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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA016059 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Healthy Relationships Intervention (HRI) |
|
| Attention-control group | Active Comparator | health education & support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual and group HIV risk behavior counseling sessions | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis) | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey H. Samet, MD, MA, MPH | Boston Medical Center, Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Drug Addiction Center | Saint Petersburg | Russia | ||||
| Pavlov State Medical University and Botkin Infectious Disease Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37158538 | Derived | Greene MC, Kane J, Alto M, Giusto A, Lovero K, Stockton M, McClendon J, Nicholson T, Wainberg ML, Johnson RM, Tol WA. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries. Cochrane Database Syst Rev. 2023 May 9;5(5):CD013350. doi: 10.1002/14651858.CD013350.pub2. | |
| 30964750 | Derived | Samet JH, Blokhina E, Cheng DM, Walley AY, Lioznov D, Gnatienko N, Quinn EK, Bridden C, Chaisson CE, Toussova O, Gifford AL, Raj A, Krupitsky E. A strengths-based case management intervention to link HIV-positive people who inject drugs in Russia to HIV care. AIDS. 2019 Jul 15;33(9):1467-1476. doi: 10.1097/QAD.0000000000002230. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D047568 | Unsafe Sex |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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|
|
| health education and support group | Behavioral | general health information (nutrition, stress reduction) in 2 individual sessions and 3 group sessions. |
|
| Saint Petersburg |
| Russia |
| St. Petersburg AIDS Center | Saint Petersburg | Russia |
| 28600603 | Derived | Lunze K, Lioznov D, Cheng DM, Nikitin RV, Coleman SM, Bridden C, Blokhina E, Krupitsky E, Samet JH. HIV Stigma and Unhealthy Alcohol Use Among People Living with HIV in Russia. AIDS Behav. 2017 Sep;21(9):2609-2617. doi: 10.1007/s10461-017-1820-8. |
| 25170994 | Derived | Samet JH, Raj A, Cheng DM, Blokhina E, Bridden C, Chaisson CE, Walley AY, Palfai TP, Quinn EK, Zvartau E, Lioznov D, Krupitsky E. HERMITAGE--a randomized controlled trial to reduce sexually transmitted infections and HIV risk behaviors among HIV-infected Russian drinkers. Addiction. 2015 Jan;110(1):80-90. doi: 10.1111/add.12716. Epub 2014 Oct 16. |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |