Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021775
Status:
COMPLETED
Last Update Posted:
2014-01-03
First Post:
2001-08-04
Brief Title:
HIV Prevention Preparedness Study in Russia China and India
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
HIV Prevention Preparedness Study
Status:
COMPLETED
Status Verified Date:
2013-12
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 set up a system for doing research on HIV prevention in various parts of the world
In order to plan large long-term studies on the prevention of HIV in different areas of the world it is necessary to get certain information first It is important to know about the rate of HIV infection and how to get people to enroll for any future studies This study will be done at 4 study locations
In order to plan large long-term studies on the prevention of HIV in different areas of the world it is necessary to get certain information first It is important to know about the rate of HIV infection and how to get people to enroll for any future studies This study will be done at 4 study locations
Detailed Description:
In order to realistically plan for future Phase III studies on HIV prevention information must be obtained to characterize study population parameters at HTPN sites Very different study designs may be required depending on these parameters such as the ability of HPTN research centers to recruit study participants and the rate of HIV incidence observed in study populations This study will be conducted at 4 HPTN sites to establish the necessary research knowledge and infrastructure
This study enrolls participants from St Petersburg Russia Xinjiang and Guangxi China and Chennai India who are at high risk for HIV infection due to sexual andor drug use behaviors Participants who meet the screening criteria then complete an HIV risk assessment interview receive HIV pre-test and risk reduction counseling and undergo phlebotomy for HIV antibody testing Participants who test positive are referred to available services and studies Those who test HIV-negative and meet eligibility criteria are enrolled and maintained in follow-up over the next 12 months Participants complete locator contacts at Months 3 and 9 and have follow-up visits at Months 6 and 12 for similar tests as performed at entry In a substudy of this trial in China participants will be interviewed about their drug use social networks needs and perceptions about HIVAIDS These results will be used by HPTN to design more culturally sensitive and appropriate trials in the future
This study enrolls participants from St Petersburg Russia Xinjiang and Guangxi China and Chennai India who are at high risk for HIV infection due to sexual andor drug use behaviors Participants who meet the screening criteria then complete an HIV risk assessment interview receive HIV pre-test and risk reduction counseling and undergo phlebotomy for HIV antibody testing Participants who test positive are referred to available services and studies Those who test HIV-negative and meet eligibility criteria are enrolled and maintained in follow-up over the next 12 months Participants complete locator contacts at Months 3 and 9 and have follow-up visits at Months 6 and 12 for similar tests as performed at entry In a substudy of this trial in China participants will be interviewed about their drug use social networks needs and perceptions about HIVAIDS These results will be used by HPTN to design more culturally sensitive and appropriate trials in the future
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 |
|---|---|---|---|
| 10611 | REGISTRY | DAIDS ES Registry Number | None |