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HIV/AIDS clinical trials

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NCT ID: NCT03429842 Completed - HIV/AIDS Clinical Trials

HIV Awal (Early) Testing & Treatment Indonesia Project Observational Phase

Start date: September 15, 2015
Phase: N/A
Study type: Observational

This study will be one of the first to systematically evaluate strategies to improve the implementation of a T&T strategy in a concentrated epidemic in Asia. While large controlled randomized trials assessing the efficacy of T&T at the community level are underway, they are being run in the generalised epidemic settings of Africa with the population HIV prevalence above 15%. Findings on implementation of T&T strategy from such settings will not be readily applicable to concentrated epidemics. This study will run in parallel with the trials so that the key implementation data in concentrated epidemic settings are available in a timely fashion. Finally, the study aims to develop capacity in implementation research in Indonesia. In line with principles of implementation science, the components of the intervention package will be designed from extensive discussions with all stakeholders including affected communities. This will ensure that the intervention is acceptable, feasible and could be integrated in to larger policy framework beyond the study. Further, the study will utilize and explore the role of primary care centres (Puskesmas) in providing 'Test and Treat' services. The success of T&T strategy based on primary care model will be critical for the wider penetration of services to the key affected populations. It will generate key data on critical steps in the cascade of care and show how current prevention services might enhance the uptake of HIV testing and immediate treatment. The study will identify which programmatic areas, under current resources, need strengthening for a larger scale implementation of T&T for HIV treatment and prevention. This will be a prospective implementation research study assessing the impact of enhanced community based interventions, on the uptake of HIV treatment and retention in care among key populations as part of a T&T strategy in three urban settings in Indonesia. The enhanced package of interventions will be introduced in a series of steps over time. This phase 1- Pre-implementation of the enhanced intervention package (Year 1) Current standard practices for HIV treatment and care will be observed ('business as usual'), utilising a comprehensive data collection system at each participating site. In accordance with current national guidelines, all HIV positive participants will be offered immediate ART initiation after being diagnosed as HIV positive.

NCT ID: NCT03426670 Completed - HIV/AIDS Clinical Trials

HIV Self-Testing to Empower Prevention Choices in Sex Workers

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

Transgender, male, and female sex workers are 49, 21 and 14 times as likely to be HIV-infected as other adults in the general population. In Uganda, sex workers have high HIV seroprevalence (35-37%) and account for 10% of new HIV infections. Two robust, evidence-based, self-controlled HIV prevention tools are available -- HIV self-testing (HIVST) and antiretroviral pre-exposure prophylaxis (PrEP) -- but these are not currently well utilized among sex workers. HIVST and PrEP are complementary tools that could be combined to build self-efficacy and empowerment, increase PrEP adherence and reduce sexual risk behaviors. However, research is needed to show how combination HIVST and PrEP may have a synergistic impact on uptake and use of each prevention intervention. The investigators will conduct a randomized trial among sex workers initiating PrEP in Uganda to test if HIV self-testing increases PrEP adherence among HIV-uninfected sex workers (Aim 1), changes sexual risk behavior in sex workers taking PrEP (Aim 2), and influences prevention choices among sex workers and their partners (Aim 3). The investigators will use novel technologies (real-time electronic monitoring with Wise pill technology and mobile phone surveys) to characterize patterns of PrEP adherence, and assess how use of HIVST and PrEP aligns with sexual risk behaviors. Additionally, the investigators will conduct in-depth qualitative interviews to explore the mechanisms through which combined HIVST and PrEP delivery may be synergistic and empowering. This study will be the first to jointly evaluate HIVST and PrEP in sex workers.

NCT ID: NCT03414372 Completed - Hiv Clinical Trials

Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)

Start date: May 7, 2019
Phase: N/A
Study type: Interventional

Tough Talks is a virtual reality based HIV disclosure intervention that allows HIV+ individuals to practice disclosing to romantic partners. Tough Talks allows participants to have the opportunity to practice disclosing using a variety of strategies and experience different outcomes including acceptance, confusion, lack of HIV knowledge, and rejection.

NCT ID: NCT03413696 Completed - Hepatitis C Clinical Trials

Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients

Start date: September 8, 2017
Phase:
Study type: Observational

A clinical observational study for patients with HIV co-infected with hepatitis C that investigates the levels of their health literacy, hepatitis C and HIV knowledge. Participants will complete a one-time assessment of these studied domains and categorized in three groups defined by their hepatitis C treatment referral status: not-referred, referred-attended, referred and no-show.

NCT ID: NCT03409328 Completed - HIV/AIDS Clinical Trials

Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men

Start date: June 11, 2021
Phase: N/A
Study type: Interventional

Young gay, bisexual, and other men who have sex with men (MSM) are disproportionately affected by HIV. Despite this burden, most HIV prevention interventions target adult MSM (most of whom identify as gay) and heterosexual youth, creating an urgent need for interventions for gay and bisexual adolescents. Further, self-identified bisexual men, especially adolescents, have been neglected in research. Therefore, little is known about factors that drive engagement in risk behavior among self-identified bisexual adolescent men. The goals of this study are to: (1) examine factors that drive engagement in HIV risk behavior and substance use among self-identified bisexual adolescent men; and (2) develop and pilot test a tailored HIV and substance use prevention intervention for this population.

NCT ID: NCT03396367 Completed - HIV/AIDS Clinical Trials

Prevention and Risk: Treatment With a New Emphasis on Relationships

PARTNER
Start date: February 14, 2018
Phase: N/A
Study type: Interventional

This research examines the efficacy of an individually-delivered intervention tailored for YMSM in relationships. The intervention - termed PARTNER - utilizes a brief (4 session) motivational interviewing format to target Pre-Exposure Prophylaxis (PrEP) uptake/adherence, HIV transmission risk behavior, and associated drug use.

NCT ID: NCT03391375 Completed - HIV/AIDS Clinical Trials

Evaluation of the Effect of Late Boost on HIV-uninfected Vaccines From EV06 Trial

Start date: March 15, 2017
Phase: Phase 1
Study type: Interventional

EV07 is an open label phase I clinical trial to evaluate the effect of late boost on HIV-uninfected vaccinees from EV06 trial. The outcome of the EV06 trial has shown that the vaccine regimen is safe and well tolerated. Preliminary antibody immunogenicity analysis has demonstrated that the DNA/gp120 protein vaccine regimen induced strong gp120, gp140 and V1V2 region-focused binding IgG and neutralizing antibody responses. There is also preliminary evidence that S. mansoni infection may modulate antibody responses induced by vaccination1. Based on these preliminary immunogenicity results of the EV06 study, a study with an additional boost with DNA-HIV-PT123 and AIDSVAX®B/E (Late Boost) is warranted in order to better investigate and understand the effects of the late boost on the response rate, magnitude and durability of vaccine induced immune responses. The primary objective of EV07 is to evaluate the ability of the late boost combination of DNA-HIV-PT123 and AIDSVAX® B/E to enhance the pre-existing vaccine induced antibody responses.

NCT ID: NCT03390114 Completed - Insomnia Clinical Trials

Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection

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

The goal of this preliminary study is to determine the efficacy of an internet-based treatment program for insomnia for HIV-infected persons.

NCT ID: NCT03377608 Completed - Contraception Clinical Trials

Modifiers of Tenofovir in the Female Genital Tract

Start date: November 17, 2017
Phase:
Study type: Observational

Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal contraception.

NCT ID: NCT03369249 Completed - HIV Infections Clinical Trials

Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)

Start date: December 9, 2017
Phase: N/A
Study type: Interventional

This research study proposes to embed HIV testing outreach workers from a young adult focused medical and HIV treatment program into an alternative sentencing program to deliver a new service delivery model (Link2CARE) that integrates evidence-based protocols for justice-involved young adults to: a) promote HIV and STI testing, and HIV and SU risk screening, b) provide onsite intervention, and c) cross-system linkage to HIV, STI, and SU care. Phase 1 has already been completed. In phase 1, the intervention components were adapted for use among justice involved young adults and the resulting protocols were piloted with justice involved young adults, finalizing the resulting 4-session Link2CARE intervention. In phase 2, we will test Link2CARE among N=450 justice-involved young adults enrolled at the alternative sentencing program and conduct process evaluations with N=15 alternative sentencing program staff.