Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Ibadan | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Control Group | No Intervention | Study participants in the control group will receive the Standard of Care only, offered by the clinics:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Chatbot use | Another relevant aspect is to assess usage patterns of the chatbot, especially the intensity of chatbot use. These four main indicators will be extracted from the technical chatbot platform.
| 50 day follow up |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Disease Institute, (IDI) UCH | Ibadan | Oyo State | Nigeria | |||
| St. Mary's Catholic General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38547192 | Background | 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. | |
| 35226343 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003075 | Coitus |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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). | 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). | 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. | at 25 day follow up |
| Relationship between sociodemographic characteristics, chatbot use and perception of chatbot, and outcomes: | The following relationships will be assessed:
| at 50-day follow up (and for viral load at 6-month follow up) |
| Qualitative goals | Given the novelty of the intervention in the context at hand, a relevant aspect is to explore the experience of the user to be able to generate an in-depth understanding of the ways in which they perceive the chatbot. This will be achieved through interviews with 15-25 participants from the intervention group. A particular goal of the interviews is to understand whether, and if so, how, female chatbot users perceive the chatbot differently as compared to male users. Trained interviewers will carry out interviews with selected users of the chatbot, i.e. with participants from the intervention group | about 60 - 90 days after the participant's enrollment, depending on their availability. |
| Ibadan |
| Oyo State |
| Nigeria |
| Baptist Medical Centre | Saki | Oyo State | Nigeria |
| Adeoyo Maternity Teaching Hospital | Ibadan | Oyo | Nigeria |
| Our Lady of Apostle Catholic Hospital | Ibadan | Nigeria |
| Ring Road State Hospital | Ibadan | Nigeria |
| 31350712 | 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. |
| 31939032 | 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. |