NCT06932796

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

April 10, 2025

Last Update Submit

July 16, 2025

Conditions

Keywords

Intersectional StigmaHIVLinkage to Prevention and CareService DeliveryWomenDrug UseSex Work

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 months

Secondary Outcomes (2)

  • Total Number of PrEP Prescriptions Issued to Clients

    6 months

  • Total Number of Clients

    6 Months

Study Arms (1)

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.

Behavioral: Health Care Provider Stigma Training and Clinic-Based Messaging Campaign

Interventions

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.

Provider Training and Clinic Messaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Global Health Research Center for Central Asia

Almaty, Kazakhstan

Location

MeSH Terms

Conditions

Social StigmaSex Work

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorSexual Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Pre/Post Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 17, 2025

Study Start

August 15, 2024

Primary Completion

May 15, 2025

Study Completion

May 15, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

After further testing, we will share study protocols.

Locations