Pilot RCT and Interview Study on an HIV Chatbot in Nigeria

N/AActive Not RecruitingNCT06814041

Christoph Pimmer314 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

314

Conditions

HIV

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Infectious Disease Institute, (IDI) UCH

Ibadan, Oyo State, Nigeria

St. Mary's Catholic General Hospital

Ibadan, Oyo State, Nigeria

Baptist Medical Centre

Saki, Oyo State, Nigeria

Adeoyo Maternity Teaching Hospital

Ibadan, Nigeria

Our Lady of Apostle Catholic Hospital

Ibadan, Nigeria

Ring Road State Hospital

Ibadan, Nigeria

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 50-day follow-up

Secondary Outcomes

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: 1. 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 ) 2. are very relevant but not covered by the PHKQ, such as knowing about Post-Exposure-Prophylaxis (PEP) to prevent further infections.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: at 25 day follow up