Clinical trial NCT06814041: Pilot RCT and Interview Study on an HIV Chatbot in Nigeria
Official title: A Pilot Randomized Controlled Trial and an Interview Study to Evaluate a Chatbot for People Living With HIV in Nigeria
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Keywords: Chatbot
HIV
Nigeria
HIV knowledge
gender
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: University of Ibadan
First posted: 2025-02-07
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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 (18-45 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, and viral load. 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


Eligibility criteria: Inclusion Criteria:

* Diagnosed with HIV
* ART enrollment: at the day of recruitment or in the subsequent 7 days, but no longer than 4 weeks prior to enrolment in the study.
* Age ≥ 18 and ≤ 45 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

Primary outcomes:
measure: Participant's HIV knowledge
timeFrame: Baseline to 50-day follow-up
Secondary outcomes:
measure: Participants' extended HIV knowledge
timeFrame: at 50 day follow up
measure: Participants' Resilience (PLHIV Scale)
timeFrame: At 50 day follow up
measure: Participants' psychological well-being (SRQ-20)
timeFrame: at 50 day follow up
measure: Patients' viral load
timeFrame: at 6 months follow up
measure: Users' perception of the chatbot: trust and parasocial relationships
timeFrame: at 25 day follow up
Other outcomes:
measure: Chatbot use
timeFrame: 50 day follow up
measure: Relationship between sociodemographic characteristics, chatbot use and perception of chatbot, and outcomes:
timeFrame: at 50-day follow up (and for viral load at 6-month follow up)
measure: Qualitative goals
timeFrame: about 60 - 90 days after the participant's enrollment, depending on their availability.
Locations:
city: Ibadan
country: Nigeria
facility: Infectious Disease Institute, (IDI) UCH
state: Oyo
city: Saki
country: Nigeria
facility: Baptist Medical Centre
state: Oyo
city: Ibadan
country: Nigeria
facility: Adeoyo Maternity Teaching Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.