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

NCT07080138 | Not Yet Recruiting

• 1 other identifier: YXLL-2024-162
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV-1-infection; Anxiety Depression

Outcome Measures

Primary Outcomes (1)

• The prevalence of AO among different treatment strategies

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

  2025.8-2026.7

Secondary Outcomes (1)

• The changes of Poor EM after the treatment of newly diagnosed PLWH

  2025.8-2026.7

Other Outcomes (2)

• The changes of Poor EM after the treatment of treated PLWH

  2025.8-2026.7

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

  2025.8-2026.7

Study Arms (2)

Group INSTI

Treated by INSTI

Drug: All kinds of INSTI medications

Group CONV

Treated by Conventional medicines

Drug: All kinds of conventional medications

Interventions

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

Also known as: 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

Group INSTI

All kinds of conventional medications DRUG

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

Also known as: Abacavir, Efavirenz, Emtricitabine, Lamivudine, Lopinavir/Ritonavir, Nevirapine, Tenofovir, Tenofovir alafenamide Fumarate, Zidovudine

Group CONV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People Living With HIV

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanxi Bethune Hospital: lead

Related Publications (17)

• 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.

  PMID: 27082749 BACKGROUND

• 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.

  PMID: 11483137 BACKGROUND

• 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.

  PMID: 37904369 BACKGROUND

• 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.

  PMID: 30950883 BACKGROUND

• 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.

  PMID: 32799204 BACKGROUND

• 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.

  PMID: 36302295 BACKGROUND

• 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.

  PMID: 33319677 BACKGROUND

• 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.

  PMID: 37253338 BACKGROUND

• 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.

  PMID: 33691321 BACKGROUND

• 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.

  PMID: 35128398 BACKGROUND

• 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.

  PMID: 31603624 BACKGROUND

• 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.

  PMID: 38380124 BACKGROUND

• 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.

  PMID: 25478433 BACKGROUND

• 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.

  PMID: 33598866 BACKGROUND

• 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.

  PMID: 33472520 BACKGROUND

• 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.

  PMID: 31356466 BACKGROUND

• 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.

  PMID: 33540057 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gender, Age, therapeutic regimen, medication time, Clinical patient blood, PsychoSocial Index, PSQI, and MemTrax.

MeSH Terms

Interventions

bictegravir; dolutegravir; abacavir, dolutegravir, and lamivudine drug combination; albuvirtide; Lamivudine; elvitegravir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; lamivudine, zidovudine drug combination; Raltegravir Potassium; Rilpivirine; abacavir; efavirenz; Lopinavir; Nevirapine; Tenofovir; Zidovudine

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Pyrrolidinones; Pyrrolidines; Nitriles; Pyrimidinones; Pyridines; Thymidine

Study Officials

• Xingyu Li, doctor

  Shanxi Bethune Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wang, Doctor

CONTACT

13513635015; wangyaner7711@163.com

Junyan Zhang, doctor

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2025

Record last verified: 2024-09