Project HERMITAGE: HIV Prevention in Hospitalized Russian Drinkers

Study Overview
=================
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 (i.e., 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.

Official Title
-----------------
Maximizing Opportunity: HIV Prevention in Hospitalized Russian Drinkers

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Individual and group HIV risk behavior counseling sessions
* Behavioral: health education and support group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 years old; HIV positive; Alcohol consumption at NIAAA at-risk drinking levels (greater than 14 drinks per week [or more than 4 drinks per day] for men, and greater than 7 drinks per week [or more than 3 drinks per day] for women) during the 30 days prior to hospital admission, For subjects whose drinking was not risky 30 days prior to hospital admission, we will ask if their drinking was equivalent to binge amounts on any day in the prior 6 months; Self-reported unprotected anal or vaginal sex in the last 6 months; Provision of contact information (e.g., name, home address, telephone number) of two relatives or close friends who can be contacted to share information that may be used to assist with follow-up; Stable address within St. Petersburg or districts within 150 kilometers of St. Petersburg; and Possession of a home telephone; Fluent in Russian; Ability to provide informed consent. Exclusion Criteria: Severe cognitive impairment (i.e., clinically apparent dementia, active psychosis, or severe paranoid disorder) as judged by a hospital clinician and stated in the records; Acute illness precluding ability to participate in assessment for eligibility (however these patients may be assessed again on a subsequent day); Trying to get (partner) pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Healthy Relationships Intervention (HRI) | Behavioral: Individual and group HIV risk behavior counseling sessions<br>* Healthy Relationships Intervention (HRI) culturally adapted and modified to address substance use and associated risk behaviors; subjects will attend three 2-hour structured group sessions in addition to two 1-hour individualized sessions over the course of 10 days.<br>* Other names: HRI;|
| Active Comparator: Attention-control group<br>health education & support | Behavioral: health education and support group<br>* general health information (nutrition, stress reduction) in 2 individual sessions and 3 group sessions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of protected sex episodes, percentage of unprotected sex episodes Multiple drug partners, Number of sexually transmitted infections (by self report), Alcohol consumption, Disclosure of HIV serostatus |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Unsafe sex, High-risk sex, Needle sharing, STDs