Clinical Research Directory

PREVAIL VIIIa: Evaluation of Latent Tuberculosis Infection Screening Methods in People Living With Retroviral Infection in Liberia

Background: Tuberculosis (TB) is a health threat for people living with human immunodeficiency virus (HIV). People living with HIV are more likely than others to develop active TB. Also, TB makes HIV progress faster. TB is a leading cause of death among people in the West African country of Liberia. Researchers want to find an effective testing method for latent tuberculosis infection (LTBI) to help people living with HIV in Liberia. Objective: To compare the interferon-gamma release assay (IGRA) and tuberculin skin test (TST) as LTBI screening tests in people living with HIV in Liberia. Eligibility: People ages 18 and older who take part in NIH study #19-I-N014 and are scheduled to have or have had IGRA at a Month 12 HONOR study visit. Design: Participants will be screened with a medical history and physical exam. Their medical records and HONOR study records will be reviewed. Participants will have TST. Purified protein derivative will be placed in the skin of their forearm. They will be observed for adverse reactions for 15 minutes. Between 48 and 72 hours after placement, they will have a second study visit to have the TST read. If they miss this time frame, they can return up to 7 days after placement. If they have a positive test result, they will have a chest x-ray. They will have a third study visit to review the results of the chest x-ray. They will be referred for clinical care if needed. They will take a pregnancy test if needed. Participation will last from 2 days to 6 weeks.

Natural History Study of Kaposi Sarcoma

Background: Kaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract. KS is most common in people with compromised immunity, but it also appears in otherwise healthy people. Researchers want to understand more about how KS develops, why it may recur, and how it affects the immune system and organs. Objective: To learn more about the natural history of KS. Eligibility: People aged 18 years and older with KS. Design: Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan. They may need a new biopsy: Tissue samples may be cut from their tumor. Their ability to perform normal activities will be assessed. Participants will visit the clinic to have their KS evaluated. In addition to the imaging scans and other tests performed during screening, procedures may include: Eye exam. Ultrasound exam of the heart (electrocardiogram). Collection of saliva and urine samples. Biopsies of the skin or lymph nodes. Swabs of the anus and cervix. Photographs of skin lesions. Removal of fluid samples from the space around the lungs, intestine, or heart. The evaluation visit will be repeated 5 more times over 18 months and then yearly for up to 10 years. Participants will follow their standard treatment for KS during the study.

Olfactory Function and Model-Based Behavior in People Living With HIV and SUD

Background: Human immunodeficiency virus (HIV) infection can affect areas of the brain that control thinking ability. These same areas of the brain also control the sense of smell. HIV infection is common in people with substance use disorder (SUD). SUD also affects thinking ability. Researchers want to learn more about the connection between the sense of smell and decision-making ability in people with HIV, SUD, or both. Objective: To test the sense of smell in people with HIV and/or SUD and how they make choices based on odors. Eligibility: People aged 18 to 65 years with any of these: (1) HIV, (2) SUD, (3) both HIV and SUD, or (4) neither SUD nor HIV. Design: Participants will have 2 visits. Each visit will last 3 to 5 hours. In visit 1, participants will have a blood draw and a saliva swab. They will answer questions about their health, sleep habits, food intake, and substance use. They will have smell tests: They will smell scented sticks and answer questions about them. They will be blindfolded for some tests. They will perform tasks on a computer. They will look at pictures and smell pleasant food odors, such as chocolate cake or pizza. Smells will be delivered using a nasal mask. Their sniffing and breathing will be measured. They may also be exposed to odor-free air. They will eat food that corresponds to one of the food odors they smelled. In visit 2, participants will do a saliva swab and a different computer task that involves odors. They will also have tests of their attention and memory. Participants may opt to have an imaging scan of the brain.

Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...

Background: People living with HIV(PLWH) are at a higher risk for cancers that may be curable with a bone marrow transplant. HIV infection itself is no longer a reason to not get a transplant, for patients who otherwise have a standard reason to need transplant. Objective: This study is being done to see if a new combination of drugs (cyclophosphamide, maraviroc, and bortezomib) is both safe and effective at protecting against graft-versus-host disease after bone marrow transplant. The study will also test the transplant s impact on your survival and control of your cancer. Eligibility: People aged 18 years and older living with HIV and a blood cancer that is eligible for a transplant. Healthy family members aged 12 or older who are half matched to transplant recipients are also needed to donate bone marrow. Design: The study will be done in 2 phases. The first phase will be to see if we can safely use a new combination of drugs to prevent GVHD. If the combination is safe in the first phase, the study will proceed to the second phase. In the second phase, we will see if this new combination can better protect against GVHD after transplant. Participants will be screened. Their diagnoses, organ function and eligibility will be confirmed. Participants will have a catheter inserted into a vein in their chest or neck. Medications and transfusions will be given through the catheter; blood will be drawn from it. Participants will be in the hospital for 6 weeks or longer. They will receive various drugs for 2 weeks to prep their body for the transplant. The transplant cells will be administered through the catheter. Participants will continue to receive drug treatments after the transplant. Blood transfusions may also be needed. Participants will return 1-2 times per week for follow-up visits for 3 months after discharge. Participants will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years....

Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection

This study will investigate HIV infection and associated conditions by monitoring infected patients. The study will also serve as a means for recruiting HIV-infected individuals to NIAIDs ongoing clinical and laboratory studies and supporting the institute s infectious disease training program by providing Infectious Disease fellows with ongoing training in the management of HIV infection. People 18 years of age and older with suspected or confirmed HIV infection who live in the Washington, D.C., metropolitan area may be eligible for this study. Physician referral is required. Participants come to the NIH Clinical Center a minimum of once every 3 to 4 months for evaluation with a physical examination; blood tests for research purposes, safety, immune status and viral load; and response to any treatment they may be receiving. Other procedures, such as a biopsy, are done only as needed for standard medical practice, and informed consent is obtained before any such procedure is done. Treatment offered is consistent with standard medical practice; no experimental treatments are offered under this protocol.

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption

Background: Human immunodeficiency virus (HIV) infects CD4 T cells. There is no cure for HIV. People with HIV need to take daily medications called antiretroviral therapy (ART) to control their infection. ART stops HIV from infecting cells, but HIV does not go away. Some infected cells remain. If ART is stopped, then HIV levels will rise and infect more cells. Objective: To compare changes in the amount of virus in blood and lymph nodes after a short treatment interruption. Eligibility: Adults aged 18 years or older who are undergoing ART for HIV infection. Design: Participants will be screened with a physical exam, including blood tests. They will be assigned to 1 of 2 groups: One group will stay on ART. They will have 2 study visits: the first 45 days after screening, and the second 12 to 16 weeks later. They will have a PET/CT scan at each visit. A substance called a tracer will be injected into their arm. They will lie still on a table that moves through a doughnut-shaped machine. This process takes up to 2 hours. The other group will stop ART for no more than 90 days. This group will have 3 PET/CT scans over 8 months. Once they stop ART, they will visit the clinic weekly for blood tests. After restarting ART, they will continue to visit the clinic weekly until their HIV level is safe. All participants will have small samples of tissue taken from lymph nodes. They may also opt to provide semen samples or vaginal fluid. They may have samples taken of bone marrow or the fluid inside their spinal column....

Ending the HIV Epidemic: An All-facility Intervention for Patient and Healthcare Staff Well-being

The scope of this study is to engage Ryan White HIV/AIDS Program (RWHAP) funded organizations in the South/East US to co-develop context-responsive programs utilizing evidence-informed interventions to reduce stigma against living with HIV (PLH) who have difficulties accessing and remaining engaged in life-saving treatment. Five RWHAP clinics will be selected for this trial. Clinic members will participate in interactive trainings to raise awareness of and reduce stigma, from the clinic policy level to individual attitudes. Clinic members and select patients will complete self-administered surveys every 6 months over 24 months.

Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults

The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk.

Reducing Stigma and Building Employability Skills for Young People With HIV in Zambia

The goal of this clinical trial is to learn if a program called Kupambana can improve mental health and HIV care outcomes in young people with HIV in Zambia by combining stigma-reduction support with financial and job-skills training. The main questions it aims to answer are whether Kupambana is feasible and acceptable to young people with HIV and whether it improves mental health, reduces stigma, and improves progress along the HIV care continuum, such as staying in care and taking HIV medicine as prescribed. Researchers will compare young people who participate in Kupambana with those who receive a one-time financial literacy training session (usual care) to determine whether Kupambana leads to greater improvements in stigma, mental health, and HIV care outcomes. Participants will complete a baseline questionnaire and then be randomly assigned to either the Kupambana program or the one-time financial literacy training. Those assigned to Kupambana will attend eight weekly peer-led support group sessions focused on reducing HIV- and poverty-related stigma, receive a voucher for technical and vocational education and training, and attend a one-time financial literacy session. Those assigned to the comparison group will attend only the one-time financial literacy session. All participants will complete follow-up surveys at the end of the program and again 3 and 6 months later.

Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women

Purpose of this Study: The main purpose of this study is to adapt an existing evidence-based intervention, Project Accept Post-Test Support Services (PTSS) Module 3, specifically for pregnant and postpartum women living with HIV (WLWH) in Ghana. The adapted intervention aims to reduce HIV-related stigma and improve adherence to antiretroviral therapy (ART) and mental health symptoms, such as depression and anxiety, among this vulnerable population. Why was this study done? (Background): HIV-related stigma is a major obstacle for women living with HIV, particularly pregnant women in Sub-Saharan Africa (SSA), hindering their engagement in HIV care and adherence to ART. This contributes to poor health outcomes, including inadequate viral suppression, depression, and an ongoing risk of HIV transmission to their children and sexual partners. While effective HIV stigma-reduction interventions exist for the general adult population living with HIV, there is a critical lack of tailored interventions for pregnant and postpartum WLWH in SSA. This study addresses this gap by adapting a proven intervention (Project Accept PTSS Module 3), which has shown success in reducing stigma and improving outcomes in other populations, for this specific group in Ghana, where HIV-related stigma remains disproportionately high. Who participated in this study? (Target Population): This study will involve several groups: Pregnant and postpartum women living with HIV: 30 women will participate in in-depth interviews to share their experiences with stigma and HIV care. HIV care providers: 20 providers will participate in in-depth interviews to offer their perspectives on stigma and care provision. Stakeholders: This group will include HIV care providers, program administrators/directors, and pregnant and postpartum women. They will collaborate in the iterative process of adapting the intervention. Pregnant women living with HIV (for feasibility testing): 90 pregnant women will be randomized, with half receiving the adapted intervention and half receiving standard care, to assess the intervention's feasibility, acceptability, and preliminary impact. What happened in this study? (Intervention/Methods): This 3-year study has three main aims: Understanding Stigma Experiences: Researchers will describe the experiences of stigma and HIV care from the perspectives of pregnant and postpartum WLWH and compare them with providers' experiences. This will involve longitudinal data collection and in-depth interviews to understand how stigma affects women's health, clinical care (e.g., provider discrimination, ART adherence), and mental health over time. Intervention Adaptation: Project Accept PTSS Module 3 will be adapted specifically for pregnant and postpartum WLWH using the ADAPT-ITT framework. This involves an iterative process with stakeholders to ensure the intervention is culturally and gender-appropriate, enhancing its acceptability for the target population. Feasibility and Preliminary Impact Assessment: The study will assess the feasibility and acceptability of the adapted intervention. Ninety pregnant women will be randomly assigned to either receive the intervention or continue with standard care. Researchers will then estimate the intervention's potential impact on anticipated and internalized HIV-related stigma (primary outcomes), as well as ART adherence and symptoms of anxiety and depression (secondary outcomes). What were the results of this study? (Outcomes): As a preliminary and adaptation study, this research aims to: Provide essential data to inform and justify a larger, fully-powered randomized clinical trial to rigorously evaluate the adapted intervention's effectiveness. Identify potential indicators associated with mother-to-child transmission of HIV. Develop a model that can be applied to other Sub-Saharan African countries facing similar challenges. Foster new collaborations focused on HIV-related stigma among women in Ghana. Build research capacity among researchers in sub-Saharan Africa. What are the side effects of the treatments in this study? (Safety): This study focuses on a behavioral intervention (a support and counseling module) rather than a drug or medical treatment. Therefore, typical physical side effects associated with medications are not expected. The intervention aims to improve well-being and health outcomes by addressing psychosocial factors. Any adverse events or discomfort experienced by participants will be carefully monitored and addressed in accordance with ethical guidelines. What are the conclusions of this study? (Implications/Future Plans): The findings from this study are expected to demonstrate the feasibility and potential impact of a culturally and gender-tailored HIV stigma-reduction intervention for pregnant and postpartum WLWH in Ghana. This research will be foundational for launching a larger-scale clinical trial to definitively test the intervention's efficacy.

Development and Evaluation of a PrEP Decision Aid for Women Seeking Domestic Violence Services in Baltimore

This study is designed to develop and test an individual decision aid for pre-exposure prophylaxis (PrEP) tailored to Black women who have been exposed to intimate partner violence and are working with a domestic violence service provider. three different ways of delivering the tailored decision aid are being tested: 1) as an individual tool; or 2) as a shared decision-making tool with a domestic violence advocate; as compared to generalized information. The goal of decision aid will be to address key cultural and structural factors affecting these women and can help them gain PrEP awareness and access.

Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity

This study will gain information about a rare disorder called KSHV-associated multicentric Castleman's disease (MCD). KSHV, a virus, causes several kinds of cancer, including some forms of MCD. KSHV stands for the Kaposi's sarcoma herpes virus, also called human herpes virus-8, or HHV-8. Researchers want to understand the biology of KSHV-MCD to identify how this disease causes illness and to find ways to treat it. There is no standard therapy effective for all cases of KSHV-MCD. The disease is often fatal, and about half the people who have it die within 2 years of diagnosis. Participants ages 18 and older may be eligible for this study. Participation entails more drawing of blood and having repeated tumor biopsies than if patients received treatment in a non-research setting. Researchers would like to learn more about the relationship of KSHV and Castleman's disease symptoms, and they want to obtain at least three biopsies in this study. There are some side effects of experimental therapy that participants may take for KSHV-MCD. Zidovudine, or Retrovir(R), is used at a high dose. It is given orally or through a vein, four times daily, for 7 days or longer. Zidovudine can cause nausea, vomiting, decreased bone marrow function, and decreased blood counts. Combined with valganciclovir, or Valcyte(TM), it is likely to be more toxic to bone marrow. Valganciclovir can cause problems with bone marrow function, leading to low blood counts, sterility, and defects in a fetus. Combined with zidovudine, valganciclovir may cause more toxicity to the bone marrow. It is given twice daily for 7 days or longer. Bortezomib, or Velcade(TM), is given for a few seconds by a rapid push through a needle into the vein. It is given twice weekly for four doses and then stopped for 1 week. Bortezomib can sometimes cause low blood pressure; it also can cause gastrointestinal problems and a low blood platelet count. Rituximab and liposomal doxorubicin are drugs given by a catheter into a vein. Interferon-alpha is given by injection into the skin. Those drugs are not experimental, but their use in Castleman's disease is experimental. Some participants may be treated with a combination of chemotherapy followed by interferon-alpha. Interferon-alpha is infected into the skin by a needle. The natural form of interferon is produced by the body and helps to control viral infections. KSHV decreases the effect of the body's interferon, and the researchers want to see if giving higher doses of interferon will help to control KSHV infection. A positron emission tomography (PET) scan, for research purposes only, may be done up to three times a year. A radioactive sugar molecule called fluorodeoxyglucose, or FDG, is used. It is believed that activated lymphocytes that may be found in participants' disease might use more FDG because these cells burn more glucose fuel. This study may or may not have a direct benefit for participants. However, detailed assessments made throughout the study may provide information to help the doctors treat KSHV-MCD better.

PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)

Background: There are many people living with human immunodeficiency virus (HIV) infection in Liberia. Most experts consider HIV an epidemic there. Researchers want to collect health data from Liberians with HIV over several years. This may help HIV prevention and treatment programs in Liberia. Objective: To learn more about how HIV affects people in Liberia. Eligibility: People with HIV in Liberia Design: Participants will be screened with a blood sample. Participants will visit the study clinic about 10 times over 3 years. They will need to return to the clinic after some visits to get test results. The visits will be closer together during the first part of the study and less frequent later. At each study visit, participants will: * Have a brief physical exam * Answer questions about how they are feeling and what medicines they are taking * Have blood taken from an arm vein by a needle * Give urine samples Participants ages 12 years or older may be asked questions about HIV risk behaviors. These include sex practices and drug use. Participants ages 18 years or older may be asked how their HIV infection makes them feel emotionally. Participants may be asked to join a research substudy. This will be about tuberculosis (TB) testing in people with HIV. For this substudy, participants will have a TB skin test. A small amount of liquid will be injected under the skin on the arm. Participants will return to the clinic a few days later. The test area will be checked. They will get their test results. ...

Improving Engagement in HIV and Cancer Care in Zimbabwe

In Zimbabwe, people who have cancer and HIV may have a difficult time staying engaged in their HIV care while they are being treated for cancer. This is because HIV and cancer care are usually provided at different health facilities, which can result in barriers to accessing clinical care for both HIV and cancer at the same time. It is important to remain engaged in HIV care, and continue taking medication to treat HIV throughout cancer treatment. The goal of this project is to identify barriers that make it difficult to stay engaged in HIV care and continue HIV treatment during cancer treatment and develop strategies to address them. The investigators will accomplish this by first observing a group of 150 people with cancer and HIV who are receiving cancer treatment at Parirenyatwa Hospital, in Harare, Zimbabwe. The investigators will measure barriers to accessing HIV care, and disruptions to HIV care engagement during cancer treatment. Next, the investigators will work with experts and key stakeholders to develop strategies that can be put in place at Parirenyatwa Hospital to better support engagement in HIV care during cancer treatment. The investigators will work with the cancer ward at the hospital to implement these strategies. Finally, the investigators will observe a second group of 150 people with cancer and HIV, who begin their cancer treatment at Parirenyatwa Hospital after the strategies have been put in place. The investigators will measure acceptability of these strategies to both patients and hospital staff. The investigators will also measure barriers to accessing HIV care and disruptions to HIV care engagement in the second group. The investigators will compare barriers to HIV care and HIV care engagement in the second group to the first group, to determine whether the strategies make it easier for people with cancer and HIV to remain engaged in HIV care during cancer treatment.

Analysis of HIV-1 Replication During Antiretroviral Therapy

This study will determine if the level of virus in HIV-infected patients taking antiretroviral medications for prolonged periods decreases or persists at a stable level. It will also examine whether new gene changes (mutations) occur during drug suppression. HIV-infected patients who are 18 years of age or older, have been enrolled in another NIH protocol, have been suppressed on antiretroviral therapy and have very low levels of virus in their blood may be eligible for this 5-year (or more) study. Participants come to the NIH Clinical Center about every 6 months for a physical examination, routine and research blood tests and leukapheresis to collect white blood cells for T cell analysis. For leukapheresis, blood is collected through a vein much like donating whole blood, but the blood is directed through a machine that separates and extracts the white cells and returns the rest of the blood components to the patient. Patients may also have an optional third clinic visit each year for another blood draw.

HIV/HBV/HCV Triple Screening in Primary Care

Design: This will be a within-subjects repeated-measures design, testing an electronic medical record pop-up alert linked to order panels for screening blood tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). Study participants will be primary care providers. For each participating provider, their encounter will be randomized to either control (no alert; no changes to EMR interface) or an alert with triple-testing order panel intervention arm (alert linked to order panel with screening tests for all three bloodborne viruses (BBVs) selected by default; the alert will be triggered when a provider attempts to order a screening test for at least one BBV). The alert linked to triple testing orders will only be triggered if the provider orders a virus BBV screening test based on their normal practice and standard of care for their patient. Providers will see which orders are selected prior to signing (finalizing) them; therefore, this study will be unblinded. To mitigate the effect of unblinding, randomization will occur at the encounter level which will lead to providers experiencing both the control and intervention conditions randomly throughout the duration of the study. Outcomes/endpoints: The investigators will compare incidences of HIV, HBV, and HCV diagnoses between the two encounter conditions, estimate number of cases missed by not triple-testing, estimate laboratory costs per condition, and measure patient encounters per condition.

Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV

We are studying virologic and/or immunologic parameters of HIV infection and other infectious or non-infectious immune deficiency diseases in order to better understand the pathogenesis of HIV. Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood cells for studying aspects of either in vivo or in vitro HIV infection. We wish to be able to continue to elucidate many pathogenic aspects of HIV infection in relation to other infectious or non-infectious immune regulation and dysregulation using human peripheral blood mononuclear cells as a model....

Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study

The goal of this clinical trial is to find out if sex work managers (also called "queen mothers") can help female sex workers (FSW) get tested for HIV and other sexually transmitted infections (STIs) by giving out and collecting test kits at the places where FSW meet and work, also known as venues. This study will also find out if this approach helps link FSW to HIV and STI treatment and prevention services. The main questions it aims to answer are: * Can this approach increase HIV diagnosis and connection to HIV treatment and prevention services? * Can this approach increase STI diagnosis and connection to STI treatment services? * Is this approach acceptable, appropriate, and feasible, and what are the costs associated with the approach? Researchers will compare a venue-based, peer-supported strategy for HIV self-testing and self-collected STI testing among FSW to the current standard of care to see if the new approach helps to increase HIV and STI identification and linkage to HIV and STI treatment and prevention services. FSW participants will: * Complete questionnaires when they join the study and again about three months later. * Complete HIV self-testing and self-collected STI testing when they join the study and as needed, with the help of queen mothers. * Agree to have their medical records reviewed. Queen mother participants will: * Complete questionnaires when they join the study and again about three months later. * Help FSW participant complete HIV self-testing and self-collected STI testing when they join the study and again as needed (at intervention sites). Additionally, some FSW participants will complete a one-time interview so that the investigators can learn more about their experiences with and views on HIV and STI services. The investigators will also be holding focus group discussions with queen mothers, clinicians, and others involved in study activities to understand their experiences with providing services through the study strategy.

Bwelela Easy Study

Treatment interruption in HIV care is one of the most enduring challenges to HIV programs globally and is associated with high rates of detectable virus in the blood and overall morbidity and mortality. Existing approaches to reengaging people living with HIV (PLH) have largely focused on return-to-care strategies but have not adequately addressed long-term retention after return. Effective strategies must integrate interventions that not only facilitate the return to care but also sustain engagement to prevent future lapses. Active follow-up of clients is a strategy that can promote both timely return to care and sustained long-term engagement. The Bwelela Easy study seeks to identify person centered strategies using combinations of navigation and community-based medication delivery to both facilitate return to HIV care as well as sustain long-term reengagement post-return among individuals with treatment lapses in Zambia. The study is designed to randomly assign participants to different approaches at two different points, with the second assignment based on their earlier response. This is to compare different step-by-step combinations of approaches for improving return to care and staying in care after treatment interruptions for people living with HIV. In the first stage (return) we will randomly assign individuals who are more than 30 days late for an appointment to routine phone outreach alone (control) versus Navigator+ Community Based medication groups. Among those who return to care, we will then re-randomly assign them in the second-stage (return and stay in care) to routine care and counseling (control), Navigator only, Navigator+ Community Based medication groups. This study advances a high priority research agenda to identify the most effective and efficient strategies for improving reengagement in care and will help maximize not only the public health impact of HIV programs but also advance strategies to improve care delivery for chronic diseases worldwide.

Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors

This study will collect white blood cells and plasma for research on how the immune system controls HIV infection. The immune system of a very small group of people with HIV, called non-progressors, has been able to control HIV for long periods without antiretroviral therapy. Some immune system-related genes important for this control have been identified in these patients. People living with HIV who are 18 years of age and older, documented or suspected long-term nonprogressors in generally good health may be eligible to screen for the study. Participants will undergo apheresis (a method for collecting larger quantities of certain blood components than can safely be collected through a simple blood draw) if venous access is adequate once yearly. Some may be asked to return every six months. * Automated apheresis - Blood is drawn through a needle placed in an arm vein and spun in a machine, separating the blood components. The white cells are extracted and the red cells, with or without plasma (liquid part of the blood), are re-infused into the donor through a needle in the other arm. An anticoagulant (medication to prevent blood from clotting) is usually added to the blood while in the machine to prevent it from clotting during processing. * Blood draw - a needle placed in an arm vein for large volume (approx 75ml) blood draw if veins considered inadequate for apheresis procedure. Some of the blood collected through apheresis may be stored for future studies of HIV disease and immune function and for HLA testing, a genetic test of markers of the immune system.

Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants

There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection. This study will use leukapheresis (drawing blood, separating out the white cells and returning the blood to the patient) to obtain blood cells from HIV-infected patients in either the acute or chronic stage of infection who are being treated with early highly active antiretroviral therapy (HAART). Leukapheresis is necessary to obtain enough cells to delineate the response of B cells to CD4+ T cell help, the CD8 factors associated with suppression of viral replication and normalization of immune function, and natural killer function relative to HIV disease. Study participants will be adult (older than 18 years) HIV primary or acutely affected patients (those with a history of exposure to HIV but not yet showing chronic symptoms of HIV disease) and HIV chronically infected patients (those infected with HIV for longer than 12 months or showing other symptoms of HIV disease) who are not receiving HAART at the beginning of the study. The study seeks to enroll 30 primary and 30 chronic patients. Pregnant women will not be enrolled in the study; women who become pregnant will be dropped from the study. Leukapheresis will be performed on each patient before HAART therapy begins and then three times a year. Each session will take between 1 and 3 hours. This longitudinal study will enable researchers to examine the function of certain B cells, natural killer cells, and CD8+ T cells in people who do not have chronic HIV disease and in those who do have the disease and are treated with HAART. ...

Community Health Worker Optimization of Antihypertensive Care in HIV

To adapt and assess the implementation and preliminary effectiveness of an integrated COBRA and CHAMP multi-component community health worker-delivered hypertension intervention in improving blood pressure control among PLWH in northern Tanzania.

Evaluating the Healthy Families PrEP Program for Women at Risk for HIV

Study investigators developed and piloted a counselling intervention, Healthy Families-PrEP, that supports women to use HIV prevention strategies while trying for and during pregnancy. They will now adapt the intervention to community clinics and postpartum women and test the intervention. The goal is to reduce HIV incidence among women and children.

Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults With Cancer

Background: \- There are very few documents to help young adults living with advanced cancer discuss their concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young adults to explain what kind of care they would want if they became unable to communicate or make medical decisions on their own. Researchers want to study if this document is helpful. Objective: \- To study if Voicing My CHOiCES(TM) can reduce anxiety, improve sense of support, and improve communication about advanced care planning. Eligibility: \- Adults 18 to 39 years old being treated for cancer. Design: * Participants will answer questions about their age, sex, employment, religion, health, and marital status. They will also complete several brief questionnaires: 1. General Anxiety Short Form 2. Peace, Equanimity and Acceptance in the Cancer Experience 3. Functional Assessment of Social Support 4. Quality of Communication 5. Prior Communication about Advanced Care Planning * Then a health care professional will introduce Voicing My CHOiCES . Participants will review the document and comment on parts they find relevant. They will also say if any important items are missing. Participants will complete 3 pages of the document with the assistance of a health care provider. They will be asked for positive and negative observations. * The second stage of the study will take place about 1 month later. Participants will repeat the brief questionnaires listed above. They will be asked if they shared any of the preferences they described when completing the 3 pages of Voicing My CHOiCES during visit 1 with a family member, friend, or health care provider. Research staff will ask the participant for permission to contact the people they spoke with in order to learn whether their conversations about the document were helpful. They will ask for feedback on how to make Voicing My CHOiCES more helpful.