Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436306
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2007-02-15
Brief Title:
Stage Matched Intervention to Increase Dual Method Use
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Stage Matched Intervention to Increase Dual Method Use
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
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:
PROTECT
Brief Summary:
The primary purpose of Project PROTECT was to evaluate two different intervention approaches that encourage young women to use dual methods of contraception The individualized intervention is a computer assisted fully-tailored interactive intervention based on the transtheoretical model of behavior change This intervention was compared to an enhanced standard care intervention that provided computer-based non-tailored information and advice regarding the use of contraceptive methods The two primary outcomes of this trial include 1 a behavioral outcome the reported use of dual methods of contraception and 2 a biological outcome an incident or recurrent STI or unintended pregnancy The hypotheses of this trial were 1 the individualized intervention will result in a greater increase in dual contraceptive use than the standard care approach and 2 the individualized intervention would result in greater protection against incident or recurrent cases of sexually transmitted infections and unplanned pregnancies
Detailed Description:
Protection from both sexually transmitted infections STIs human immunodeficiency virus HIV and unintended pregnancy can be achieved with the use of dual methods of contraception This proposal was designed to develop implement and evaluate the impact of an innovative computer-assisted stage-based individualized interactive intervention Individualized Intervention based on the transtheoretical compared to enhanced standard care counseling on the use of dual methods of contraception Primary outcomes including behavioral and biological outcomes were assessed in this randomized clinical trial of 550 high-risk women Participants were followed at 6 month intervals for 24 months with follow-up interviews to determine reported use of dual methods of contraception behavioral outcome Clinical examinations at 12 and 24 months and with new onset of symptoms assessed biological outcomes including incident or recurrent cases of STI and unintended pregnancy Secondary outcomes included intermediate outcome variables such as changes in stage of change processes of change decisional balance and self-efficacy The primary hypotheses of this study were 1 the Individualized Intervention will result in increased dual contraceptive use 2 the Individualized Intervention will result in protection against new cases of STIs re-infection with sexually transmitted organisms and unplanned pregnancies and 3 the Individualized Intervention will lead to the greatest changes in secondary outcome measures If found to be effective the stage-matched intervention has potential for widespread dissemination in schools clinics offices and community centers to prevent STIsHIV and unintended pregnancy
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?:
None