Research on the Psychological Status of Patients With HIV-1 Infection

Not yet recruiting

• Conditions: HIV-1-infection; Anxiety Depression
• Interventions: Drug: All kinds of INSTI medications; Drug: All kinds of conventional medications

• Registration Number: NCT07080138
• Lead Sponsor: Shanxi Bethune Hospital

Brief Summary

The goal of this observational study is to investigate the neuropsychological states of People Living With HIV(PLWH), the prevalence of social and psychological stress adaptation overload and poor episodic memory in PLWH. The main questions it aims to observe are: to observe the prevalence of psychopathic states in PLWH with different viral loads and to compare the effects of different treatments on the prevalence of psychopathic states in PLWH. It is helpful to understand the mental health burden faced by PLWH in China, to improve clinicians' awareness of PLWH's mental and psychological state, and formulate targeted psychological support, treatment and nursing programs.

Detailed Description

Our research is a prospective cohort of PLWH, mainly observing the differences in the prevalence of AO among different treatment strategies; Secondly, observe: ① The changes of neuropsychological symptoms such as newly diagnosed PLWH, AO, and Poor EM compared with the baseline; ② Changes in neuropsychological symptoms such as PLWH, AO, and Poor EM after treatment with different treatment regimens compared to the baseline; ③ For PLWH at different stages, after half a year of treatment, the changes of neuropsychological symptoms such as PLWH, AO, and Poor EM compared with the baseline; ④ Changes in Interpersonal Stress, Work Stress and Daily Stress conditions of PLWH compared with the baseline.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Study Start: 2025-08-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Diagnosis: PLWH can be diagnosed if one of the following three items is met according to the Chinese AIDS Diagnosis and Treatment Guidelines (2021):

   ① HIV antibody screening test positive and HIV supplementation test positive (antibody supplementation test positive or nucleic acid qualitative test positive or nucleic acid quantification>5000 copies/mL);

   ② Has a history of epidemiology or clinical manifestations related to AIDS, tested positive for HIV nucleic acid twice;

   ③ HIV isolation test positive;

2. Receive treatment at the hospital participating in the study; Age range: 18-80 years old, male or female not limited;

3. Patients who are willing to participate in this clinical study and sign the informed consent form for this study.

Exclusion Criteria

Individuals who meet any of the following criteria are not eligible to participate in this study:

1. Pregnant or lactating women; Men and women who are preparing for natural conception or artificial assisted reproduction;
2. Severe aphasia, physical disability, or any other non neuropsychological factors that may hinder the completion of the assessment;
3. is currently involved in other research;
4. Having a tendency towards violence may endanger the safety of others.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group INSTI	All kinds of INSTI medications	Treated by INSTI
Group CONV	All kinds of conventional medications	Treated by Conventional medicines

Primary Outcome Measures

Name	Time	Method
The prevalence of AO among different treatment strategies	2025.8-2026.7	Observe the differences in the prevalence of AO in PLWH under different treatment strategies

Secondary Outcome Measures

Name	Time	Method
The changes of Poor EM after the treatment of newly diagnosed PLWH	2025.8-2026.7	The changes of Poor EM neuropsychological symptoms in newly diagnosed PLWH compared with the baseline under different treatment regimens