Ignite Creation Date:
2025-12-18 @ 9:03 AM
Ignite Modification Date:
2025-12-18 @ 9:03 AM
Study NCT ID:
NCT02752282
Status:
None
Last Update Posted:
2019-04-18 00:00:00
First Post:
2016-04-15 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anticipatory Counseling on LNG-IUS Continuation, Utilization and Satisfaction
Sponsor:
None
Organization:
Study Overview
Official Title:
Anticipatory Counseling on LNG-IUS Continuation, Utilization and Satisfaction
Status:
None
Status Verified Date:
2019-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCCUSS
Brief Summary:
Enhanced anticipatory counseling detailing side effects when initiating progestin-only injectable contraception improved its continued use among women.While continuation rates at one year among levonorgestrel intrauterine system (LNG-IUS) users are considerably higher than those for progestin-only injectable users in the United States (80% versus 56%), enhanced anticipatory counseling could have an impact on the 20% of LNG IUS users who choose to discontinue the method within one year of use. For this reason, the investigators propose a study that would develop and pilot-test an anticipatory counseling intervention detailing unscheduled bleeding and other side effects such as pelvic pain or cramping among new LNG IUS users and compare this with a "control," using video technology. The investigators have chosen video technology for the counseling intervention to ensure that all participants receive the exact same information about LNG side effects, which would be not possible using a face-to-face clinician-participant counseling model.
The investigators propose three phases for this study. In Phase 1, a systematic literature search evaluating effective components in videos used for contraceptive counseling and the development of two separate video scripts will lead to: (1) an intervention, detailing expected side effects and safety of the LNG IUS, and (2) a similar-looking "control," detailing only recommended screening guidelines for women, as well as information about LNG IUS safety. This phase of the study uses focus groups prior to the development of the video interventions, initially with family planning experts for content accuracy and cultural sensitivity, and secondarily with new LNG IUS users for acceptability. Findings from this phase will be used to fine-tune the scripts prior to the development of the videos.
In Phase 2 of the study, the investigators will pilot a trial in the clinical setting to evaluate the anticipatory counseling video intervention and its impact on LNG-IUS knowledge, continuation, health care utilization, and satisfaction. After receiving comprehensive contraceptive counseling from their clinicians, women who choose to have the LNG IUS inserted will be given a brochure that asks them to participate in an online study. After signing-on to an innovative website, participants will be randomized to either an intervention or control video and complete short questionnaires related to demographics, baseline menstruation, satisfaction, and LNG IUS knowledge before and after viewing their assigned video. Women will be followed for six months. They will be asked to complete a short online survey at three and six months regarding LNG IUS continuation, health care utilization, and satisfaction. Findings from this study will serve to design a future, appropriately powered randomized controlled trial assessing LNG IUS continuation, utilization, and satisfaction rates at 12 months.
In Phase 3, we will use the findings from Phase 2 to develop a similar protocol and recruit up to 178 women at three sites across the US to test the same primary aims of the video: LNG-IUS continuation, utilization, and satisfaction over a 12 month period. In phase 3, subjects will be randomized to watch either the control or intervention video.
The investigators propose three phases for this study. In Phase 1, a systematic literature search evaluating effective components in videos used for contraceptive counseling and the development of two separate video scripts will lead to: (1) an intervention, detailing expected side effects and safety of the LNG IUS, and (2) a similar-looking "control," detailing only recommended screening guidelines for women, as well as information about LNG IUS safety. This phase of the study uses focus groups prior to the development of the video interventions, initially with family planning experts for content accuracy and cultural sensitivity, and secondarily with new LNG IUS users for acceptability. Findings from this phase will be used to fine-tune the scripts prior to the development of the videos.
In Phase 2 of the study, the investigators will pilot a trial in the clinical setting to evaluate the anticipatory counseling video intervention and its impact on LNG-IUS knowledge, continuation, health care utilization, and satisfaction. After receiving comprehensive contraceptive counseling from their clinicians, women who choose to have the LNG IUS inserted will be given a brochure that asks them to participate in an online study. After signing-on to an innovative website, participants will be randomized to either an intervention or control video and complete short questionnaires related to demographics, baseline menstruation, satisfaction, and LNG IUS knowledge before and after viewing their assigned video. Women will be followed for six months. They will be asked to complete a short online survey at three and six months regarding LNG IUS continuation, health care utilization, and satisfaction. Findings from this study will serve to design a future, appropriately powered randomized controlled trial assessing LNG IUS continuation, utilization, and satisfaction rates at 12 months.
In Phase 3, we will use the findings from Phase 2 to develop a similar protocol and recruit up to 178 women at three sites across the US to test the same primary aims of the video: LNG-IUS continuation, utilization, and satisfaction over a 12 month period. In phase 3, subjects will be randomized to watch either the control or intervention video.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: