HIV and Drug Use in Georgian Women (IMEDI)
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ClinicalTrials.gov Identifier: NCT01331460 |
Recruitment Status
:
Completed
First Posted
: April 8, 2011
Last Update Posted
: August 15, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus | Behavioral: RBT Other: Case-Management | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 128 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Prevention |
Official Title: | HIV and Drug Use in Georgian Women |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | January 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: RBT Experimental |
Behavioral: RBT
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. Other Name: Women's Health CoOp
|
Active Comparator: Case-Management: Treatment as Usual |
Other: Case-Management
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 Other Names:
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- 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
- Sexual practices [ Time Frame: 3 months after randomization and 6 months after randomization ]Unprotected sex at last encounter measured by revised risk behavior assessment
- Condom Use and Sexual Encounter Negotiation [ Time Frame: 3 months after randomization and 6 months after randomization ]To use a condom in past 30 days and to negotiate sexual encounters in past 30 days measured by revised risk behavior assessment
- Injecting practices [ Time Frame: 3 months after randomization and 6 months after randomization ]Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
- Drug use [ Time Frame: 3 months after randomization and 6 months after randomization ]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.
- Alcohol Use [ Time Frame: 3 months after randomization and 6 months after randomization ]
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Male
- Younger than 18 years
- Not sexually active at least once in past 30 days
- Not able to provide informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331460
Georgia | |
Addiction Research Center, Union Alternative Georgia office | |
Tbilisi, Georgia, 0177 |
Principal Investigator: | Irma Kirtadze, MD | Addiction Research Center, Union Alternative Georgia, Tbilisi | |
Principal Investigator: | Hendree Jones, PhD | UNC Chapel Hill |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT01331460 History of Changes |
Other Study ID Numbers: |
R01DA029880 ( U.S. NIH Grant/Contract ) |
First Posted: | April 8, 2011 Key Record Dates |
Last Update Posted: | August 15, 2016 |
Last Verified: | August 2016 |
Keywords provided by University of North Carolina, Chapel Hill:
HIV HIV risk Sexually Transmitted Diseases Drug Use Women |
Drug Treatment opioids injection drug use stimulants gender-specific treatment |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |