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Couples ART Adherence Intervention for PWID in Kazakhstan

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ClinicalTrials.gov Identifier: NCT03555396
Recruitment Status : Not yet recruiting
First Posted : June 13, 2018
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Alissa Davis, Columbia University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
HIV Infections Substance Use Disorders Behavioral: SMART Couples 2 Behavioral: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Couple-based Antiretroviral Therapy Adherence Intervention for People Who Inject Drugs in Kazakhstan
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention
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.
Behavioral: SMART Couples 2
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.

Active Comparator: Standard of Care
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.
Behavioral: Standard of Care
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.




Primary Outcome Measures :
  1. Adherence Rate to Antiretroviral Therapy [ Time Frame: Day 1 to Day 180 (daily) ]
    Electronic monitoring device measures every time the pill bottle was opened to take medication. Each day can be scored as a Yes/No. Adherence will be collected daily over a 6 month period.


Secondary Outcome Measures :
  1. HIV Viral Load Level [ Time Frame: Baseline, 3 month follow-up, 6 month follow-up ]
    HIV viral load level as collected through a blood draw at the AIDS Center

  2. Medication Adherence Rate (Self-Report Score) [ Time Frame: Week 1 to Week 24 (weekly) ]
    Self-reported; 3 items questionnaire asking participants how well they took their medication

  3. Number of subjects that had access to substance use treatment [ Time Frame: Baseline, 3 month follow-up, 6 month follow-up ]
    Self-reported; participants asked if and where they accessed substance use treatment



Information from the National Library of Medicine

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

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:

  1. both partners are ≥18 years old,
  2. both identify each other as their primary sexual partner (e.g. spouse, girlfriend/boyfriend, regular sexual partner),
  3. the relationship has existed at least 3 months,
  4. both report feeling safe participating with their partner in the study,
  5. neither reports any severe physical or sexual violence perpetrated by the other partner in the past year,
  6. both are able to provide informed consent and follow study procedures, and
  7. 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:

  1. unable to provide informed consent,
  2. unwilling or unable to participate in study procedures,
  3. 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.

Information from the National Library of Medicine

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): NCT03555396


Contacts
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Contact: Alissa Davis, PhD 208-403-7054 ad3324@columbia.edu
Contact: Nabila El-Bassel, PhD 212-851-2391 ne5@columbia.edu

Locations
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Kazakhstan
Columbia University Global Health Research Center of Central Asia Not yet recruiting
Almaty, Kazakhstan, 050040
Contact: Assel Terlikbayeva, MD    7272642888    assel.terlikbayeva@ghrcca.org   
Contact: Sholpan Primbetova, MS    7272642999    sholpan.primbetova@ghrcca.org   
Sponsors and Collaborators
Columbia University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Alissa Davis, PhD Columbia University

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Responsible Party: Alissa Davis, Professor of Social Work, Columbia University
ClinicalTrials.gov Identifier: NCT03555396     History of Changes
Other Study ID Numbers: AAAR7144
1K01DA044853-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Unidentified data can be shared with other researchers in accordance with IRB regulations upon completion and analysis of the study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Data will become available to other researchers starting 12 months after publication of the final results.
Access Criteria: Data can be accessed by emailing the PI of the study and obtaining appropriate IRB approvals.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents