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290 active trials for HIV Infections

Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil

Access to antiretroviral therapy (ART) in low-income and middle-income countries has been scaled-up effectively over recent years. Recently, the World Health Organization (WHO) guidelines changed to recommend the use of Dolutegravir (DTG) combined with two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir and lamivudine, for first-line ART; however, there is still a need for further data on the outcomes of DTG-based regimens for people with HIV-1. This study aims to describe the outcomes of drug-naïve and experienced patients starting a dolutegravir (DTG)-based regimen in a large cohort of HIV - infected patients in Brazil and compare to outcomes obtained from a retrospective control group of subjects who initiated non-DTG-based ART.

Start: February 2021

PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya

This a prospective, open-label implementation project to catalyze integration of HIV prevention and PrEP care services for adolescent girls and young women in family planning clinics in Kenya.

Start: April 2021

MOVIDA 1 Ter - Evaluation of the Cobas® Plasma Separation Card in the Field in Vietnam

In low- and middle-income countries, viral load (VL) monitoring of patients living with HIV and followed on antiretroviral therapy (ART) in remote settings is still scarce. Barriers to VL monitoring are essentially the limited access to a laboratory able to perform this measurement, its cost, as well as the lack of human and material resources. Blood sampling using dried blood spots (DBS), which has been validated and is immediately available, could overcome these barriers. With DBS, transfer and conservation of samples are simplified enabling access to VL monitoring to patients seeking care in sites far from laboratory facilities. Use of DBS also offers the advantage not to require extensive investments. To guide decision makers in the implementation of strategies to scale-up HIV VL monitoring in remote settings, field evaluations of DBS in routine conditions are needed. It is in this context that we propose this field evaluation of the Cobas® plasma separation card in Vietnam

Start: May 2021

Peer Intervention Latino Immigrant MSM

This study evaluates a peer intervention with HIV/STI self-testing kits to increase HIV/STI testing and PrEP uptake among Latino immigrant men who have sex with men. Half of participants will receive the "Listos" intervention (peer counseling, PrEP information, and HIV/STI testing kits) and half will receive the active control intervention (peer only group with no HIV/STI testing kits).

Start: May 2019

Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction Compared to Placebo and a Single Oral Dose of Moxifloxacin

This study will aim to evaluate the effect of therapeutic and supratherapeutic oral doses of GSK3640254 on cardiac conduction compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. The study has 2 parts: Part 1 will determine the supratherapeutic dose for Part 2, which will be the main corrected QT interval (QTc) study. Part 1 consists of 2 sequential cohorts: Sentinel Cohort 1 will evaluate once daily (QD) dosing of GSK3640254 or placebo for 7 days and Sentinel Cohort 2 will evaluate twice daily (BID) dosing of GSK3640254 or placebo for 7 days. Part 2 will investigate the safety, tolerability and Pharmacokinetics (PK) of GSK3640254 doses on cardiac conduction as compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. Moxifloxacin will be included as a positive control. All doses of study intervention will be administered under fed conditions and will receive a moderate-fat meal 30 minutes prior to dosing. The total duration of the study is approximately 91 days. Approximately 58 participants will be enrolled in the study.

Start: October 2020

PrEP Among MSM and TG in Myanmar

HIV is concentrated among key populations in Myanmar. Globally, HIV-prevalence among transgender (TG) women is one of the highest; laboratory-confirmed prevalence is reported up to 40%. In September 2015, WHO recommended the use of Pre-Exposure Prophylaxis (PrEP) for people at substantial risk of HIV as part of a combination HIV prevention strategy. A demonstration project will take place to implement and evaluate the uptake and effectiveness of PrEP among MSM, and TG women in a clinic in Hlaingtharyar township, Yangon. The aim is to describe PrEP uptake, as well as HIV-seroconversion and STI infection rates among those who use PrEP.

Start: April 2021

Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People

Sub Saharan Africa is home to only 12% of the population, but accounts for approximately 70% of the global burden of HIV infection and 84% of infections among young people aged 10-24 years. South Africa, which currently has the largest SARS-CoV-2 pandemic in SSA, also has the largest HIV epidemic globally. Access and service delivery barriers to engaging in HIV care have contributed to estimates that only 49% of adolescents (aged 10-19 years) entering care from 2005-2016 have initiated antiretroviral therapy (ART). In response to the SARS-CoV-2 pandemic the South African government has implemented national lock-down orders that we predict will further inhibit treatment engagement among young people. Research is needed to identify best practices for safely retaining young people living with HIV (YPLWH) in care during COVID-19.

Start: February 2021

A Crossover Adherence and Acceptability Study Assessing a DPP Capsule for HIV and Pregnancy Prevention

A randomized, crossover study to compare adherence, preference and acceptability of an over-encapsulated dual prevention pill (DPP capsule) containing oral pre-exposure prophylaxis (PrEP) and a combined oral contraceptive (COC) versus two separate tablets (PrEP and COC) among women at risk of HIV and unintended pregnancy in Johannesburg, South Africa

Start: January 2022

A Crossover Acceptability Study Assessing a DPP Capsule for HIV and Pregnancy Prevention

A randomized, crossover study to evaluate the acceptability of an over-encapsulated dual prevention pill (DPP capsule) containing pre-exposure prophylaxis (PrEP) and a combined oral contraceptive (COC) pill versus two separate tablets (PrEP and COC) among adolescent girls and young women (AGYW) at risk of HIV and unintended pregnancy in Harare, Zimbabwe

Start: January 2022

Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE)

This study will test the effects of an intervention to reduce substance use and related harms among people leaving rural jails or otherwise involved in the criminal justice system. This study will compare people in a health linkage intervention with people who will get overdose (OD) education. Everyone will take part in the baseline and follow-up surveys and receive OD education. Participants will be assigned to one of the two groups by chance based on when they are enrolled to the study and if their county is randomly assigned to an intervention or a comparison condition. By doing this study, the investigators hope to learn if providing linkage to health services along with HIV, hepatitis C virus (HCV), and overdose education to people leaving rural jails or otherwise involved in the criminal justice system will reduce substance use and related harms.

Start: November 2019

Antibodies Production After Covid-19 Vaccination Among Patients With Medical History of Cancer and Anti-CD-20 Treatment

This is a Phase II study designed to investigate if the Covid 19 vaccines are capable of eliciting production of antibodies against S protein of Sar-S-Cov-2 virus among patients with medical history of cancer previously treated with monoclonal anti CD-20 antibodies. The antibody production is defined based on the detection of antibodies in the serologic Covid-19 rapid test against S protein or with semiquantitative assay when it becomes available.

Start: February 2021

Camu Camu in ART-treated People Living With HIV

Persons living with HIV and receiving antiretroviral therapy (ART) remain with inflammation leading to higher risks of cardiovascular diseases, fatty liver and cancer. It has been observed in colitis and in HIV infection that abnormal composition of the gut microbes and leaky gut induce inflammation contributing to diabetes, fatty liver and cardiovascular risks. Abundance of Akkermansia muciniphila in stool, a type of good bacteria acting as a shield on the gut barrier has been shown to prevent obesity, diabetes and to improve cancer treatment response. Health food (prebiotic) increases the frequency of A. muciniphila in overweight individuals. Dr Marette, a study collaborator from Laval University, has recently published (Gut, 2018) that an extract from a Brazilian fruit called Camu Camu (CC) protects mice from obesity, reduce LPS, a marker for passage of microbes from the gut into the blood and decreases inflammation in association with the frequency of A. muciniphila in stools. The extract of CC is sold in nutritional stores to regulate body fat. The investigators will invite 22 participants to take 2 capsules of CC daily for 12 weeks in addition to their ART. CC tolerance and changes in blood and stools for inflammation and microbe composition will be evalutated at the end of the 12-week treatment and 8 weeks post-intake. An optional sub study will assess the changes of gut barrier by doing biopsies by colonoscopy. CC is expected to beassociated with an enrichment of A. muciniphila in stools, combined with reduced gut damage and inflammation.

Start: November 2020

Risk of Morbidity, Mortality and Long-term Monitoring of Antiretroviral Treatment in People Living With HIV

HIV infection is now a chronic disease in countries where antiretroviral treatments (ART) are largely available. Long-term follow-up is required to describe and understand the evolution of morbidities and complications as well as new treatments side effects. The main objective of the cohort is to describe and study the evolution of HIV infection in ART-treated individuals.

Start: July 2017

ERADICATING CERVICAL CANCER IN KENYA (MISP 60403)

We propose a study of a strategy designed to 1) increase cervical cancer screening using a community-based approach, and 2) determine the efficacy of HPV vaccination in a region of Kenya where half of all children are chronically exposed to aflatoxin.

Start: April 2021

St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin

This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin versus placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain; 2) inflammation; and 3) measures of HIV control. Participants will be followed for 12 weeks. Assessments of study outcomes will be compared at week 8 (end of treatment phase).

Start: January 2021

ANRS 12392 Sanu Gundo

Sanu Gundo ANRS 12392 is a non-randomized and non-comparative intervention trial in Mali. The main objective of the project is to study the feasibility of the community-based HIV care in the context of the artisanal gold mining zones and to evaluate its contribution to the linkage-to-care of PLWHIV with the health system and their retention in care, as well as its effect on their health status.

Start: November 2020

Uptake of Medical Male Circumcision Among Men With Sexually Transmitted Infections

The intervention includes use of transport reimbursement for men who will undergo voluntary medical male circumcision (VMMC), intensified health education by VMMC mobilizer, VMMC champions and women, use of a cell phone short messaging service (SMS) tracing to remind clients of their VMMC appointment and use of clinic escorts to accompany clients from the sexually transmitted infections (STI) clinic to the VMMC clinic for circumcision or appointment scheduling (the RITE intervention). The investigators will assess the uptake of VMMC, and acceptability and feasibility of the RITE intervention among uncircumcised men attending a STI clinic. The purpose of the study is to evaluate the impact of using transport reimbursement, intensified health education, cell phone tracing and clinic escort in increasing the uptake of voluntary medical male circumcision at this clinic.

Start: February 2020

Prevention Support for People Leaving Jail

This study will provide HIV prevention and related support services to men who have sex with men and transgender women who have substance use disorders and are either leaving jail or recently released from jail. The researchers will compare the utilization of HIV prevention and other support services between individuals who receive routine case management provided following enrollment to those who have access to GeoPassport, a global position service (GPS)-based mobile app, incentives, and peer mentor support.

Start: November 2019

Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers ( NEUROPSY-HEU )

Main objective: to evaluate the executive functioning of the HIV exposed uninfected children (HEU) versus children from the same socio-economic and cultural environment, not infected or affected by HIV. Secondary objective (s): to evaluate Intellectual Quotient, Child development, Behavior, Language and investigate link between executive functioning disorders, exposure to ARVs, HIV and family environment.

Start: November 2019

Defining the PrEP Care Continuum Among Recently Incarcerated Men at High-Risk for HIV Infection

Background: Several major studies have demonstrated the success of Truvada as pre-exposure prophylaxis (PrEP) in preventing HIV infection.The CDC guidelines recommend PrEP for people who are at elevated risk of HIV including men who have sex with men (MSM) and people who use injection drugs. People who are incarcerated bear a disproportionate of disease burden, including HIV. Furthermore, men who have been involved with the criminal justice system are more likely to engage in risky behaviors following their release, including condomless sex with partners of unknown serostatus, and injection drug use. The incarceration setting provides a place to engage men who may be at risk of HIV after they are released. Following release, community clinics, including the STD clinic at The Miriam Hospital (TMH) Immunology Center, that perform routine testing for HIV and other sexually transmitted diseases (STDs) may be ideal settings to engage vulnerable populations in care, including PrEP. Despite the demonstrated clinical efficacy of PrEP in reducing HIV transmissions, few clinical programs have piloted the use of PrEP in real-world settings, particularly criminal justice settings. Furthermore, studies demonstrate numerous challenges to PrEP uptake and adherence, including a lack of access or discontinuing care. Engaging at risk men in PrEP care before they leave prison and potentially lost to care during the transition may increase uptake, adherence, and retention. Objective: This study protocol will evaluate a clinical program that aims to prevent new HIV infections among recently-incarcerated men using a once daily dosing of tenofovir/emtricitabine (Truvada) as pre-exposure prophylaxis (PrEP). This protocol presents an overview of the clinical program, which uses standard-of-care clinical practices and Centers for Disease Control and Prevention (CDC) guidelines for prescribing and monitoring PrEP. Male inmates at the Rhode Island Department of Corrections (RIDOC) will be screened for HIV risk and, if eligible and interested, will be prescribed and given a one-month supply of PrEP shortly before their release, and receive follow up care at The Miriam Hospital (TMH) Immunology Center following their release.

Start: November 2019