The Effectiveness of High Resolution Microendoscopy for People Living With HIV

ID#: NCT04563754

Age: 18 years - 66+

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: July 01, 2019

End Date: November 01, 2023

Contact Information:
Sharmilla Anandasabapathy, MD
Elizabeth Y Chiao, MD
Summary: The investigators have developed a portable, battery-operated, mobile high-resolution microendoscope (mHRME) that provides subcellular images of the anal epithelium, delineating the cellular and morphologic changes associated with neoplasia. The investigators' central hypothesis is that this 'optical' approach will increase the efficiency, clinical impact, and cost-effectiveness of the current standard of HRA (High resolution anoscopy)-guided biopsy thus facilitating usage by less-experienced clinicians in community-based or low-resource settings. To validate this, the investigators will conduct a study to determine the efficiency and diagnostic characteristics of the mHRME 'optical biopsy' approach versus the current standard of HRA-based tissue biopsy. Successful results will allow for improved efficacy and resource utilization for cancer screening in people living with HIV for anal cancer and other epithelial cancers including the cervix, oral cavity, bladder, and GI tract.

Inclusion Criteria:

- Consentable patients with documented HIV disease

- Either: 1) previously documented HSIL or 2) abnormal anal cytology within the past 2 years

- Ages 18 years and older

- Seen at the Baylor-affiliated Thomas Street Clinic (TSC), Mount Sinai Hospital and affiliated clinics

Exclusion Criteria:

- Patients with a platelet count less than 75,000 cells/mm3 and an absolute neutrophil count less than 1000 cells/mm3

- A known permanent or irreversible bleeding disorder that, in the opinion of the principal investigator (PI), would contraindicate any biopsy of the anal canal; current or prior history of anal cancer

- Allergy or prior reaction to the fluorescent contrast agent proflavine

- Patients who are unable to give informed consent.

- Women who are pregnant.