Digital PrEP Micro-Intervention for PWUD in Kazakhstan

Digital Micro-Interventions to Reduce Stigma-Driven Barriers and Improve PrEP Readiness Among People Who Use Drugs in Kazakhstan

This study is a mixed-methods pilot designed to evaluate the feasibility, acceptability, and appropriateness of a brief digital micro-intervention aimed at reducing stigma-related barriers to pre-exposure prophylaxis (PrEP) engagement among people who use drugs (PWUD) in Kazakhstan. Participants will complete baseline and post-intervention surveys and receive structured informational content via Telegram or WhatsApp over approximately 2-3 weeks. The intervention focuses on addressing anticipated stigma, confidentiality concerns, and misinformation that may prevent PWUD from seeking PrEP services. No clinical procedures, medication provision, or biological specimen collection are involved.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV; Drug Use
• Intervention / Treatment: Behavioral: Dgital micro-intervention

Detailed Description

The proposed study has three aims:

1. To refine a brief, stigma-informed digital micro-intervention designed to address structural and anticipated barriers to PrEP uptake among people who use drugs (PWUD) in Kazakhstan.
2. To assess the feasibility, acceptability, and appropriateness of delivering this intervention through secure digital platforms (e.g., Telegram or WhatsApp).
3. To evaluate preliminary changes in PrEP-related knowledge, perceived stigma- related barriers, and readiness to seek PrEP services following exposure to the intervention.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Assel Terlikbayeva, MD, MS, MPH; Phone Number: +77017368679; Email: assel.terlikbayeva@ghrcca.org
• Study Contact Backup: Name: David Oliveros, MPH; Phone Number: +12028058118; Email: david.oliveros@yale.edu

Study Locations

• Kazakhstan
  • Almaty, Kazakhstan
    • Center for Scientific and Practical Initiatives
    • Principal Investigator: Assel Terlikbayeva, MD, MS, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Self-reported drug use within the past six months
• HIV-negative or unknown HIV status (self-reported)
• Not currently taking PrEP
• Able to provide informed consent
• Have access to a personal mobile phone capable of receiving Telegram or WhatsApp messages

Exclusion Criteria:

• Are unable to provide informed consent
• Do not have access to a mobile device for digital message delivery
• Are currently enrolled in another PrEP behavioral intervention study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Digital micro-intervention; Participants will receive digital micro-intervention modules via Telegram or WhatsApp over approximately 2-3 weeks.

Behavioral: Dgital micro-intervention; Intervention will include 6-10 brief modules delivered asynchronously consisting of text-based content with optional simple visuals. There is no requirement for participant response. Messages will avoid explicit labeling referencing HIV or drug use in preview text and be written using neutral language. Participants are allowed to discontinue receipt at any time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Score Acceptability of Intervention Measure (AIM)	Acceptability of the intervention will be assessed using the Acceptability of Intervention Measure (AIM). It has 4-items scored on a 5-point Likert scale summed to achieve a total score. Total score range of 0-20. Higher scores indicate more acceptability.	Baseline and Post intervention (Week 4)
Mean Score Intervention Appropriateness Measure (IAM)	The Intervention Appropriateness Measure (IAM) is a 4-item, 5-point Likert scale ( 1=Completely Disagree to 5=Completely Agree) used to evaluate the perceived fit, relevance, or compatibility of an intervention or implementation strategy. Total score range 0-20. Higher scores indicate better appropriateness.	Baseline and Post intervention (Week 4)
Mean Score Feasibility of Intervention Measure (FIM)	Feasibility of intervention measured using Feasibility of Intervention Measure (FIM)- a 4-item instrument to assess perceived intervention feasibility. Total score 1-5 with higher scores indicating greater feasibility.	Baseline and Post intervention (Week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PrEP knowledge	Measured by a structured survey. Total score range 1-10. Higher scores indicate increased knowledge.	Baseline and Post intervention (Week 4)
Change in perceived stigma-related barriers	Measured by a structured survey. Total score range 8-40. Higher scores indicate more barriers.	Baseline and Post intervention (Week 4)
Change in readiness to seek PrEP	Measured by Likert scale survey items. Total score range 1-5. Higher scores indicate increased readiness.	Baseline and Post intervention (Week 4)
Mean number of clicks or links accessed	Mean number of clicks or links accessed among participants that used the intervention	Baseline and Post intervention (Week 4)
Mean number of messages delivered	Mean number of confirmed messages delivered	Baseline and Post intervention (Week 4)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Frederick L Altice, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2000042287; 2P30MH062294-21 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual-level participant data collected during the study may be shared with other researchers upon reasonable request after publication of the study results. Shared data will include de-identified survey data and study documentation, such as the study protocol and data dictionary. Data will be shared in a manner consistent with institutional policies and participant confidentiality protections.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No