An interventional study of Video counseling and Conversational counseling in Contraceptive Usage and Contraception Behavior, sponsored by Oregon Health and Science University. Completed at 2 sites in Colombia. Open to female participants aged 14 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Prevention
A randomized trial comparing LARC uptake and satisfaction after either video or conversational-based contraceptive counseling for pregnant women in labor.
This was a multi-center randomized, controlled trial examining contraceptive counseling in the setting of long-acting reversible contraception (LARC) uptake and immediate provision. At two urban public hospitals with large adolescent populations, participants were randomized to a structured, in-person conversation with a trained counselor or a 14-minute video providing the same information. Both participant groups were provided written materials and both had the opportunity to ask questions of the counselor. The total time to complete counseling was measured, as well as participant satisfaction, pre- and post-intervention contraceptive knowledge, and intended postpartum contraceptive method.
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's enrollment of 240 is below the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end.
Other: Video counseling
The conversation group participated in a structured, face-to-face conversation with a trained counselor.
Other: Conversational counseling
Video counseling
Conversational counseling
Total Counseling Time
Duration of counseling in minutes (from initiation of counseling to conclusion of all questions answered.) The clock was not stopped for breaks, which were allowed as needed.
Time frame: Immediately following the intervention, an average of less than 30 minutes
Knowledge Scores
Mean total correct answer (score) to 7 multiple-choice contraceptive knowledge questions. Total possible score is 0-7, with 7 representing 100% correct answers. Score measured after completion of the knowledge questionnaire, on average less than one hour, before (pre) and after (post) counseling.
Time frame: One hour
Number of Participants Initiating Postpartum LARC Uptake
Number of participants initiating long-acting reversible contraception (LARC - intrauterine device (IUD) or implant) prior to hospital discharge.
Time frame: Assessed at the time of hospital discharge, on average less than 2 days
| Milestone | Video Counseling | Conversational Counseling |
|---|---|---|
| Started | 121 | 119 |
| Completed | 120 | 119 |
| Not completed | 1 | 0 |
Duration of counseling in minutes (from initiation of counseling to conclusion of all questions answered.) The clock was not stopped for breaks, which were allowed as needed.
| minutes | Video Counseling | Conversational Counseling |
|---|---|---|
| Total Counseling Time | 16.8 ± 4.6 | 16.3 ± 4.6 |
Mean total correct answer (score) to 7 multiple-choice contraceptive knowledge questions. Total possible score is 0-7, with 7 representing 100% correct answers. Score measured after completion of the knowledge questionnaire, on average less than one hour, before (pre) and after (post) counseling.
| score on a scale | Conversational Counseling | Video Counseling |
|---|---|---|
| Pre-counseling | 3.1 ± 1.5 | 3.1 ± 1.5 |
| Post-counseling | 5.3 ± 1.0 | 5.1 ± 1.2 |
Number of participants initiating long-acting reversible contraception (LARC - intrauterine device (IUD) or implant) prior to hospital discharge.
| Participants | Conversational Counseling | Video Counseling |
|---|---|---|
| Number of Participants Initiating Postpartum LARC Uptake | 46 | 44 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Video Counseling | 0/120 (0%) | 0/120 (0%) | 0/120 (0%) |
| Conversational Counseling | 0/119 (0%) | 0/119 (0%) | 0/119 (0%) |
| Age, Categorical(Participants) | Video Counseling | Conversational Counseling | Total |
|---|---|---|---|
| <=18 years | 20 | 23 | 43 |
| Between 18 and 65 years | 100 | 96 | 196 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Video Counseling | Conversational Counseling | Total |
|---|---|---|---|
| Female | 120 | 119 | 239 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Video Counseling | Conversational Counseling | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Video Counseling | Conversational Counseling | Total |
|---|---|---|---|
| Colombia | 120 | 119 | 239 |
Plan to share: No — Individual sites hold the paper data under monitoring plan through their site Institutional Review Board (IRB - University de Antioquia). They entered de-identified data electronically into REDCap for our use for analysis. We have shared aggregate analysis with the individual sites.
Ran from Apr 2015 to primary completion in Aug 2016, 15 months.
Results were first posted in Jun 2019, 2 years 10 months after primary completion.
Of 64 non-industry interventional studies with no phase under Contraception Behavior, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 40. This study's 15 months is below that.
Counting every sponsor, half of 64 studies reached it within 20 months; a quarter within 13 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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