Adaptation and Evaluation of an Intersectional Stigma Reduction Intervention to Increase HIV Care Engagement Among Women Who Use Drugs

N/ANot Yet RecruitingNCT07751978

Johns Hopkins Bloomberg School of Public Health100 enrolled

Overview

The goal of this study is to test whether a program reduce stigma will help women living HIV remain in HIV care.

This study will evaluate the feasibility, acceptability, and preliminary efficacy of a behavioral intervention designed to reduce intersectional HIV- and drug use-related stigma and improve HIV care engagement among women living with HIV who use drugs in Ukraine. A total of 100 eligible women will be randomized to either the intervention or a control condition. Participants in both groups will receive standard HIV care and a one-time consultation with a social worker, complete baseline, 3-month, and 6-month assessments, and have HIV care outcomes assessed. Participants assigned to the intervention will additionally attend five small-group sessions focused on stigma coping, cognitive-behavioral skills, communication, social support, and HIV care engagement, with an optional individual session involving a support person. The study will examine effects on HIV care engagement, antiretroviral therapy adherence, and stigma-related psychosocial outcomes to inform a future fully powered randomized controlled trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

HIV

Interventions

Light InsideBEHAVIORAL

Adapted intersectional stigma reduction intervention consisting of five facilitator-led, small-group sessions delivered over approximately 2-3 weeks. The intervention uses cognitive-behavioral strategies to reduce HIV- and drug use-related stigma by strengthening adaptive coping, cognitive restructuring, communication skills, social support, and HIV care self-efficacy to improve HIV care engagement and antiretroviral therapy adherence. Participants may also complete an optional individual session with a psychologist facilitator and a support person.

standard of careBEHAVIORAL

Standard of Care: Participants will continue to receive standard HIV and substance use care available through their usual healthcare providers. In addition, they will receive a one-time consultation with a social worker, delivered either in person or remotely, to provide support and linkage to available services.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female; Age 18 years or older; * Registered in the national Medical Information System (MIS) as having received an HIV-positive diagnosis; * Registered in the MIS with injection drug use (IDU) as the probable mode of HIV transmission or with a documented history of injection drug use at any clinical visit. Exclusion Criteria: * Does not meet the inclusion criteria; * Unable to provide informed consent; * Unable to provide informed consent due to intoxication, the effects of drug use, or severe psychiatric impairment at the time of consent.

Outcomes

Primary Outcomes

HIV care engagement as assessed by the Number of participants who re-engage in HIV care

Number of participants who re-engage in HIV care, defined as attending at least one HIV clinical care visit within 6 months after study enrollment, as documented in the Medical Information System (MIS).

Time frame: 6 months

Antiretroviral therapy (ART) adherence as assessed by the percentage of days covered by dispensed antiretroviral medication

ART adherence, measured as the percentage of days covered by dispensed antiretroviral medication during the 6 months after study enrollment, based on Medical Information System pharmacy records.

Time frame: 6 months

Central Contacts

Jill Owczarzak, PhD

CONTACT

667-306-8360 jillowczarzak@jhu.edu

Data from ClinicalTrials.gov

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