Screening Test Accuracy of Gynocular™, HR-HPV Testing, VIA for Detection of Cervical Neoplastic Lesions, in Women Living With HIV
Screening Test Accuracy of Gynocular™, HR-HPV Testing, VIA for Detection of Cervical Neoplastic Lesions, in Women Living With HIV
Cervical cancer in HIV-positive women is largely preventable through regular screening. The
 World Health Organization (WHO) recommends cervical screening for HIV-positive women every
 three years. Currently the least costly method for screening and the most viable option for
 many countries is visual inspection after application of acetic acid (VIA). Alternative
 testing methods are HPV testing and assessment with a portable magnification device. The
 investigators plan to assess and compare the screening test accuracy of these screening tests
 in women living with HIV. All women will receive histopathology reference standard.
The simplest and least costly method for cervical cancer screening is visual inspection after
 application of acetic acid (VIA). However, the ability of this screening method to correctly
 identify precancerous lesions (sensitivity) and women free from these lesions (specificity)
 is limited. The investigators aim to identify alternative screening methods which maximize
 sensitivity and specificity, particularly in HIV-infected women in receiving care in Southern
 Africa. The investigators will evaluate the screening test accuracy of a new portable
 magnification device , the Gynocular™ with Swede score assessment, in women who are
 HIV-positive and eligible for cervical cancer screening. The investigators will assess the
 accuracy of the device when used as a stand alone test, as well as when used subsequent to
 positive VIA or HPV tests. The investigators will make comparisons with current screening
 practices (VIA alone), as well as, recommended screening practices (HPV testing). The
 investigators will enrol 450 HIV-positive women receiving care for HIV/AIDS at the Centre for
 Infectious Disease Research in Zambia, in Lusaka, Zambia. Consenting women will be screened
 with VIA, HPV testing and visual assessment with Gynocular™. All women undergo biopsy
 (reference standard) and receive treatment as indicated and in accordance with national
 guidelines.
Inclusion Criteria:

 1. HIV-infected women confirmed through medical records

 2. Women residing within Lusaka district and plans to stay in this area for the next 6
 months

 3. Women between 18 and 65 years of age (age bracket as per Zambian guidelines for
 cervical cancer screening)

 4. Able and willing to consent

 5. Willing to undergo a pelvic examination and cancer screening

 6. Has had sexual intercourse before

 7. Agrees to have follow-up appointment in 6 months

 Exclusion Criteria:

 1. Women with a history of cervical cancer or previous hysterectomy (where the cervix was
 also removed)

 2. Pregnant women or women who plan to get pregnant within the next 6 months

 3. Women who have been vaccinated against HR-HPV