HIV Prevention for Injecting Drug Users in Kazakhstan

NCT01690442 | Completed Phase 2 DMC

• 1 other identifier: AAAD2056
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study addresses a significant public health threat of HIV, HCV and other STIs among a very high risk population of active IDUs and their sexual partners in Kazakhstan a region that is experiencing one of the fastest rising HIV epidemics in the world. There is a race to develop and implement effective HIV preventive interventions for IDUs and their sexual partners to stem the spread of HIV, HCV and other STIs in Almaty, Shu and other Central Asian towns along drug trafficking routes. The proposed study will test the effectiveness of a couplesbased HIV/STI risk reduction intervention to decrease new cases of HIV and Hepatitis C (HCV) and incidence of sexually transmitted infections (STIs), as well as to reduce unsafe injection practices and increase condom use among injecting drug users (IDUs) and their heterosexual, intimate partners in Kazakhstan.

Conditions

HIV; AIDS

Keywords

HIV; AIDS; Prevention

Outcome Measures

Primary Outcomes (4)

• The proportion of condom protected acts of vaginal and anal intercourse

  12 months

• The number of incidents of unclean syringes or needles in the past 90 days

  12 months

• Proportion of injection acts in which unclean needles or syringes were used in the past 90 days

  12 months

• The number of acts of unprotected vaginal and anal intercourse during the 90 days prior to the assessment period

  12 months

Secondary Outcomes (1)

• Number of people participants shared needles or syringes with in the past 90 days

  12 months

Study Arms (2)

Couples Based HIV/STI Risk Reduction Intervention (CHSR)

EXPERIMENTAL

The intervention includes a combination of empowerment and couple self-efficacy building strategies, which are employed to help couples overcome resistance to risk reduction.

Behavioral: Couples Based HIV/STI Risk Reduction Intervention (CHSR)

Renaissance Wellness Promotion (WP)

ACTIVE COMPARATOR

This intervention employs a psychoeducational approach to promote wellness, focusing on: maintaining a healthy diet on a low budget, exercising and fitness, stress reducing strategies and specific health related issues that affect IDUs, such as overdose.

Behavioral: Renaissance Wellness Promotion (WP)

Interventions

Couples Based HIV/STI Risk Reduction Intervention (CHSR) BEHAVIORAL

The intervention includes a combination of empowerment and couple self-efficacy building strategies, which are employed to help couples overcome resistance to risk reduction.

Couples Based HIV/STI Risk Reduction Intervention (CHSR)

Renaissance Wellness Promotion (WP) BEHAVIORAL

This intervention employs a psychoeducational approach to promote wellness, focusing on: maintaining a healthy diet on a low budget, exercising and fitness, stress reducing strategies and specific health related issues that affect IDUs, such as overdose.

Renaissance Wellness Promotion (WP)

Eligibility Criteria

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

You may qualify if:

• Couples are eligible to participate if both partners are aged 18 or older
• both partners identify each other as their main partner of the opposite sex and someone whom the participant considers a boy/girlfriend, spouse, lover and/ or parent of his/her child
• the relationship has existed at least 3 months
• each partner intends to remain together for at least 12 months
• at least one partner reports having had unprotected vaginal or anal intercourse with the other partner at least once in the previous 90 days
• at least one partner reports injecting drugs in the past 90 days
• neither partner has plans to relocate beyond a reasonable distance from the study site

You may not qualify if:

• Couples are excluded if either partner shows evidence of significant psychiatric, physical or neurological impairment that would limit effective participation as confirmed on a MiniMental State Examination and/or Quick Test
• either partner reports severe physical violence perpetrated by the other partner in the past year on the Revised Conflict Tactics Scale
• either partner is unable to commit to participate in the study through to completion
• either partner reports that the couple is planning a pregnancy within the next 18 months
• either partner is not fluent in Russian as determined during Informed Consent

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Global Health Research Center of Central Asia

Almaty, Kazakhstan

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Nabila El-Bassel

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Social Intervention Group, Global Health Research Center of Central Asia

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 21, 2012
• Study Start: May 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 27, 2014

Record last verified: 2014-02

Locations

KA (1)