Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000928
Status:
COMPLETED
Last Update Posted:
2016-11-06
First Post:
1999-11-02
Brief Title:
Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
Status:
COMPLETED
Status Verified Date:
2012-10
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:
None
Brief Summary:
To assess the acceptability of and participation in a group counseling intervention including an assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate To evaluate the profile of adverse experiences social psychological and physical harms of individuals resulting from participation in counseling and testing and attempts to initiate condom use within a stable HIV serodiscordant partnership To assess the potential for the intervention to result in increased condom use among stable sexual partners
There is a significant risk of HIV transmission to HIV-uninfected partners in HIV-discordant couples While condom use has been a major component of most AIDS prevention programs since the mid-1980s there has been little emphasis on promoting condom use within stable partnerships The most effective way to promote condom use among discordant couples remains largely unknown
There is a significant risk of HIV transmission to HIV-uninfected partners in HIV-discordant couples While condom use has been a major component of most AIDS prevention programs since the mid-1980s there has been little emphasis on promoting condom use within stable partnerships The most effective way to promote condom use among discordant couples remains largely unknown
Detailed Description:
There is a significant risk of HIV transmission to HIV-uninfected partners in HIV-discordant couples While condom use has been a major component of most AIDS prevention programs since the mid-1980s there has been little emphasis on promoting condom use within stable partnerships The most effective way to promote condom use among discordant couples remains largely unknown
A pilot study to assess the acceptability of intervention precedes the main study The Phase I study recruits 15 HIV-infected men and 15 HIV-infected women and their partners at each of three sites India Thailand and Uganda Volunteers participate in a multi-session group-based condom promotion program for approximately 12 months Couples are organized into small groups consisting of 4 to 6 couples per group Each group meets for a total of 4 sessions within a 2- to 4-week period Follow-up interviews are conducted at Months 1 and 3 following completion of the intervention
A pilot study to assess the acceptability of intervention precedes the main study The Phase I study recruits 15 HIV-infected men and 15 HIV-infected women and their partners at each of three sites India Thailand and Uganda Volunteers participate in a multi-session group-based condom promotion program for approximately 12 months Couples are organized into small groups consisting of 4 to 6 couples per group Each group meets for a total of 4 sessions within a 2- to 4-week period Follow-up interviews are conducted at Months 1 and 3 following completion of the intervention
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