Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women
Condition: Cervical Intraepithelial Neoplasia; Cervical Cancer; HIV
MeSH terms: Uterine Cervical Neoplasms; Neoplasms; Uterine Cervical Dysplasia
Study type: Interventional

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
    

Intervention name(s): Visual Inspection with Acetic Acid; Visual Inspection with Lugol's Iodine
Intervention type(s): Procedure; Procedure
Intervention description(s): Visual Inspection with Acetic Acid is the application of acetic acid to a cervix, followed by examination with a light source. It is not a new drug or device, and has been used in resource-limited settings for several decades. The purpose of this trial is to compare the two screening techniques, which had not been done previously.; Visual Inspection with Lugol's Iodine is the application of lugol's iodine to a woman's cervix, followed by examination with a light source with the goal of detecting precancerous lesions. Like Visual Inspection with Acetic Acid, it is not a new drug or device.
Intervention MeSH terms: Acetic Acid; Retinol acetate; Lugol's solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Diagnostic
Keywords: Visual Inspection with Acetic Acid; Visual Inspection with Lugol's Iodine; Cervical Intraepithelial neoplasia; Cervical Cancer Screening; HIV infected women