Active clinical trials for "HIV Infections"

Oral pre-exposure prophylaxis (PrEP) has been proven effective in reducing HIV infection in high-risk men who have sex with men, heterosexually active women and men, and injecting drug users. Despite its 2012 approval by the FDA and the development of Centers for Disease Control and Prevention (CDC) clinical guidelines, PrEP uptake has been limited. Significant impediments to PrEP implementation include: system barriers (lack of a medical "home" and of models for implementing PrEP); provider barriers (difficulty identifying those likely to benefit from PrEP, inexperience with PrEP, and concerns about adherence and risk compensation); and user barriers (lack of awareness of PrEP, inability to access providers comfortable with prescribing PrEP, and concerns about stigma and side effects). Cost is not a barrier in New York State, where PrEP is covered by many insurance plans, including Medicaid. Primary Care for PrEP (PC4PrEP) is a structural, multilevel intervention that will integrate PrEP into primary care practices that care for underserved communities in the Bronx, NY, an epicenter of continuing HIV infection in the US. PC4PrEP will develop an organizational protocol for prescribing PrEP in primary care; identify high-risk individuals in primary care clinics and community HIV testing sites using a new PrEP Eligibility Tool; link them to primary care providers (PCPs) who can provide PrEP; and counsel potential users about PrEP both before they receive a prescription (to enhance receptivity), and after they initiate PrEP (to enhance adherence). In the course of this study, investigator(s) will (1) develop and pilot PC4PrEP; (2) implement and evaluate it in "real-world" settings (Federally Qualified Health Centers; FQHCs) on objective outcomes as well as provider and patient reports; and (3) present a new model, the PrEP Cascade that - as with the HIV Care Cascade for HIV+ populations - may be used to evaluate the impact of PrEP programs in the US and other countries. PC4PrEP is consistent with CDC and New York State Department of Health (NYSDOH) Guidelines and the Affordable Care Act in integrating PrEP into primary care practices and is responsive to recent 2014 NYSDOH recommendations which now position PrEP as a first-line intervention for MSM and transgender women who engage in ongoing anal sex without condoms, HIV- partners in sero-discordant relationships, and high-risk heterosexual women in high seroprevalence areas.There are two Specific Aims: (1) Finalize the PC4PrEP intervention and, in a clinic-randomized Phase 2 futility trial, assess whether it shows promise for increasing PrEP prescription rates in the Bronx, NY; and (2) Identify strengths and limitations of PC4PrEP in two ways: (a) through a mixed-methods process evaluation PrEP-eligible patients and PCPs, counselors and navigators; and (b) by identifying "fall-off" at each step of the PrEP Cascade.

This is a Phase 1/2a open label study to evaluate the safety, tolerability, pharmacokinetics and anti-viral activity of PGT121, VRC07-523LS and PGDM1400 for HIV prevention and therapy.

The purpose of this study is to evaluate the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's government-managed health system.

This is a randomized controlled trial of a new behavioral intervention designed to improve engagement in HIV care for couples. Investigators will compare the HIV viral load outcomes of couples randomized to a couples-based adherence intervention (DuoPACT) or to an individual adherence intervention (LifeSteps).

Ebola and HIV are found predominately in the same regions of the world and countries in sub-Saharan Africa are most affected by both diseases. For Ebola, no approved therapies exist. However, new investigational drugs are being evaluated to understand if they are effective against the Ebola virus. Remdesivir is an anti-Ebola investigational drug for the treatment of Ebola. Little is known about how the blood levels of remdesivir relate to how effective it is in patients with HIV taking antiretroviral therapy. This study will explore how commonly utilized ART (tenofovir/lamivudine and atazanavir/ritonavir) affect the drug levels of remdesivir.

This CDC-funded study sought to evaluate the effect of an adapted Community Score Card Approach on maternal retention in ART, maternal retention across the PMTCT service cascade, and the uptake of early infant diagnosis services in Malawi. The study also estimated the cost of the implementation of the Community Score Card Approach.

This study aims to improve maternal and child health (MCH) outcomes by implementing and evaluating a multidisciplinary "Integrated Management Team to Improve Maternal-Child Outcomes (IMPROVE)" intervention to increase MCH, antiretroviral therapy (ART), and HIV services uptake and retention in Lesotho. The proposed intervention will focus efforts to improve the effectiveness of existing village health workers (VHW) and HIV support organizations (Lesotho Network of AIDS Service Organizations [LENASO] and Mothers2Mothers [M2M]) based at the facility and coordination between the facility and community. The IMPROVE intervention includes: (1) Multidisciplinary integrated management teams to coordinate patient-focused and outcome-oriented PMTCT and MCH services; (2) Enhanced Positive Health, Dignity, and Prevention (PHDP)-focused counseling and skills-building training and job aids; and (3) Increased early community-based counseling and support for first (antenatal care clinic) ANC attendees with particular attention to HIV-positive women to minimize loss to follow-up. The study will be a cluster randomized design with facilities randomized to receive the IMPROVE intervention or routine services offering the national standard of care. A cohort of HIV-positive and HIV-negative pregnant women will be enrolled and prospectively followed every three months through pregnancy and until the participant's child reaches 24 months of age. The primary HIV objectives will be to evaluate the effect of the intervention on retention in HIV care, viral suppression, adherence to ART in HIV-positive women, and HIV retesting in HIV-negative women. The investigators will also assess the effect of the IMPROVE intervention on general MCH indices including antenatal care (ANC) attendance, facility delivery, family planning, and immunization coverage. Secondary objectives include evaluation of adherence self-efficacy (HIV positive) or prevention self-efficacy (HIV negative), depression and stigma as well as disclosure, knowledge of partner status, and identification of discordant couples in intervention versus control facilities. Analysis of the cost-effectiveness of the IMPROVE intervention will also be conducted. In addition, qualitative interviews and focus group discussions will be conducted with study women, health care workers (HCW), LENASO, and VHWs to evaluate the feasibility and acceptability of integrating this intervention into routine care.

In many sub-Saharan African countries, the scale-up of lifelong antiretroviral treatment (ART) to all pregnant and breastfeeding women under Option B+ has the potential to radically improve maternal health and reduce mother-to-child HIV transmission. However, loss to HIV care after delivery has emerged as an important threat to the hoped-for impact of Option B+. Evidence suggests that one important contributor to postpartum loss to HIV care is perinatal depression (PND). In non-pregnant HIV-infected populations, depression has been linked to poor ART adherence, reduced engagement in care, and ultimately worse HIV clinical outcomes. Thus, interventions that integrate PND treatment with targeted support for HIV care retention are critical to the success of Option B+. The Friendship Bench is an evidence-based depression counseling intervention delivered by trained, supervised lay health workers. It is proven to reduce depression in the general population in low-resource settings, but has not been adapted to address PND, or enhanced to support engagement in HIV care. The Friendship Bench offers an ideal framework for integrating retention support into a proven depression treatment model. Our long-term goal is to adapt, test, and scale up resource-appropriate interventions to reduce PND and improve engagement in HIV care. The objective of this proposal is to lay the groundwork for an effectiveness trial by adapting the Friendship Bench intervention to address PND and support engagement in care among perinatal HIV-infected women and assessing the feasibility, acceptability, and fidelity of the adapted intervention in Lilongwe, Malawi. In-depth perspectives on PND and its role in engagement in care will be gathered from HIV-infected women with PND, healthcare providers, clinic directors, and Ministry of Health officials using qualitative interviews and focus groups. This formative research will be used to develop an intervention protocol adapted to the unique needs of HIV-infected women during the perinatal period (Adapted Friendship Bench) and further enhanced to support engagement in HIV care (Enhanced Friendship Bench). The Adapted and Enhanced Friendship Bench interventions will be compared to enhanced standard care in a 3-arm pilot study. Feasibility, acceptability, and fidelity will be assessed at 6 months postpartum, along with the interventions' preliminary effectiveness across several mental health and engagement in HIV care measures.

The North Carolina Bridge Counselor system is designed to help link out of care HIV positive patients back into HIV care. It has improved initial linkages and patient re-engagement overall, but for a sizable group of patients, the current system has not been effective, leaving a population of hard-to-reach, lost-to-care patients who remain out of care. There is limited understanding of the lived experiences of patients who fall out of HIV care and become recalcitrant to re-engagement because they are difficult to reach and therefore underrepresented in research. Out of care HIV+ patients who have not reengaged in care following the standard of care who chose to enroll in the study will participate in 2 semi-structured interviews and receive a field-based HIV re-engagement and treatment intervention (Project RAMP). Project RAMP will consist of up to 4 visits from an outreach research nurse designed to serve as an "on-ramp" to HIV care. At these visits, the outreach number will counsel on HIV care and treatment and obtain a medical history and labs. Results will be communicated to the participant's clinic provider in an effort to both encourage the patient to return to care and facilitate more rapid antiretroviral therapy (ART) initiation by the clinic provider. The research team will also provide the participant in-person assistance with scheduling a clinic visit. Clinic providers may re-initiate ART prior to the reengagement clinic visit, with adherence support provided by the outreach nurse.

The purpose of the study is to assess the ability to swallow the Darunavir/Cobicistat (DRV/COBI) fixed dosed combination (FDC) tablet dispersed in water.