Project Orleu: Reducing Intersectional and HIV Stigma Among Health Care Providers and High Risk Women Who Use Drugs in Kazakhstan

NCT ID: NCT06932796

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Suboptimal linkage to and retention in HIV prevention and care is prevalent among high-risk women who use or inject drugs in both the US and globally, including high HIV incidence contexts like Kazakhstan; addressing HIV and intersectional stigma, especially from health care providers (HCP) within clinics, is necessary to increase engagement in the HIV care and prevention continuum. To address this challenge and increase HIV prevention and care, the proposed study will involve the design and assessment of the acceptability, feasibility, and usability of a three component, multi-level participatory intervention to promote stigma resistance/coping and reduce anticipated/internalized stigma among high-risk women who use drugs as well as to reduce enacted stigma among HCP in Kazakhstan, Central Asia. Results of this study will generate information in order to power a future preliminary effectiveness trial and will be unique in utilizing multilevel anti-stigma approaches for both high risk women who use drugs and HCP, all of which will have important implications for advancing HIV prevention and care engagement among highly stigmatized populations in diverse settings.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Suboptimal linkage to and retention in HIV prevention and care is prevalent among high-risk women who use or inject drugs in both the US and globally, stemming, in part, from high levels of stigma. In Kazakhstan, increasing engagement in the HIV care and prevention continuum is a major public health goal, as the number of new HIV infections doubled from 2010 to 2017 and AIDS-related deaths increased by 32%. Among high-risk women who use drugs in this context, research has found that \~30% are HIV-infected and that they are less likely to test and receive care. Numerous studies have documented that experienced, anticipated and internalized stigma, especially from health care providers (HCP), are key barriers to HIV testing and treatment in global contexts. For high-risk women who use drugs, HIV and associated stigmas, specifically stigma related to sex and drug use, as well as gender discrimination, work independently and synergistically to inhibit access to HIV prevention and treatment; yet, there are no existing anti-stigma interventions designed and tested in Kazakhstan for this key population of women and that focus on HCP as sources of stigma. This study proposes to design and assess acceptability, feasibility, and generate information in order to power a preliminary effectiveness trial of a three component, multi-level participatory intervention to reduce HIV-associated and intersectional stigma - and thus increase access to HIV prevention and care. The first component is aimed at high-risk women and designed to increase stigma resistance/coping and reduce anticipated/internalized stigma via: a) crowdsourcing of anti-stigma messaging for HCP; and b) adaptation of an HCP training for optimal sexual health and healthcare engagement among high-risk women who used drugs. The second and third components, aimed at the HCP and other clinic staff and emerging from the execution of the first component, include: a) the resultant messaging campaign; and b) the training that will be delivered to HCP. Both the messaging campaign and the training components will be designed to reduce enacted stigma by HCP/staff (and thus experienced stigma among women) and increase stigma resistance and resilience among high-risk women who use drugs. All components will work synergistically to reduce enacted, experienced and internalized, intersectional stigma. The approach relies on evidence-based methods, including media campaigns, to reduce HCP enacted stigma, and integrates innovative methods, like crowdsourcing and participatory research, to increase stigma resistance. Results of this study will be unique in utilizing multilevel anti-stigma approaches for both high-risk women who use drugs and HCP and have important implications for advancing HIV prevention and care engagement among highly stigmatized populations globally and in the US.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stigma, Social

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre/Post Design
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Provider Training and Clinic Messaging

Providers receive a 5-session stigma-free clinic training and anti-stigma messaging campaign materials to display in clinic.

Group Type EXPERIMENTAL

Health Care Provider Stigma Training and Clinic-Based Messaging Campaign

Intervention Type BEHAVIORAL

Providers in 10 HIV clinics participated in a 5 session anti-stigma health facility training focused on: 1) raising awareness about stigma and discrimination at the facility; and 2) changing attitudes and behaviors towards women who use drugs and/or trade sex; and 3) building a stigma-free clinic. Each of these clinics also received anti-stigma messaging materials (i.e., pamphlets, posters) to display in their clinics over a 6 month period. Providers received text-based message twice a month during this time to reinforce skills learned during trainings and to empower providers to be stigma change agents. Providers completed pre/post survey assessments.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Health Care Provider Stigma Training and Clinic-Based Messaging Campaign

Providers in 10 HIV clinics participated in a 5 session anti-stigma health facility training focused on: 1) raising awareness about stigma and discrimination at the facility; and 2) changing attitudes and behaviors towards women who use drugs and/or trade sex; and 3) building a stigma-free clinic. Each of these clinics also received anti-stigma messaging materials (i.e., pamphlets, posters) to display in their clinics over a 6 month period. Providers received text-based message twice a month during this time to reinforce skills learned during trainings and to empower providers to be stigma change agents. Providers completed pre/post survey assessments.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Providers (e.g., physicians, nurses, clinic directors, epidemiologists, outreach workers)
* Aged 18 years or older
* Currently employed part or full-time at an AIDS Center friendly clinic (city clinics focused on the provision of HIV and sexual health care).

Exclusion Criteria

\- Providers who are less than 18 years of age and/or do not work at an AIDS center friendly clinic.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brooke West

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Global Health Research Center for Central Asia

Almaty, , Kazakhstan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Kazakhstan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01TW012405

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU3129

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

HIV Risk and Prevention in Women
NCT02263391 COMPLETED NA
HST for Female Sex Workers/Drug Users in Kazakhstan
NCT06150937 ACTIVE_NOT_RECRUITING NA
A Women-Focused PrEP Intervention
NCT03699722 COMPLETED PHASE1