Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000931
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
1999-11-02
Brief Title:
HIV Prevention Counseling for Men Who Have Sex With Men
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Clinical Trial of the Efficacy of a Behavioral Intervention to Prevent Acquisition of HIV Among Men Who Have Sex With Men
Status:
COMPLETED
Status Verified Date:
2006-11
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 see if a behavioral intervention a special kind of counseling can reduce the risk of HIV infection in men who have sex with men The behavioral intervention will be compared to the standard risk reduction counseling that is given before and after getting an HIV test
In standard pre- and post-test counseling everyone is told the same things about how to prevent HIV The behavioral intervention used in this study is designed to help each individual prevent HIV according to his specific problems and needs
In standard pre- and post-test counseling everyone is told the same things about how to prevent HIV The behavioral intervention used in this study is designed to help each individual prevent HIV according to his specific problems and needs
Detailed Description:
The intervention being evaluated in this trial is based on the extensive literature on behavioral approaches to risk reduction in MSM These reviews recommend an intervention that unlike the current standard HIV pre-test and post-test risk-reduction counseling is tailored to an individuals unique problems and needs lifestyle and situations that contribute to high-risk behavior Furthermore there is a need for HIV-prevention intervention trials using biological endpoints eg HIV seroconversion in addition to behavioral change indices
Participants are randomly assigned to receive either the behavioral intervention or the control risk-reduction counseling The same counseling staff provides the two types of treatment The behavioral intervention consists of 10 counseling sessions within a 4-month period followed by quarterly maintenance sessions for the remainder of the 3-year follow-up The intervention is conducted on a one-to-one basis and targets condom use change in sexual practices associated with HIV risk and change in sexual practices in the context of alcohol and drug use Participants in the control group receive pre- and post-test counseling at enrollment then semiannually through Month 36 Beginning at Month 6 all participants complete routine semiannual visits At each visit Risk Assessment and phlebotomy for specimen collection for HIV antibody tests are administered As is routine in most public counseling and testing venues participants in the control condition do not see the same counselor consistently
Participants are randomly assigned to receive either the behavioral intervention or the control risk-reduction counseling The same counseling staff provides the two types of treatment The behavioral intervention consists of 10 counseling sessions within a 4-month period followed by quarterly maintenance sessions for the remainder of the 3-year follow-up The intervention is conducted on a one-to-one basis and targets condom use change in sexual practices associated with HIV risk and change in sexual practices in the context of alcohol and drug use Participants in the control group receive pre- and post-test counseling at enrollment then semiannually through Month 36 Beginning at Month 6 all participants complete routine semiannual visits At each visit Risk Assessment and phlebotomy for specimen collection for HIV antibody tests are administered As is routine in most public counseling and testing venues participants in the control condition do not see the same counselor consistently
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