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Effect of an AI Chatbot Intervention in Improving Mental Health Among People Living with HIV: A Cluster Randomized Controlled Trial

Effect of an AI Chatbot Intervention in Improving Mental Health Among People Living with HIV: A Cluster Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126742
Enrollment
Unknown
Registered
2026-06-15
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS/HIV

Interventions

AI Chatbot Psychological Intervention Group:In the first phase (weeks 1–4), all participants will receive a low-intensity intervention using the "ShuXinLiao" AI chatbot. The research team will provide
Control Group:The control group will receive standard HIV counseling services for a duration of eight weeks.

Sponsors

Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. be aged 18 years or older; 2. be clinically diagnosed with HIV/AIDS and currently receiving antiretroviral therapy (ART); 3. experience psychological distress, defined as a PHQ-9 score of 5 or higher or a GAD-7 score of 5 or higher; 4. be able to use a smartphone or tablet with basic operational skills; 5. be capable of effective communication in Mandarin Chinese.

Exclusion criteria

Exclusion criteria: 1. having a severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or cognitive impairment; 2. having severe somatic comorbidities, end-stage disease, or other serious chronic infectious diseases (e.g., active tuberculosis, hepatitis B-related cirrhosis, decompensated hepatitis C); 3. currently receiving systematic psychological therapy or psychiatric medication; 4. having a close social relationship with other participants enrolled in this study (e.g., spouse, relatives, or close friends).

Design outcomes

Primary

MeasureTime frame
Changes in depressive symptoms;Changes in anxiety symptoms;

Secondary

MeasureTime frame
ART adherence;Changes in perceived stigma;social support;Self-efficacy;Sleep disturbance;Quality of life;Feasibility and Acceptability of AI Chatbot;

Countries

China

Contacts

Public ContactBingyu Liang

Guangxi Medical University

liangbingyu@gxmu.edu.cn+86 180 7481 4940

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026