HIV and Drug Use in Georgian Women

NCT01331460 | Completed

• 1 other identifier: R01DA029880
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus

Keywords

HIV; HIV risk; Sexually Transmitted Diseases; Drug Use; Women; Drug Treatment; opioids; injection drug use; stimulants; gender-specific treatment

Outcome Measures

Primary Outcomes (4)

• Sexual practices

  Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment

  3 months after randomization

• Injection Practices

  Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment

  6 months after randomization

• Injection practices

  Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment

  3 months after randomization

• Sexual Practices

  Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment

  6 months after randomization

Secondary Outcomes (5)

• Sexual practices

  3 months after randomization and 6 months after randomization

• Condom Use and Sexual Encounter Negotiation

  3 months after randomization and 6 months after randomization

• Injecting practices

  3 months after randomization and 6 months after randomization

• Drug use

  3 months after randomization and 6 months after randomization

• Alcohol Use

  3 months after randomization and 6 months after randomization

Study Arms (2)

RBT Experimental

EXPERIMENTAL

Behavioral: RBT

Case-Management: Treatment as Usual

ACTIVE COMPARATOR

Other: Case-Management

Interventions

RBT BEHAVIORAL

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.

Also known as: Women's Health CoOp

RBT Experimental

Case-Management OTHER

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

Also known as: Treatment-as-Usual, Standard Intervention

Case-Management: Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Male
• Younger than 18 years
• Not sexually active at least once in past 30 days
• Not able to provide informed consent

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Addiction Research Center, Union Alternative Georgia office

Tbilisi, 0177, Georgia

Location

Related Publications (3)

• 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.

  PMID: 19444667 BACKGROUND

• Jones 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.

  PMID: 16002021 BACKGROUND

• Jones 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.

  PMID: 26644132 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases

Interventions

Case Management

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Irma Kirtadze, MD

  Addiction Research Center, Union Alternative Georgia, Tbilisi

  PRINCIPAL INVESTIGATOR

• Hendree Jones, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: April 8, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 15, 2016

Record last verified: 2016-08

Locations

GE (1)