Drug UseNCT07508137
Digital PrEP Micro-Intervention for PWUD in Kazakhstan
A study testing Dgital micro-intervention in people with Drug Use and HIV, run by Yale University at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Dgital micro-intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteKazakhstan
- Study dates
- Jan 2027to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kazakhstan1 site
Center for Scientific and Practical Initiatives
Almaty
Assel Terlikbayeva, MD, MS, MPH
About this study
Official title: 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.
Read the detailed description
The proposed study has three aims:
- 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.
- To assess the feasibility, acceptability, and appropriateness of delivering this intervention through secure digital platforms (e.g., Telegram or WhatsApp).
- To evaluate preliminary changes in PrEP-related knowledge, perceived stigma- related barriers, and readiness to seek PrEP services following exposure to the intervention.
- Being tested
- Dgital micro-intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dgital micro-interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital micro-intervention | Experimental | Participants will receive digital micro-intervention modules via Telegram or WhatsApp over approximately 2-3 weeks. Receives: Behavioral: Dgital micro-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Post intervention (Week 4)
Secondary outcomes (5)
Change in PrEP knowledge
Measured by a structured survey. Total score range 1-10. Higher scores indicate increased knowledge.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline and Post intervention (Week 4)
Mean number of messages delivered
Mean number of confirmed messages delivered
Measured: Baseline and Post intervention (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study startJan 2027 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug UseStudies of the same condition, open and under way.
- More trials run by Yale 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Frederick L Altice, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508137
- Sponsor's protocol ID
- 2000042287
- Other IDs
- 2P30MH062294-21
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Micro-Interventions to Reduce Stigma-Driven Barriers and Improve PrEP Readiness Among People Who Use Drugs in Kazakhstan
- ClinicalTrials.gov ID
- NCT07508137
- Acronym / sponsor ID
- 2000042287
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 2 Apr 2026 (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.
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.
Detailed description
The proposed study has three aims:
- 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.
- To assess the feasibility, acceptability, and appropriateness of delivering this intervention through secure digital platforms (e.g., Telegram or WhatsApp).
- To evaluate preliminary changes in PrEP-related knowledge, perceived stigma- related barriers, and readiness to seek PrEP services following exposure to the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Digital micro-intervention | Experimental | Behavioral: Dgital micro-interventionParticipants will receive digital micro-intervention modules via Telegram or WhatsApp over approximately 2-3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Dgital micro-interventionIntervention 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. | Behavioural | Digital micro-intervention |
Primary outcome
Mean Score Acceptability of Intervention Measure (AIM)
Time frame: Baseline and Post intervention (Week 4)
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.
Mean Score Intervention Appropriateness Measure (IAM)
Time frame: Baseline and Post intervention (Week 4)
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.
Mean Score Feasibility of Intervention Measure (FIM)
Time frame: Baseline and Post intervention (Week 4)
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.
5 secondary outcomes
Change in PrEP knowledge
Time frame: Baseline and Post intervention (Week 4)
Change in perceived stigma-related barriers
Time frame: Baseline and Post intervention (Week 4)
Change in readiness to seek PrEP
Time frame: Baseline and Post intervention (Week 4)
Mean number of clicks or links accessed
Time frame: Baseline and Post intervention (Week 4)
Mean number of messages delivered
Time frame: Baseline and Post intervention (Week 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Frederick L Altice, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dgital micro-intervention in people with Drug Use and HIV, run by Yale 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assel Terlikbayeva, MD, MS, MPH (+77017368679, assel.terlikbayeva@ghrcca.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score Acceptability of Intervention Measure (AIM) (time frame: Baseline and Post intervention (Week 4)). The study lists 3 primary outcomes in all. 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 8 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.