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285 active trials for HIV

Mhealth for PrEP Adherence by Young Adult MSM, Phase 2

This Phase 2 project aims to enhance and test a mobile health intervention designed to increase adherence to the daily PrEP pill among culturally-diverse young adult men who have sex with men. The intervention will include: a) personalized PrEP pill reminders b) culturally- and developmentally-sensitive text messages targeting patient education, motivation, and stress c) a gamification avatar and d) a linked online community of peers. Effectively promoting PrEP adherence would reduce new HIV infections in this at-risk population, which is subject to health disparities

Start: February 2021

Mechanisms of Impaired HIV-associated B Cell and Pneumococcal Vaccine Responses

Human Immunodeficiency Virus (HIV) infection is complicated by high rates of infections and cancers which are often the cause of death rather than the HIV/acquired immune deficiency syndrome (AIDS) virus itself. Treatment of HIV with antiretroviral medications has decreased the frequency of many complications by over 90%, but bacterial pneumonia remains extremely high. Current vaccines are not very effective in preventing these infections in patients with HIV infection. The investigators are studying the cells (B cells) that make antibodies to fight infection by binding to and killing bacteria. The goal is to understand how HIV impairs the ability of B cells to make antibodies in sufficient quantity and of sufficient quality to protect patients with HIV to learn how to enhance protection against these infections. The investigators also seek to understand the role of the bacteria (specifically Streptococcus pneumoniae) that normally live in the nose and throat in the development of pneumonia and other infections.

Start: August 2014

Smartphone Game Trial

This project, funded by the National Institute of Mental Health, will test the efficacy of an electronic game to prevent HIV among African adolescents (aged 12-17), delivered via inexpensive Android smartphones. This study involves a sample of 912 young people and 500 of their parents in Kenya's former Nyanza province, where 11.4% of young women and 3% of men ages 15-24 are HIV-infected. This study will be carried out by Emory University and the Kenya Medical Research Institute (KEMRI).

Start: October 2020

Providing Suboxone and PrEP Using Telemedicine

The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program. The initial visit will be conducted in person or remotely via telemedicine given COVID-19 protocols at the SSP sites in Charlotte and Wilmington, North Carolina (NC); follow-up visits will be conducted via telemedicine.

Start: November 2020

Expanding PrEP By Embedding Unannounced SNAPS Navigators in High STI Testing Clinical Sites

The goal of this study is to assess the impact of an intervention, known as SNAPS, to expand Preexposure Prophylaxis (PrEP) prescriptions at Health + Hospitals (H+H)/Bellevue. In addition, evaluating whether this intervention, ie SNAPS, helps patients get on PrEP and stay on PrEP to prevent STIs like HIV. PrEP is a medication that needs to be taken on a regular basis in order to be effective to prevent HIV transmission.

Start: July 2019

A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults

The "Thrive With Me" (TWM) trial is testing the efficacy of a mobile enhanced website aimed at improving Antiretroviral Therapy (ART) adherence for HIV-positive men who have sex with men (MSM). TWM is a technology-delivered peer-to-peer social support intervention with social networking and gaming components. In addition to real-time peer-to-peer support capabilities, the TWM intervention provides participants with Antiretroviral Therapy (ART) adherence self-monitoring tools, medication dose reminders, and HIV-related informational content.

Start: October 2016

Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya

The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts for providers) to increase retention in guideline-adherent prevention of mother-to-child transmission of HIV services (PMTCT) and to increase viral suppression and appropriate clinical action through the extended period of 6 months postpartum, compared to standard of care PMTCT services in a matched, cluster randomized controlled trial.

Start: October 2020

Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis

The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP will continue with a fixed dose combination of daily oral F/TAF substituting for F/TDF. Subjects will receive the iTAB text messaging adherence reminders to provide personalized, automated text messages to support and monitor adherence that will vary by participant choice until 12 weeks after switching medication. This study will enroll 60 individuals to take F/TAF as PrEP for 48 weeks.

Start: October 2019

A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes

The researchers of this study are observing the treatment of multi-drug resistant Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the usual TB drugs and needs to be treated with special drugs. The patients need to take these drugs for up to two years. Certain hospitals have already agreed to participate in this research project, half of the hospitals will be assigned a nurse case manager and the other half will not. The researchers are studying the benefits of having a nurse case manager to improve treatment response for patients with drug resistant TB. The researchers believe that nurse case management (NCM) in the intervention sites will increase MDR-TB cure and completion rates (i.e. treatment success) in comparison to usual care (UC), i.e. standardized programmatic management alone, in patients with and without HIV co-infection. To do this, the researchers will review the medical information collected at the hospital as part of the patient's treatment after obtaining the patient's permission.

Start: October 2014

Development and Pilot Testing of a PHCI for Emergency Department Patients Who Decline Rapid HIV/ HCV Screening

The Centers for Disease Control and Prevention (CDC) recommends that emergency departments (EDs) and other health care facilities conduct HIV and HCV screening to identify and link to care those with undiagnosed infections. Screening for both infections in EDs is preferable due to: the shared overlap of some risk behaviors for HIV and HCV acquisition (e.g., drug use) the relatively high co-occurrence of these infections in some populations the more complex medical needs and worse sequelae for those co-infected, and efficiency. Although some EDs have experimented with dual HIV and HCV screening, best practices on how to conduct screening so as to maximize patient screening uptake have yet to be identified. In this pilot RCT, the investigators will examine the efficacy of the persuasive health communication intervention in convincing adult ED patients who decline rapid HIV/HCV screening to be tested for these infections. Adult ED patients who decline rapid HIV/HCV screening will be randomly assigned to the ED medical staff arm or the HIV/HCV counselor arm. Within each arm, participants further will be randomly assigned to receive the persuasive health communication intervention or to watch a CDC HIV/HCV testing brochures-based video. Following the intervention or control condition, all participants will be offered rapid HIV/HCV testing again.

Start: October 2019

The DTG-SWITCH Study: Longitudinal Analysis of Virologic Failure and Drug Resistance at and After Switching to Dolutegravir-based First-line ART

This is a prospective observational cohort study of 2820 patients on first-line ART switching to a DTG-based first-line regimen, according to the standard of care. The study is conducted in Malawi and Zambia, in ART programs that participate in the IeDEA collaboration. Sequencing will be done on blood samples of patients with a viral load above 400 copies/mL to identify mutations.

Start: November 2019

High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya

Knowledge of HIV status is a first step towards accessing HIV care, treatment, and prevention services.The GIRLS study will rigorously compare two 'seek' recruitment strategies, three 'test' strategies, and two enhancements to an adaptive (SMART trial design) 'linkage' to care intervention, among young at-risk women, 15-24 years old, in Homa Bay County, western Kenya. Additionally, we will evaluate a scalable primary prevention messaging intervention to support identified HIV-negative young women in reducing HIV risk and adhering to recommended HIV re-testing recommendations. We will also conduct an economic evaluation, using cost effectiveness analyses to determine the relative utility of each seek, test, link, and prevention interventions. Lessons learned will inform Government of Kenya, and other key policymakers, implementing partners and agencies throughout sub-Saharan Africa that are exploring policies about appropriate scale up of these multiple seek, test, link, retain, and prevention strategies to realize the dream of an AIDS-free future for adolescent girls and young women.

Start: May 2017

Pilot Study of Financial Incentives for YMSM for HIV Testing and PrEP

This pilot, three-arm, randomized trial study involves 200 18-24-year-old young adult men-who-have-sex-with-men (YMSM) recruited through the internet. YMSM are eligible if they are 18-24 years-old, live in the United States, are not known to be HIV infected (self-report), have ever had condomless anal sex with another man, and have never taken HIV pre-exposure prophylaxis (PrEP). The aim of this pilot project is to compare the effect of financial incentives on encouraging YMSM to get tested for HIV and start PrEP for HIV. Potential study participants will be recruited online through advertising on the internet and complete the study eligibility and consent procedures. Following provision of consent online, participants will be contacted via the email they provided and asked to confirm their willingness to participate. Email addresses are being collected as part of this study to help ensure that individuals do not attempt to participate more than once in this study. Study staff will review the email addresses for duplications. Anyone who attempts to enroll more than once will be disqualified from the study. Participants will not ask for their name as part of the study. Once study interest is confirmed, participants will be provided a study identification number and study arm assignment. They also will be provided with instructions specific to their study arm assignment for the study as well as online resources about HIV testing and PrEP, including options for paying for PrEP. Participants will be randomly assigned to one of three study arms (no financial incentive, a fixed incentive ($25 Amazon.com gift card) or a lottery (20% for a $100 Amazon.com gift card). Participants in each study arm will be asked to contact the telehealth company PlushCare and make an appointment within two weeks. For this appointment, participants will speak with a PlushCare doctor about being tested for HIV and starting PrEP. They will provide PlushCare with their study identification number. As part of their services, PlushCare will obtain personal identifiers from participants but will not share this information with the study staff. For this study, participants are asked to undergo an evaluation for PrEP through the PlushCare doctor, but will NOT be required to be tested for HIV nor start PrEP. It will be the participants choice whether or not to be tested for HIV and start or continue PrEP after consultation with the PlushCare doctor. For some participants, the PlushCare doctor might recommend against starting PrEP. PlushCare will follow usual standard-of-care practices for their evaluation, counseling and consideration of PrEP as well as provision and maintenance of services for PrEP. Using only the study identification numbers and not the participant's personal identifiers, PlushCare will provide the study staff with data on completion of the primary and secondary study outcomes. Participants will be informed that they or their healthcare insurance will bear the costs of HIV testing and PrEP, but not the consultation with PlushCare. They will be provided with resources about how to pay for PrEP from the study as well as PlushCare. Completion of the primary study outcome (completing an appointment with the telehealth provider PlushCare for a PrEP evaluation) and secondary outcomes (undergoing HIV testing, starting PrEP, time elapsed from study enrollment to PlushCare evaluation, time elapsed to HIV testing and PrEP initiation) will be compared by study arms.

Start: November 2020

Tracking and Exploring the Source of Viral REbound

Phylogenic analysis of viruses hosted in marker positive reservoir cells including CD32a+ CD4 T lymphocytes and rebounding viruses after treatment interruption

Start: February 2017

Epidemiological and Clinical Description of Women Living With HIV in Selected Countries of Latin America

A cross-sectional study that uses ecological data from (1) PLWHIV under care at 31st December 2017, and (2) from yearly admissions to care occurred during 2013 - 2017, from centers belonging to LAW-HIV.

Start: July 2020

Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence

The goal of Suubi+Adherence is to examine the impact and cost associated with an innovative intervention to increase adherence to HIV treatment for HIV-infected adolescents. Multiple intervention studies by our team in Rakai and Masaka Districts of southern Uganda with AIDS-orphaned adolescents have revealed that if given an opportunity to participate in economic empowerment interventions, youth and their caregivers take full advantage of these interventions to save and invest in their future, show improvements in family financial outcomes, future aspirations, health functioning, sexual-risk taking behaviors, and mental health. The Suubi+Adherence study capitalizes on this prior work, positing that economic empowerment may be a missing, yet critical ingredient to HIV treatment adherence interventions for adolescents and young people. Suubi+Adherence incorporates an economic empowerment design, with a savings-led income generating component, to promote economic stability, and apply it to adherence to HIV treatment regimens for HIV-positive adolescents in a region of southern Uganda with the highest HIV incidence and prevalence in the country.

Start: September 2013

Impact of Probiotics in HIV-positive Patients With Neurocognitive Disorders

The prevalence of HIV-associated neurocognitive disorders (Human Immunodeficiency Virus) remains high during the era of effective triple therapy. The main clinical phenotypes of cognitive impairment are currently represented by asymptomatic neurocognitive neurocognitive impairment (ANI) and mild neurocognitive disorders (MND). In contrast, HIV-associated dementia has almost disappeared. Among the hypotheses to explain the persistence of such a high prevalence is the persistent activation of the immune system despite virological success. This chronic immune activation is believed to be responsible for an inflammatory response and therefore for accelerated cell aging. Several organ complications in HIV-positive patients have been associated with high markers of immune activation. Among the causes of chronic immune activation in virologically controlled patients, an imbalance in the intestinal flora is suspected. In fact, shortly after HIV infection, the virus causes significant apoptosis of intestinal lymphocytes, responsible for a loss of integrity of the intestinal barrier and an imbalance of flora, defined as "dysbiosis". Loss of epithelial integrity and intestinal dysbiosis are suspected of causing systemic passage of bacterial fragments, of which lypopolisaccharide is best known, resulting in chronic activation of the immune system. Several studies suggest a link between digestive bacterial translocation and HIV-related neurocognitive disorders. An improvement in intestinal dysbiosis could therefore contribute to reducing immune activation and the severity of cognitive impairment. A recent study showed that probiotics can reduce levels of neopterin, a marker of monocytic activation, in the cerebrospinal fluid of HIV-positive patients without neurological symptoms. Our objective is to evaluate the impact of probiotic supplementation on immune activation and cognitive performance in virologically controlled HIV-positive patients with a diagnosis of ANI or MND. The potential improvement of cognition through probiotic treatment could therefore improve their quality of life at a lower cost than a drug and without the risk of serious side effects.

Start: September 2019

HIV Study on MEasuring the Reservoir on Cellular Level to CUre Infection

The aim of this study is to gain new insights into HIV latency and reversal through extensive blood and tissues sampling (lymph node and colon biopsies) from 25 individuals under ART.

Start: October 2020

Functional Imaging Reserve in NeuroHIV

The purpose of this research study is to look at the brain's efficiency and ability to make up for deficits in the front of the brain to see if people living with HIV (PLWH) are still able to perform well on various cognitive tasks even though there are other underlying processes at work, like inflammation, that affect the brain in a negative way. Results of this study may provide insight into the pathophysiology of disease and may reveal arenas for future possible interventions in PLWH who have impaired neuropsychological performance.

Start: November 2018

Smoking Cessation Interventions for People Living With HIV in Nairobi, Kenya

The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. The study will randomize 300 participants people living with HIV , who smoke and who are receiving care in a methadone maintenance program in Nairobi, Kenya to one of the following 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for people living with HIV smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care.

Start: August 2020