CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 132 enrolled
Drug / intervention
SMART Couples 2 +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03555396
NCT03555396N/ACompleted

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

Columbia University·interventional·Posted Jun 13, 2018·Updated Oct 10, 2024

In Brief

A clinical study evaluating SMART Couples 2 and Standard of Care for HIV Infections and Substance Use Disorders. Completed, enrolled 132 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesKazakhstan

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 13, 2018
Enrollment StartOct 26, 2020
Primary CompletionMar 9, 2023
Study CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.1 years ago

Interventions

SMART Couples 2behavioral

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 Carebehavioral

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.