Trial Outcomes & Findings for Couples ART Adherence Intervention for PWID in Kazakhstan (NCT NCT03555396)
NCT ID: NCT03555396
Last Updated: 2024-10-10
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
Day 1 to Day 180 (daily)
Results posted on
2024-10-10
Participant Flow
Participants were recruited from the Almaty City AIDS Center from October 2020 to March 2023.
Participants were randomized as a dyad to the intervention or standard of care arm. Numbers reported represent individual participants (not dyads).
Participant milestones
| Measure |
Intervention
Subjects will receive an intervention based off of current evidence-based practices that will consist of activities designed to strengthen support within the couple to improve adherence to antiretroviral therapy.
SMART Couples 2: The intervention will consist of 3 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 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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
68
|
|
Overall Study
Index Case
|
32
|
34
|
|
Overall Study
Treatment Support Partner
|
32
|
34
|
|
Overall Study
COMPLETED
|
61
|
65
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Intervention
Subjects will receive an intervention based off of current evidence-based practices that will consist of activities designed to strengthen support within the couple to improve adherence to antiretroviral therapy.
SMART Couples 2: The intervention will consist of 3 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 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.
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.
|
|---|---|---|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Couples ART Adherence Intervention for PWID in Kazakhstan
Baseline characteristics by cohort
| Measure |
Intervention
n=64 Participants
Subjects will receive an intervention based off of current evidence-based practices that will consist of activities designed to strengthen support within the couple to improve adherence to antiretroviral therapy.
SMART Couples 2: The intervention will consist of 3 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 Care
n=68 Participants
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.
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.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.11 Years
STANDARD_DEVIATION 11.10 • n=5 Participants
|
43.97 Years
STANDARD_DEVIATION 9.59 • n=7 Participants
|
45.01 Years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Kazakhstan
|
64 participants
n=5 Participants
|
68 participants
n=7 Participants
|
132 participants
n=5 Participants
|
|
HIV status
HIV-positive
|
45 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
HIV status
HIV-negative
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 180 (daily)Population: Participants analyzed included only those who were HIV-positive and who used the electronic monitoring device: 35 out of 64 in the intervention arm and 45 out of 68 in the standard of care arm. Not all participants were able to collect evaluable data using the device since there were no in-person study visits during the pandemic to help with troubleshooting.
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).
Outcome measures
| Measure |
Intervention
n=35 Participants
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.
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.
|
Standard of Care
n=45 Participants
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.
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.
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|---|---|---|
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Adherence Rate to Antiretroviral Therapy
|
10.49 Days
Standard Deviation 11.21
|
14.02 Days
Standard Deviation 27.97
|
SECONDARY outcome
Timeframe: 6 month follow-upPopulation: Participants who had viral load testing data from the AIDS Center.
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.
Outcome measures
| Measure |
Intervention
n=40 Participants
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.
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.
|
Standard of Care
n=40 Participants
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.
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.
|
|---|---|---|
|
Number of Participants Stratified by Viral Load Suppression
Detectable viral load (>500 copies/ml) at baseline decreased to virally suppressed at 6 months
|
14 Participants
|
11 Participants
|
|
Number of Participants Stratified by Viral Load Suppression
Viral load remained detectable (>500 copies/ml) at baseline and 6 months
|
12 Participants
|
11 Participants
|
|
Number of Participants Stratified by Viral Load Suppression
Viral load remained suppressed (≤500 copies/ml) at baseline and 6 months
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 6 month follow-upPopulation: Only HIV-positive participants had outcome data in the analysis.
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.
Outcome measures
| Measure |
Intervention
n=45 Participants
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.
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.
|
Standard of Care
n=50 Participants
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.
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.
|
|---|---|---|
|
Medication Adherence Rate (Self-Report Score)
Baseline
|
69.29 units on a scale
Standard Error 2.52
|
68.33 units on a scale
Standard Error 2.20
|
|
Medication Adherence Rate (Self-Report Score)
6-month follow-up
|
86.73 units on a scale
Standard Error 2.56
|
76.23 units on a scale
Standard Error 2.37
|
SECONDARY outcome
Timeframe: 6 month follow-upPopulation: Only participants who reported ever injecting drugs who completed the 6-month follow-up survey: 42 out of 64 in the intervention arm and 49 out of 68 in the standard of care arm.
Self-reported; participants reported if they were currently receiving methadone or opioid substitution therapy
Outcome measures
| Measure |
Intervention
n=42 Participants
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.
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.
|
Standard of Care
n=49 Participants
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.
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.
|
|---|---|---|
|
Number of Subjects That Had Access to Substance Use Treatment
|
1 Participants
|
3 Participants
|
Adverse Events
Intervention
Serious events: 4 serious events
Other events: 3 other events
Deaths: 3 deaths
Standard of Care
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intervention
n=64 participants at risk
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.
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.
|
Standard of Care
n=68 participants at risk
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.
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.
|
|---|---|---|
|
Infections and infestations
Hospitalization
|
6.2%
4/64 • Number of events 4 • Up to 6 months
|
4.4%
3/68 • Number of events 3 • Up to 6 months
|
Other adverse events
| Measure |
Intervention
n=64 participants at risk
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.
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.
|
Standard of Care
n=68 participants at risk
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.
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.
|
|---|---|---|
|
Social circumstances
Jailed
|
4.7%
3/64 • Number of events 3 • Up to 6 months
|
0.00%
0/68 • Up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place