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285 active trials for HIV

The Impact of Insomnia on Pain in HIV

The overall objective of this application is to investigate the impact of insomnia on pain, physical functioning, and inflammation in people living with HIV. The two aims of this study to determine 1) whether insomnia promotes increased sensitivity and inflammatory reactivity to pain stimuli, and 2) if weekly fluctuations in insomnia burden drive changes in inflammation, pain severity, and physical functioning in people living with HIV. This research could help confirm insomnia as a therapeutic target for the suppression of pain and inflammation in people living with HIV.

Start: January 2020

Quantitative Measurement and Correlates of the Latent HIV Reservoir in Virally Suppressed Ugandans

Background: Human Immunodeficiency Virus (HIV) is the virus that causes AIDS. HIV can hide in the blood for many years, even in people who have their HIV infection under control. HIV that is hiding in the blood is called the latent HIV reservoir. Researchers want to find out more about it in this study. This knowledge may help them develop new ways to prevent or control HIV. This study will draw its participants from the Rakai Health Sciences Program in rural southwestern Uganda. Objective: - To measure and learn about the latent HIV reservoir in Ugandans with HIV. Eligibility: - Men and women at least 18 years of age with HIV. Design: Participants will have a medical history and physical exam. Their medical records will be reviewed. Researchers will ask participants about their health and recent illnesses. Participants able to get pregnant will have their urine tested for pregnancy. Participants will have their finger pricked to see if they have enough red blood cells to be eligible for the study. If eligible, participants will have blood drawn through a needle in the arm. Their blood will also be tested for other diseases. After the blood draw, participants will be asked to stay seated or lying down if they are not feeling well for up to 30 minutes.

Start: May 2014

Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury

This study applies a hypothesis-driven approach to examine the effects of chronic marijuana use on HIV-associated inflammation and its subsequent impacts on central nervous system function, with the goal of identifying the mechanisms through which cannabinoids modulate neurological disorders and other comorbidities in persons with HIV.

Start: July 2021

IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya

IPrEP Men's Study is a prospective cohort study enrolling male clients (MC) of female sex workers (FSW) in Kisumu, Kenya. HIV-negative MC participants will be offered oral PrEP (emtricitabine/tenofovir [FTC/TDF]) combined with two adherence self-management interventions: (1) real-time feedback from point of care urine drug-level assay, (2) HIV self-testing (HIVST) and (3) 2-way text message reminders. Potential MC participants will be recruited from pre-specified community-based venues ("hotspots") or through referral by FSW using convenience sampling. Potential participants will be prescreened for age; residence and intent to stay in Kisumu for study duration, and having exchanged money, goods, or services for sex with a woman in the past three months. Individuals who meet prescreening eligibility criteria will be invited to the study site to undergo informed consenting process. Consenting individuals will complete a baseline questionnaire and undergo HIV counseling and testing as per national guidelines. Participants found to be HIV-positive will receive appropriate post-test counseling, including referral for immediate HIV treatment initiation at local health facility. Participants with negative HIV test results will complete eligibility screening for PrEP as per national guidelines. Eligible individuals will be prescribed once-daily oral PrEP, undergo HIV risk-reduction counseling session and receive HIVST kits for use between study visits. Participants who are not eligible for PrEP will be compensated for the visit and informed that they will not have further study follow-up. Enrollment will end when 120 HIV-negative MC eligible and willing to start PrEP are enrolled into the cohort. Study participants will have a baseline visit, will be followed for a total of 6 months and attend 3 study visits over this period (1 month, 3 months and 6 months). At each follow-up visit, participants will undergo HIV rapid testing; screening for adverse events, sexually transmitted infections and acute HIV infection; a focused clinical exam, urine and blood specimen collection; receive HIV risk-reduction counseling (as per national guidelines), PrEP prescription refills and tailored adherence self-management counseling and HIVST kits; and complete study questionnaires. This trial will be conducted in Kisumu County, Kenya.

Start: June 2021

Adjunctive Corticosteroids for Tuberculous Meningitis in HIV-infected Adults (The ACT HIV Trial)

The investigators will conduct a randomized, double blind, placebo controlled trial of adjunctive dexamethasone in the initial (6-8 weeks) treatment of tuberculous meningitis in Vietnamese adults. The trial will address a primary hypothesis in all enrolled patients, and a secondary hypothesis in a sub-group of enrolled patients who develop anti-tuberculosis drug-induced liver injury (DILI). The primary hypothesis is adjunctive dexamethasone increases survival from TBM in HIV co-infected adults. The secondary hypothesis is current guidelines for the management of anti-tuberculosis drug-induced liver injury in those with TBM result in the premature interruption of rifampicin and isoniazid (the critical active drugs in early therapy) and are thereby placing participants at risk of poor outcomes.

Start: May 2017

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

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

Start: January 2019

Standardized Patients to Measure and Address Intersectional Stigma

This study aims to carry out study activities in preparation for a pilot randomized control trial (RCT) to evaluate the effectiveness of a stigma reduction intervention for healthcare providers. This 1) preparatory phase consists of collecting baseline data and conducting formative research in order to inform design of the 2) RCT phase of research. l.

Start: July 2021

WeMen! Improving Women's Access to Healthcare System Through Men's Inclusion

Background: More than two-thirds of people living with HIV live in Sub-Saharan Africa, where the HIV prevalence in the adult population (aged 15-49) is 3.9%. In these countries a critical issue is represented by low level of adherence to treatment particularly in HIV positive pregnant women. Among the causes, the lack of male partner involvement represents a significant criticality. This issue emerge in Malawi, one of the countries with the highest prevalence of HIV in the world: 9.2% of the adult population living with HIV in 2018. Objective: to assess three different interventions aimed at improving adherence and retention to Anti Retroviral therapy among HIV positive women through engagement with their life partner in four Malawian healthcare centres. Methods: The prospective, controlled before-and-after study is articulated in three phases (total 24 months): pre-intervention, intervention and post-intervention analyses. The number of selected clinical centres is limited to four, one for each intervention plus a centre where no intervention will be performed (control arm). The interventions are 1) opening the facility on Saturday a month, only for men, defined "special day"; 2) peer-to-peer counselling among men, "male champions"; 3) providing incentive to all women accompanied by their partners at the facility, "nudge" (note1). The primary outcome of the study is the evaluation of the variations in retention in care and women's adherence to therapeutic protocols; the intermediate outcome is the assessment of the variations in Male Involvement (MI). The level of MI in the health of female partners (intermediate outcome) will be evaluated through a questionnaire administered at baseline and in the post-intervention phase. Data will be collected at the clinical centres and will be stored in two electronic databases. Results: Analysis of data collected in the four centres during the pre-intervention phase is on-going as the enrolment is stopped 31st March 2020. Total patients enrolled are 452 (133 Namandanje: 133, Kapeni: 78, Kapire: 75, Balaka: 166). Meantime, several meetings are performed in the centres to organize the intervention phase. Conclusions: The study will identified the better intervention to involve male partners in women's health according to an approach based on a broad spectrum of behaviours. - Note1: the reason of the incentive is not reward the participation in the study but is the main activity of the intervention assessed. The intervention consist in giving an incentive. For this reason is not recommendable to eliminate this information as requested by the reviewer.

Start: July 2019

Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk

The purpose of this study is to evaluate the effects of IL-1β inhibition on safety, measures of systemic and vascular inflammation and endothelial function (all indicators of cardiovascular risk) in treated and suppressed HIV infected individuals This study will assess the safety and effects of canakinumab on endothelial function (assessed by flow-mediated vasodilation [FMD] of the brachial artery), vascular inflammation (assessed by FDG-PET/CT scanning), key inflammatory markers of cardiovascular disease (CVD) risk (high-sensitivity C-reactive protein [hsCRP]), interleukin-6 (IL-6), soluble CD163 (sCD163), D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir. 20 individuals will receive a single dose of 150mg canakinumab with follow-up for 18 weeks.

Start: September 2015

HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients

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

Start: April 2018

A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa

ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The investigators propose a full-scale randomized controlled trial to examine the effect of ImpACT+ on clinical outcomes in the period after antiretroviral therapy (ART) initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved. ImpACT+ will target women who are newly initiating ART in order to take advantage of a window of opportunity in HIV care and maximize care engagement. The aims are to test the effectiveness of ImpACT+ and explore its potential for implementation.

Start: February 2021

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

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.

Start: May 2019

Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin.

Start: June 2021

IPREP Study #2: Evaluating Enhanced PrEP Packages for Young Female Sex Workers in Kisumu, Kenya

The overall aim of the proposed study is to compare the effectiveness, feasibility and acceptability of two adherence support interventions, peer support (PS) and reminders plus resource transfer (RRT), in combination with daily oral pre-exposure prophylaxis (PrEP) to optimize PrEP adherence among young female sex workers (FSW) in Kisumu, Kenya. This is an open-label randomized controlled trial (n=200) in which HIV-negative young FSW will be randomized to receive oral PrEP combined with specific behavioral and structural adherence interventions, either: (1) Intensive Peer Support (PS) or (2) Reminders and Resource Transfer (RRT).Respondent-driven sampling (RDS) will be used to recruit FSW as potential study participants.The study adherence interventions will be delivered over the first 12-month period in conjunction with PrEP. Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines. Trial participants will be followed for a total of 24 months and attend 11 study visits over this period.

Start: October 2019

Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV

The objectives of this study are to pilot test the effect of reducing time to spaced-out appointments from 18 to 6 months for newly-diagnosed people living with HIV (PLWH) in Rwanda who have initiated antiretroviral therapy (ART). PLWH are currently required to visit the health center monthly for ART and clinical appointments for the first 18 months on ART, after which they can attend quarterly. Reducing the time to spaced-out appointments from 18 to 6 months has the potential to reduce the burden on patients and the health system, but may lead to suboptimal treatment outcomes. To better understand the effects of early spaced-out appointments as well as the degree of viral load monitoring needed to determine stability on ART, the investigators will conduct a 3-arm pilot intervention study. The investigators will randomize participants to 1) 6-month advancement to spaced-out appointments after 1 viral load measurement; 2) 6-month advancement to spaced-out appointments after 2 viral load measurements; or 3) usual care. The investigators will compare the study arms with respect to viral suppression at 12 months after enrollment in ART care (primary outcome) and appointment/ pharmacy adherence (secondary outcome).

Start: October 2020

Study to Evaluate the Safety of a Gene and Cell Therapy Product in Participants With HIV That is Well-Controlled on Antiretroviral Therapy

This is a Phase 1 study to assess the safety of a gene and cell therapy for autologous donor lymphocyte infusion in HIV+ participants with well-controlled viremia on antiretroviral therapy.

Start: October 2020

A Psychosocial Tele-health Stigma Intervention for Youth Living With HIV in Vietnam

The overall goals of the study are to deepen understanding of the spectrum of stigma experienced by YLHIV in Vietnam, to develop a multi-level stigma intervention for YLHIV delivered by telephone, and to evaluate the feasibility, acceptability, and preliminary efficacy of the intervention on intra- and inter-personal stigma, psychological wellbeing, and treatment adherence. The project has the following Specific Aims: Adapt a psychosocial stigma-reduction intervention for YLHIV in Vietnam based on cognitive-behavioral therapy principles and delivered by telephone, using input from youth during intervention development. Assess the feasibility, acceptability and preliminary efficacy of this innovative approach to reduce stigma, and improve psychosocial wellbeing and ART adherence among YLHIV through a small pre-post study. Explore the multiple facets of stigma experienced by YLHIV in Vietnam and their relationships with ART adherence and psychosocial wellbeing via quantitative surveys and electronic adherence monitoring. The study will assess the feasibility and acceptability of this approach among YLVIV in Vietnam, and generate preliminary evidence for the potential effect of the intervention on important endpoints including stigma, psychosocial wellbeing, adherence, CD4 count, and viral load (VL).

Start: April 2021

Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-Zambia

In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization (WHO) called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for HIV. However, to date neither the WHO nor the Zambia Ministry of Health has provided detailed guidance on how to implement this recommendation. In sub-Saharan Africa, where most HIV patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications (ARVs). Among facility-level reasons for these losses are treatment initiation protocols that require multiple clinic visits and long waiting times before a patient who tests positive for HIV is dispensed an initial supply of medications. There is very little published evidence on the practical details of the process and the extent to which it varies by facility, setting, or country. Without a robust baseline evidence base, it is challenging to identify opportunities for making improvements. The SPRINT (Survey of Procedures and Resources for Initiating Treatment of HIV in Africa) study will begin to develop this evidence base. SPRINT will combine a facility-level description of the standard of care with a retrospective record review of patients who recently initiated ART at the study sites. Data will be collected from 12 health facilities in Zambia. The survey will elicit detailed information about current procedures through structured interviews with clinic staff at the selected health facilities. The record review for a retrospective cohort of patients eligible for ART will estimate actual numbers of clinic visits, services provided, and duration of the steps for treatment initiation from start to finish. SPRINT is expected to identify differences in approaches to treatment initiation and potential opportunities for improvement.

Start: September 2020

Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-Malawi

In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization (WHO) called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for HIV. However, to date neither the WHO nor the Malawi Ministry of Health has provided detailed guidance on how to implement this recommendation. In sub-Saharan Africa, where most HIV patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications (ARVs). Among facility-level reasons for these losses are treatment initiation protocols that require multiple clinic visits and long waiting times before a patient who tests positive for HIV is dispensed an initial supply of medications. There is very little published evidence on the practical details of the process and the extent to which it varies by facility, setting, or country. Without a robust baseline evidence base, it is challenging to identify opportunities for making improvements. The SPRINT (Survey of Procedures and Resources for Initiating Treatment of HIV in Africa) study will begin to develop this evidence base. SPRINT will combine a facility-level description of the standard of care with a retrospective record review of patients who recently initiated ART at the study sites. Data will be collected from 12 health facilities in Malawi. The survey will elicit detailed information about current procedures through structured interviews with clinic staff at the selected health facilities. The record review for a retrospective cohort of patients eligible for ART will estimate actual numbers of clinic visits, services provided, and duration of the steps for treatment initiation from start to finish. SPRINT is expected to identify differences in approaches to treatment initiation and potential opportunities for improvement.

Start: May 2020

Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-South Africa

In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for HIV. The South African National Department of Health adopted this recommendation in October 2017. Neither organization provided detailed guidance, however, on how to implement the recommendation. In sub-Saharan Africa, where most HIV patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications (ARVs). Among facility-level reasons for these losses are treatment initiation protocols that require multiple clinic visits and long waiting times before a patient who tests positive for HIV is dispensed an initial supply of medications. There is very little published evidence on the practical details of the process and the extent to which it varies by facility, setting, or country. Without a robust baseline evidence base, it is challenging to identify opportunities for making improvements. The SPRINT (Survey of Procedures and Resources for Initiating Treatment of HIV in Africa) study will begin to develop this evidence base. SPRINT will combine a facility-level description of the standard of care with a retrospective record review of patients who recently initiated ART at the study sites. Data will be collected from 12 clinics across 3 provinces in South Africa (KwaZuluNatal Province, Gauteng Province, and Limpopo Province). The survey will elicit detailed information about current procedures through structured interviews with clinic staff. The record review for a retrospective cohort of patients eligible for ART will estimate actual numbers of clinic visits, services provided, and duration of the steps for treatment initiation from start to finish. SPRINT is expected to identify differences in approaches to treatment initiation and potential opportunities for improvement.

Start: November 2020