HIVNCT06814041
Pilot RCT and Interview Study on an HIV Chatbot in Nigeria
A study testing Chatbot as an informational coach in people with HIV, run by Christoph Pimmer at 6 sites in Nigeria.
Trial summary
This study will investigate the use of a HIV chatbot that acts as an informational coach. The main question the study aims to answer is: Does the chatbot improve HIV knowledge in adults (older than 18-years) newly diagnosed with HIV in Nigeria - compared to a control group? Moreover, the study will also determine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Chatbot as an informational coach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 6 sitesNigeria
- Study dates
- 14 Apr 2025to 20 Jun 2026
- 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
- Diagnosed with HIV
- ART enrollment: at the day of recruitment or in the subsequent 7 days. But no longer than 30 months prior to enrolment in the study..
- Age ≥ 18 years
- Have a personal internet-enabled smartphone with WhatsApp installed
- Carry the phone with them at the time of recruitment
- Able to understand, read, and write in English (the official language in Nigeria)
- Able to understand the information about the study
- Provide written informed consent.
Who cannot join
- Known pregnancy or ≤3 months postpartum
- Persons with suicidal ideation and/or severe mental distress
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Nigeria6 sites
Infectious Disease Institute, (IDI) UCH
Ibadan, Oyo State
St. Mary's Catholic General Hospital
Ibadan, Oyo State
Adeoyo Maternity Teaching Hospital
Ibadan, Oyo
Our Lady of Apostle Catholic Hospital
Ibadan
Ring Road State Hospital
Ibadan
Baptist Medical Centre
Saki, Oyo State
About this study
Official title: A Pilot Randomized Controlled Trial and an Interview Study to Evaluate a Chatbot for People Living With HIV in Nigeria
This study will investigate the use of a HIV chatbot that acts as an informational coach.
The main question the study aims to answer is:
Read more
Does the chatbot improve HIV knowledge in adults (older than 18-years) newly diagnosed with HIV in Nigeria - compared to a control group?
Moreover, the study will also determine potential effects of the chatbot use on patients' resilience, psychological well-being. The study will explore patients' use and perceptions of the chatbot, as well as potential gender differences.
The control group will receive Standard of Care only. Patients in the chatbot intervention group will interact with the chatbot in addition to receiving Standard of Care. They will be able to:
- Use a chatbot via WhatsApp
- Receive information on relevant HIV topics
- Get automated responses to their HIV-related questions
- Be reminded of medical appointments and medication schedules
- Conditions
- HIV
- Being tested
- Chatbot as an informational coach
- Keywords
- Chatbot, HIV, Nigeria, HIV knowledge, gender
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot as an informational coachOther
The chatbot acts as an empathic informational coach, performing three main functions: (1) offering short conversation sessions about key topics on living with HIV; (2) responding to users' ad-hoc questions on HIV; (3) reminding users of medical appointments and drug taking.
The chatbot comprises a conversational system, utilizing WhatsApp for user interaction, with messages routed through the backend Voiceflow. User can access the chatbot system via WhatsApp. That means that they access the chatbot like any other contact in their WhatsApp chat list. The bot incorporates mostly text-based input- and output modalities, and a few images, which are more protective of users' privacy than speech. Concretely, chatbot users interact with the chatbot on WhatsApp by selecting from pre-defined options (buttons) or, in some parts, writing text.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot Intervention | Experimental | In addition to the Standard of Care described, participants in the intervention group will be able to use a chatbot system. The chatbot was designed especially with the goal to support people newly diagnosed with HIV at the beginning of their antiretroviral therapy (ART). Receives: Other: Chatbot as an informational coach |
| Control Group | No intervention | Study participants in the control group will receive the Standard of Care only, offered by the clinics: 1. st visit in the clinic: Testing and ART enrolment: When patients in the clinic have a positive HIV test, various health assessments are carried out, including TB testing. The patient has a session with an adherence counsellor. A medical consultation takes place where a doctor addresses health issues and prescribes ART medication. First-time patients receive a 3-month prescription. 2. nd visit in the clinic in the first three months: Patients return to the clinic within the first 3 months. They are given the results of the tests carried out during their first visit, undergo health checks (vital signs) and receive health information. The patient is also seen by a doctor who prescribes ART for the next 3 months. 3. rd visit to the clinic at 6 months: The procedure is the same as for the 3-month visit, except that a viral load test is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's HIV knowledge
The primary endpoint is the change of HIV knowledge from baseline to the 50-day follow-up assessed using the Patient's HIV Knowledge Questionnaire (PHKQ). The questionnaire consists of 15 items and includes the components (subscales) Transmission and Misconceptions, Causes and Treatment Outcomes, and Diet and Immunity (Jackson, Okonta, \& Ukwe, 2020). Participants are required to evaluate statements such as "HIV infection is caused by evil spirits" using a three-point scale: "Yes," "No," and "I don't know." The correct answer is awarded one point, while incorrect responses or the option "I don't know" are each awarded zero points.
Measured: Baseline to 50-day follow-up
Secondary outcomes (4)
Participants' extended HIV knowledge
In addition to the Patient's HIV knowledge questionnaire (PHKQ), we will use another knowledge test, which includes 10 additional questions, to more compressively assess the participants' knowledge. The test measures additional knowledge areas, which:
- are geared to the study participants' specific situation, i.e. being new to the ART regime (such as how much time it takes until the virus may become undetectable )
- are very relevant but not covered by the PHKQ, such as knowing about Post-Exposure-Prophylaxis (PEP) to prevent further infections.
Measured: at 50 day follow up
Participants' Resilience (PLHIV Scale)
To assess whether the availability of an empathic digital agent can also increase people's resilience, i.e. their "positive adaptation within the context of significant adversity", we use the People Living with HIV (PLHIV) Resilience Scale (Gottert et al., 2019). The scale is particularly suited as it is tailored to the situation of people living with HIV, measured and psychometrically validated in three African countries including Uganda, Senegal and Cameroon. The 10-item PLHIV Resilience Scale covers topics such as self-confidence, self-respect etc. and invites participants to indicate whether these have been positively, negatively, or not affected by their HIV status. Higher resilience was associated with less depression in each country (Gottert et al., 2019).
Measured: At 50 day follow up
Participants' psychological well-being (SRQ-20)
Participants' psychological well-being (SRQ-20) - measured at 50 day follow up We will measure participants' psychological well-being with the WHO 20-item Self-Reporting Questionnaire (SRQ-20) (Beusenberg, 1994). SRQ-20 was designed to screen for general psychological distress, especially in developing countries. It contains 20 questions which have to be answered by 'yes' or 'no', such as "are you easily frightened" (Beusenberg, 1994). Scores range from 0 to 20, with higher scores indicating higher levels of distress. SRQ-20 is a widely used and validated measurement to assess psychological distress, including in the context of Nigeria and HIV care. For example, people living with HIV Nigeria were reported to have a thirty-fold increase of psychological distress in the first year on ART (Pierce et al., 2023).
Measured: at 50 day follow up
Users' perception of the chatbot: trust and parasocial relationships
The different ways in which users perceive the chatbot will be measured by assessing users' trust and their perceived relationship with the chatbot.
Trust is a multidimensional construct and thus a validated measurement tool which consists of three components will be used: competence, benevolence and integrity (Hu \& Lu, 2021). Competence consists of 4 items. Benevolence and integrity consist of 3 items each. For example, for benevolence, one question is "whether the digital assistant is interested in my well-being".
Parasocial relationships questionnaires were originally developed to measure relationships between celebrities and people. They have been applied recently to measure the perceived relational connectedness between chatbots and their users (Youn \& Jin, 2021). In this study, the interaction subscale, which consists of 4 items, will be applied. It requires users to evaluate their perceived relationship with the chatbot.
Measured: at 25 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start14 Apr 2025
- Primary completion11 Feb 2026
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The model is: two-arm (1:1), open label, randomised controlled trial (RCT). The intervention group will use the chatbot in addition to the Standard of Care (SoC), the control group will receive SoC only.
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christoph Pimmer
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ibadan
- Responsible party
- Sponsor-investigator, Christoph Pimmer, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814041
- Sponsor's protocol ID
- IZSTZ0_202602
- Status last verified
- Aug 2025
- First submitted
- 3 Feb 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Boyd AT, Rocconi LM, Morrow JA. Construct validation and measurement invariance of the Parasocial Relationships in Social Media survey. PLoS One. 2024 Mar 28;19(3):e0300356. doi: 10.1371/journal.pone.0300356. eCollection 2024.
PubMed 38547192Pierce LJ, Regan S, Idigbe I, Adeola J, Musa Z, Ezechi O, Oladeji B, Gureje O, Freedberg KA, Okonkwo P, Ahonkhai AA. Psychological Distress Increases 30-Fold Among People with HIV in the First Year on ART in Nigeria-a Call for Integrated Mental Health Services. Int J Behav Med. 2023 Feb;30(1):38-48. doi: 10.1007/s12529-022-10068-8. Epub 2022 Feb 28.
PubMed 35226343Gottert A, Friedland B, Geibel S, Nyblade L, Baral SD, Kentutsi S, Mallouris C, Sprague L, Hows J, Anam F, Amanyeiwe U, Pulerwitz J. The People Living with HIV (PLHIV) Resilience Scale: Development and Validation in Three Countries in the Context of the PLHIV Stigma Index. AIDS Behav. 2019 Sep;23(Suppl 2):172-182. doi: 10.1007/s10461-019-02594-6.
PubMed 31350712Jackson IL, Okonta JM, Ukwe CV. Development and psychometric evaluation of the patient's HIV knowledge questionnaire (PHKQ). Int J Clin Pharm. 2020 Apr;42(2):695-702. doi: 10.1007/s11096-020-00963-z. Epub 2020 Jan 14.
PubMed 31939032
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial and an Interview Study to Evaluate a Chatbot for People Living With HIV in Nigeria
- ClinicalTrials.gov ID
- NCT06814041
- Acronym / sponsor ID
- IZSTZ0_202602
- Conditions
- HIV
- Keywords
- Chatbot, HIV, Nigeria, HIV knowledge, gender
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Christoph PimmerUniversity, hospital or other
- Collaborators
- University of Ibadan
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 7 Feb 2025 (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 will investigate the use of a HIV chatbot that acts as an informational coach.
The main question the study aims to answer is:
Does the chatbot improve HIV knowledge in adults (older than 18-years) newly diagnosed with HIV in Nigeria - compared to a control group?
Moreover, the study will also determine potential effects of the chatbot use on patients' resilience, psychological well-being. The study will explore patients' use and perceptions of the chatbot, as well as potential gender differences.
The control group will receive Standard of Care only. Patients in the chatbot intervention group will interact with the chatbot in addition to receiving Standard of Care. They will be able to:
- Use a chatbot via WhatsApp
- Receive information on relevant HIV topics
- Get automated responses to their HIV-related questions
- Be reminded of medical appointments and medication schedules
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The model is: two-arm (1:1), open label, randomised controlled trial (RCT). The intervention group will use the chatbot in addition to the Standard of Care (SoC), the control group will receive SoC only.
| Arm | Type | Receives |
|---|---|---|
| Chatbot Intervention | Experimental | Other: Chatbot as an informational coachIn addition to the Standard of Care described, participants in the intervention group will be able to use a chatbot system. The chatbot was designed especially with the goal to support people newly diagnosed with HIV at the beginning of their antiretroviral therapy (ART). |
| Control Group | No intervention | –Study participants in the control group will receive the Standard of Care only, offered by the clinics: 1. st visit in the clinic: Testing and ART enrolment: When patients in the clinic have a positive HIV test, various health assessments are carried out, including TB testing. The patient has a session with an adherence counsellor. A medical consultation takes place where a doctor addresses health issues and prescribes ART medication. First-time patients receive a 3-month prescription. 2. nd visit in the clinic in the first three months: Patients return to the clinic within the first 3 months. They are given the results of the tests carried out during their first visit, undergo health checks (vital signs) and receive health information. The patient is also seen by a doctor who prescribes ART for the next 3 months. 3. rd visit to the clinic at 6 months: The procedure is the same as for the 3-month visit, except that a viral load test is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with HIV
- ART enrollment: at the day of recruitment or in the subsequent 7 days. But no longer than 30 months prior to enrolment in the study..
- Age ≥ 18 years
- Have a personal internet-enabled smartphone with WhatsApp installed
- Carry the phone with them at the time of recruitment
Key exclusion criteria (2 listed)
- Known pregnancy or ≤3 months postpartum
- Persons with suicidal ideation and/or severe mental distress
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 as an informational coachThe chatbot acts as an empathic informational coach, performing three main functions: (1) offering short conversation sessions about key topics on living with HIV; (2) responding to users' ad-hoc questions on HIV; (3) reminding users of medical appointments and drug taking. The chatbot comprises a conversational system, utilizing WhatsApp for user interaction, with messages routed through the backend Voiceflow. User can access the chatbot system via WhatsApp. That means that they access the chatbot like any other contact in their WhatsApp chat list. The bot incorporates mostly text-based input- and output modalities, and a few images, which are more protective of users' privacy than speech. Concretely, chatbot users interact with the chatbot on WhatsApp by selecting from pre-defined options (buttons) or, in some parts, writing text. | Other | Chatbot Intervention |
Primary outcome
Participant's HIV knowledge
Time frame: Baseline to 50-day follow-up
The primary endpoint is the change of HIV knowledge from baseline to the 50-day follow-up assessed using the Patient's HIV Knowledge Questionnaire (PHKQ). The questionnaire consists of 15 items and includes the components (subscales) Transmission and Misconceptions, Causes and Treatment Outcomes, and Diet and Immunity (Jackson, Okonta, \& Ukwe, 2020). Participants are required to evaluate statements such as "HIV infection is caused by evil spirits" using a three-point scale: "Yes," "No," and "I don't know." The correct answer is awarded one point, while incorrect responses or the option "I don't know" are each awarded zero points.
4 secondary outcomes
Participants' extended HIV knowledge
Time frame: at 50 day follow up
Participants' Resilience (PLHIV Scale)
Time frame: At 50 day follow up
Participants' psychological well-being (SRQ-20)
Time frame: at 50 day follow up
Users' perception of the chatbot: trust and parasocial relationships
Time frame: at 25 day follow up
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 22 Apr 2026.
- Background: PubMed 38547192Boyd AT, Rocconi LM, Morrow JA. Construct validation and measurement invariance of the Parasocial Relationships in Social Media survey. PLoS One. 2024 Mar 28;19(3):e0300356. doi: 10.1371/journal.pone.0300356. eCollection 2024.
- Background: PubMed 35226343Pierce LJ, Regan S, Idigbe I, Adeola J, Musa Z, Ezechi O, Oladeji B, Gureje O, Freedberg KA, Okonkwo P, Ahonkhai AA. Psychological Distress Increases 30-Fold Among People with HIV in the First Year on ART in Nigeria-a Call for Integrated Mental Health Services. Int J Behav Med. 2023 Feb;30(1):38-48. doi: 10.1007/s12529-022-10068-8. Epub 2022 Feb 28.
- Background: PubMed 31350712Gottert A, Friedland B, Geibel S, Nyblade L, Baral SD, Kentutsi S, Mallouris C, Sprague L, Hows J, Anam F, Amanyeiwe U, Pulerwitz J. The People Living with HIV (PLHIV) Resilience Scale: Development and Validation in Three Countries in the Context of the PLHIV Stigma Index. AIDS Behav. 2019 Sep;23(Suppl 2):172-182. doi: 10.1007/s10461-019-02594-6.
- Background: PubMed 31939032Jackson IL, Okonta JM, Ukwe CV. Development and psychometric evaluation of the patient's HIV knowledge questionnaire (PHKQ). Int J Clin Pharm. 2020 Apr;42(2):695-702. doi: 10.1007/s11096-020-00963-z. Epub 2020 Jan 14.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot as an informational coach in people with HIV, run by Christoph Pimmer at 6 sites in Nigeria.
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 8 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Nigeria. 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?
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?
Participant's HIV knowledge (time frame: Baseline to 50-day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06814041, which also lists 4 linked publications.
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 22 Apr 2026.