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NCT Number: NCT07080138

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

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

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

Treatment and study plan

All kinds of INSTI medications

Drug

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

Other names: Bictegravir/Emtricitabine/Tenofovir alafenamide Fumarate, Dolutegravir/Emtricitabine/Tenofovir alafenamide Fumarate, Abacavir/Dolutegravir/Lamivudine, Albuvirtide, Dolutegravir, Dolutegravir/Lamivudine, Elvitegravir/Cobicistat/Emtricitabine/Tenofovir alafenamide Fumarate, Emtricitabine/Tenofovir, Emtricitabine/Tenofovir alafenamide Fumarate, Enovirin, Lamivudine/Zidovudine, Raltegravir, Rilpivirine

All kinds of conventional medications

Drug

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

Other names: Abacavir, Efavirenz, Emtricitabine, Lamivudine, Lopinavir/Ritonavir, Nevirapine, Tenofovir, Tenofovir alafenamide Fumarate, Zidovudine

Primary outcomes

  1. The prevalence of AO among different treatment strategies

    Time frame: 2025.8-2026.7

    Observe the differences in the prevalence of AO in PLWH under different treatment strategies

Secondary outcomes

  1. The changes of Poor EM after the treatment of newly diagnosed PLWH

    Time frame: 2025.8-2026.7

    The changes of Poor EM neuropsychological symptoms in newly diagnosed PLWH compared with the baseline under different treatment regimens

Other outcomes

  1. The changes of Poor EM after the treatment of treated PLWH

    Time frame: 2025.8-2026.7

    The changes of Poor EM neuropsychological symptoms in treated diagnosed PLWH compared with the baseline under different treatment regimens

  2. The changes in Interpersonal Stress, Work Stress and Daily Stress conditions of PLWH

    Time frame: 2025.8-2026.7

    The changes in Interpersonal Stress, Work Stress and Daily Stress conditions of PLWH compared with the baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Junyan Zhang, doctor

CONTACT

Yan Wang, Doctor

CONTACT

[email protected]

13513635015

Sponsors and collaborators

Lead sponsor

Shanxi Bethune Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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