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HIV Infections clinical trials

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NCT ID: NCT05576844 Completed - HIV Infections Clinical Trials

Ai Youmian (Love Better Sleep) for People Living With HIV

Start date: September 28, 2021
Phase: N/A
Study type: Interventional

People living with HIV (PLWH) frequently report sleep disturbances. The social rhythm theory, which proposes that stressful life events can interfere with sleep by disrupting the stability of daily routines, provides new insights into identifying predictors of sleep disturbances and improving sleep in PLWH. This study is a randomized controlled trial. PLWH with poor self-reported sleep quality (Pittsburgh sleep quality index>7) was randomly divided into a control group or an intervention group. The control group receives the usual care, that is, daily disease management and routine drug guidance (set as waitlist). The intervention group received a sleep promotion intervention program based on social rhythm theory, along with daily disease management and routine drug guidance. The intervention period was 8 weeks, once a week, and the duration of each intervention was about 40-60 minutes. The sleep-related outcome indicators were measured before the intervention (T0), immediately after the intervention (T1), and 3 months after the intervention (T2), and the participants' social rhythm, daytime sleepiness, sleep belief and attitude, depression, etc. were evaluated to verify the effects of the intervention. At the same time, participants who insisted on completing all intervention modules were selected from the intervention group after the end of the whole study. Self-designed satisfaction questionnaires and semi-structured interviews were used to understand the participants' experience and feedback on the intervention program. In addition, the investigator asked the reasons for the withdrawal of participants who withdrew from the study through an interview during the outcome period.

NCT ID: NCT05563116 Completed - HIV Infections Clinical Trials

French CAC-HIV Cohort Study

CAC-HIV
Start date: June 1, 2013
Phase:
Study type: Observational

Clinical study: - Methods: observational transversal two-arm cohort study including adults living with HIV (PLHIV) and HIV negative subjects (HIV-) at intermediate cardiovascular risk. No study specific interventions were performed. - Participants: consecutively recruited at two large public hospitals in Paris and Annecy, France where participants were referred for routine cardiac risk stratification. - Recruitment: was from June 2013 until April 2016. - Data: anonymous study data were collected during the ambulatory visit. No follow-up was conducted. Study objectives: - Primary: compare coronary artery calcification (CAC) score between PLHIV and HIV- in order to bridge gaps in current knowledge. - Secondary: assess parameters linked to CAC score including predictors and their prevalence, association with carotid/femoral atherosclerosis, and cardiovascular risk scores (ASCVD and HEART score). Study hypotheses: - Primary: CAC scores would not be different between PLHIV and HIV- - Secondary: prevalence of traditional CV risk factors would be lower in PLHIV but that HIV-related nontraditional CV risk factors (including lower grade chronic inflammation, immune dysregulation, and ARV exposure duration) would be associated with higher CAC scores and higher CV risk scores Study Rational: - PLHIV have an increased risk of atherosclerotic cardiovascular events compared to the general population. Primary prevention for PLHIV is important but challenging as traditional cardiovascular risk scores do not account for HIV-related factors. - Computed tomography coronary artery calcium (CAC) score using the Agatston score is useful for detecting and quantifying coronary calcifications. In the general population, CAC score is predictive of future cardiovascular events.

NCT ID: NCT05560243 Completed - HIV Infections Clinical Trials

Tobacco Cessation Tailored to Patients Living With HIV (PLWH) in Brazil

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The overall goal of this feasibility study is to make adaptations to these evidence-based approaches in collaboration with PLWH and health care providers working with this population, and develop, implement, and evaluate the feasibility and scalability of a theory-based, culturally relevant tobacco cessation intervention for PLWH receiving care through the public health system in a southern town in Brazil (Londrina). This proposal will focus on the intervention development, pretesting, and feasibility testing. The primary outcome will be a 7-day point prevalence abstinence (defined as no tobacco use in the past 7 days and verified through measurement of salivary cotinine and exhaled carbon monoxide levels) at 6-month follow-up. We will also conduct detailed treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) to inform a full-scale efficacy trial.

NCT ID: NCT05554146 Completed - HIV Infections Clinical Trials

Pain Inflammation and Cannabis in HIV

PITCH-E
Start date: October 28, 2022
Phase: N/A
Study type: Interventional

This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. The investigators will observe how varying ratios of THC (tetrahydrocannabinol) and CBD (cannabidiol) in medical cannabis impact neuropathic pain, inflammation and adverse events.

NCT ID: NCT05503680 Completed - Clinical trials for Human Immunodeficiency Virus

The Effect of Yoga for Stress Among HIV Patients in Indonesia

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

This study is aimed to evaluate the effects of yoga intervention versus usual care (control group) for reducing stress among people living with HIV in Indonesia.

NCT ID: NCT05494736 Completed - Clinical trials for Human Immunodeficiency Virus

MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)

Start date: November 17, 2022
Phase: Phase 1
Study type: Interventional

This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. The primary hypothesis is that, at a dose that is safe and generally well tolerated, MK-8527 will have antiretroviral activity as measured by a reduction from baseline in plasma HIV-1 ribonucleic acid (RNA) of ≥1.0 log10 copies/mL.

NCT ID: NCT05482217 Completed - Depression Clinical Trials

The Effectiveness of CBI on Depression and Adherence in HIV Infected Adolescents

Start date: July 26, 2021
Phase: N/A
Study type: Interventional

Aim: To explore the effectiveness of psychoeducation and problem-solving (Life-steps) on depression and adherence in HIV-infected adolescents. Methods: Forty-two adolescents were randomized into 21 controls and 21 intervention groups. The intervention group was exposed to 5-week sessions of life steps applied by a lay counselor. The PHQ-9 and visual analog scale (VAS) were used to measure the outcomes: depression and adherence. They were applied at baseline, 5-weeks, and 24 weeks post-intervention.

NCT ID: NCT05472051 Completed - HIV Infections Clinical Trials

Health and Migration Trajectories of Housekeepers in Bamako

2DM2K
Start date: February 28, 2022
Phase:
Study type: Observational

In Mali, migration from rural zones is a cultural phenomenon existing since 1970. During the dry season (9 months), an important number of young women leave their villages and migrate towards urban zones to seek for a job. In Bamako, the estimated number of housekeepers is 100 000 coming from rural regions and aged between 11 and 19 years. The current healthcare offer seems to be non-adapted to their particularities. This is a community-based research constructed on the basis of the activities of two NGOs in Mali: ADDAD (association for the defense of the rights of Housekeepers and domestic helpers ) and ARCAD Santé PLUS (the main NGO for healthcare access for HIV, hepatitis, and sexual health services). The research is conducted by the SanteRCom team in the UMR1252 SESSTIM research unit. The main objective of this observational study is to study the knowledge, beliefs, behaviors and practices in terms of health in general, and sexual health in particular; and to assess the acceptability of an offer of community-based prevention and health services provided by ARCAD Santé PLUS integrated in the activities of ADDAD. The integrating of community-based healthcare offer in a familiar and reassuring framework, such as that of ADDAD, should promote access to health services among housekeepers. The research is organized in 3 stages: 1. Preliminary qualitative survey based on focus group discussions. Allowing the identification of the housekeepers' needs in terms of prevention and healthcare services; and the behavioral particularities of the housekeepers community. It is planned to conduct 7 focus groups including between 42 and 56 housekeepers. 2. Communication and awareness campaigns in the regions of origin of housekeepers. Campaigns will be constructed on the basis of the results obtained from the preliminary qualitative survey. 3. Communication and awareness campaigns in Bamako; community-based activities for housekeepers will be organized 3 times per week during 5 months by the NGO ADDAD. Activities will include the community-based offer of prevention and healthcare services provided by the NGO ARCAD Santé PLUS, i.e. the novelty in the ADDAD's activities. A quantitative and qualitative surveys will be conducted over 5 months with participants recruited during the community-based activities. It is expected to enroll at least 1134 housekeepers, and to conduct a maximum of 25 individual interviews with selected housekeepers.

NCT ID: NCT05454514 Completed - HIV Infections Clinical Trials

Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS

Start date: September 9, 2021
Phase: N/A
Study type: Interventional

This is a 90-day medication adherence study testing the HiDO is an automated AI-driven direct observation medication adherence platform, which is a 510K-exempt, Class I medical device with 24 people with HIV/AIDS, ages 18 to 55, who are currently taking ART and reporting less than 100% adherence. The aims of the study are to see whether the device can achieve >95% ART adherence among all participants averaged over 90 days and to perform usability testing using the System Usability Scale and Net Promoter scores.

NCT ID: NCT05435027 Completed - COVID-19 Clinical Trials

Study of Self-Amplifying Messenger Ribonucleic Acid (samRNA) Vaccines Against COVID-19 in Healthy Adults and People Living With Human Immunodeficiency Virus (HIV)

Start date: February 28, 2022
Phase: Phase 1
Study type: Interventional

The primary objective is to assess the safety and tolerability of samRNA vaccines GRT-R912, GRT-R914, and GRT-R918 when administered as prime and/or boost in healthy adult participants naïve to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), SARS-CoV-2 convalescent, previously vaccinated, or non-vaccinated participants, and people living with HIV (PLWH) or HIV-negative.