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Couples ART Adherence Intervention for PWID in Kazakhstan

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03555396
Enrollment
132
Registered
2018-06-13
Start date
2020-10-26
Completion date
2024-06-30
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Substance Use Disorders

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.

Interventions

BEHAVIORALSMART 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.

BEHAVIORALStandard 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Participant inclusion criteria for Phase 3: 66 couples (n=132) will participate in a randomized control trial of the adapted couple-based intervention. Couples are eligible to participate if: 1. both partners are ≥18 years old, 2. both identify each other as their primary sexual partner (e.g. spouse, girlfriend/boyfriend, regular sexual partner), 3. the relationship has existed at least 3 months, 4. both report feeling safe participating with their partner in the study, 5. neither reports any severe physical or sexual violence perpetrated by the other partner in the past year, 6. both are able to provide informed consent and follow study procedures, and 7. both are fluent in Russian. In addition, the index case (partner initially recruited from AIDS Center) must: (1) be confirmed HIV+ by the AIDS Center, (2) have been on ART at least 3 months, (3) not be virally suppressed according to the AIDS Center standard (\<500 copies/ml), and (4) report injecting any drug in the past year. Participant

Exclusion criteria

for Phase 3: Individuals who do not meet inclusion criteria or who meet any of the following criteria will be excluded from the study: 1. unable to provide informed consent, 2. unwilling or unable to participate in study procedures, 3. any condition that, in the opinion of the principal investigator and research staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Design outcomes

Primary

MeasureTime frameDescription
Adherence Rate to Antiretroviral TherapyDay 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

MeasureTime frameDescription
Number of Participants Stratified by Viral Load Suppression6 month follow-upHIV 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.
Medication Adherence Rate (Self-Report Score)6 month follow-upSelf-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.
Number of Subjects That Had Access to Substance Use Treatment6 month follow-upSelf-reported; participants reported if they were currently receiving methadone or opioid substitution therapy

Countries

Kazakhstan

Participant flow

Recruitment details

Participants were recruited from the Almaty City AIDS Center from October 2020 to March 2023.

Pre-assignment details

Participants were randomized as a dyad to the intervention or standard of care arm. Numbers reported represent individual participants (not dyads).

Participants by arm

ArmCount
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.
64
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.
68
Total132

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath31
Overall StudyLost to Follow-up02

Baseline characteristics

CharacteristicStandard of CareTotalIntervention
Age, Continuous43.97 Years
STANDARD_DEVIATION 9.59
45.01 Years
STANDARD_DEVIATION 10.36
46.11 Years
STANDARD_DEVIATION 11.1
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
68 Participants132 Participants64 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
HIV status
HIV-negative
18 Participants37 Participants19 Participants
HIV status
HIV-positive
50 Participants95 Participants45 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
23 Participants39 Participants16 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
45 Participants93 Participants48 Participants
Region of Enrollment
Kazakhstan
68 participants132 participants64 participants
Sex: Female, Male
Female
31 Participants59 Participants28 Participants
Sex: Female, Male
Male
37 Participants73 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 641 / 68
other
Total, other adverse events
3 / 640 / 68
serious
Total, serious adverse events
4 / 643 / 68

Outcome results

Primary

Adherence Rate to Antiretroviral Therapy

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).

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
InterventionAdherence Rate to Antiretroviral Therapy10.49 DaysStandard Deviation 11.21
Standard of CareAdherence Rate to Antiretroviral Therapy14.02 DaysStandard Deviation 27.97
p-value: 0.48395% CI: [-13.53, 6.46]t-test, 2 sided
Secondary

Medication Adherence Rate (Self-Report Score)

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.

Time frame: 6 month follow-up

Population: Only HIV-positive participants had outcome data in the analysis.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
InterventionMedication Adherence Rate (Self-Report Score)Baseline69.29 units on a scaleStandard Error 2.52
InterventionMedication Adherence Rate (Self-Report Score)6-month follow-up86.73 units on a scaleStandard Error 2.56
Standard of CareMedication Adherence Rate (Self-Report Score)Baseline68.33 units on a scaleStandard Error 2.2
Standard of CareMedication Adherence Rate (Self-Report Score)6-month follow-up76.23 units on a scaleStandard Error 2.37
p-value: 0.03795% CI: [0.59, 18.49]Mixed Models Analysis
Secondary

Number of Participants Stratified by Viral Load Suppression

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.

Time frame: 6 month follow-up

Population: Participants who had viral load testing data from the AIDS Center.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants Stratified by Viral Load SuppressionDetectable viral load (>500 copies/ml) at baseline decreased to virally suppressed at 6 months14 Participants
InterventionNumber of Participants Stratified by Viral Load SuppressionViral load remained detectable (>500 copies/ml) at baseline and 6 months12 Participants
InterventionNumber of Participants Stratified by Viral Load SuppressionViral load remained suppressed (≤500 copies/ml) at baseline and 6 months14 Participants
Standard of CareNumber of Participants Stratified by Viral Load SuppressionDetectable viral load (>500 copies/ml) at baseline decreased to virally suppressed at 6 months11 Participants
Standard of CareNumber of Participants Stratified by Viral Load SuppressionViral load remained detectable (>500 copies/ml) at baseline and 6 months11 Participants
Standard of CareNumber of Participants Stratified by Viral Load SuppressionViral load remained suppressed (≤500 copies/ml) at baseline and 6 months18 Participants
p-value: 0.637Chi-squared
Secondary

Number of Subjects That Had Access to Substance Use Treatment

Self-reported; participants reported if they were currently receiving methadone or opioid substitution therapy

Time frame: 6 month follow-up

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Subjects That Had Access to Substance Use Treatment1 Participants
Standard of CareNumber of Subjects That Had Access to Substance Use Treatment3 Participants
p-value: 0.621Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026