Digital PrEP Micro-Intervention for PWUD in Kazakhstan

NCT07508137 | Not Yet Recruiting

• 2 other identifiers: 20000422872P30MH062294-21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Use; HIV

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change in PrEP knowledge

  Baseline and Post intervention (Week 4)

• Change in perceived stigma-related barriers

  Baseline and Post intervention (Week 4)

• Change in readiness to seek PrEP

  Baseline and Post intervention (Week 4)

• Mean number of clicks or links accessed

  Baseline and Post intervention (Week 4)

• Mean number of messages delivered

  Baseline and Post intervention (Week 4)

Study Arms (1)

Digital micro-intervention

EXPERIMENTAL

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

Behavioral: Dgital micro-intervention

Interventions

Dgital micro-intervention BEHAVIORAL

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.

Digital micro-intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for Scientific and Practical Initiatives

Almaty, Kazakhstan

Location

Study Officials

• Frederick L Altice, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Assel Terlikbayeva, MD, MS, MPH

CONTACT

+77017368679; assel.terlikbayeva@ghrcca.org

David Oliveros, MPH

CONTACT

+12028058118; david.oliveros@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adults in Kazakhstan who report recent drug use and who are not currently using pre-exposure prophylaxis (PrEP). Participants will be recruited through established community-based harm-reduction organizations that serve people who use drugs (PWUD).

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

KA (1)