Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137670
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2005-08-27
Brief Title:
Video-based Intervention Study to Prevent HIVSexually Transmitted Diseases STDs Among STD Clinic Patients
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Effectiveness of a Video-based Educational Intervention to Prevent Human Immunodeficiency Virus HIV and Sexually Transmitted Diseases STDs Among Patients Attending STD Clinics
Status:
COMPLETED
Status Verified Date:
2012-09
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:
None
Brief Summary:
The purpose of this study is to assess the effectiveness of a brief 23-minute video-based educational waiting room intervention to reduce incident STD and high risk behavior among STD patients attending STD clinics in three United States US cities
Detailed Description:
Approximately 15 million incident cases of sexually transmitted diseases STDs occur annually As a result primary prevention of HIVSTDs among persons who have chosen to be sexually active remains a high public health priority A number of effective interventions to prevent HIVSTDs have been developed however many require considerable time and resource investments from both service providers and participants These programs are often difficult to implement and sustain over time As a result simple practical interventions that can reduce transmission or acquisition of HIVSTDs among STD clinic patients while being both easily implemented and sustainable are urgently needed and will ultimately enhance the menu of effective programs that are currently available to the STD clinic population
The intervention trial was designed to develop and evaluate a video-based HIVSTD prevention intervention for STD clinic clients The primary goals of this study are to assess whether a brief video-based educational waiting room intervention can reduce STD incidence STD incidence outcome study and high risk behavior behavioral outcome study among male and female patients attending STD clinics when compared with patients who receive standard clinic services This study is being conducted as a multi-site trial in 3 urban STD clinics
The intervention condition consists of a 23-minute educational video focused on preventing STD and HIV infection shown on a large television in the waiting room Health promotion posters supplement the video The control condition consists of the current standard waiting room experience in each citys STD clinic
In the STD incidence outcome study groups of patients attending the participating STD clinics are randomly assigned to blocks of clinic weeks to either the intervention or control condition A waiver of informed consent was obtained whereby no subjects are actively enrolled for this phase of the study Through a retrospective review of existing medical records and STD surveillance registry data we will determine and compare the incidence of new STDs over a 12-month period on average by assigned waiting room conditions
In the behavioral outcome study investigators administer computer-based survey instruments to a random sample of 1600 male and female patients 800 per arm both at enrollment and at 3 months following their initial clinic visit The primary objective of the behavioral study is to assess the effectiveness of the video intervention by comparing levels of high-risk behavior between waiting room conditions at 3 months follow-up
The intervention trial was designed to develop and evaluate a video-based HIVSTD prevention intervention for STD clinic clients The primary goals of this study are to assess whether a brief video-based educational waiting room intervention can reduce STD incidence STD incidence outcome study and high risk behavior behavioral outcome study among male and female patients attending STD clinics when compared with patients who receive standard clinic services This study is being conducted as a multi-site trial in 3 urban STD clinics
The intervention condition consists of a 23-minute educational video focused on preventing STD and HIV infection shown on a large television in the waiting room Health promotion posters supplement the video The control condition consists of the current standard waiting room experience in each citys STD clinic
In the STD incidence outcome study groups of patients attending the participating STD clinics are randomly assigned to blocks of clinic weeks to either the intervention or control condition A waiver of informed consent was obtained whereby no subjects are actively enrolled for this phase of the study Through a retrospective review of existing medical records and STD surveillance registry data we will determine and compare the incidence of new STDs over a 12-month period on average by assigned waiting room conditions
In the behavioral outcome study investigators administer computer-based survey instruments to a random sample of 1600 male and female patients 800 per arm both at enrollment and at 3 months following their initial clinic visit The primary objective of the behavioral study is to assess the effectiveness of the video intervention by comparing levels of high-risk behavior between waiting room conditions at 3 months follow-up
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R18CCR821004 | None | None | None |
| R18CCR921007 | None | None | None |
| R18CCR121005 | None | None | None |