Antiviral Therapy

Researchers are evaluating new medicines to prevent infection with Human Immunodeficiency Virus Type 1 (HIV-1). This Phase 3 clinical trial aims to find out if taking MK-8527 once a month is as effective or better than a standard daily pre-exposure prophylaxis (PrEP) in preventing HIV-1 infection. The study also assesses the safety and tolerability of MK-8527. Participants are randomly assigned to one of two groups: one group takes 11 mg of MK-8527 once monthly plus a placebo daily pill matching FTC/TDF, and the other group takes 200 mg FTC/245 mg TDF daily plus a placebo monthly pill matching MK-8527. This treatment phase lasts up to approximately two years. Afterward, all participants receive open-label FTC/TDF daily for an additional 28 days. During the study, participants are closely monitored for HIV-1 infection, adverse events, and any discontinuation due to side effects over the two-year treatment period. The primary outcomes include the number of participants who acquire HIV-1 infection, experience any adverse events, or stop the study intervention because of adverse events. Follow-up and safety assessments continue through the entire treatment period to evaluate the medicine's performance and participant well-being.

Researchers are evaluating a multilevel trauma-informed approach to increase HIV pre-exposure prophylaxis (PrEP) initiation among Black cisgender women in Baltimore, who are considered a high-risk group for HIV. This study aims to address socio-structural challenges such as intimate partner violence and gendered racism that may limit access to PrEP, focusing on both women with and without experiences of intimate partner violence. The research is sponsored by the Johns Hopkins Bloomberg School of Public Health and involves a randomized design without masking. Participants will be randomly assigned to one of two groups. The intervention group will receive behavioral lifestyle education related to biomedical HIV prevention, consisting of four weekly group sessions and four individual sessions with a peer navigator. The control group will receive a single group session. These sessions aim to increase understanding and uptake of PrEP among eligible Black women. During the study, researchers will monitor PrEP initiation up to six months after baseline and assess adherence at two, four, and six months post-randomization. Participant involvement includes attending scheduled educational sessions and follow-up assessments. The study will track how well participants start and continue PrEP use, with safety and sustainability of the intervention also evaluated. The total study duration extends through February 2028.

Researchers are evaluating new medicines to prevent HIV-1 infection, focusing on women who are at risk. The study aims to find out if taking MK-8527 once a month can prevent HIV-1 infection better than the usual daily HIV prevention pill (known as PrEP). The research also looks at the safety of MK-8527 and how well people tolerate the medication. Participants will be randomly assigned to one of two groups for about two years. One group will take 11 mg of MK-8527 once a month along with a placebo pill daily, while the other group will take a daily dose of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) with a monthly placebo. After this period, all participants will take an open-label daily dose of FTC/TDF for 28 days. During the study, participants will be monitored for HIV-1 infection, side effects, and whether they stop treatment due to side effects. Safety and effectiveness will be assessed over the two years of treatment. The study includes regular check-ins to evaluate health and collect information about adverse events associated with the treatments.

This research aims to evaluate the added effect of Amantadine or Duloxetine when combined with Pregabalin on the development of post mastectomy pain syndrome (PMPS), a common chronic pain condition occurring after breast surgery. PMPS affects 20% to 50% of patients and is a type of chronic post-surgical pain. The study investigates how these medications might influence pain pathways and nerve excitability in patients undergoing modified radical mastectomy for breast cancer. Participants are assigned randomly to one of three groups. Two hours before surgery, one group receives Pregabalin 75 mg with a placebo tablet; another group receives Pregabalin 75 mg plus Amantadine 100 mg; and the third group receives Pregabalin 75 mg plus Duloxetine 30 mg. All treatments are continued twice daily for seven days after surgery. This double-blind study compares the effect of these treatments on pain development following mastectomy. During the study, researchers will monitor the occurrence of post mastectomy pain syndrome 12 weeks after surgery as the primary outcome. Secondary outcomes include patient quality of life, activity level, pain severity at 12 weeks, and opioid use during and after surgery. Side effects related to each medication are tracked for 48 hours post-procedure. Participants are evaluated through clinical assessments and medication monitoring over the course of the treatment and follow-up period.

Researchers are evaluating the safety and effectiveness of low-dose Apixaban combined with standard medical therapy compared to standard therapy alone to prevent left ventricular (LV) thrombus formation after primary PCI in patients with acute anterior myocardial infarction and severe LV dysfunction. This open-label, randomized controlled trial focuses on patients aged 18 to 65 years with an ejection fraction below 35% and specific heart motion abnormalities. Participants will be randomly assigned to receive either Apixaban 2.5 mg twice daily plus dual antiplatelet therapy (aspirin and clopidogrel) for four weeks along with guideline-directed medical therapy, or guideline-directed medical therapy alone including dual antiplatelet therapy. After four weeks, those in the Apixaban group will continue with dual antiplatelet therapy. In case of stent thrombosis, some medication adjustments may be made. Follow-up includes phone assessments at two weeks and an in-person visit with echocardiography at four weeks. During the study, participants will be monitored for LV thrombus formation using echocardiography at four weeks, and clinical status, medication side effects, and adherence will be assessed. The primary outcome is the incidence of LV thrombus formation at one month. Secondary measures include rates of death, recurrent heart attacks, stent thrombosis, heart failure hospitalizations, bleeding events, and drug discontinuation due to side effects. Safety and outcomes will be independently reviewed by a clinical events committee.

Researchers are evaluating how patients and physicians feel about offering medications called pre-exposure prophylaxis (PrEP) to prevent HIV in a family planning clinic. The study focuses on whether patients find it acceptable to be asked about PrEP during their clinic visits, as well as understanding the challenges and supports for discussing and starting PrEP in this setting. The study aims to provide data to help design better ways to offer PrEP in family planning clinics. The study offers standardized counseling about PrEP to patients and provides an opportunity to begin PrEP as part of routine care. Physicians receive training on a standardized PrEP screening and initiation protocol and support patients interested in starting PrEP. There is no control group; this is a pilot study to assess feasibility and acceptability of integrating PrEP into family planning services. Participants will complete surveys about their experiences with PrEP screening and initiation. Patients complete a post-intervention survey and receive a gift card, while physicians complete pre- and post-study surveys and some may take part in in-depth interviews. Researchers measure how acceptable, feasible, and appropriate the intervention is for both patients and physicians during the study period, which lasts up to 12 months for physicians and up to 6 hours for patients.

This research aims to evaluate the effects of dyadic and focused case management on improving financial wellbeing, food access, linkage to and retention in care, and viral suppression rates among individuals living with or vulnerable to HIV, including men who have sex with men, gender-diverse persons, and cis-gender women. The study compares these outcomes to those receiving routine Ryan White Non-Medical Case Management to assess the potential benefits of this emerging practice. Participants are randomly assigned to one of two groups: the standard care group receiving Ryan White Non-Medical Case Management, which is need-focused and client-initiated, or the experimental group receiving dyadic case management with two case managers. The dyadic approach emphasizes goal setting, future planning, and financial stability using components from Appreciative Inquiry, aiming to provide more focused support. Throughout the 18-month study period, participants will be assessed for financial wellbeing and food security as primary outcomes. Secondary outcomes include persistence with PrEP and viral suppression among those living with HIV. Researchers will monitor these measures to determine the impact of the interventions on health and wellbeing, with participation involving ongoing engagement and support from case managers.

Researchers are evaluating an unconditional cash transfer intervention to improve mental capacity, antiretroviral therapy (ART) adherence, and postpartum retention among pregnant women with HIV in Botswana. This pilot Hybrid Type 2 effectiveness-implementation trial aims to answer whether monthly cash transfers improve mental bandwidth and ART adherence during pregnancy and postpartum compared to usual care. It also assesses the feasibility and acceptability of delivering cash transfers via mobile money in public antenatal clinics and explores barriers and facilitators to implementation. The study enrolls 100 pregnant women with HIV in their second trimester, randomly assigned to two groups: one receives usual care plus 1,000 Botswana Pula (BWP) monthly cash transfers through six months postpartum, and the other receives usual care with standard social support. Participants attend visits at baseline, late pregnancy prior to delivery, and three to six months postpartum. Selected participants will also take part in qualitative interviews to explore their experiences with the intervention. Throughout the study, participants complete surveys, mental bandwidth assessments using the Psychomotor Vigilance Task and Raven's Progressive Matrices, and clinical data are collected from electronic health records. The study measures ART adherence, mental bandwidth, feasibility, and acceptability of the cash transfer intervention at specified visits. Secondary outcomes include food security, stress, psychological distress, pregnancy status, birth outcomes, and clinic attendance. Findings will guide future larger trials and policy development.

This research aims to evaluate the use of high concentration 2% Ganciclovir Eye Drops in treating cytomegalovirus retinitis, a serious eye infection. The study is a single-center, prospective trial where patients diagnosed with this condition are carefully monitored. The study follows ethical guidelines, and participants provide informed consent after being fully informed about the treatment and potential risks. Participants receive 2% Ganciclovir Eye Drops with a specific dosing schedule: 10 times per day for the first two weeks, then 8 times per day for the following two weeks, 6 times per day for the next two weeks, and finally 4 times per day for more than six weeks. The study focuses on one experimental group using this eye drop therapy. Throughout the study, researchers assess various eye health measures including visual acuity, eye pressure, corneal condition, inflammation, optical coherence tomography, and wide-angle fundus imaging. The main outcome measured is the condition of fundus lesions over 24 weeks, along with changes in best corrected visual acuity. Safety and effectiveness are monitored during this period, with the total participation lasting up to 24 weeks.

People living with HIV (PLWH) often face challenges in care due to intersectional stigma related to HIV, mental health, and other dimensions like sexual and gender minority status and ethnicity. This stigma leads to poor clinical outcomes globally. The study aims to evaluate the acceptability and feasibility of a digital health tool called INCLUDE, designed to assess and reduce intersectional stigma in ART centers in Nepal to improve HIV care engagement and outcomes. INCLUDE is a digital tool with three parts: a dynamic assessment strategy used during clinic visits to collect quantitative ratings and qualitative client perspectives on stigma; a dashboard that links stigma data with routine clinical data to identify stigma-related care barriers; and a collection of culturally appropriate, evidence-based stigma-reduction activities at individual, interpersonal, and clinic levels. The study will be conducted in four ART centers and involves both people living with HIV and healthcare workers. Participants will be involved in using the INCLUDE tool during clinic visits, providing feedback through surveys, interviews, and focus groups, and their app usage will be monitored. Researchers will measure acceptability ratings, assessment completion rates, application performance, and the implementation of stigma-reduction activities over a nine-month period. This pilot trial will gather comprehensive data to refine the tool and potentially support wider use to address intersectional stigma in HIV care.