Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483483
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2007-06-06
Brief Title:
Project HERMITAGE HIV Prevention in Hospitalized Russian Drinkers
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
Maximizing Opportunity HIV Prevention in Hospitalized Russian Drinkers
Status:
COMPLETED
Status Verified Date:
2017-07
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 objective of this study is to test in a randomized controlled trial the effectiveness of a US secondary HIV prevention program to reduce HIV risk behaviors STD acquisition and alcohol consumption among HIV-infected Russians with risky drinking
Detailed Description:
Russia has one of the fastest growing AIDS epidemics in the world with an estimated 1 million HIV-infected persons Initially the Russian HIV epidemic was almost exclusively among injection drug users IDUs however concern exists that HIV is expanding into the general population via sexual transmission Alcohol use highly prevalent in Russia may increase high-risk sexual behaviors among IDUs and alcohol dependent persons Furthermore animal models suggest that alcohol consumption plays a permissive role for HIV replication as the resultant higher viral loads may increase risk of transmission Thus alcohol use may accelerate HIV transmission to the general population in Russia
The study will randomize 700 HIV-infected patients with risky alcohol consumption to an adapted Healthy Relationships Intervention HRI or attention-control support groups The intervention will be culturally adapted and modified to address substance use and associated risk behaviors Subjects participating in the HRI will attend three 90-120 min structured group sessions in addition to two 30-60 min individualized sessions over the course of 5-10 days Subjects in the attention-control group will participate in general health information sessions in the same format ie 2 individualized and 3 group sessions during the same timeframe
All patients will be assessed at baseline pre-randomization and 6-months and 12-months post-randomization at the recruitment site Primary outcomes are HIV sex and drug risk behaviors and sexually transmitted diseases Additionally subjects will be assessed regarding secondary outcomes including alcohol consumption quality of life and social support victimization suicide overdose and disclosure of HIV serostatus
We hypothesize that relative to the comparison group participants receiving the adapted Healthy Relationships Intervention will have reduced HIV sex and drug risk behaviors and STD acquisition If the intervention is effective among HIV-infected hospitalized patients it could be used to address other HIV infected persons in a variety of Russian settings potentially reducing the transmission of HIV by decreasing risky sex and drug use behaviors among Russians
The study will randomize 700 HIV-infected patients with risky alcohol consumption to an adapted Healthy Relationships Intervention HRI or attention-control support groups The intervention will be culturally adapted and modified to address substance use and associated risk behaviors Subjects participating in the HRI will attend three 90-120 min structured group sessions in addition to two 30-60 min individualized sessions over the course of 5-10 days Subjects in the attention-control group will participate in general health information sessions in the same format ie 2 individualized and 3 group sessions during the same timeframe
All patients will be assessed at baseline pre-randomization and 6-months and 12-months post-randomization at the recruitment site Primary outcomes are HIV sex and drug risk behaviors and sexually transmitted diseases Additionally subjects will be assessed regarding secondary outcomes including alcohol consumption quality of life and social support victimization suicide overdose and disclosure of HIV serostatus
We hypothesize that relative to the comparison group participants receiving the adapted Healthy Relationships Intervention will have reduced HIV sex and drug risk behaviors and STD acquisition If the intervention is effective among HIV-infected hospitalized patients it could be used to address other HIV infected persons in a variety of Russian settings potentially reducing the transmission of HIV by decreasing risky sex and drug use behaviors among Russians
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| R01AA016059 | NIH | None | httpsreporternihgovquickSearchR01AA016059 |