Couples ART Adherence Intervention for PWID in Kazakhstan

NCT03555396 | Completed Results

• 2 other identifiers: AAAR71441K01DA044853-01A1
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 1 to Day 180 (daily)

Secondary Outcomes (3)

• Number of Participants Stratified by Viral Load Suppression

  6 month follow-up

• Medication Adherence Rate (Self-Report Score)

  6 month follow-up

• Number of Subjects That Had Access to Substance Use Treatment

  6 month follow-up

Study Arms (2)

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.

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.

Behavioral: Standard of Care

Interventions

SMART Couples 2 BEHAVIORAL

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.

Intervention

Standard of Care BEHAVIORAL

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Columbia University Global Health Research Center of Central Asia

Almaty, 050040, Kazakhstan

Location

Related Publications (1)

• 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. 2025 Aug 7:10.1007/s10461-025-04841-5. doi: 10.1007/s10461-025-04841-5. Online ahead of print.

  PMID: 40773102 DERIVED

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Data were collected during the Coronavirus-19 (COVID-19) pandemic. Many participants experienced problems using electronic monitoring devices, and research staff were not allowed to make home visits to trouble-shoot. During COVID-19, many opioid substitution therapy (OST) clinics in Kazakhstan also closed, making it difficult for participants to access (OST).

Results Point of Contact

• Title: Dr. Alissa Davis
• Organization: Columbia University

ad3324@columbia.edu

212-851-2224

Study Officials

• Alissa Davis, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Social Work

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 13, 2018
• Study Start: October 26, 2020
• Primary Completion: March 9, 2023
• Study Completion: June 30, 2024
• Last Updated: October 10, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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 Institutional Review Board (IRB) approvals.

Locations

KA (1)