This study compares different screening approaches to detect abnormal cell growth on the cervix that could be an early sign of cervical cancer. The lesions are caused by an infection of human papillomavirus, also called HPV. Using new methods to detect HPV may help doctors find ways to improve cervical cancer screening for women living with human immunodeficiency virus (HIV) in the Dominican Republic and in other countries.

OUTLINE:

Participants participate in three annual interviews and clinical exams that last approximately 2 hours. Study participants provide blood, urine, and swab samples from the cervix, anus, and vagina and receive a pelvic exam. Any positive results are followed up in the study clinic.

Inclusion Criteria:

• Women ages 25 - 49 years old will be eligible to participate in the study
• Women living with HIV who have an intact cervix
• Intent to reside in the Santo Domingo area
• Ability to attend routine study visits at IDCP for at least 24 months during the study. If women report that they anticipate relocating in the subsequent 24 months or anticipate difficulty attending study visits they will not be eligible
• Ability to understand the study timeline and procedures and the willingness to complete the informed consent process are also inclusion criteria

Exclusion Criteria:

• Women with a prior diagnosis of cervical cancer or a history of treatment for cervical precancerous lesions (CIN2+) will be excluded
• Women with significant physical, mental, or social conditions that would limit participation with study procedures will not be eligible for the study
• Women who are pregnant or report an intent to become pregnant in the subsequent 3 months will not be eligible for the study
• Women who have no history of vaginal sexual exposure will not be eligible for the study

After publication of original data, data and specimens may be shared upon request with other investigators at academic or nonprofit institutions in a limited data set, as defined under HIPAA. The final dataset and specimens will be stripped of identifiers prior to release for sharing.

One month after publication of the final report in manuscript form to a peer-reviewed journal.

Investigators requesting access to data and specimens must sign a data-sharing agreement that provides for: (1) a commitment to using the data or specimens only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) not sharing the data or specimens with third parties. We reserve the right to limit data provided to outside investigators. We will not share data if we believe there is a possibility of deductive disclosure of subjects with unusual characteristics.