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HIV/AIDS clinical trials

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NCT ID: NCT03549689 Withdrawn - HIV/AIDS Clinical Trials

Effect of Reducing Nucleotide Exposure on Bone Health (ReNew)

ReNew
Start date: August 1, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label, randomized pilot study to assess the effect on bone mineral density (BMD) of a switch from a tenofovir alafenamide-containing antiretroviral regimen to dolutegravir/lamivudine vs. a continuation of the tenofovir alafenamide-containing regimen.

NCT ID: NCT03549312 Recruiting - HIV/AIDS Clinical Trials

Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy

Start date: February 1, 2018
Phase: Phase 4
Study type: Interventional

The study hypothesis is to determine the feasibility of switching HIV-HCV co-infected patients receiving methadone or buprenorphine/naloxone as opioid substitution therapy with suppressed HIV RNA viral load on current antiretroviral therapy to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF, Genvoya™) followed by 12 weeks of HCV antiviral therapy with sofosbuvir/velpatasvir (SOF/VEL, Epclusa™), followed then by switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, Biktarvy™) for an additional 48 weeks.

NCT ID: NCT03547245 Completed - HIV/AIDS Clinical Trials

A Phase I Trial to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted

Start date: June 15, 2018
Phase: Phase 1
Study type: Interventional

This is a phase 1 first-in-human clinical trial to assess the safety, tolerability, and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted, in up to 48 healthy adult HIV-negative volunteers.

NCT ID: NCT03541642 Completed - HIV/AIDS Clinical Trials

PrEP Communication Intervention for Female Clients of a Needle Exchange

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

This study will identify perceptions of PrEP in women who inject drugs (WWIDs) and develop and pilot test a targeted intervention that will be embedded in a large, urban syringe exchange program through an extensive formative evaluation process. Using perceptual mapping, an innovative marketing evaluation technique, WWIDs' PrEP perceptions will be incorporated into messaging in targeted counseling, materials, and text messaging to encourage PrEP adherence. This will then be tested in a pilot Randomized Controlled Trial (RCT) by comparing it to a general PrEP intervention to assess for uptake and adherence to PrEP, as well as improved self-efficacy and lower decisional conflict.

NCT ID: NCT03541382 Completed - HIV/AIDS Clinical Trials

A Cluster Randomised Trial of Community-led Distribution of HIV Self-tests in Rural Malawi (HIV Self-Testing Africa [STAR])

Start date: October 8, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to determine the benefits, costs and safety of community-led delivery of HIV self-testing (HIVST) kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older.

NCT ID: NCT03533868 Completed - HIV/AIDS Clinical Trials

Reaching 90% HIV Suppression: The Role of POC Viral Load Monitoring in Nigeria

POC
Start date: April 9, 2018
Phase: N/A
Study type: Interventional

The UNAIDS 90-90-90 goals represents an ambitious strategy to end the acquired immunodeficiency syndrome (AIDS) epidemic by 2020 [UNAIDS, 2015]. While viral load (VL) quantification is the gold standard of HIV treatment monitoring, it is only routinely available and employed in resource-rich countries. The use of an affordable, reliable, point-of-care (POC) VL assay has been considered a "game-changer", where increased access, minimal lab worker training, and same day results could be addressed in a single solution. To date, POC VL assays have been evaluated by their manufacturers with reference panels of samples with some in-country laboratory evaluations. While these are appropriate and critical first steps, it is also important to evaluate the impact of this new technology against the standard of care (SOC) method of VL monitoring in an actual resource-limited setting. Nigeria has the second highest burden of HIV in the world, with an estimated 3.2 million infected and serves as a relevant setting for testing feasibility and efficacy of POC VL monitoring [UNAIDS, 2016]. In order to present the case for implementing the use of POC VL testing across Nigeria, data on the acceptability, feasibility and efficacy of using POC testing for VL monitoring are needed. To address this need, the investigators have designed a randomized controlled trial comparing POC VL to monitoring to the SOC, which follows the Nigerian National Guidelines, to provide operational evidence for implementation of POC VL testing in Nigeria. This trial is aimed at testing the hypothesis that using POC versus SOC VL monitoring in HIV-infected patients newly initiating ART will improve overall ART outcomes, increase ART adherence and program retention rates, and result in faster switches to second-line treatment of patients failing first-line ART.

NCT ID: NCT03532191 Completed - HIV/AIDS Clinical Trials

Improving the HIV PrEP Cascade Using an Intervention for Healthcare Providers

PrEP-OI
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

The PrEP Optimization Intervention (PrEP-OI) aims to educate healthcare providers on PrEP and assist providers in the appropriate targeting of patients at increased risk for HIV acquisition, initiating PrEP when appropriate, and providing guidance on the ongoing monitoring and adherence counseling of patients on PrEP. The intervention includes a web-based panel management tool (called PrEP-Rx) and PrEP coordination (by a PrEP Coordinator). The PrEP-OI study will take place among participating primary care and specialty clinics across the San Francisco Department of Public Health.

NCT ID: NCT03525340 Completed - HIV/AIDS Clinical Trials

Improving Health Outcomes for Women Living With HIV

Start date: May 7, 2018
Phase: N/A
Study type: Interventional

This study will develop and conduct a trans-specific peer navigation intervention in Brazil, which integrates the I-Care approach developed in South Africa with the Model of Gender Affirmation (GA), developed by the investigators to specifically address HIV prevention and care among trans women.

NCT ID: NCT03517878 Completed - Depression Clinical Trials

Evaluation of a Home-based Community Health Worker Program in Rural Eastern Cape, South Africa

Start date: August 11, 2014
Phase:
Study type: Observational

The purpose of this early Phase 2 comparison trial is to evaluate the impact of community health worker (CHW) home visitors on pregnant women and their children in a rural setting in the rural Eastern Cape of South Africa. The intervention provided by the CHWs targets underweight children, mothers living with HIV (MLH), mothers using alcohol, and depressed mothers with the goal of supporting pregnant women to improve birth outcomes, decrease the number of children born with a low birthweight, and develop child caretaking skills over time. UCLA has identified and matched four areas surrounding primary health care clinics: two intervention areas in which this CHW program has been running for one year, and two control areas without the program. Mothers in the research area are followed for one year after giving birth.

NCT ID: NCT03494777 Completed - HIV/AIDS Clinical Trials

Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa

Start date: April 11, 2018
Phase: N/A
Study type: Interventional

This study will implement an intervention in a two-year randomized controlled trial (RCT) to establish efficacy on viral suppression as a biological endpoint, compare the effectiveness of two different modes of implementation (including one entirely based on readily available clinic data), and investigate cost-effectiveness. Participants in the first intervention group (T1, n=110) will be eligible for small lottery prizes based on timely clinic visits, and qualify for an annual lottery conditional if demonstrating viral suppression; those in the second group (T2, n=110) will draw prizes conditional on electronically measured adherence at each clinic visit, and also participate in an annual lottery that is conditional on high adherence throughout the year. The control group (n=110) will receive the usual standard of care. Assessments will be conducted at baseline and then every six months. Primary outcomes are undetectable viral load and electronically measured adherence.