Couples ART Adherence Intervention for PWID in Kazakhstan

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555396
• Other study ID #: AAAR7144
• Secondary ID: 1K01DA044853-01A
• Status: Completed
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: March 9, 2023

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Kazakhstan	Columbia University Global Health Research Center of Central Asia	Almaty

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence Rate to Antiretroviral Therapy	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.	Day 1 to Day 180 (daily)
Secondary	HIV Viral Load Level	HIV viral load level as collected through a blood draw at the AIDS Center	Baseline, 3 month follow-up, 6 month follow-up
Secondary	Medication Adherence Rate (Self-Report Score)	Self-reported; 3 items questionnaire asking participants how well they took their medication	Week 1 to Week 24 (weekly)
Secondary	Number of subjects that had access to substance use treatment	Self-reported; participants asked if and where they accessed substance use treatment	Baseline, 3 month follow-up, 6 month follow-up