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

July 16, 2025 updated by: Brooke West, Columbia University

Reducing Intersectional and HIV Stigma Among High Risk Women Who Use Drugs in Kazakhstan, Central Asia: A Multilevel Stigma Resistance and Enacted Stigma Reduction Intervention for Women and Providers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan
        • Global Health Research Center for Central Asia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Provider Training and Clinic Messaging
Providers receive a 5-session stigma-free clinic training and anti-stigma messaging campaign materials to display in clinic.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Provider HIV Enacted Stigma Measure
Time Frame: 6 months
This 4-item measure is adapted from the "Measuring HIV Stigma and Discrimination among Health Facility Staff" questionnaire enacted stigma sub-scale. Across the 4 items, Likert-responses range from 1 (never observed) to 4 (always observed).
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Number of PrEP Prescriptions Issued to Clients
Time Frame: 6 months
Through review of clinic-level administrative data, this study will measure the total number of prescriptions for PrEP over a 6-month period.
6 months
Total Number of Clients
Time Frame: 6 Months
Through review of clinic-level administrative data, this study will measure the total number of clients over a 6-month period.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pennsylvania
Fogarty International Center of the National Institute of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAU3129
  • R01TW012405 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After further testing, we will share study protocols.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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