HIV Prevention for Injecting Drug Users in Kazakhstan
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ClinicalTrials.gov Identifier: NCT01690442 |
Recruitment Status
:
Completed
First Posted
: September 21, 2012
Last Update Posted
: February 27, 2014
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Condition or disease | Intervention/treatment | Phase |
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HIV AIDS | Behavioral: Couples Based HIV/STI Risk Reduction Intervention (CHSR) Behavioral: Renaissance Wellness Promotion (WP) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Couples Based HIV/STI Prevention for Injecting Drug Users in Kazakhstan |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |
Arm | Intervention/treatment |
---|---|
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.
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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.
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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.
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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.
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- The proportion of condom protected acts of vaginal and anal intercourse [ Time Frame: 12 months ]
- The number of incidents of unclean syringes or needles in the past 90 days [ Time Frame: 12 months ]
- Proportion of injection acts in which unclean needles or syringes were used in the past 90 days [ Time Frame: 12 months ]
- The number of acts of unprotected vaginal and anal intercourse during the 90 days prior to the assessment period [ Time Frame: 12 months ]
- Number of people participants shared needles or syringes with in the past 90 days [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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): NCT01690442
Kazakhstan | |
Global Health Research Center of Central Asia | |
Almaty, Kazakhstan |
Principal Investigator: | Nabila El-Bassel | Columbia University |
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 |
First Posted: | September 21, 2012 Key Record Dates |
Last Update Posted: | February 27, 2014 |
Last Verified: | February 2014 |
Keywords provided by Nabila El-Bassel, PhD, Columbia University:
HIV AIDS Prevention |