NCT03555396Completed
Couples ART Adherence Intervention for PWID in Kazakhstan
A Couple-based Antiretroviral Therapy Adherence Intervention for People Who Inject Drugs in Kazakhstan
Source: ClinicalTrials.gov · Last updated 10 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 132 (actual)
- First submitted
- 1 Jun 2018
- Start date
- 26 Oct 2020
- Primary completion date
- 9 Mar 2023
- Lead sponsor
- Columbia University
- Diseases
- HIV
- NCT number
- NCT03555396
What you commit to
- Study type: Interventional
- Participants enrolled: 132
- From 26 Oct 2020 to the primary completion date, 9 Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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 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:
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Global Health Research Center of Central Asia Coordinator of this site? Confirm its status | Almaty | Kazakhstan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.