Stigma, SocialNCT06932796
Project Orleu: Reducing Intersectional and HIV Stigma Among Health Care Providers and High Risk Women Who Use Drugs in Kazakhstan
A study testing Health Care Provider Stigma Training and Clinic-Based Messaging Campaign in people with Stigma, Social, run by Columbia University at 1 site in Kazakhstan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stigma, Social
- What is being tested?
- Health Care Provider Stigma Training and Clinic-Based Messaging Campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteKazakhstan
- Study dates
- 15 Aug 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Providers who are less than 18 years of age and/or do not work at an AIDS center friendly clinic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stigma, Social
- Being tested
- Health Care Provider Stigma Training and Clinic-Based Messaging Campaign
- Keywords
- Intersectional Stigma, HIV, Linkage to Prevention and Care, Service Delivery, Women, Drug Use, Sex Work
- Medical subject headings
- Social Stigma, Sex Work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Care Provider Stigma Training and Clinic-Based Messaging CampaignBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Provider Training and Clinic Messaging | Experimental | Providers receive a 5-session stigma-free clinic training and anti-stigma messaging campaign materials to display in clinic. Receives: Behavioral: Health Care Provider Stigma Training and Clinic-Based Messaging Campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider HIV Enacted Stigma Measure
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).
Measured: 6 months
Secondary outcomes (2)
Total Number of PrEP Prescriptions Issued to Clients
Through review of clinic-level administrative data, this study will measure the total number of prescriptions for PrEP over a 6-month period.
Measured: 6 months
Total Number of Clients
Through review of clinic-level administrative data, this study will measure the total number of clients over a 6-month period.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start15 Aug 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stigma, SocialStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre/Post Design
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, University of Pennsylvania
- Responsible party
- Principal investigator, Brooke West, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932796
- Sponsor's protocol ID
- AAAU3129
- Other IDs
- R01TW012405
- Status last verified
- Jul 2025
- First submitted
- 10 Apr 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After further testing, we will share study protocols.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06932796
- Acronym / sponsor ID
- AAAU3129
- Conditions
- Stigma, Social
- Keywords
- Intersectional Stigma, HIV, Linkage to Prevention and Care, Service Delivery, Women, Drug Use, Sex Work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, University of Pennsylvania
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre/Post Design
| Arm | Type | Receives |
|---|---|---|
| Provider Training and Clinic Messaging | Experimental | Behavioral: Health Care Provider Stigma Training and Clinic-Based Messaging CampaignProviders receive a 5-session stigma-free clinic training and anti-stigma messaging campaign materials to display in clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Providers who are less than 18 years of age and/or do not work at an AIDS center friendly clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Care Provider Stigma Training and Clinic-Based Messaging CampaignProviders 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. | Behavioural | Provider Training and Clinic Messaging |
Primary outcome
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).
2 secondary outcomes
Total Number of PrEP Prescriptions Issued to Clients
Time frame: 6 months
Total Number of Clients
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No. After further testing, we will share study protocols.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Care Provider Stigma Training and Clinic-Based Messaging Campaign in people with Stigma, Social, run by Columbia University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider HIV Enacted Stigma Measure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.