HIV InfectionsNCT00483483
Project HERMITAGE: HIV Prevention in Hospitalized Russian Drinkers
A study testing Individual and group HIV risk behavior counseling sessions and health education and support group in people with HIV Infections, run by Boston Medical Center at 3 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Individual and group HIV risk behavior counseling sessions and health education and support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 3 sitesRussia
- Study dates
- Oct 2007to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Possession of a home telephone;
- Fluent in Russian;
- Ability to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
City Drug Addiction Center
Saint Petersburg
Pavlov State Medical University and Botkin Infectious Disease Hospital
Saint Petersburg
St. Petersburg AIDS Center
Saint Petersburg
About this study
Official title: Maximizing Opportunity: HIV Prevention in Hospitalized Russian Drinkers
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Individual and group HIV risk behavior counseling sessions, health education and support group
- Keywords
- HIV, Unsafe sex, High-risk sex, Needle sharing, STDs
- Medical subject headings
- HIV Infections, Unsafe Sex, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual and group HIV risk behavior counseling sessionsBehavioural
Also called HRI
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.
health education and support groupBehavioural
general health information (nutrition, stress reduction) in 2 individual sessions and 3 group sessions.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Healthy Relationships Intervention (HRI) Receives: Behavioral: Individual and group HIV risk behavior counseling sessions |
| Attention-control group | Active comparator | health education \& support Receives: Behavioral: health education and support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis)
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jeffrey Samet, Boston Medical Center
- Investigators
- Jeffrey H. Samet, MD, MA, MPH, Principal investigator, Boston Medical Center, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483483
- Sponsor's protocol ID
- H-25082
- Other IDs
- R01AA016059
- Status last verified
- Jul 2017
- First submitted
- 6 Jun 2007
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37158538Samet 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.
PubMed 30964750Lunze 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.
PubMed 28600603Samet 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.
PubMed 25170994
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Opportunity: HIV Prevention in Hospitalized Russian Drinkers
- ClinicalTrials.gov ID
- NCT00483483
- Acronym / sponsor ID
- H-25082
- Conditions
- HIV Infections
- Keywords
- HIV, Unsafe sex, High-risk sex, Needle sharing, STDs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Oct 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Individual and group HIV risk behavior counseling sessionsHealthy Relationships Intervention (HRI) |
| Attention-control group | Active comparator | Behavioral: health education and support grouphealth education \& support |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual and group HIV risk behavior counseling sessionsAlso: HRIHealthy 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. | Behavioural | 1 |
| health education and support groupgeneral health information (nutrition, stress reduction) in 2 individual sessions and 3 group sessions. | Behavioural | Attention-control group |
Primary outcome
Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis)
Time frame: 12 months
1 secondary outcome
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
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Derived from this study: PubMed 37158538Greene 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.
- Derived from this study: PubMed 30964750Samet 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.
- Derived from this study: PubMed 28600603Lunze 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.
- Derived from this study: PubMed 25170994Samet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey H. Samet, MD, MA, MPH principal investigator
Boston Medical Center, Boston University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual and group HIV risk behavior counseling sessions and health education and support group in people with HIV Infections, run by Boston Medical Center at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00483483, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.