HIV Prevention for Injecting Drug Users in Kazakhstan - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV AIDS	Behavioral: Couples Based HIV/STI Risk Reduction Intervention (CHSR) Behavioral: Renaissance Wellness Promotion (WP)	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Couples Based HIV/STI Prevention for Injecting Drug Users in Kazakhstan

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

The proportion of condom protected acts of vaginal and anal intercourse [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The number of incidents of unclean syringes or needles in the past 90 days [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Proportion of injection acts in which unclean needles or syringes were used in the past 90 days [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The number of acts of unprotected vaginal and anal intercourse during the 90 days prior to the assessment period [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of people participants shared needles or syringes with in the past 90 days [ Time Frame: 12 months ] [ Designated as safety issue: No ]


Enrollment:	600
Study Start Date:	May 2008
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Couples Based HIV/STI Risk Reduction Intervention (CHSR) 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) The intervention includes a combination of empowerment and couple self-efficacy building strategies, which are employed to help couples overcome resistance to risk reduction.
Active Comparator: Renaissance Wellness Promotion (WP) 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) 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.

Detailed Description:

The proposed study will rigorously test the efficacy of an innovative, 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. Central Asia has experienced one of the fastest growing HIV/AIDS epidemics due to a sharp increase in injection drug use. For the proposed study, the participants will be 400 IDUs and their heterosexual intimate partners. These 400 couples will be randomized to one of two interventions: a 5session couplesbased HIV/STI risk reduction intervention or a 5session couplesbased wellness promotion intervention, which will serve as a control condition. Participants will be assessed with repeated measures at baseline, 3, 6, and 12months postintervention. The primary behavioral outcomes are selfreported proportion of injection acts in which needles or syringes are shared in the past 90 days and proportion of condom protected acts of sexual intercourse in the past 90 days. The primary biological outcomes are the rate of new HIV and HCV cases, and the cumulative incidence of Chlamydia, gonorrhea, and syphilis over the 12month postintervention period. The proposed study will advance the understanding of HIV/HCV/STI risk reduction among IDUs and thereby may help to stem the rising epidemic of HIV, HCV, and STIs in Kazakhstan and Central Asia.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
both partners do not meet all eligibility criteria or meet one or more exclusion criteria

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690442

Locations


Kazakhstan
Global Health Research Center of Central Asia
Almaty, Kazakhstan

Sponsors and Collaborators

Columbia University

Investigators


Principal Investigator:	Nabila El-Bassel	Columbia University

More Information


Responsible Party:	Nabila El-Bassel, PhD, Director of the Social Intervention Group, Global Health Research Center of Central Asia, Columbia University
ClinicalTrials.gov Identifier:	NCT01690442 History of Changes
Other Study ID Numbers:	AAAD2056
Study First Received:	September 19, 2012
Last Updated:	February 25, 2014
Health Authority:	Kazakhstan: Ministry of Public Health United States: Columbia University IRB

Keywords provided by Columbia University:


HIV AIDS Prevention

ClinicalTrials.gov processed this record on September 23, 2016