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NCT ID: NCT03878186 Recruiting - HIV Clinical Trials

Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In HIV Participants Initiating Antiretroviral

Start date: March 26, 2019
Phase: N/A
Study type: Interventional

Studies in the field of health and HIV indicate that threat appraisal is associated with poor adherence to treatment, anxiety, poor quality of life, avoidance behavior, less antiretroviral adherence, negative affect, social, instrumental and emotional stress, depression, global distrés, poor subjective health and psychological distres. Most psychological interventions have been oriented to behavioral aspects, leaving aside cognitive aspects such as threat appraisal, so is necessary to investigate psychological treatments and its impact in threat appraisal an in an clinical and psychological outcomes. Primary objective: To evaluate the efficacy of a cognitive behavioral therapy (CBT) to decrease threat appraisal in comparison with Usual Care (UC) in HIV patients initiating antiretroviral treatment at week 8. Secondary objectives: To evaluate the effect of a cognitive behavioral therapy intervention compared with Usual Care in HIV patients initiating antiretroviral treatment in the following variables: challenge appraisal, affect (positive and negative), adherence, quality of life, anxiety and depression, HIV viral load and loss to follow-up at weeks 8, 20 and 52. Exploratory objectives: To assess the threat appraisal cut-off value that predicts favorable outcomes in adherence, virologic suppression, retention in care and adverse events at week 52. The study is an open label, single center, parallel group clinical trial, in which 50 participants will be randomly assigned using a blocked design to one of the 2 arms: Usual Care (single individual psycho-educative session) or Cognitive Behavioral Therapy (Usual care + 6 sessions of individual Cognitive Behavioral Therapy). The sample will be conformed with 50 adults with HIV, naïve to ARV treatment, starting care at INCMNSZ, who have scores of threat appraisal ≥40 in the CEAT scale, without severe mental disorders or cognitive impairment. We will use independent t test and chi square and intention to treat analysis for the primary outcome, also for secondary outcomes t student for continuous variables, chi square for categorical variables and per protocol analysis in participants adherent to the intervention.

NCT ID: NCT03862196 Recruiting - HIV Clinical Trials

Efficacy of SMS to Improve Early Retention in HIV Care for PLWH in Lima

Start date: December 21, 2018
Phase: N/A
Study type: Interventional

Randomized controlled study that will evaluate the effect of a text message-based strategy to improve retention in HIV care.

NCT ID: NCT03831945 Recruiting - HIV Clinical Trials

Combination Therapy With VRC-HIVMAB060-00-AB (VRC01) and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions

Start date: April 4, 2019
Phase: Phase 1
Study type: Interventional

Background: A daily drug combination can keep human immunodeficiency virus (HIV) levels low for a long time. But if this combination antiretroviral therapy (ART) stops, HIV levels go back up. People can also develop resistance or permanent side effects. Researchers want to see if 2 new drugs can help control HIV when a person is not on ART. Objective: To see if VRC01 and 10-1074 are safe and control HIV when a person is not on ART. Eligibility: Adults 18 65 with HIV Design: All participants must agree to practice safer sex. Those who can get pregnant will have a pregnancy test every visit. Participants will be screened with: Physical exam Medicine review Blood and urine tests Some participants may need to change their HIV medicine for a brief period of time during the study. A few weeks later, participants will repeat screening tests and stop taking their HIV medicines. Interruption phase 1: Participants will have blood tests every 2 weeks, and repeat screening tests every 4 weeks. Treatment phase: Once their HIV reaches a certain level in the blood, participants will get the 2 study drugs or a salt water placebo. They will not know which they get. Each substance will be given through a thin tube in an arm vein for about 1 hour. Participants will restart their HIV medicines and repeat screening tests every 4 weeks. Interruption phase 2: Once the level of HIV in the blood becomes undetectable for 3 months, participants will again stop taking their HIV medicines and have blood tests every 2 weeks to monitor the level of HIV in the blood. Participants will restart their medicines by week 24. They will start sooner if they have certain symptoms or blood levels of HIV become too high. They will repeat most screening tests 3 times over 24 weeks.

NCT ID: NCT03823911 Recruiting - Clinical trials for Cardiovascular Diseases

Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication

Start date: November 18, 2018
Phase: Phase 4
Study type: Interventional

This is an interventional, non-randomized, controlled prospective study to treat HCV in mono-infected and HIV co-infected individuals and compare cardiovascular risk outcomes to HIV mono-infected controls. This pilot study will demonstrate whether functional cure of HCV reduces myocardial injury and risk of cardiovascular disease.

NCT ID: NCT03768986 Recruiting - HIV Clinical Trials

Incentives for HIV Testing in Women

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

African American and Latina women, as well as women living in poverty, are at disproportionate risk for contracting HIV (CDC, 2018). Prevalence is increased further in these women if they have other risk factors for HIV, including substance use, history of intimate partner violence, and homelessness. Despite the relatively high prevalence rates in these populations, many women with these characteristics have never been tested for HIV (CDC, 2016a). Knowledge of one's HIV status is crucial for rapid access to treatment and reducing the spread of HIV. Thus, effective interventions for enhancing testing in these women are an imminent need. This project will evaluate a systems approach for enhancing HIV testing in high risk women. The investigators will train ~50 staff from multiple community agencies that provide services to high risk women to encourage HIV testing and deliver reinforcement for testing. After staff training, 334 women recruited at these community agencies will be randomized to standard care referral procedures plus HIV risk reduction education or the same plus reinforcement, in which they can receive monetary compensation for completing HIV testing at study initiation and for repeat testing 6 and 12 months later. This project evaluates new models to promote HIV testing. It institutes trainings and provides direct resources for integrating reinforcement-based HIV testing referral procedures to women accessing services at substance abuse treatment clinics, Federally Qualified Heath Centers, domestic violence agencies, and homeless shelters. Trainings address systemic and structural issues and provide concrete methods and resources to enhance testing (i.e., reinforcers).

NCT ID: NCT03762772 Recruiting - Hiv Clinical Trials

Safety, PK, and PD Study of a Vaginal Insert Containing TAF and EVG

Start date: December 10, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this Phase I study is to assess the safety, pharmacokinetics, and pharmacodynamics of a combination vaginal insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG). This study will be the first-in-human study for a vaginally administered TAF/EVG insert and will evaluate safety, PK and PD after a single dose. It is hypothesized that the combination insert will be safe and well-tolerated by study participants and that the insert will offer an expanded window of preventive activity and a regimen with flexibility and forgiveness.

NCT ID: NCT03757104 Recruiting - HIV Clinical Trials

Home-based Intervention to Test and Start

Start date: February 6, 2018
Phase: N/A
Study type: Interventional

This study aims to establish the causal impact of two interventions - micro-incentives and a male-sensitive HIV- specific decision support app - on population-level HIV viral load and HIV-related mortality in men, as well as on population-based HIV incidence in young women.

NCT ID: NCT03751020 Recruiting - Depression Clinical Trials

Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults

Project LEAP
Start date: October 15, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to test the feasibility of writing interventions specifically designed for lesbian, gay, and bisexual (LGB) emerging adults (ages 18-29) that are aimed at improving the outcomes: depression, suicidality, substance abuse and HIV risk behaviors.

NCT ID: NCT03734393 Recruiting - Hiv Clinical Trials

HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients

Start date: January 4, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications

NCT ID: NCT03733093 Recruiting - HIV Clinical Trials

PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)

Start date: April 24, 2019
Study type: Observational

Background: There are many people living with human immunodeficiency virus (HIV) infection in Liberia. Most experts consider HIV an epidemic there. Researchers want to collect health data from Liberians with HIV over several years. This may help HIV prevention and treatment programs in Liberia. Objective: To learn more about how HIV affects people in Liberia. Eligibility: People with HIV in Liberia Design: Participants will be screened with a blood sample. Participants will visit the study clinic about 10 times over 3 years. They will need to return to the clinic after some visits to get test results. The visits will be closer together during the first part of the study and less frequent later. At each study visit, participants will: - Have a brief physical exam - Answer questions about how they are feeling and what medicines they are taking - Have blood taken from an arm vein by a needle - Give urine samples Participants ages 12 years or older may be asked questions about HIV risk behaviors. These include sex practices and drug use. Participants ages 18 years or older may be asked how their HIV infection makes them feel emotionally. Participants may be asked to join a research substudy. This will be about tuberculosis (TB) testing in people with HIV. For this substudy, participants will have a TB skin test. A small amount of liquid will be injected under the skin on the arm. Participants will return to the clinic a few days later. The test area will be checked. They will get their test results.