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Clinical Trials/NCT03555396
NCT03555396
Completed
Not Applicable

A Couple-based Antiretroviral Therapy Adherence Intervention for People Who Inject Drugs in Kazakhstan

Columbia University1 site in 1 country132 target enrollmentOctober 26, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Columbia University
Enrollment
132
Locations
1
Primary Endpoint
Adherence Rate to Antiretroviral Therapy
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 26, 2020
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alissa Davis

Professor of Social Work

Columbia University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • 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 Sites (1)

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