N/A Completed N=132 Randomized Single-blind Treatment

Couples ART Adherence Intervention for PWID in Kazakhstan

HIV · Substance Use Disorder

Source: ClinicalTrials.gov NCT03555396 ↗

Enrolled (actual)

132

Serious AEs

5.3%

Results posted

Jul 2024

Primary outcomePrimary: Adherence Rate to Antiretroviral Therapy — 10.49; 14.02 Days — p=0.483

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Adherence Rate to Antiretroviral Therapy	10.49; 14.02	0.483
SECONDARY Number of Participants Stratified by Viral Load Suppression	14; 11; 12; 11; 14; 18	0.637
SECONDARY Medication Adherence Rate (Self-Report Score)	69.29; 68.33; 86.73; 76.23	0.037 sig
SECONDARY Number of Subjects That Had Access to Substance Use Treatment	1; 3	0.621

Eligibility 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:

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03555396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.