None listed
Conditions
Interventions
TO BE ELIGIBLE, PARTICIPANTS MUST HAVE NO HISTORY OF CERVICAL, VAGINAL OR VULVAR CANCER
NO PRIOR CERVICAL CRYOTHERAPY, CERVICAL CONIZATION, OR HYSTERECTOMY
AND NO PRIOR RECEIPT OF HPV VACCINES.
THE SCREENING LABORATORY EVALUATIONS INCLUDE CD4 CELL COUNT, PLASMA HIV-1 RNA VIRAL LOAD, AND COMPLETE BLOOD COUNT. ALL PARTICIPANTS WILL UNDERGO A SPECULUM EX
Sponsors
El Instituto Nacional de Alergia y Enfermedades Infecciosas (NIAID) de los Estados Unidos,
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 4.1.1 HIV-1 INFECTION, DOCUMENTED BY ANY LICENSED RAPID HIV TEST OR HIV ENZYME OR CHEMILUMINESCENCE IMMUNOASSAY (E/CIA) TEST KIT AT ANY TIME PRIOR TO STUDY ENTRY AND CONFIRMED BY A LICENSED WESTERN BLOT OR A SECOND ANTIBODY TEST BY A METHOD OTHER THAN THE INITIAL RAPID HIV AND/OR E/CIA, OR BY HIV-1 ANTIGEN, PLASMA HIV-1 RNA VIRAL LOAD. NOTE: FOR SITES LOCATED IN COUNTRIES OTHER THAN THE UNITED STATES, THE TERM LICENSED REFERS TO A KIT THAT HAS BEEN CERTIFIED OR LICENSED BY AN OVERSIGHT BODY WITHIN THAT COUNTRY AND VALIDATED INTERNALLY. WORLD HEALTH ORGANIZATION (WHO) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) GUIDELINES MANDATE THAT CONFIRMATION OF THE INITIAL TEST RESULTS MUST USE A TEST THAT IS DIFFERENT FROM THE ONE USED FOR THE INITIAL ASSESSMENT. A REACTVE INITIAL RAPID TEST SHOULD BE CONFIRMED BY EITHER ANOTHER TYPE OF RAPID ASSAY OR AN E/C1A THAT IS BASED ON A DIFFERENT ANTIGEN PREPARATION AND/OR DIFFERENT TEST PRINCIPLE (e.g., INDIRECT VERSUS COMPETITIVE), OR A WESTERN BLOT OR A PLASMA HIV-1 RNA VIRAL LOAD.
Exclusion criteria
Exclusion criteria: 4.2.1 CURRENT PRIOR HISTORY OF CERVICAL, VAGINAL OR VULVAR CANCER. 4.2.2 PRIOR CERVICAL CRYOTHERAPY, LEEP, CERVICAL CONIZATION, OR TOTAL OR PARTIAL HYSTERECTOMY. 4.2.3 CERVICAL, VAGINAL OR VULVAR LESIONS THAT ARE SUSPICIOUS ON CLINICAL EXAM FOR CANCER. 4.2.4 VISUAL EVIDENCE OF BACTERIAL STIs OR SUSPICION OF PELVIC INFLAMMATORY DISEASE. NOTE: CERVICITIS OR SUSPECTED PELVIC INFLAMMATORY DISEASE MUST BE TREATED WITH APPROPRIATE ANTIBIOTICS AT LEAST 7 DAYS PRIOR TO ENTRY. 4.2.5 PRIOR VACCINATION WITH AN HPV VACCINE. 4.2.6.HEMOPHILIA 4.2.7 CURRENTLY ON COAGULATION THERAPY OTHER THAN ACETYLSAJICYLIC ACID. 4.2.8 SERIOUS ILLNESS REQUIRING SYSTEMIC TREATMENT AND/OR HOSPITALIZATION WITHIN 21 DAYS PRIOR TO STUDY ENTRY. 4.2.9 ACTIVE DRUG OR ALCOHOL USE OR DEPENDENCE OR ANY OTHER CONDITION THAT, IN THE OPINION OF THE SITE INVESTIGATOR, WOULD INTERFERE WITH THE PARTICIPANT´S ABILITY TO ADHERE TO STUDY REQUIREMENTS.
Countries
Botswana, Haiti, India, Malawi, Peru, South Africa, Zambia, Zimbabwe
Outcome results
None listed