Couples ART Adherence Intervention for PWID in Kazakhstan

Not Applicable

Completed

• Conditions: HIV Infections; Substance Use Disorders
• Interventions: Behavioral: SMART Couples 2; Behavioral: Standard of Care

• Registration Number: NCT03555396
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-13
• Study Start: 2020-10-26
• Primary Completion: 2023-03-09
• Results First Submitted: 2024-06-05
• Study Completion: 2024-06-30
• Results First Submitted QC: 2024-07-01
• Results First Posted: 2024-07-03
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	SMART Couples 2	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.
Standard of Care	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.

Primary Outcome Measures

Name	Time	Method
Adherence Rate to Antiretroviral Therapy	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants Stratified by Viral Load Suppression	6 month follow-up	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.
Medication Adherence Rate (Self-Report Score)	6 month follow-up	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.
Number of Subjects That Had Access to Substance Use Treatment	6 month follow-up	Self-reported; participants reported if they were currently receiving methadone or opioid substitution therapy

Trial Locations

Locations (1)

Columbia University Global Health Research Center of Central Asia; 🇰🇿 Almaty, Kazakhstan