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NCT ID: NCT03774160 Active, not recruiting - HIV Clinical Trials

Community and Systems-level HIV Prevention in Peru

Start date: April 6, 2017
Phase: N/A
Study type: Interventional

This project involves adapting 3 new intervention components, and then testing them, in combination with a multi-level, community-based intervention, to promote HIV prevention and sexual health among men who have sex with men and transgender women in Lima, Peru. The total intervention has a community-based intervention and a systems-level intervention at the hospital where people living with HIV get care and medications.

NCT ID: NCT03768986 Not yet recruiting - HIV Clinical Trials

Incentives for HIV Testing in Women

Start date: February 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 Not yet recruiting - Hiv Clinical Trials

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

Start date: December 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: NCT03762382 Not yet recruiting - HIV Clinical Trials

Tenofovir/Levonorgestrel Intravaginal Ring and Tenofovir Intravaginal Ring

Start date: December 2018
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety, pharmacokinetics and pharmacodynamics of, and the tolerability and acceptance of an intravaginal ring (IVR) delivering both tenofovir and levonorgestrel (TFV/LNG) and an IVR delivering TFV only, compared to a placebo IVR, in women in Western Kenya.

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: NCT03751826 Not yet recruiting - HIV Clinical Trials

Peer Delivery of HIV Self Test to Improve Linkage to HIV Prevention

Start date: January 14, 2019
Phase: N/A
Study type: Interventional

Hypothesis: HIV-Self-Test (HIV-ST) will allow peers or peer-networks to effectively and efficiently link older adolescent girls and young women into HIV prevention and care services. Design: A cluster randomized control trial comparing two models of peer delivery of HIV-ST, through incentivized respondent driven peer networks and direct distribution by peer navigators compared to standard of care (referral to HIV testing, prevention and care services by peer navigators) in improving the uptake of HIV prevention and care amongst young women (18-24) living in the rural uMkhanyakude district of KwaZulu-Natal, South Africa. Objectives: 1. To increase the knowledge of HIV status among young women aged 18-24 years old through distribution of HIV-ST through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into HIV testing services. 2. To determine an increase in the rate of linkage among young women aged 18-24 to HIV prevention and treatment services facilitated by distribution of HIV-ST through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into services. 3. To conduct a process evaluation of the acceptability, feasibility, and reach (out of school, recently migrant and living in remote areas) in linking 18-24-year-old women to HIV prevention and treatment services of HIV-ST distribution through incentivized peer networks, or direct distribution by peer navigators or peer navigators referring into services. 4. To measure the cost per 18-24-year-old linked to prevention and care through peer-led incentivized HIV-ST delivery system or direct distribution of HIV-SS by peer navigators, compared to peer navigator referring into services. Primary Outcomes: The difference between the rate of linkage within three months of 18-24 years old women to HIV confirmatory testing and pre-exposure prophylaxis (PrEP) eligibility screening if HIV-negative and antiretroviral treatment (ART) starting if HIV-positive. It will be between the two peer-delivery approaches to HIV-ST distribution (incentivized HIV-ST delivery through peer network and direct distribution of HIV-ST by peer navigators) compared to standard of care (peer navigator referral to HIV testing, treatment and prevention services). Rate is defined as the number of linkages per month of peer navigator outreach activity.

NCT ID: NCT03751046 Not yet recruiting - HIV Clinical Trials

Cognitive Therapy in Patients Failing ART

Start date: December 17, 2018
Phase: N/A
Study type: Interventional

Highly active antiretroviral therapy (HAART) has been the greatest achievement to control the HIV/AIDS epidemic in the world. HAART has been shown to reduce virus replication to undetectable levels and to favor the recovery of immune function, avoiding the occurrence of opportunistic diseases. Although existing treatments have been shown to lower AIDS-related morbimortality and to increase patients' quality of life, the success of HAART requires high levels of adherence to the prescribed treatment regimen. Adherence to HAART has become the major challenge for global public policy managers and healthcare teams involved in the care of HIV/AIDS patients. Mental healthcare professionals should use structured and effective intervention as strategies to facilitate a better approach, increase patients' autonomy and achieve optimal adherence. Trial-Based Cognitive Therapy (TBCT) is a new, structured, and short-term version of cognitive behavior therapy developed by de Oliveira (2011). TBCT is an active approach that aims to change negative cognitions, especially dysfunctional core beliefs, that negatively influence patient's life in different domains. TBCT helps patients recognize situationally based thoughts, unhelpful beliefs and maladaptive behaviors that exacerbate emotional distress. This study aims to assess the efficacy of TBCT in helping the patients to identify thoughts, emotions, assumptions and behaviors associated with non-adherence to antiretroviral therapy, and to improve adherence to treatment.

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 Not yet recruiting - Hiv Clinical Trials

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

Start date: December 15, 2018
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: December 19, 2018
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.