HIV InfectionsNCT04910984
Developing a Chatbot to Promote HIV Testing
An observational study of HIV Infections, run by Yale University at 1 site in Malaysia.
Trial summary
In this study, the feasibility of a Chatbot in promoting HIV testing in men who have sex with men in Kuala Lumpur, Malaysia will be studied. Participants will receive automated personalized messages containing HIV testing-related information, motivation and skills. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Chatbot messages and Attention-matched educational materials
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2022to 31 May 2023
- Phase
- Observational
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult males
Who may be able to join
- cis-gender male
- 18+ years;
- had condomless sex with men in the past 6 months
- has a smartphone
- speaks Bahasa Malay or English.
Who cannot join
- Not able to read Malay or English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing an Artificial Intelligence Chatbot to Promote HIV Testing
In this study, the feasibility of a Chatbot in promoting HIV testing in men who have sex with men in Kuala Lumpur, Malaysia will be studied. Participants will receive automated personalized messages containing HIV testing-related information, motivation and skills.
Read the detailed description
Participants will receive attention-matched educational materials manually sent by the research assistant. In each round of the interactive communication, the Chatbot will provide automated personalized messages containing HIV testing-related information, motivation and skills based on participants' answers and will continuously update over time. An independent assessment of recent testing and reasons why will be sent by link participant using a link to a Qualtrics survey housed on REDCap. The RA will send an additional REDCap survey to intervention participants to assess the feasibility of the Chabot to measure 4 key elements: acceptability, practicality, demand, and adaptation.
Study was changed from Interventional to Observational half way through,. Record was updated accordingly in 2026.
- Conditions
- HIV Infections
- Being tested
- Chatbot messages, Attention-matched educational materials
- Keywords
- HIV testing, PrEp, HIV care, Chatbot, MSM
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot messagesBehavioural
Automated personalized messages containing HIV testing-related information, motivation and skills
Attention-matched educational materialsBehavioural
Attention-matched educational materials manually sent by our research assistant. These educational materials will be retrieved from CDC and WHO websites and curated into short articles (<200 words) and pictures. All educational materials will be screened by HIV experts from University of Malaya to ensure accuracy before being sent to participants.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot group | Not described Receives: Behavioral: Chatbot messages; Behavioral: Attention-matched educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HIV testing
The efficacy of the Chatbot versus TAU with HIV testing as the primary outcome will be measured. The primacy efficacy outcome is the proportion of MSM who get tested within 180 days. This will be measured every 30 days by asking if MSM tested for HIV in the past 30 days.
Measured: 30 days, 60 days, 90 days, 120 days, 150 days, and 180 days
Secondary outcomes (4)
Recruitment rate
The number of participants contacted divided by the number of participants who signed the consent form
Measured: 180 days
Completion rate
The number of participants who signed the consent form divided by the number of participants who completed the study
Measured: 180 days
Interaction time
The time of the interaction between participants and Chatbot
Measured: 180 days
Interaction frequency
The frequency of the interaction between participants and Chatbot
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Mar 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Jeffrey A. Wickersham, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910984
- Sponsor's protocol ID
- 2000027864
- Other IDs
- 1R21AI152927-01A1
- Status last verified
- Sep 2026
- First submitted
- 27 May 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Artificial Intelligence Chatbot to Promote HIV Testing
- ClinicalTrials.gov ID
- NCT04910984
- Acronym / sponsor ID
- 2000027864
- Conditions
- HIV Infections
- Keywords
- HIV testing, PrEp, HIV care, Chatbot, MSM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Malaya, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 2 Jun 2021 (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.
In this study, the feasibility of a Chatbot in promoting HIV testing in men who have sex with men in Kuala Lumpur, Malaysia will be studied. Participants will receive automated personalized messages containing HIV testing-related information, motivation and skills.
Detailed description
Participants will receive attention-matched educational materials manually sent by the research assistant. In each round of the interactive communication, the Chatbot will provide automated personalized messages containing HIV testing-related information, motivation and skills based on participants' answers and will continuously update over time. An independent assessment of recent testing and reasons why will be sent by link participant using a link to a Qualtrics survey housed on REDCap. The RA will send an additional REDCap survey to intervention participants to assess the feasibility of the Chabot to measure 4 key elements: acceptability, practicality, demand, and adaptation.
Study was changed from Interventional to Observational half way through,. Record was updated accordingly in 2026.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chatbot group | – | Behavioral: Chatbot messages, Behavioral: Attention-matched educational materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult males
Key inclusion criteria (5 listed)
- cis-gender male
- 18+ years;
- had condomless sex with men in the past 6 months
- has a smartphone
- speaks Bahasa Malay or English.
Key exclusion criteria (1 listed)
- Not able to read Malay or English
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 |
|---|---|---|
| Chatbot messagesAutomated personalized messages containing HIV testing-related information, motivation and skills | Behavioural | Chatbot group |
| Attention-matched educational materialsAttention-matched educational materials manually sent by our research assistant. These educational materials will be retrieved from CDC and WHO websites and curated into short articles (<200 words) and pictures. All educational materials will be screened by HIV experts from University of Malaya to ensure accuracy before being sent to participants. | Behavioural | Chatbot group |
Primary outcome
Change in HIV testing
Time frame: 30 days, 60 days, 90 days, 120 days, 150 days, and 180 days
The efficacy of the Chatbot versus TAU with HIV testing as the primary outcome will be measured. The primacy efficacy outcome is the proportion of MSM who get tested within 180 days. This will be measured every 30 days by asking if MSM tested for HIV in the past 30 days.
4 secondary outcomes
Recruitment rate
Time frame: 180 days
Completion rate
Time frame: 180 days
Interaction time
Time frame: 180 days
Interaction frequency
Time frame: 180 days
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 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Jeffrey A. Wickersham, PhD 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?
An observational study of HIV Infections, run by Yale University at 1 site in Malaysia.
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 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 21 Sep 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 Malaysia. 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?
Change in HIV testing (time frame: 30 days, 60 days, 90 days, 120 days, 150 days, and 180 days). 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 21 Sep 2026.