surveys asking participants to rate hormonal IUC as a contraceptive method for themselves, with 0=terrible method and 10=great method
Outcome measures
| Measure |
Control
n=211 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=119 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Mean Change in Attitude About Hormonal IUC as Method for Self Between Pre-survey and Post-survey
|
0.16 units on a scale
Interval -0.22 to 0.53
|
0.50 units on a scale
Interval 0.01 to 0.98
|
SECONDARY outcome
Timeframe: 12 days post-baselinePopulation: Number analyzed is less than what is pictured in participant flow diagram because analysis for this outcome only includes those participants who have complete pre-survey and post-survey data pertaining to this outcome.
Responses to scale in pre- and post-surveys asking participants to rate hormonal IUC as a contraceptive method for women in general, with 0=terrible method and 10=great method
Outcome measures
| Measure |
Control
n=211 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=119 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Mean Change in Attitude About Hormonal IUC as Method for Women in General Between Pre-survey and Post-survey
|
0.05 units on a scale
Interval -0.27 to 0.38
|
0.65 units on a scale
Interval 0.25 to 1.04
|
SECONDARY outcome
Timeframe: 12 days post-baselinePopulation: Number analyzed is less than what is pictured in participant flow diagram because analysis for this outcome only includes those participants who have complete pre-survey and post-survey data pertaining to this outcome.
Responses to scale in pre- and post-surveys asking participants to rate non-hormonal IUC as a contraceptive method for themselves, with 0=terrible method and 10=great method
Outcome measures
| Measure |
Control
n=207 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=114 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Mean Change in Attitude About Non-hormonal IUC as Method for Self Between Pre-survey and Post-survey
|
0.04 units on a scale
Interval -0.34 to 0.4
|
0.22 units on a scale
Interval -0.33 to 0.41
|
SECONDARY outcome
Timeframe: 12 days post-baselinePopulation: Number analyzed is less than what is pictured in participant flow diagram because analysis for this outcome only includes those participants who have complete pre-survey and post-survey data pertaining to this outcome.
Responses to scale in pre- and post-surveys asking participants to rate non-hormonal IUC as a contraceptive method for women in general, with 0=terrible method and 10=great method
Outcome measures
| Measure |
Control
n=211 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=114 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Mean Change in Attitude About Non-hormonal IUC as Method for Women in General Between Pre-survey and Post-survey
|
0 units on a scale
Interval -0.34 to 0.34
|
0.50 units on a scale
Interval 0.08 to 0.92
|
SECONDARY outcome
Timeframe: 12 days post-baselineResponse on 5-point Likert scale of agreement in post-survey on IUC safety. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.
Outcome measures
| Measure |
Control
n=226 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=128 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Number of Participants With Responses Indicating Knowledge of IUC Safety
|
172 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: 12 days post-baselineResponse on 5-point Likert scale of agreement in post-survey on IUC effectiveness. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.
Outcome measures
| Measure |
Control
n=226 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=128 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Number of Participants With Responses Indicating Knowledge of IUC Effectiveness
|
203 Participants
|
115 Participants
|
SECONDARY outcome
Timeframe: 12 days post-baselineCorrect response to post-survey item asking whether IUC is more, less, or as effective as the birth control pill (correct response: more effective).
Outcome measures
| Measure |
Control
n=226 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=128 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Number of Participants With Responses Indicating Knowledge of IUC Being More Effective Than Birth Control Pill
|
105 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: 12 days post-baselineResponse on 5-point Likert scale of agreement in post-survey on whether Birth Control Connect group gave participants information on IUC they didn't have before. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.
Outcome measures
| Measure |
Control
n=226 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=128 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Number of Participants Reporting Informational Support (Receiving New Information From Birth Control Connect)
|
116 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: 12 days post-baselineResponse on 5-point Likert scale of agreement in post-survey on whether Birth Control Connect gave them a better idea of what using IUC would be like. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.
Outcome measures
| Measure |
Control
n=226 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=128 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Number of Participants Reporting Informational Support (Better Idea of What IUC Would be Like)
|
116 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: 12 days post-baselineReport (Yes/No) in post-survey of whether participant had looked on the Internet (outside of Birth Control Connect) for information on IUC since study start. Outcome is count of participants reporting yes.
Outcome measures
| Measure |
Control
n=226 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=128 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Number of Participants Reporting Information-seeking on Internet
|
103 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: 12 days post-baselineReport (Yes/No) in post-survey of whether participant had consulted a health care provider about IUC since study start. Outcome is count of participants reporting yes.
Outcome measures
| Measure |
Control
n=226 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=128 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Number of Participants Reporting Information-seeking From a Health Care Provider
|
15 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 days post-baselineReport (Yes/No) in post-survey of whether participant had talked to women they know about IUC since study start. Outcome is count of participants reporting yes.
Outcome measures
| Measure |
Control
n=226 Participants
Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.
Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. "If you're using a birth control method right now, how did you choose it?"). Participants will also be able to pose questions to other members of the group and respond to other members' questions.
|
Intervention
n=128 Participants
IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.
Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users.
|
|---|---|---|
|
Number of Participants Reporting Information-seeking From Peers
|
87 Participants
|
56 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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