A Couple-based Antiretroviral Therapy Adherence Intervention for People Who Inject Drugs
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|ClinicalTrials.gov Identifier: NCT03555396|
Recruitment Status : Not yet recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
|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 :||July 2018|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
The investigators anticipate the intervention will consist of 4 sessions over the course of two months. The 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 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.
Behavioral: Standard of Care
Standard of Care is the comparison arm that consists of care currently provided at the AIDS Center. This care includes a consultation with a healthcare provider every three months, prescription refills, and blood draws for viral load and CD4 testing.
- Adherence to Antiretroviral Therapy [ Time Frame: Daily over a 6 month period ]Electronic monitoring device measures every time the pill bottle was opened to take medication. Each day can be scored as a Yes/No.
- Viral Load [ Time Frame: Collected at baseline, 3 month follow-up, and 6 month follow-up ]HIV viral load level as collected through a blood draw at the AIDS Center
- Self-report measure for Medication Adherence [ Time Frame: Collected on a weekly basis over a 6 month period ]Self-report; 3 items asking participants how well they took their medication
- Access to substance use treatment [ Time Frame: Collected at baseline, 3 month follow-up, and 6 month follow-up ]Self-report; participants asked if they accessed substance use treatment and where they accessed it
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, PhDfirstname.lastname@example.org|
|Contact: Nabila El-Bassel, PhDemail@example.com|
|Columbia University Global Health Research Center of Central Asia||Not yet recruiting|
|Almaty, Kazakhstan, 050040|
|Contact: Assel Terlikbayeva, MD 7272642888 firstname.lastname@example.org|
|Contact: Sholpan Primbetova, MS 7272642999 email@example.com|
|Principal Investigator:||Alissa Davis, PhD||Columbia University|