Human Immunodeficiency VirusIMEDINCT01331460
HIV and Drug Use in Georgian Women
A study testing RBT and Case-Management in people with Human Immunodeficiency Virus, run by University of North Carolina, Chapel Hill at 1 site in Georgia.
Trial summary
The purpose of this study is to determine how drug abuse treatment interventions can be integrated with established Human Immunodeficiency Virus prevention approaches to optimize their combined effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- RBT and Case-Management
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteGeorgia
- Study dates
- Apr 2011to Jan 2016
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Conversant in Georgian
- Able to provide informed consent
- Age 18 years or older
- Has ever injected illicit drugs
- Sexually active at least once in the past 30 days.
Who cannot join
- Male
- Younger than 18 years
- Not sexually active at least once in past 30 days
- Not able to provide informed consent
Trial locations and contacts
1 site in 1 country.
Georgia1 site
Addiction Research Center, Union Alternative Georgia office
Tbilisi, 0177
About this study
The purpose of this study is to determine how drug abuse treatment interventions can be integrated with established Human Immunodeficiency Virus prevention approaches to optimize their combined effectiveness.
Read the detailed description
Eastern Europe is an emerging epicenter of injection drug use and Human Immunodeficiency Virus infection, among women. Within Eastern Europe, the Republic of Georgia is one of the last countries where an Human Immunodeficiency Virus epidemic can still be averted. This proposal responds to RFA-DA-10-008 International Research Collaborations on Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome and Drug Use by building on the successful collaboration among United States and Eastern European investigators from the Republic of Georgia and Russia. Recent data from Georgia's neighbor, Russia, reported 59% of Injection Drug Using women Human Immunodeficiency Virus seropositive; this is a threat that looms over Georgia. Understanding the risk factors that operate in Russia that drive this epidemic may help forestall such a catastrophe in Georgia. As such, this proposal directly responds to the Eastern European Region question of "How can drug abuse treatment interventions be integrated with established Human Immunodeficiency Virus prevention approaches to optimize their combined effectiveness?" Injection drug using Georgian women show prevalence rates of 2% for Human Immunodeficiency Virus and 25% for hepatitis C. The low prevalence of Human Immunodeficiency Virus in Georgian women provides an important window of opportunity to intervene and avoid the possibility of a Human Immunodeficiency Virus epidemic. In Georgia, women's expected subordination to men makes women vulnerable to Human Immunodeficiency Virus/Hepatitis C infection. The public health impact of the proposed project is far-reaching. Taken to scale, our Georgian reinforcement-based treatment model holds the promise not only to lessen the possibility of a Human Immunodeficiency Virus epidemic and slow the increase in the Hepatitis C transmission rate in Georgia, but also to strongly influence the development of women-focused drug abuse intervention models for treatment tailoring and dissemination in other nations.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- RBT, Case-Management
- Keywords
- HIV, HIV risk, Sexually Transmitted Diseases, Drug Use, Women, Drug Treatment, opioids, injection drug use, stimulants, gender-specific treatment
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBTBehavioural
Also called Women's Health CoOp
Intervention for Injection Drug Using Women:
Incorporates elements of Reinforcement-Based Treatment and Women's Health CoOp to help prevent drug abuse (and promote drug abstinence) and lower risk of Human Immunodeficiency Virus, violence, and high-risk sexual behaviors.
Case-ManagementOther
Also called Treatment-as-Usual, Standard Intervention
Standard Intervention:
Incorporates standard practice elements like accessing resources, service linkage, monitoring the success of patient-service linkages, and advocating for the patient to help her meet her needs
| Study group | Role | What they receive |
|---|---|---|
| RBT Experimental | Experimental | Not described Receives: Behavioral: RBT |
| Case-Management: Treatment as Usual | Active comparator | Not described Receives: Other: Case-Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual practices
Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment
Measured: 3 months after randomization
Injection Practices
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Measured: 6 months after randomization
Injection practices
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Measured: 3 months after randomization
Sexual Practices
Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment
Measured: 6 months after randomization
Secondary outcomes (5)
Sexual practices
Unprotected sex at last encounter measured by revised risk behavior assessment
Measured: 3 months after randomization and 6 months after randomization
Condom Use and Sexual Encounter Negotiation
To use a condom in past 30 days and to negotiate sexual encounters in past 30 days measured by revised risk behavior assessment
Measured: 3 months after randomization and 6 months after randomization
Injecting practices
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Measured: 3 months after randomization and 6 months after randomization
Drug use
Frequency of opioid use in past 30 days revised risk behavior assessment plus urine test Self-Report verified by biological sample Poisson. Also frequency of stimulant use in past 30 days revised risk behavior assessment and urine test. Addiction Severity Index drug composite score.
Measured: 3 months after randomization and 6 months after randomization
Alcohol Use
Frequency of alcohol use in past 30 days Revised Risk Behavior Assessment and breath test. Self-Report verified by biological sample Poisson.
Addiction Severity Index alcohol composite score.
Measured: 3 months after randomization and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Irma Kirtadze, MD, Principal investigator, Addiction Research Center, Union Alternative Georgia, TbilisiHendree Jones, PhD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331460
- Sponsor's protocol ID
- R01DA029880
- Other IDs
- R01DA029880
- Acronym
- IMEDI
- Status last verified
- Aug 2016
- First submitted
- 22 Feb 2011
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Costenbader EC, Otiashvili D, Meyer W, Zule WA, Orr A, Kirtadze I. Secrecy and risk among MSM in Tbilisi, Georgia. AIDS Care. 2009 May;21(5):591-7. doi: 10.1080/09540120802385587.
PubMed 19444667Jones HE, Wong CJ, Tuten M, Stitzer ML. Reinforcement-based therapy: 12-month evaluation of an outpatient drug-free treatment for heroin abusers. Drug Alcohol Depend. 2005 Aug 1;79(2):119-28. doi: 10.1016/j.drugalcdep.2005.01.006. Epub 2005 Feb 24.
PubMed 16002021Jones HE, Kirtadze I, Otiashvili D, Murphy K, O'Grady KE, Zule W, Krupitsky E, Wechsberg WM. Feasibility and initial efficacy of a culturally sensitive women-centered substance use intervention in Georgia: Sex risk outcomes. Subst Abuse Treat Prev Policy. 2015 Dec 8;10:47. doi: 10.1186/s13011-015-0043-0.
PubMed 26644132
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV and Drug Use in Georgian Women
- ClinicalTrials.gov ID
- NCT01331460
- Acronym / sponsor ID
- IMEDI / R01DA029880
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, HIV risk, Sexually Transmitted Diseases, Drug Use, Women, Drug Treatment, opioids, injection drug use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 8 Apr 2011 (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 purpose of this study is to determine how drug abuse treatment interventions can be integrated with established Human Immunodeficiency Virus prevention approaches to optimize their combined effectiveness.
Detailed description
Eastern Europe is an emerging epicenter of injection drug use and Human Immunodeficiency Virus infection, among women. Within Eastern Europe, the Republic of Georgia is one of the last countries where an Human Immunodeficiency Virus epidemic can still be averted. This proposal responds to RFA-DA-10-008 International Research Collaborations on Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome and Drug Use by building on the successful collaboration among United States and Eastern European investigators from the Republic of Georgia and Russia. Recent data from Georgia's neighbor, Russia, reported 59% of Injection Drug Using women Human Immunodeficiency Virus seropositive; this is a threat that looms over Georgia. Understanding the risk factors that operate in Russia that drive this epidemic may help forestall such a catastrophe in Georgia. As such, this proposal directly responds to the Eastern European Region question of "How can drug abuse treatment interventions be integrated with established Human Immunodeficiency Virus prevention approaches to optimize their combined effectiveness?" Injection drug using Georgian women show prevalence rates of 2% for Human Immunodeficiency Virus and 25% for hepatitis C. The low prevalence of Human Immunodeficiency Virus in Georgian women provides an important window of opportunity to intervene and avoid the possibility of a Human Immunodeficiency Virus epidemic. In Georgia, women's expected subordination to men makes women vulnerable to Human Immunodeficiency Virus/Hepatitis C infection. The public health impact of the proposed project is far-reaching. Taken to scale, our Georgian reinforcement-based treatment model holds the promise not only to lessen the possibility of a Human Immunodeficiency Virus epidemic and slow the increase in the Hepatitis C transmission rate in Georgia, but also to strongly influence the development of women-focused drug abuse intervention models for treatment tailoring and dissemination in other nations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBT Experimental | Experimental | Behavioral: RBT |
| Case-Management: Treatment as Usual | Active comparator | Other: Case-Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Conversant in Georgian
- Able to provide informed consent
- Age 18 years or older
- Has ever injected illicit drugs
- Sexually active at least once in the past 30 days.
Key exclusion criteria (4 listed)
- Male
- Younger than 18 years
- Not sexually active at least once in past 30 days
- Not able to provide informed consent
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 |
|---|---|---|
| RBTAlso: Women's Health CoOpIntervention for Injection Drug Using Women: Incorporates elements of Reinforcement-Based Treatment and Women's Health CoOp to help prevent drug abuse (and promote drug abstinence) and lower risk of Human Immunodeficiency Virus, violence, and high-risk sexual behaviors. | Behavioural | RBT Experimental |
| Case-ManagementAlso: Treatment-as-Usual, Standard InterventionStandard Intervention: Incorporates standard practice elements like accessing resources, service linkage, monitoring the success of patient-service linkages, and advocating for the patient to help her meet her needs | Other | Case-Management: Treatment as Usual |
Primary outcome
Sexual practices
Time frame: 3 months after randomization
Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment
Injection Practices
Time frame: 6 months after randomization
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Injection practices
Time frame: 3 months after randomization
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Sexual Practices
Time frame: 6 months after randomization
Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment
5 secondary outcomes
Sexual practices
Time frame: 3 months after randomization and 6 months after randomization
Condom Use and Sexual Encounter Negotiation
Time frame: 3 months after randomization and 6 months after randomization
Injecting practices
Time frame: 3 months after randomization and 6 months after randomization
Drug use
Time frame: 3 months after randomization and 6 months after randomization
Alcohol Use
Time frame: 3 months after randomization and 6 months after randomization
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 15 Aug 2016.
- Background: PubMed 19444667Costenbader EC, Otiashvili D, Meyer W, Zule WA, Orr A, Kirtadze I. Secrecy and risk among MSM in Tbilisi, Georgia. AIDS Care. 2009 May;21(5):591-7. doi: 10.1080/09540120802385587.
- Background: PubMed 16002021Jones HE, Wong CJ, Tuten M, Stitzer ML. Reinforcement-based therapy: 12-month evaluation of an outpatient drug-free treatment for heroin abusers. Drug Alcohol Depend. 2005 Aug 1;79(2):119-28. doi: 10.1016/j.drugalcdep.2005.01.006. Epub 2005 Feb 24.
- Derived from this study: PubMed 26644132Jones HE, Kirtadze I, Otiashvili D, Murphy K, O'Grady KE, Zule W, Krupitsky E, Wechsberg WM. Feasibility and initial efficacy of a culturally sensitive women-centered substance use intervention in Georgia: Sex risk outcomes. Subst Abuse Treat Prev Policy. 2015 Dec 8;10:47. doi: 10.1186/s13011-015-0043-0.
- Related InfoLink provided by the sponsor.
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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.
Irma Kirtadze, MD principal investigator
Addiction Research Center, Union Alternative Georgia, Tbilisi
Hendree Jones, PhD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RBT and Case-Management in people with Human Immunodeficiency Virus, run by University of North Carolina, Chapel Hill at 1 site in Georgia.
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 5 inclusion and 4 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 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. 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?
Sexual practices (time frame: 3 months after randomization). The study lists 4 primary outcomes in all. 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 NCT01331460, which also lists 3 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 15 Aug 2016.