An interventional study of Intervention video and Control video in Contraception Behavior, sponsored by Ohio State University. Completed at 1 site in Jamaica. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-16.
Sponsored by Ohio State University · Not applicable, Interventional, and Prevention
The primary hypothesis is that the intervention video - based on strategies from cognitive psychology - can correct women's misinformation about long-acting reversible contraception (LARC) and result in higher use of LARC. While there are no direct benefits to participants from being in the study, the research could benefit women in general by providing evidence to help prevent unintended pregnancy. Unlike many interventions that are not feasible for scaling up once shown to be effective in changing people's behavior, the proposed intervention has been carefully designed to impose a low burden to clinic staff and require few resources for translating to wider use. Thus, the investigators expect the intervention to have high potential for influencing clinical care and research for addressing the overall goal of reducing unintended pregnancy.
The investigators will conduct a randomized trial (RT) of consenting adult women (N=220) to test the effectiveness of the final intervention video.
Participants in the RT will complete the "Enrollment Questionnaire" and then will be randomized to either watch a short video on 1) debiasing about LARC safety (intervention arm; n=110) or 2) vector control (control arm; n=110) (Figure 2). Participants then will have the option of receiving routine contraceptive services that follow standard care. After three months, trained interviewers will contact participants to administer the short "Follow-up Questionnaire" via telephone. To corroborate participant reporting of contraception use during follow-up, the investigators also will extract data on LARC use from participant medical records.
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's enrollment of 225 is below the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) 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 intervention video will employ debiasing strategies to correct women's misinformation about the safety of the IUD and implant safety.
Behavioral: Intervention video
The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration.
Behavioral: Control video
The intervention video will employ the debiasing strategies. It will avoid directly articulating contraception-related myths, but instead will provide a limited number of alternative explanations related to IUD and implant safety.
The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration
Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use)
Based on survey question on use of the IUD (y/n) and implant (y/n)
Time frame: within 3 months of enrollment
Self-reported belief about IUD safety
"Do you think the IUD is very safe, mostly safe, mostly unsafe, or very unsafe?" Responses will be coded as 1-4 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm.
Time frame: 3 months after enrollment
Self-reported belief about implant safety
"Do you think the implant is very safe, mostly safe, mostly unsafe, or very unsafe?" Responses will be coded as 1-4 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm.
Time frame: 3 months after enrollment
Self-reported attitudes toward LARC-related bleeding patterns
"How do you feel about your bleeding pattern?" Response options consist of "very satisfied, satisfied, neutral, unsatisfied, very unsatisfied." Responses will be coded as 1-5 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm
Time frame: 3 months after enrollment
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2018 to primary completion in Sep 2019, 9 months.
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 9 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 Apr 2020. You cannot join it, but the record below documents what was studied.
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