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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07080138
Enrollment
500
Registered
2025-07-23
Start date
2025-08-01
Completion date
2026-12-31
Last updated
2025-07-23

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

Conditions

Anxiety Depression, HIV-1-infection

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.

Interventions

DRUGAll kinds of INSTI medications

All kinds of INSTI medications, such as Bictegravir/Emtricitabine/Tenofovir alafenamide Fumarate, Dolutegravir/Emtricitabine/Tenofovir alafenamide Fumarate for PLWH

DRUGAll kinds of conventional medications

All kinds of conventional medications, such as Abacavir, Efavirenz for PLWH

Sponsors

Shanxi Bethune Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The prevalence of AO among different treatment strategies2025.8-2026.7Observe the differences in the prevalence of AO in PLWH under different treatment strategies

Secondary

MeasureTime frameDescription
The changes of Poor EM after the treatment of newly diagnosed PLWH2025.8-2026.7The changes of Poor EM neuropsychological symptoms in newly diagnosed PLWH compared with the baseline under different treatment regimens

Other

MeasureTime frameDescription
The changes of Poor EM after the treatment of treated PLWH2025.8-2026.7The changes of Poor EM neuropsychological symptoms in treated diagnosed PLWH compared with the baseline under different treatment regimens
The changes in Interpersonal Stress, Work Stress and Daily Stress conditions of PLWH2025.8-2026.7The changes in Interpersonal Stress, Work Stress and Daily Stress conditions of PLWH compared with the baseline

Contacts

Primary ContactYan Wang, Doctor
wangyaner7711@163.com13513635015
Backup ContactJunyan Zhang, doctor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026