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The mLab App combines HIV prevention information with push notifications/reminders to complete HIV testing and an automated image processing feature to provide real-time feedback on home-based HIV test results. Theoretically-guided by the Health Information Technology Usability Evaluation Model (Health-ITUEM), the proposed project will refine and test a next-generation diagnostic intervention delivered on a mobile platform to improve HIV testing and linkage-to-care outcomes among youth living with and at-risk for HIV. Given the pervasiveness, low cost, and convenience of mobile technology, the investigators hope that the App can help achieve the goals of the National HIV/AIDS Strategy in the US by increasing the number of persons living with HIV who know their serostatus, decreasing HIV-related disparities, and ultimately reducing the risk of HIV transmission and acquisition.
Efavirenz (EFV)-based antiretroviral therapy (ART) remains the preferred regimen in human immunodeficiency virus (HIV)-infected children aged 3 years or older on rifampin-containing antituberculosis (anti-TB) therapy. This is because drug interactions between first-line anti-TB therapy with protease inhibitors (PIs) are more severe to adjust for, and interactions with integrase strand transfer inhibitors (INSTIs) are not well studied in that age group. Although, current weight-based EFV dosing recommendation is not optimal in some children, pharmacokinetic-treatment response (PK-PD) data to guide optimal dosing of EFV during concurrent rifampin-containing therapy in children is very limited. The study team propose that EFV concentrations outside the optimal therapeutic range in children will be associated with virologic failure due to lack of efficacy because of low concentrations or increased central nervous system (CNS) toxicities from high concentrations leading to poor medication adherence. The study will determine virological suppression rates in HIV-infected children with and without TB coinfection treated with standard efavirenz-based therapy and examine the factors contributing to poor virologic response.
Tenofovir (TFV) disoproxil fumarate (TDF) plus emtricitabine (FTC) or lamivudine (3TC) is the preferred nucleoside backbone of first-line antiretroviral therapy (ART) for adolescents in sub-Saharan Africa. In addition, TDF/FTC is recommended for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection in adolescents at substantial risk of acquisition of HIV infection, as well as for hepatitis B virus (HBV) treatment in those with HBV/HIV coinfection. The efficacy TDF and FTC are dependent on intracellular concentrations of the active phosphate anabolites, called TFV diphosphate (TFV-DP) and FTC triphosphate (FTC-TP). However, the intracellular pharmacokinetics of TFV-DP and FTC-TP to examine the adequacy of current dosages in African adolescents has not been previously studied. Thus, examining the pharmacokinetics (PK) of these widely used antiretrovirals in African adolescents is important as ART outcomes remain poor and the recommended dosages of these drugs for children and adolescent were extrapolated from drug approval clinical trials in adult in the United States and Europe.
Lack of quality-assured pediatric formulations of the first-line antituberculosis (anti-TB) drugs is barrier to optimized tuberculosis (TB) treatment outcome in children. In 2010 and subsequently modified in 2014, the World Health Organization (WHO) recommended increased dosages of the first-line anti-TB drugs for children, but there were no child-friendly fixed-dose combination (FDC) formulations based on the guidelines. A large proportion of children treated with the new guidelines using old formulations did not achieve the desired rifampin peak concentration (Cmax) > 8 mg/L and pyrazinamide Cmax > 35 mg/L. The TB Alliance and the WHO led the development of a new child-appropriate isoniazid/rifampin/pyrazinamide (HRZ) and isoniazid/rifampin (HR) FDC formulation in line with current WHO recommended dosing guidelines. The new formulations dissolve quickly in liquid, have palatable fruit flavors, and are expected to improved daily adherence but no studies have evaluated the pharmacokinetics (PK) of the FDC formulation in children. The study team hypothesize that the new dispersible HRZ FDC tablet, dosed according to current WHO weight-band dosing recommendations will result in better PK parameters for each drug component than that achieved by the old formulation.
Antiretroviral therapy is currently the only way to control HIV disease progression in HIV infected subjects and to prevent transmission. However a sustained virological control through antiretroviral therapy is requested for these objectives. There is currently 8-10% of patients who failed therapy for many reasons other than virological resistance including social unstability, psychiatric disorders, migrant status, drug or alcohol addictions. Because many of these vulnerabilities can be managed and patients helped for following adequately cares and treatments, study team designed the OPTICARE Program to help reduce impact of the patients' vulnerabilities. The OPTICARE study is designed as a prospective implementation interventional study which aims to improve retention in care among vulnerable HIV infected patients over 48 weeks. The OPTICARE program is a support program dedicated to patients either lost to follow up or in highly fraility situation that will offer an individualized care management to fill their gaps towards optimized care and control of viral replication. Our aim is, in patients virally failing in relation with poor adherence to care and treatment to test first part whether tracking proactively lost to follow up patients or detecting frail individuals at risk of lost to care is effective and secondly to evaluate the efficacy, the feasibility and the acceptability of an intervention tailored to each individual to get them to treatment success with viral suppression. In our context, a randomized approach would not be seen as ethical or possible in an environment where investigators need to evaluate such intervention as a pilot approach. Investigators therefore enrolled patients in a cohort population study OPTICARE program aim to actively identify vulnerable HIV+ population and promote optimal access to health care to this population using retention in care program in order to enable long term HIV infection control. The primary objective is to assess the feasability and the effectiveness of the OPTICARE program. The OPTICARE program aims to propose an individualized care to vulnerable HIV infected patients (UNAIDS/Second 90% goal) and to drive them to treatment success (UNAIDS/Third 90% goal) within a one-year period.
A total of 40 HIV infected patients will be randomly assigned into intervention or control group. Participants in the intervention group will use an smart phone application for two months. Participants will receive reminder notifications and use the app to take and send videos of themselves taking the pill(s), uploaded videos will be centrally reviewed by a study nurse . Control group participants will receive standard care. Antiretroviral Therapy adherence will be measured by self-report, pill count, and smart bottle as well as the App. Participants' perceptions of app using experience will be recorded via face to face interview.
This clinical trial seeks to determine if male-centered recruitment increases men's testing for HIV and whether or not individualized introduction to clinics increases male engagement in treatment for HIV. The study is being conducted in rural KwaZulu Natal.
Cervical cancer is the most common cause of cancer and a leading cause of death among HIV-infected women living in resource-limited settings. Although screening for premalignant lesions is an effective way of reducing cervical cancer incidence, its uptake in low-resource settings to date is low. The use of HPV testing for primary screening is currently recommended by many guidelines - including the WHO guidelines for cervical cancer screening in resource-limited settings - because of its greater sensitivity and ease of use compared to other options. However, these WHO guidelines have both highlighted the need to conduct more research on appropriate HPV-based algorithms among HIV-infected women, as immunodeficiency may affect the screening performance. Indeed, HPV infections in HIV-infected women are very common, so there is a need for additional triage to identify women most at risk and there remains considerable uncertainty on the optimal option for such triage. Most of the evidence available comes from HIV-negative populations living in high-resource settings and is not necessarily relevant for low-resource contexts where the epidemiological background is different, women access late to screening and may not have follow up visits, where financial constraints are important and health service resources limited. Hence, the proposed project aims to provide evidence on the effectiveness and feasibility of HPV-based screening algorithms among HIV-infected women in low-resource settings. This multicenter cross-sectional study will include 3,000 HIV-infected women (30-59 years old) receiving HAART and followed in Mfou (Cameroun), Abidjan (Ivory Coast), Bobo-Dioulasso (Burkina Faso) and Phnom Penh (Cambodia). After self-collection of cervico-vaginal samples, each participant will have an HPV test with partial genotyping primary using the Xpert HPV assay, a real-time PCR assay that provides the possibility of identifying 14 HR-HPV types within one hour. The Xpert HPV test has been chosen because of the wide availability of the Genexpert platform in HIV care centers from resource-limited settings. Furthermore, it can specifically detect HPV-16, 18 and 45, the most carcinogenic HPV types in both HIV-negative and HIV-positive women, separately from other high-risk HPV types. VIA will be another triage option either alone or combined to HPV DNA genotyping.
The purpose of this study is to evaluate the safety and immunotherapeutic activity of an anti-PD-1 antibody (cemiplimab) in HIV-1-infected participants on suppressive combination antiretroviral therapy (cART).
Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic exposure to combination anti-retroviral therapy identified anti-retroviral associated long-term toxicities. Hence, there is a need to prevent these co-morbidities. GSK3640254 is a next-generation HIV-1 Maturation Inhibitor (MI) which may be effective for HIV-1 infection. This study will evaluate the antiviral effect, safety, tolerability and pharmacokinetics/ pharmacodynamics of GSK3640254 in HIV-1 infected treatment-naive adults. This study will consists of two parts; Part 1 and Part 2. Part 1 will evaluate two active doses of GSK3640254, 200 milligrams (mg) (Cohort 1) and 10 mg (Cohort 2) along with placebo to match GSK3640254 Mesylate salt. Part 2 will evaluate three active doses of GSK3640254. Dose level 1 of GSK3640254 that can provide at least 30 percent of the maximum effect (Cohort 1), dose level 2 of GSK3640254 that can provide at least 75 percent of the maximum effect (Cohort 2) and dose level 3 of GSK3640254 that can provide at least 90 percent of the maximum effect (Cohort 3). These doses are anticipated to be 5 mg, 40 mg and 100 mg respectively, but could be modified based on data obtained in Part 1. Subjects will also receive placebo to match GSK3640254 Mesylate salt in Part 2 of the study. All doses will be administered after a moderate fat meal. This study will consist of Screening period (up to 14 days), Treatment period (Day 1- Day 10), post-dose Follow-up (Day 11- Day 17) and final Follow-up (Day 18-24). A total of approximately 34 subjects will be enrolled, of which, 14 subjects will be randomized in Part 1 and 20 in Part 2 of the study. Six subjects will be enrolled in each of the active dose cohorts and 2 subjects will be enrolled in each of the placebo cohorts.