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临床试验/NCT03555396
NCT03555396已完成不适用

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

Columbia University1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2020年10月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
1
主要终点
Adherence Rate to Antiretroviral Therapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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:
  • •both partners are ≥18 years old,
  • •both identify each other as their primary sexual partner (e.g. spouse, girlfriend/boyfriend, regular sexual partner),
  • •the relationship has existed at least 3 months,
  • •both report feeling safe participating with their partner in the study,
  • •neither reports any severe physical or sexual violence perpetrated by the other partner in the past year,
  • •both are able to provide informed consent and follow study procedures, and
  • •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

排除标准

  • •for Phase 3:
  • •Individuals who do not meet inclusion criteria or who meet any of the following criteria will be excluded from the study:
  • •unable to provide informed consent,
  • •unwilling or unable to participate in study procedures,
  • •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.

研究组 & 干预措施

Intervention

Experimental

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.

干预措施: SMART Couples 2 (Behavioral)

Standard of Care

Active Comparator

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.

干预措施: Standard of Care (Behavioral)

结局指标

主要结局

Adherence Rate to Antiretroviral Therapy

时间窗: Day 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).

次要结局

  • Number of Participants Stratified by Viral Load Suppression(6 month follow-up)
  • Medication Adherence Rate (Self-Report Score)(6 month follow-up)
  • Number of Subjects That Had Access to Substance Use Treatment(6 month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alissa Davis

Professor of Social Work

Columbia University

研究点 (1)

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