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HIV clinical trials

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NCT ID: NCT04782180 Active, not recruiting - Hiv Clinical Trials

PrEP at a Syringe Services Program

Start date: February 1, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if providing participants with pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative.

NCT ID: NCT04774835 Completed - Hiv Clinical Trials

Assisted Partner Services and HIVST in Western Kenya

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

This study includes different designs with Aim 1 being a cluster randomized controlled trial to investigate the use of HIV self-testing (HIVST) as a mode of HIV testing in Western Kenya in addition to the standard of care, assisted partner services (aPS). Aim 2 includes focus group discussions, in-depth interviews, semi-structured interviews, direct observation of facility infrastructure and clinic procedures, and data extraction from facility and county/national databases and expenditure reports to study acceptability, costs, and implementation aspects of HIVST within the aPS framework.

NCT ID: NCT04769492 Recruiting - HIV Clinical Trials

#ChopViolence/#ChopHIV

Start date: July 30, 2020
Phase: N/A
Study type: Interventional

Black young gay, bisexual and other men who have sex with men (B-YGBMSM) and transgender women (B-YTW) are disproportionately affected by HIV/AIDS in the U.S. Youth in the House Ball Community (HBC), a subculture of the Black gay community that offers a social network to freely express diverse sexual and gender identities, are among the most at-risk for HIV infection and loss to care, but barriers exist to the provision of HIV services within this community. One barrier is the increasing rates of violence. Interventions are needed that will interrupt the cycle of violence within the HBC to allow for adequate provision of HIV services and increased access to HIV care. The investigators propose to tailor the Cure Violence model for violence prevention for developmental-appropriateness, cultural-specificity and HIV relevance, then pilot test the new intervention (#ChopViolence/#ChopHIV) with B-YGBMSM and B-TW in the Chicago HBC. The proposed research activities will take place in six steps. In Step 1, the investigators will hold Youth Advisory Board meetings, finalize our assessment battery and conduct multiple baseline assessments (months 3, 9 & 15; n=75 per assessment point) at HBC venues to track trends in violence (i.e., intimate partner, HBC and neighborhood violence), HIV stigma, substance use, mental health, sexual risk and HIV care engagement. In Step 2, the investigators will employ ADAPT-ITT strategies for adapting evidence-based interventions including conducting a series of focus groups (n=32) with youth and leaders from the HBC in order to identify persuasive messaging around decreasing violence and improving HIV outcomes. Based on the focus group data as well as consultation with community experts, the investigators will then tailor the intervention to be relevant for the Chicago HBC and develop training materials along with standard operating procedures. In Step 3, the investigators will identify, recruit and train trusted members of the HBC to work as Violence Interrupters (VI) or Outreach Workers (OW). VI and OW will undergo training over the course of several weeks. Training activities include didactic seminars, webinars from the Cure Violence team, HIV education, conflict mediation skills and mock interruption and outreach activities. In Step 4, the investigators will pilot test the tailored intervention. VI will monitor HBC events as well as social media venues for potential violence and intervene. OW will build their client caseload with HIV+ youth identified as of highest-risk for violence and schedule sessions, phone calls, and assist with HIV care linkage. In Step 5, the investigators will conduct follow-up assessments (months 21, 27 & 33; n=75 per assessment point) at HBC events to continue to monitor trends in violence, HIV stigma, substance use, mental health, sexual risk and HIV care engagement. Qualitative interviews will be conducted with VI, OW and HIV+ intervention clients to explore the processes and strategies of intervention implementation, with a focus on implementation barriers and facilitators. Finally, in Step 6, the investigators will conduct data analysis, disseminate findings and produce scientific publications.

NCT ID: NCT04760691 Recruiting - Hiv Clinical Trials

Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW

Start date: March 1, 2021
Phase: Phase 1
Study type: Interventional

This is a research study to determine the best way to dose Truvada®, an oral medication licensed to be taken as Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection, in transgender women who are also taking feminizing hormones. The duration of the study is about 4 months, and involves a screening visit, a baseline visit with colon biopsies and kidney function testing, and several outpatient visits, including 5 intensive sampling visits that last about 9 hours and involve colon biopsies, kidney function testing and other blood specimen collections. After the baseline visit, participants will start on PrEP, daily Truvada® pills, and will continue on the Truvada® for 5 weeks. Participants will then receive either an injection of Lupron, oral low-dose estradiol or oral high-dose estradiol, which will be taken along with the Truvada® PrEP for 1-2 weeks before returning for an intensive sampling visit.

NCT ID: NCT04757987 Completed - HIV Clinical Trials

An Observational Study of Distress, Immune Function, and Pain in HIV.

Start date: February 11, 2021
Phase:
Study type: Observational

This case-control study focuses on pain in HIV, which is common despite antiretroviral therapy and compromises quality of life, mental health and daily functioning. Specifically, it will investigate the relationships between psychosocial distress, inflammation and pain in HIV.

NCT ID: NCT04747756 Enrolling by invitation - Hiv Clinical Trials

Creating a Virtual Village for People Aging With HIV During COVID-19

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

In a PCORI-funded project on HIV and aging engagement that was co-led by the study team, the topics of isolation and depressions were identified as priority areas of deep concern among older PLWH. The COVID-19 pandemic has enhanced the urgency to test interventions to mitigate depression and isolation among older PLWH. However, there is scant evidence on effective interventions that help mitigate depression and isolation among older PLWH. While physical distancing and stay at home orders are a necessary strategy to flatten the curve, ease pressure on the healthcare system, and protect the most vulnerable, the order further increases the isolation faced by people aging with HIV, and creates barriers to accessing medications, health services, and other resources. This project will include 6 virtual focus groups and 12 individual interviews with adults ages 50 or older in California (Palm Spring, Los Angeles) and the Tampa-Bay region, Florida to (1): further characterize issues related to depression, isolation, and basic needs of people aging with HIV during the COVID-19 pandemic (2) utilizing results from Aim 1, co-develop ideas for what to include in a virtual village, and (3) create and pilot the virtual village in a group of people aging with HIV. The overall goal of this study is to execute an innovative solution to address issues related to isolation for older PLWH which have been exacerbated during the COVID-19 pandemic.

NCT ID: NCT04746547 Recruiting - Hiv Clinical Trials

Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TB

ORCHID
Start date: August 19, 2021
Phase: Phase 4
Study type: Interventional

Stage 1 proposed study will provide evidence to support the use of twice-daily dose 50mg DTG in children (20-35kgs) co-treated with RIF. Note: An amendment has been added to include children from 3kgs and a dose of 10mg dispersible DTG

NCT ID: NCT04741100 Withdrawn - HIV Clinical Trials

Evaluation of Innovative Combinatorial stratégies of Anti-latency and Anti-immune Activation Drugs Targeting HIV Reservoir

ERAVIR
Start date: September 15, 2020
Phase:
Study type: Observational

Several barriers prevent the remission of HIV infection: low level viremia, HIV latency in the genome of host infected immune cells and persistent immune activation. Targeting immune activation and viral latency, represent the two intimately intricate goals to be envisaged for purging the reservoir, in the perspective of HIV cure. There is an urgent to develop and to test drugs targeting HIV latency, HIV residual replication and immune activation, alone or in synergistic combinations. We propose in this study to test agents with a potential effect on HIV latency by combining classical agents and newly discovered agents. The Pitié-Salpêtrière virology group has identified some new diaminopiperidine based compounds that have some antilatency properties through an activation of transcription. Compounds of this new class will be tested in combination with classical agents (HDAC inhibitors, HMT inhibitors, inducers of P-TEFb release, PKC agonists, DNMT inhibitors) and less toxic compounds from classical categories for which Carine Van Lint (University of Brussels) has obtained preliminary HIV reactivation data. All the experimentations will be conducted in J-Lat cells and in ex- vivo CD4 cells sampled in patients from the Pitié-Salpêtrière HIV cohort.

NCT ID: NCT04725617 Recruiting - Clinical trials for Cardiovascular Diseases

Wellness Intervention for Smoking and HIV

(WISH)
Start date: November 16, 2021
Phase: N/A
Study type: Interventional

The investigators propose to use a parallel group, randomized controlled trial to test the efficacy of a 13-week personalized approach to reducing smoking intervention versus a second approach using a different health intervention on smoking cessation, healthy sleep metrics, and biomarkers of cardiovascular risk in a sample of 200 treatment-seeking smokers who are adults living with HIV (ALHIV). To enroll in the study, treatment-seeking ALHIV smokers will undergo phone and in-person study eligibility assessments, including a history, physical examination, screening laboratory tests, and an overnight in-home objective sleep assessment. Eligible subjects (N=200) will be randomized to the 13-week Approach 1 (N=100) or Approach 2 (N=100) condition. All subjects will receive a 12-week course of varenicline (beginning in week 2) and 8 individual 15-minute smoking cessation counseling sessions [weeks 1, 2, 3 (target quit date), 5, 7, 9, 11, 13]. At each in-person counseling session, 30-45 minutes of Approach 1 or Approach 2 counseling will be provided as well. While receiving varenicline, the study team will monitor for side effects and changes to blood pressure at each study visit for safety reasons. Study measures are collected at all time points including EOT (week 13), and 6-month follow-up (6MFU).

NCT ID: NCT04721067 Completed - Hiv Clinical Trials

HIV-related Insomnia and Inflammation

Start date: December 2, 2021
Phase: N/A
Study type: Interventional

This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.