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The Women's Interagency HIV Study (WIHS) was established in August 1993 to investigate the impact and progression of HIV disease in women. The WIHS enrolls both HIV-positive and HIV-negative women. The core portion of the study includes a detailed and structured interview, physical and gynecologic examination, and laboratory testing. The WIHS participants are also asked to enroll in various sub-studies, such as cardiovascular, metabolic, musculoskeletal, and neurocognition. New proposals for WIHS sub-studies are submitted for approval by various scientific investigators from around the world.
The WIHS is funded primarily by the National Institute of Allergy and Infectious Diseases (NIAID), with additional co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Cancer Institute (NCI), the National Institute on Drug Abuse (NIDA), and the National Institute on Mental Health (NIMH). Targeted supplemental funding for specific projects is also provided by the National Institute of Dental and Craniofacial Research (NIDCR), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Deafness and other Communication Disorders (NIDCD), and the NIH Office of Research on Women's Health (ORWH). WIHS data collection is also supported by UL1-TR000004 (UCSF CTSA) and UL1-TR000454 (Atlanta CTSA).
WIHS clinical sites are located in and around 10 cities in the United States. Each is headed by one or more Principal Investigators.
In addition, the WIHS Data Management and Analysis Center (Stephen Gange, Elizabeth Topper) is located in Baltimore, MD.
Each consortium is affiliated with local research institutes to see study participants. Each also has its own Community Advisory Board. [1]
WIHS was funded in five cycles:
Initial enrollment into the WIHS occurred between October 1994 and November 1995. The total initial enrollment for the WIHS was 2,056 HIV-positive women and 569 HIV-negative women. [2] Since WIHS recruited its initial population, several new trends developed as the HIV epidemic evolved, all of which argued for an expansion of the WIHS cohort. First, despite careful follow-up of the cohort, the inevitable course of illness and time had led to attrition and death. Additionally, increased sample sizes were needed because the effectiveness and consequences of Highly Active Antiretroviral Therapy (HAART) added new strata to many key analyses, and decreased the incidence of clinical outcomes. And finally, as the original cohort continued to age, it became less able to support studies of risk behaviors, sexually transmitted diseases, and reproductive function. Thus, WIHS funding was augmented in 2001 to empower the study to efficiently and precisely meet the study's specific aims through the recruitment of additional women. Total enrollment in 2001-02 (WIHS visits 15 and 16) was 738 HIV-positive and 403 HIV-negative participants. [3] Beginning in January 2011, the WIHS opened enrollment again, in order to replace those women who had died during WIHS III and WIHS IV. Total enrollment in 2011-12 (WIHS visits 35-37) was 276 HIV-positive and 95 HIV-negative participants. In the summer of 2013, the WIHS began enrolling approximately 800 women from the WIHS Southern sites (Atlanta, GA; Chapel Hill, NC; Miami, FL; Birmingham, AL; Jackson, MS). All potential study participants underwent an initial screening to determine study eligibility. If the woman was willing to take part in the study and gave informed consent, she participated in an in-depth interview, physical exam, and specimen collection. In 2019, the WIHS merged with the Multicenter AIDS Cohort Study (MACS), to form the MACS/WIHS Combined Cohort Study (MWCCS).
The Duesberg hypothesis is the claim that AIDS is not caused by HIV, but instead that AIDS is caused by noninfectious factors such as recreational and pharmaceutical drug use and that HIV is merely a harmless passenger virus. The hypothesis was popularized by Peter Duesberg, a professor of biology at University of California, Berkeley, from whom the hypothesis gets its name. The scientific consensus is that the Duesberg hypothesis is incorrect and that HIV is the cause of AIDS. The most prominent supporters of the hypothesis are Duesberg himself, biochemist and vitamin proponent David Rasnick, and journalist Celia Farber. The scientific community generally contends that Duesberg's arguments in favor of the hypothesis are the result of cherry-picking predominantly outdated scientific data and selectively ignoring evidence that demonstrates HIV's role in causing AIDS.
The management of HIV/AIDS normally includes the use of multiple antiretroviral drugs as a strategy to control HIV infection. There are several classes of antiretroviral agents that act on different stages of the HIV life-cycle. The use of multiple drugs that act on different viral targets is known as highly active antiretroviral therapy (HAART). HAART decreases the patient's total burden of HIV, maintains function of the immune system, and prevents opportunistic infections that often lead to death. HAART also prevents the transmission of HIV between serodiscordant same-sex and opposite-sex partners so long as the HIV-positive partner maintains an undetectable viral load.
The spread of HIV/AIDS has affected millions of people worldwide; AIDS is considered a pandemic. The World Health Organization (WHO) estimated that in 2016 there were 36.7 million people worldwide living with HIV/AIDS, with 1.8 million new HIV infections per year and 1 million deaths due to AIDS. Misconceptions about HIV and AIDS arise from several different sources, from simple ignorance and misunderstandings about scientific knowledge regarding HIV infections and the cause of AIDS to misinformation propagated by individuals and groups with ideological stances that deny a causative relationship between HIV infection and the development of AIDS. Below is a list and explanations of some common misconceptions and their rebuttals.
The Women's Health Initiative (WHI) was a series of clinical studies initiated by the U.S. National Institutes of Health (NIH) in 1991, to address major health issues causing morbidity and mortality in postmenopausal women. It consisted of three clinical trials (CT) and an observational study (OS). In particular, randomized controlled trials were designed and funded that addressed cardiovascular disease, cancer, and osteoporosis.
Following infection with HIV-1, the rate of clinical disease progression varies between individuals. Factors such as host susceptibility, genetics and immune function, health care and co-infections as well as viral genetic variability may affect the rate of progression to the point of needing to take medication in order not to develop AIDS.
The AIDS Clinical Trials Group network (ACTG) is one of the largest HIV clinical trials organizations in the world, playing a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV and AIDS in the United States and the developing world. The ACTG is composed of, and directed by, leading clinical scientists in HIV/AIDS therapeutic research. The ACTG is funded by the Department of Health and Human Services, National Institutes of Health through the National Institute of Allergy and Infectious Diseases.
The HIV Vaccine Trials Network (HVTN) is a non-profit organization which connects physicians and scientists with activists and community educators for the purpose of conducting clinical trials seeking a safe and effective HIV vaccine. Collaboratively, researchers and laypeople review potential vaccines for safety, immune response, and efficacy. The HVTN is a network for testing vaccines, and while its members may also work in vaccine development for other entities, the mission of the HVTN does not include vaccine design.
The Multicenter AIDS Cohort Study (MACS) is an ongoing cohort study involving over 6,000 men, including both those infected with HIV, as well as HIV-negative men. The MACS has four main sites: Baltimore, Pittsburgh, Los Angeles, and Chicago. The Los Angeles component of the MACS is called the Los Angeles Mens Study or LAMS. LAMS affiliated with UCLA and is supervised by Dr Roger Detels, MD & John Oishi.
The United States Military HIV Research Program was initiated by the United States Congress in 1986, in reaction to the threat of lost effectiveness of U.S./Allied troops due to HIV infection. The mission of MHRP is to develop an HIV-1 vaccine, provide prevention, care, and treatment, and conduct meaningful HIV/AIDS research for the global community through the President's Emergency Plan for AIDS Relief (PEPFAR). It is centered at the Walter Reed Army Institute of Research (WRAIR), and has established five international research sites in Africa and Asia. MHRP also partners with the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Thailand. MHRP works closely with The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF), most notably in the development of the RV144 HIV vaccine in Thailand. MHRP is the largest research program supported by the HJF.
AntiViral-HyperActivation Limiting Therapeutics (AV-HALTs) are an investigational class of antiretroviral drugs used to treat Human Immunodeficiency Virus (HIV) infection. Unlike other antiretroviral agents given to reduce viral replication, AV-HALTs are single or combination drugs designed to reduce the rate of viral replication while, at the same time, also directly reducing the state of immune system hyperactivation now believed to drive the loss of CD4+ T helper cells leading to disease progression and Acquired Immunodeficiency Syndrome (AIDS).
The STEP Study was a Phase IIb clinical trial intended to study the efficacy of an experimental HIV vaccine based on a human adenovirus 5 (HAdV-5) vector. The study was conducted in North and South America, the Caribbean, and Australia. A related study using the same experimental vaccine was conducted simultaneously in South Africa. These trials were co-sponsored by Merck, the HIV Vaccine Trials Network (HVTN), and the National Institute of Allergy and Infectious Diseases (NIAID), and had an Oversight Committee consisting of representatives from these three organizations. In South Africa the trial was overseen by the South African AIDS Vaccine Initiative.
Vaccine-induced seropositivity (VISP) is the phenomenon wherein a person who has received a vaccine against a disease would thereafter give a positive or reactive test result for having that disease when tested for it, despite not actually having the disease. This happens because many vaccines encourage the body to produce antibodies against a particular disease, and blood tests often determine whether a person has those antibodies, regardless of whether they came from the infection or just a vaccination.
HIV/AIDS research includes all medical research that attempts to prevent, treat, or cure HIV/AIDS, as well as fundamental research about the nature of HIV as an infectious agent and AIDS as the disease caused by HIV.
David DuPuy Celentano is a noted epidemiologist and professor who has contributed significantly to the promotion of research on HIV/AIDS and other sexually transmitted infections (STIs). He is the Charles Armstrong chair of the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. He holds joint appointments with the school’s departments of Health Policy and Management, Health Behavior and Society, and International Health, and the Johns Hopkins University School of Medicine’s Division of Infectious Diseases.
Pontiano Kaleebu is a Ugandan physician, clinical immunologist, HIV/AIDS researcher, academic and medical administrator, who is the executive director of the Uganda Virus Research Institute.
Adaora Alise Adimora was an American doctor and academic. She was the Sarah Graham Kenan Distinguished Professor of Medicine and professor of epidemiology at the University of North Carolina School of Medicine. Her research centered on the transmission of HIV, as well as other sexually transmitted infections (STIs), among minority populations. Her work highlighted the importance of social determinants of HIV transmission and the need for structural interventions to reduce risk. In 2019, she became an elected member of the National Academy of Medicine in recognition of her contributions.
Gypsyamber D'Souza is an American epidemiologist. She is a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health. D'Souza researches infectious diseases, cancer prevention, and translational epidemiology. She is a principal investigator of the Multicenter AIDS Cohort Study / Women's Interagency HIV Study Combined Cohort Study (Mwccs.org).
Monica Gandhi is an American physician and professor. She teaches medicine at the University of California, San Francisco (UCSF) and is director of the UCSF Gladstone Center for AIDS Research and the medical director of the San Francisco General Hospital HIV Clinic, Ward 86. Her research considers HIV prevalence in women, as well as HIV treatment and prevention. She has been noted as a critic of some aspects of the COVID-19 lockdowns in the US.
Suzanne Maman is a social scientist who is trained in public health and serving as a professor in the Department of Human Behavior at the University of North Carolina (UNC) and an associate dean for global health at the University's Gillings School. Maman also serves as UNC faculty director at the Duke-UNC Rotary Peace Center. Her specific research interests concern HIV/AIDS among women.
Stephen Gange is an American statistician, epidemiologist, and academic administrator of Johns Hopkins University. He is a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health and has a joint appointment in the Johns Hopkins School of Medicine.
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