Pilot RCT and Interview Study on an HIV Chatbot in Nigeria

NCT06814041 | Active Not Recruiting

• 1 other identifier: IZSTZ0_202602
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 6

Brief 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 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

Keywords

Chatbot; HIV; Nigeria; HIV knowledge; gender

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 50-day follow-up

Secondary Outcomes (4)

• Participants' extended HIV knowledge

  at 50 day follow up

• Participants' Resilience (PLHIV Scale)

  At 50 day follow up

• Participants' psychological well-being (SRQ-20)

  at 50 day follow up

• Users' perception of the chatbot: trust and parasocial relationships

  at 25 day follow up

Other Outcomes (3)

• Chatbot use

  50 day follow up

• Relationship between sociodemographic characteristics, chatbot use and perception of chatbot, and outcomes:

  at 50-day follow up (and for viral load at 6-month follow up)

• Qualitative goals

  about 60 - 90 days after the participant's enrollment, depending on their availability.

Study Arms (2)

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).

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.

Interventions

Chatbot as an informational coach 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.

Chatbot Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Known pregnancy or ≤3 months postpartum
• Persons with suicidal ideation and/or severe mental distress

Sponsors & Collaborators

• Christoph Pimmer: lead
• University of Ibadan: collaborator

Study Sites (6)

Infectious Disease Institute, (IDI) UCH

Ibadan, Oyo State, Nigeria

Location

St. Mary's Catholic General Hospital

Ibadan, Oyo State, Nigeria

Location

Baptist Medical Centre

Saki, Oyo State, Nigeria

Location

Adeoyo Maternity Teaching Hospital

Ibadan, Oyo, Nigeria

Location

Our Lady of Apostle Catholic Hospital

Ibadan, Nigeria

Location

Ring Road State Hospital

Ibadan, Nigeria

Location

Related Publications (4)

• 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.

  PMID: 38547192 BACKGROUND

• 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. Erratum In: Int J Behav Med. 2022 Aug;29(4):530. doi: 10.1007/s12529-022-10084-8.

  PMID: 35226343 BACKGROUND

• 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.

  PMID: 31350712 BACKGROUND

• 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.

  PMID: 31939032 BACKGROUND

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: April 14, 2025
• Primary Completion: February 11, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: April 22, 2026

Record last verified: 2025-08

Locations

NG (6)