Suspended

Women's Interagency HIV Study (WIHS)

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

HIV Infections

From 30 to 55 Years
+12 Eligibility Criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 1994

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: July 18, 2019
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 1994Actual date on which the first participant was enrolled.

The Women's Interagency HIV Study (WIHS), a multicenter, prospective study, was established in August 1993 to carry out comprehensive investigations of the impact of HIV infection and its clinical, laboratory, and psychosocial effects in women. The purpose of this study is to collect and evaluate these data from HIV infected and at-risk women to better understand and provide support for women whom are currently HIV infected or who are at risk for HIV infection. HIV in women is increasing worldwide, with women comprising approximately 14% of the total adult and adolescent AIDS cases, the highest proportion yet reported. The impact of AIDS is particularly severe in minority populations; among women, African Americans, and Hispanics combined now represent the majority of AIDS cases (76%) in the United States. AIDS is now the third leading cause of death for women aged 25 to 44 (after cancer and cardiovascular disease) and is the leading cause of death of African American women in this age group. Studies of HIV and AIDS in women can play a unique role in testing new biological or socio-behavioral hypotheses at the population level and in linking basic science findings and laboratory methods to well-defined populations and communities. Research areas that are likely to draw more attention in the near future will include the study of pathogenicity and transmissibility of different HIV subtypes or recombinant forms and their interaction with variably susceptible individuals; the change in the scope of HIV natural history studies in the era of combination antiretroviral therapy; and the contribution of such studies to the design of a wide spectrum of prevention modalities (e.g., prevention of HIV and prevention of opportunistic infections). In addition, studies of natural history of HIV-related malignancies and active surveillance of malignancies in HIV infected and high-risk uninfected women may lead to new screening and prevention modalities in high-risk populations of women. Participants will have study visits every 6 months. Questionnaires regarding sexual behavior, health care utilization, medical and obstetric/gynecological history, psychosocial factors, and sociodemographics will be completed by participants. Physical, gynecological, and lipodystrophy examinations will also be conducted at each visit, and current medication regimen will be noted. Blood and other bodily fluid samples will be collected and registered in both local and national repositories of the WIHS in conjunction with NIAID.

Official TitleWomen's Interagency HIV Study (WIHS) 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: July 18, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
4982 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

What happens to patients' samples
Samples from participants are kept, and they can be used to extract DNA in the future. These might include things like blood or frozen tissue. This allows researchers to study genetics and how DNA may relate to the disease.

Other Options for Sample Use
Samples Without DNA
: Samples are kept but not usable for DNA analysis.

None Retained
: No samples are kept after the study.

How participants are selected
Participants are chosen using a random method, so everyone has a known and fair chance of being selected. This approach helps ensure the results reflect the broader population.
Another way to select participants is through a non-probability sample, where participants are selected without randomization, often based on availability or willingness to take part.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 30 to 55 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria
8 inclusion criteria required to participate
HIV infection

Willing to be retested for HIV infection for this study unless hardcopy documentation of a positive result (HIV ELISA test and a confirmatory Western blot) is available

Either have never taken HIV antiretroviral medications or have a documented start date of highly active antiretroviral therapy (HAART) after January 1, 2008

If have taken HAART, have documentation of pre-HAART CD4 counts and HIV RNA quantification


4 exclusion criteria prevent from participating
Perinatally acquired HIV

Enrolled in the WIHS through another site

HAART started before January 1, 2008, except during pregnancy

Participant plans to move out of the area within 12 months
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 5 locations
Suspended
University of California - San FranciscoSan Francisco, United StatesSee the location
Suspended
Georgetown Univ Med CtrWashington, United States
Suspended
Chicago ConsortiumChicago, United States
Suspended
Montefiore Medical CenterBronx, United States

Suspended5 Study Centers
Women's Interagency HIV Study (WIHS) | PatLynk