HIVPhase 2NCT01690442
HIV Prevention for Injecting Drug Users in Kazakhstan
A Phase 2 study testing Couples Based HIV/STI Risk Reduction Intervention (CHSR) and Renaissance Wellness Promotion (WP) in people with HIV and AIDS, run by Columbia University at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Couples Based HIV/STI Risk Reduction Intervention (CHSR) and Renaissance Wellness Promotion (WP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteKazakhstan
- Study dates
- May 2008to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Couples Based HIV/STI Prevention for Injecting Drug Users in Kazakhstan
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.
Read the 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.
- Being tested
- Couples Based HIV/STI Risk Reduction Intervention (CHSR), Renaissance Wellness Promotion (WP)
- Keywords
- HIV, AIDS, Prevention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples Based HIV/STI Risk Reduction Intervention (CHSR)Behavioural
The intervention includes a combination of empowerment and couple self-efficacy building strategies, which are employed to help couples overcome resistance to risk reduction.
Renaissance Wellness Promotion (WP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Renaissance Wellness Promotion (WP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of condom protected acts of vaginal and anal intercourse
Measured: 12 months
The number of incidents of unclean syringes or needles in the past 90 days
Measured: 12 months
Proportion of injection acts in which unclean needles or syringes were used in the past 90 days
Measured: 12 months
The number of acts of unprotected vaginal and anal intercourse during the 90 days prior to the assessment period
Measured: 12 months
Secondary outcomes (1)
Number of people participants shared needles or syringes with in the past 90 days
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startMay 2008
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabila El-Bassel, PhD, Columbia University
- Investigators
- Nabila El-Bassel, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690442
- Sponsor's protocol ID
- AAAD2056
- Status last verified
- Feb 2014
- First submitted
- 19 Sep 2012
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couples Based HIV/STI Prevention for Injecting Drug Users in Kazakhstan
- ClinicalTrials.gov ID
- NCT01690442
- Acronym / sponsor ID
- AAAD2056
- Keywords
- HIV, AIDS, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couples Based HIV/STI Risk Reduction Intervention (CHSR) | Experimental | 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. |
| Renaissance Wellness Promotion (WP) | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Couples Based HIV/STI Risk Reduction Intervention (CHSR) |
| 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. | Behavioural | Renaissance Wellness Promotion (WP) |
Primary outcome
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
1 secondary outcome
Number of people participants shared needles or syringes with in the past 90 days
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nabila El-Bassel principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Couples Based HIV/STI Risk Reduction Intervention (CHSR) and Renaissance Wellness Promotion (WP) in people with HIV and AIDS, run by Columbia University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of condom protected acts of vaginal and anal intercourse (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.