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 : May 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Substance Use Disorders||Behavioral: SMART Couples 2 Behavioral: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Couple-based Antiretroviral Therapy Adherence Intervention for People Who Inject Drugs in Kazakhstan|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
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.
- 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.
- 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
- 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
- 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
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
|Contact: Alissa Davis, PhDemail@example.com|
|Contact: Nabila El-Bassel, PhDfirstname.lastname@example.org|
|Principal Investigator:||Alissa Davis, PhD||Columbia University|