Brief Title
Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women
Official Title
Safety and Validity Evaluation for Cervical Cancer Screening and Treatment Techniques Among HIV-infected Women
Brief Summary
The clinical trial is part of a larger study to evaluate the safety and efficacy of screening
techniques for cervical cancer among HIV-infected women. The investigators randomized women
to undergo screening with Visual Inspection with Acetic Acid (VIA) or Visual Inspection with
Lugol's Iodine (VILI), along with a colposcopy. All outcome and treatment decisions were
based on the colposcopy exam done at the study visit. The investigators then compared
outcomes between the two groups to assess the test characteristics of both VIA and VILI.
Detailed Description
Cervical cancer and HIV are intersecting epidemics that both disproportionately affect
low-income women; the impact of the socioeconomic disparity and biologic synergy of these two
diseases is seen dramatically in Kenya, where cervical cancer is the most common cancer
killer. HIV-infected women are at increased risk for the development of cervical precancer
and cancer, develop more aggressive lesions and are affected at younger ages. Although
screening for and treatment of precancer has reduced the incidence of cervical cancer to
close to zero in resource-rich countries, strategies are costly and not available in most
resource-limited countries. Novel testing and treatment methods that can be carried out in
low-resource settings are urgently needed to prevent cervical cancer in these settings,
especially among HIV-infected women. Using a cross-sectional study design, the investigators
tested two potentially low-cost and effective cervical cancer screening methods: visual
inspection with acetic acid (VIA) and protein biomarkers expressed in the presence of
cervical dysplasia, neither of which have been well-studied in HIV-infected women.
Investigators also randomized a small subset of women to undergo VIA compared to Visual
Inspection with Lugol's Iodine (VILI) to compare the test characteristics of these two
screening exams. In addition, remarkably little is known about the potential impact of the
presence, diagnosis and treatment of human papillomavirus-related dysplasia on HIV genital
shedding, a major risk factor for HIV transmission. To explore the impact of the presence,
diagnosis and treatment of human papillomavirus-related cervical dysplasia on HIV-1 in
genital secretions, investigators compared the levels of HIV-1 RNA found in the
cervicovaginal secretions of women with no evidence of cervical dysplasia to levels in women
with high-grade cervical dysplasia. They also compared the levels of HIV-1 RNA prior to and
after cervical biopsy as well as up to 14 weeks after standard treatment for cervical
dysplasia using loop electrosurgical excision procedure (LEEP). Results from this study will
inform the prioritization and design of safe, effective and low-cost cervical cancer
screening and prevention programs for HIV-infected
Study Type
Interventional
Primary Outcome
Test Positivity Rate
Secondary Outcome
Sensitivity
Condition
Cervical Intraepithelial Neoplasia
Intervention
Visual Inspection with Acetic Acid
Study Arms / Comparison Groups
Visual Inspection with Lugol's Iodine
Description: Participants underwent colposcopic exam, followed by Visual Inspection with Lugol's Iodine (VILI) by a second, blinded clinician (the order of exams was reversed to eliminate potential interference with exam results due to iodine staining). Biopsy was done after the VILI.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
654
Start Date
October 2011
Completion Date
October 2012
Primary Completion Date
June 2012
Eligibility Criteria
Inclusion Criteria:
- 23-59
- Intact cervix/uterus
- no evidence of infection
- ability to provide informed consent
Exclusion Criteria:
- pregnant
Gender
Female
Ages
23 Years - 59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
Kenya
Location Countries
Kenya
Administrative Informations
NCT ID
NCT02237326
Organization ID
SSC 1825
Secondary IDs
10-00197
Responsible Party
Sponsor
Study Sponsor
University of California, San Francisco
Collaborators
Kenya Medical Research Institute
Study Sponsor
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Verification Date
September 2014