HIV InfectionsNCT03555396
Couples ART Adherence Intervention for PWID in Kazakhstan
A study testing SMART Couples 2 in people with HIV Infections and Substance Use Disorders, run by Columbia University at 1 site in Kazakhstan.
Trial summary
The fastest growing HIV epidemics globally are driven by injection drug use, but only a small percentage of HIV-positive people who inject drugs (PWID) have achieved viral suppression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Substance Use Disorders
- What is being tested?
- SMART Couples 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteKazakhstan
- Study dates
- 26 Oct 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Participant inclusion criteria for Phase 3: 66 couples (n=132) will participate in a randomized control trial of the adapted couple-based intervention.
Couples are eligible to participate if:
- both partners are ≥18 years old,
- both identify each other as their primary sexual partner (e.g. spouse, girlfriend/boyfriend, regular sexual partner),
- the relationship has existed at least 3 months,
- both report feeling safe participating with their partner in the study,
- neither reports any severe physical or sexual violence perpetrated by the other partner in the past year,
- both are able to provide informed consent and follow study procedures, and
- both are fluent in Russian.
In addition, the "index case" (partner initially recruited from AIDS Center) must: (1) be confirmed HIV+ by the AIDS Center, (2) have been on ART at least 3 months, (3) not be virally suppressed according to the AIDS Center standard (<500 copies/ml), and (4) report injecting any drug in the past year.
Participant exclusion criteria for Phase 3:
Individuals who do not meet inclusion criteria or who meet any of the following criteria will be excluded from the study:
- unable to provide informed consent,
- unwilling or unable to participate in study procedures,
- any condition that, in the opinion of the principal investigator and research staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
Columbia University Global Health Research Center of Central Asia
Almaty, 050040
About this study
Official title: A Couple-based Antiretroviral Therapy Adherence Intervention for People Who Inject Drugs in Kazakhstan
The fastest growing HIV epidemics globally are driven by injection drug use, but only a small percentage of HIV-positive people who inject drugs (PWID) have achieved viral suppression. The proposed project will adapt a couple-based antiretroviral therapy (ART) adherence intervention for PWID and assess the feasibility and acceptability of conducting dried blood spot testing to objectively measure ART adherence as part of an intervention in a clinical setting. This project advances HIV intervention science by providing an intervention that leverages social support within the dyad to improve ART adherence among PWID, which could lead to increased viral suppression, thus decreasing HIV transmission and HIV-related morbidity and mortality.
Read the detailed description
The purpose of this Mentored Research Scientist Development Award (K01) is to provide the candidate with the training and expertise needed to transition to research independence in the science of HIV prevention and intervention. The fastest growing HIV epidemics globally are driven by injection drug use. Central Asia has some of the highest rates of injection drug use and one of the fastest growing HIV epidemics in the world. HIV-positive people who inject drugs (PWID) face many barriers to antiretroviral therapy (ART) adherence, such as misperceptions about ART, stigma and substance use. Previous research among this population has shown that couple-based HIV interventions are highly efficacious at reducing risk behaviors, but there is currently no couple-based ART adherence intervention for PWID. The research aims of this proposal are to 1) identify core components of the SMART Couples intervention and other existing ART adherence intervention strategies and assess their appropriateness and feasibility as an integrated, couple-based ART adherence intervention for HIV+ PWID living in Kazakhstan (Phase 1); 2) adapt and refine SMART Couples and identify augmentative intervention strategies to create an integrated, couple-based ART adherence intervention for HIV+ PWID and their primary sex partners using results from Aim 1 (Phase 2); and 3a) pilot test the resulting couple-based intervention among 66 heterosexual PWID couples in Kazakhstan through a randomized control trial to assess the safety, feasibility, and acceptability of the intervention and obtain preliminary estimates of adherence outcomes in the intervention arm versus standard of care; and 3b) assess the feasibility and acceptability of conducting dried blood spot testing as part of an adherence intervention in a clinical setting (Phase 3). The proposed career development plan has been designed to augment the candidate's current training in epidemiology and enable her to 1) gain research skills in the design and adaptation of HIV interventions, with an emphasis on adherence among marginalized populations; 2) obtain methodological expertise in dyad and intensive longitudinal analysis and the triangulation of behavioral, biomedical, and technological data, particularly for the purposes of interpreting and analyzing these types of data to assess intervention efficacy and measure ART adherence; 3) acquire training in the conduct and analysis of qualitative in-depth interviews and focus groups, particularly for designing and adapting HIV interventions and assessing intervention feasibility and acceptability; and 4) increase professional skills for a successful independent research career. These training goals will be achieved through a combination of didactic courses, specialized workshops and seminars, hands-on research, and an interdisciplinary team of experts. The research findings and methodological skills to be gained from this K01 have wide applicability for disease research and high transferability across diverse research settings.
- Conditions
- HIV Infections, Substance Use Disorders
- Being tested
- SMART Couples 2, Standard of Care
- Medical subject headings
- HIV Infections, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART Couples 2Behavioural
The intervention will consist of 4 sessions with activities designed to strengthen communication and support within the couple to improve adherence to antiretroviral therapy and increase linkage to drug treatment services. The activities are based on cognitive-behavioral therapy. Participants' adherence will be monitored continuously through electronic monitoring devices and surveys completed at baseline and follow-up periods.
Standard of CareBehavioural
Standard of Care consists of an appointment with an AIDS Center nurse at baseline and two months later. Under current Standard of Care in Almaty, no behavioral intervention is provided. Participants obtain prescription refills and give blood for viral load and CD4 tests once every 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects will receive an intervention is based off of current evidence-based practices and will consist of activities designed to strengthen support within the couple to improve adherence to antiretroviral therapy. Receives: Behavioral: SMART Couples 2 |
| Standard of Care | Active comparator | Standard of Care is the comparison arm that consists of care currently provided at the AIDS Center. Subjects will receive a consultation with a healthcare provider every three months, prescription refills, and blood draws for viral load and CD4 testing. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Rate to Antiretroviral Therapy
Adherence rate is defined as the number of days the electronic pill bottle was opened to take medication (out of a total of 180 days).
Measured: Day 1 to Day 180 (daily)
Secondary outcomes (3)
Number of Participants Stratified by Viral Load Suppression
HIV viral load suppression was considered at ≤500 copies/ml in accordance with the Almaty AIDS Center testing standard. Participants were classified as virally suppressed or not based on their most recent viral load test result (at baseline and at the 6 month follow-up) obtained from electronic medical records at the AIDS Center.
Measured: 6 month follow-up
Medication Adherence Rate (Self-Report Score)
Self-reported; 3 item scale (Self-Report Measure for Medication Adherence by Wilson et al., AIDS \& Behavior, 2016) asking participants how well they took their medication in the past 30 days (average score on a 0-100 scale). 0 = low adherence and 100 = high adherence.
Measured: 6 month follow-up
Number of Subjects That Had Access to Substance Use Treatment
Self-reported; participants reported if they were currently receiving methadone or opioid substitution therapy
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start26 Oct 2020
- Primary completion9 Mar 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Alissa Davis, Columbia University
- Investigators
- Alissa Davis, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555396
- Sponsor's protocol ID
- AAAR7144
- Other IDs
- 1K01DA044853-01A1
- Status last verified
- Sep 2024
- First submitted
- 1 Jun 2018
- Last updated
- 10 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unidentified data can be shared with other researchers in accordance with IRB regulations upon completion and analysis of the study.
Publications
Davis A, Rozental E, Bolger N, Gulyayev V, Gulyayev P, Denebayeva A, Wen H, Cui J, Terlikbayeva A, Primbetova S, Samandas J, Altice FL, Remien RH, Mergenova G. A Dyad-Based Intervention to Improve Adherence to Antiretroviral Therapy among People with HIV who Inject Drugs in Kazakhstan: Results of a Randomized Controlled Trial. AIDS Behav. 2026 Jan;30(1):1-13. doi: 10.1007/s10461-025-04841-5. Epub 2025 Aug 7.
PubMed 40773102
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Couple-based Antiretroviral Therapy Adherence Intervention for People Who Inject Drugs in Kazakhstan
- ClinicalTrials.gov ID
- NCT03555396
- Acronym / sponsor ID
- AAAR7144
- Conditions
- HIV Infections, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The fastest growing HIV epidemics globally are driven by injection drug use, but only a small percentage of HIV-positive people who inject drugs (PWID) have achieved viral suppression. The proposed project will adapt a couple-based antiretroviral therapy (ART) adherence intervention for PWID and assess the feasibility and acceptability of conducting dried blood spot testing to objectively measure ART adherence as part of an intervention in a clinical setting. This project advances HIV intervention science by providing an intervention that leverages social support within the dyad to improve ART adherence among PWID, which could lead to increased viral suppression, thus decreasing HIV transmission and HIV-related morbidity and mortality.
Detailed description
The purpose of this Mentored Research Scientist Development Award (K01) is to provide the candidate with the training and expertise needed to transition to research independence in the science of HIV prevention and intervention. The fastest growing HIV epidemics globally are driven by injection drug use. Central Asia has some of the highest rates of injection drug use and one of the fastest growing HIV epidemics in the world. HIV-positive people who inject drugs (PWID) face many barriers to antiretroviral therapy (ART) adherence, such as misperceptions about ART, stigma and substance use. Previous research among this population has shown that couple-based HIV interventions are highly efficacious at reducing risk behaviors, but there is currently no couple-based ART adherence intervention for PWID. The research aims of this proposal are to 1) identify core components of the SMART Couples intervention and other existing ART adherence intervention strategies and assess their appropriateness and feasibility as an integrated, couple-based ART adherence intervention for HIV+ PWID living in Kazakhstan (Phase 1); 2) adapt and refine SMART Couples and identify augmentative intervention strategies to create an integrated, couple-based ART adherence intervention for HIV+ PWID and their primary sex partners using results from Aim 1 (Phase 2); and 3a) pilot test the resulting couple-based intervention among 66 heterosexual PWID couples in Kazakhstan through a randomized control trial to assess the safety, feasibility, and acceptability of the intervention and obtain preliminary estimates of adherence outcomes in the intervention arm versus standard of care; and 3b) assess the feasibility and acceptability of conducting dried blood spot testing as part of an adherence intervention in a clinical setting (Phase 3). The proposed career development plan has been designed to augment the candidate's current training in epidemiology and enable her to 1) gain research skills in the design and adaptation of HIV interventions, with an emphasis on adherence among marginalized populations; 2) obtain methodological expertise in dyad and intensive longitudinal analysis and the triangulation of behavioral, biomedical, and technological data, particularly for the purposes of interpreting and analyzing these types of data to assess intervention efficacy and measure ART adherence; 3) acquire training in the conduct and analysis of qualitative in-depth interviews and focus groups, particularly for designing and adapting HIV interventions and assessing intervention feasibility and acceptability; and 4) increase professional skills for a successful independent research career. These training goals will be achieved through a combination of didactic courses, specialized workshops and seminars, hands-on research, and an interdisciplinary team of experts. The research findings and methodological skills to be gained from this K01 have wide applicability for disease research and high transferability across diverse research settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: SMART Couples 2Subjects will receive an intervention is based off of current evidence-based practices and will consist of activities designed to strengthen support within the couple to improve adherence to antiretroviral therapy. |
| Standard of Care | Active comparator | Behavioral: Standard of CareStandard of Care is the comparison arm that consists of care currently provided at the AIDS Center. Subjects will receive a consultation with a healthcare provider every three months, prescription refills, and blood draws for viral load and CD4 testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SMART Couples 2The intervention will consist of 4 sessions with activities designed to strengthen communication and support within the couple to improve adherence to antiretroviral therapy and increase linkage to drug treatment services. The activities are based on cognitive-behavioral therapy. Participants' adherence will be monitored continuously through electronic monitoring devices and surveys completed at baseline and follow-up periods. | Behavioural | Intervention |
| Standard of CareStandard of Care consists of an appointment with an AIDS Center nurse at baseline and two months later. Under current Standard of Care in Almaty, no behavioral intervention is provided. Participants obtain prescription refills and give blood for viral load and CD4 tests once every 6 months. | Behavioural | Standard of Care |
Primary outcome
Adherence Rate to Antiretroviral Therapy
Time frame: Day 1 to Day 180 (daily)
Adherence rate is defined as the number of days the electronic pill bottle was opened to take medication (out of a total of 180 days).
3 secondary outcomes
Number of Participants Stratified by Viral Load Suppression
Time frame: 6 month follow-up
Medication Adherence Rate (Self-Report Score)
Time frame: 6 month follow-up
Number of Subjects That Had Access to Substance Use Treatment
Time frame: 6 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40773102Davis A, Rozental E, Bolger N, Gulyayev V, Gulyayev P, Denebayeva A, Wen H, Cui J, Terlikbayeva A, Primbetova S, Samandas J, Altice FL, Remien RH, Mergenova G. A Dyad-Based Intervention to Improve Adherence to Antiretroviral Therapy among People with HIV who Inject Drugs in Kazakhstan: Results of a Randomized Controlled Trial. AIDS Behav. 2026 Jan;30(1):1-13. doi: 10.1007/s10461-025-04841-5. Epub 2025 Aug 7.
- Individual participant dataSharing planned: Yes. Unidentified data can be shared with other researchers in accordance with IRB regulations upon completion and analysis of the study.
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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.
Alissa Davis, PhD 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 study testing SMART Couples 2 in people with HIV Infections and Substance Use Disorders, 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?
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 10 Oct 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence Rate to Antiretroviral Therapy (time frame: Day 1 to Day 180 (daily)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03555396, which also lists 1 linked publication.
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 10 Oct 2024.