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

Overview

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

• Drug All kinds of INSTI medications
  All kinds of INSTI medications, such as Bictegravir/Emtricitabine/Tenofovir alafenamide Fumarate, Dolutegravir/Emtricitabine/Tenofovir alafenamide Fumarate for PLWH
• Drug All kinds of conventional medications
  All kinds of conventional medications, such as Abacavir, Efavirenz for PLWH

Primary outcome measures

• The prevalence of AO among different treatment strategies [Time frame: 2025.8-2026.7]

Secondary outcome measures (1)

• The changes of Poor EM after the treatment of newly diagnosed PLWH [Time frame: 2025.8-2026.7]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07080138 · YXLL-2024-162

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗