Phase
Condition
Cervical Intraepithelial Neoplasia
Genitourinary Cancer
Aids And Aids Related Infections
Treatment
High Resolution Anoscopy
Biopsy
Imaging Technique
Clinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documentation of HIV-1 infection by means of any one of the following:
Documentation of HIV diagnosis in the medical record by a licensed health careprovider
Documentation of receipt of antiretroviral therapy (ART) by a licensed healthcare provider (Documentation may be a record of an ART prescription in theparticipant's medical record, a written prescription in the name of theparticipant for ART, or pill bottles for ART with a label showing theparticipant's name. Receipt of at least two agents is required; each componentagent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis (PrEP)regimen alone [e.g., Truvada], which is exclusionary);
HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assaydemonstrating > 1000 RNA copies/mL
Any locally licensed HIV screening antibody and/or HIV antibody/antigencombination assay confirmed by a second licensed HIV assay such as a HIV-1Western blot confirmation or HIV rapid multispot antibody differentiation assay
NOTE: A "licensed" assay refers to a United States (U.S.) Food and DrugAdministration (FDA)-approved assay or an assay approved by the relevant localhealth authority
Age 21 years or older. Cervical HSIL/cancer screening does not usually begin until 20 years of age or older. Also, anal HSIL/cancer screening among high riskindividuals such as people living with HIV is recommended for those 25 years of ageor older. Children under the age of 18 are at low risk of developing cervical oranal HSIL/cancer and will not benefit from the kind of screening planned for thisstudy
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky score >= 70%)
Ability to understand and the willingness to sign a written informed consentdocument
Exclusion
Exclusion Criteria:
Participants who have undergone hysterectomy
History of anal cancer, penile, vulvar, vaginal, or cervical cancer
Potential participants who received prior treatment of anal, cervical, penile,vaginal, or vulvar lesions within 18 months of study enrollment
Inability in the opinion of the study investigator of the participant to comply withstudy requirements
Participants who are pregnant (a urine pregnancy test will be provided toparticipants aged 60 years or less) or within 2 months being post-partum
Study Design
Study Description
Connect with a study center
Condesa Specialized Clinic
Ciudad de México, Cdmx 06170
MexicoActive - Recruiting
Instituto Nacional de Cancerologia (INCan)
Ciudad de México, Cdmx 14080
MexicoSite Not Available
Condesa Iztapalapa Specialized Clinic
Ciudad de mexico, Cdmx 09730
MexicoActive - Recruiting
National Institute of Public Health
Santa María Ahuacatitlán, Cuernavaca, Morelos 62100
MexicoSite Not Available
University of Puerto Rico Comprehensive Cancer Center
San Juan, 00936-3027
Puerto RicoActive - Recruiting
University of California, San Francisco
San Francisco, California 94143
United StatesSite Not Available
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