Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000797
Status:
UNKNOWN
Last Update Posted:
2019-07-18
First Post:
1999-11-02
Brief Title:
Womens Interagency HIV Study WIHS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Womens Interagency HIV Study WIHS
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Womens 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
Detailed Description:
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 eg 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 obstetricgynecological 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
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 eg 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 obstetricgynecological 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None