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

NCT ID: NCT07080138

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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HIV-1-infection Anxiety Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group INSTI

Treated by INSTI

All kinds of INSTI medications

Intervention Type DRUG

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

Group CONV

Treated by Conventional medicines

All kinds of conventional medications

Intervention Type DRUG

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

Interventions

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All kinds of INSTI medications

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

Intervention Type DRUG

All kinds of conventional medications

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

Intervention Type DRUG

Other Intervention Names

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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 Abacavir Efavirenz Emtricitabine Lamivudine Lopinavir/Ritonavir Nevirapine Tenofovir Tenofovir alafenamide Fumarate Zidovudine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanxi Bethune Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xingyu Li, doctor

Role: PRINCIPAL_INVESTIGATOR

Shanxi Bethune Hospital

Central Contacts

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Yan Wang, Doctor

Role: CONTACT

13513635015

Junyan Zhang, doctor

Role: CONTACT

References

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Niu L, Luo D, Liu Y, Silenzio VM, Xiao S. The Mental Health of People Living with HIV in China, 1998-2014: A Systematic Review. PLoS One. 2016 Apr 15;11(4):e0153489. doi: 10.1371/journal.pone.0153489. eCollection 2016.

Reference Type BACKGROUND
PMID: 27082749 (View on PubMed)

Bing EG, Burnam MA, Longshore D, Fleishman JA, Sherbourne CD, London AS, Turner BJ, Eggan F, Beckman R, Vitiello B, Morton SC, Orlando M, Bozzette SA, Ortiz-Barron L, Shapiro M. Psychiatric disorders and drug use among human immunodeficiency virus-infected adults in the United States. Arch Gen Psychiatry. 2001 Aug;58(8):721-8. doi: 10.1001/archpsyc.58.8.721.

Reference Type BACKGROUND
PMID: 11483137 (View on PubMed)

Elendu C, Aguocha CM, Okeke CV, Okoro CB, Peterson JC. HIV-related neurocognitive disorders: Diagnosis, Treatment, and Mental Health Implications: A Review. Medicine (Baltimore). 2023 Oct 27;102(43):e35652. doi: 10.1097/MD.0000000000035652.

Reference Type BACKGROUND
PMID: 37904369 (View on PubMed)

Remien RH, Stirratt MJ, Nguyen N, Robbins RN, Pala AN, Mellins CA. Mental health and HIV/AIDS: the need for an integrated response. AIDS. 2019 Jul 15;33(9):1411-1420. doi: 10.1097/QAD.0000000000002227.

Reference Type BACKGROUND
PMID: 30950883 (View on PubMed)

Guidi J, Lucente M, Sonino N, Fava GA. Allostatic Load and Its Impact on Health: A Systematic Review. Psychother Psychosom. 2021;90(1):11-27. doi: 10.1159/000510696. Epub 2020 Aug 14.

Reference Type BACKGROUND
PMID: 32799204 (View on PubMed)

Bobba-Alves N, Juster RP, Picard M. The energetic cost of allostasis and allostatic load. Psychoneuroendocrinology. 2022 Dec;146:105951. doi: 10.1016/j.psyneuen.2022.105951. Epub 2022 Oct 8.

Reference Type BACKGROUND
PMID: 36302295 (View on PubMed)

Palego L, Giannaccini G, Betti L. Neuroendocrine Response to Psychosocial Stressors, Inflammation Mediators and Brain-periphery Pathways of Adaptation. Cent Nerv Syst Agents Med Chem. 2021;21(1):2-19. doi: 10.2174/1871524920999201214231243.

Reference Type BACKGROUND
PMID: 33319677 (View on PubMed)

Sonino N, Fava GA, Lucente M, Guidi J. Allostatic Load and Endocrine Disorders. Psychother Psychosom. 2023;92(3):162-169. doi: 10.1159/000530691. Epub 2023 May 30.

Reference Type BACKGROUND
PMID: 37253338 (View on PubMed)

Eory A, Bekesi D, Eory A, Rozsa S. Physical Exercise as a Resilience Factor to Mitigate COVID-Related Allostatic Overload. Psychother Psychosom. 2021;90(3):200-206. doi: 10.1159/000514331. Epub 2021 Mar 10.

Reference Type BACKGROUND
PMID: 33691321 (View on PubMed)

Zhao S, Shibata K, Hellyer PJ, Trender W, Manohar S, Hampshire A, Husain M. Rapid vigilance and episodic memory decrements in COVID-19 survivors. Brain Commun. 2022 Jan 19;4(1):fcab295. doi: 10.1093/braincomms/fcab295. eCollection 2022.

Reference Type BACKGROUND
PMID: 35128398 (View on PubMed)

Ripamonti E, Clerici M. The association of memory disorders and chronic HIV disease in the antiretroviral therapy era: a systematic literature review. HIV Med. 2020 Jan;21(1):9-20. doi: 10.1111/hiv.12793. Epub 2019 Oct 11.

Reference Type BACKGROUND
PMID: 31603624 (View on PubMed)

Ji J, Zhang Y, Ma Y, Jia L, Cai M, Li Z, Zhang T, Guo C. People who living with HIV/AIDS also have a high prevalence of anxiety disorders: a systematic review and meta-analysis. Front Psychiatry. 2024 Feb 6;15:1259290. doi: 10.3389/fpsyt.2024.1259290. eCollection 2024.

Reference Type BACKGROUND
PMID: 38380124 (View on PubMed)

Bhatia MS, Munjal S. Prevalence of Depression in People Living with HIV/AIDS Undergoing ART and Factors Associated with it. J Clin Diagn Res. 2014 Oct;8(10):WC01-4. doi: 10.7860/JCDR/2014/7725.4927. Epub 2014 Oct 20.

Reference Type BACKGROUND
PMID: 25478433 (View on PubMed)

Regan M, Muhihi A, Nagu T, Aboud S, Ulenga N, Kaaya S, Fawzi MCS, Yousafzai AK, Mugusi F, Fawzi WW, Saxena S, Koenen K, Sudfeld CR. Depression and Viral Suppression Among Adults Living with HIV in Tanzania. AIDS Behav. 2021 Oct;25(10):3097-3105. doi: 10.1007/s10461-021-03187-y. Epub 2021 Feb 17.

Reference Type BACKGROUND
PMID: 33598866 (View on PubMed)

Ruhanya V, Jacobs GB, Naidoo S, Paul RH, Joska JA, Seedat S, Nyandoro G, Engelbrecht S, Glashoff RH. Impact of Plasma IP-10/CXCL10 and RANTES/CCL5 Levels on Neurocognitive Function in HIV Treatment-Naive Patients. AIDS Res Hum Retroviruses. 2021 Sep;37(9):657-665. doi: 10.1089/AID.2020.0203. Epub 2021 Feb 17.

Reference Type BACKGROUND
PMID: 33472520 (View on PubMed)

Levy ME, Monroe AK, Horberg MA, Benator DA, Molock S, Doshi RK, Powers Happ L, Castel AD. Pharmacologic Treatment of Psychiatric Disorders and Time With Unsuppressed HIV Viral Load in a Clinical HIV Cohort. J Acquir Immune Defic Syndr. 2019 Nov 1;82(3):329-341. doi: 10.1097/QAI.0000000000002138.

Reference Type BACKGROUND
PMID: 31356466 (View on PubMed)

Stadtler H, Shaw G, Neigh GN. Mini-review: Elucidating the psychological, physical, and sex-based interactions between HIV infection and stress. Neurosci Lett. 2021 Mar 16;747:135698. doi: 10.1016/j.neulet.2021.135698. Epub 2021 Feb 1.

Reference Type RESULT
PMID: 33540057 (View on PubMed)

Other Identifiers

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YXLL-2024-162

Identifier Type: -

Identifier Source: org_study_id

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