Pilot RCT and Interview Study on an HIV Chatbot in Nigeria

NCT ID: NCT06814041

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-14

Study Completion Date

2026-06-20

Brief Summary

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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

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Chatbot Intervention

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).

Group Type EXPERIMENTAL

Chatbot as an informational coach

Intervention Type OTHER

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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chatbot as an informational coach

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Known pregnancy or ≤3 months postpartum
* Persons with suicidal ideation and/or severe mental distress
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ibadan

OTHER

Sponsor Role collaborator

Christoph Pimmer

OTHER

Sponsor Role lead

Responsible Party

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Christoph Pimmer

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Infectious Disease Institute, (IDI) UCH

Ibadan, Oyo State, Nigeria

Site Status

St. Mary's Catholic General Hospital

Ibadan, Oyo State, Nigeria

Site Status

Baptist Medical Centre

Saki, Oyo State, Nigeria

Site Status

Adeoyo Maternity Teaching Hospital

Ibadan, , Nigeria

Site Status

Our Lady of Apostle Catholic Hospital

Ibadan, , Nigeria

Site Status

Ring Road State Hospital

Ibadan, , Nigeria

Site Status

Countries

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Nigeria

References

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Jackson 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.

Reference Type BACKGROUND
PMID: 31939032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38547192 (View on PubMed)

Pierce 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.

Reference Type BACKGROUND
PMID: 35226343 (View on PubMed)

Gottert 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.

Reference Type BACKGROUND
PMID: 31350712 (View on PubMed)

Other Identifiers

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IZSTZ0_202602

Identifier Type: -

Identifier Source: org_study_id

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