Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Squamous Intraepithelial Lesions of the Cervix

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Cervical Intraepithelial Neoplasia

Participant request physician assessment for Digital anal rectal exam, Anal cytology, Anal HPV test and High resolution anoscopy for every 6 months within 12 months period

Participant request physician assessment for Digital anal rectal exam, Anal cytology, Anal HPV test for every 6 months within 12 months period

Participant request physician assessment for Digital anal rectal exam, Anal cytology and High resolution anoscopy for every 6 months within 12 months period

Participant request physician assessment for Digital anal rectal exam, Anal cytology for every 6 months within 12 months period

Participant request physician assessment for Digital anal rectal exam, Anal HPV test and High resolution anoscopy for every 6 months within 12 months period

Participant request physician assessment for Digital anal rectal exam and Anal HPV test for every 6 months within 12 months period

Participant request physician assessment for Digital anal rectal exam and High resolution anoscopy for every 6 months within 12 months period

Participant request physician assessment for Digital anal rectal exam for every 6 months within 12 months period

Participant request Self-sampling collection for Anal cytology and Anal HPV test for every 6 months within 12 months period

Participant request Self-sampling collection for Anal cytology for every 6 months within 12 months period

Participant request Self-sampling collection for Anal HPV test for every 6 months within 12 months period

Participant request Self-sampling collection for Anal cytology and Anal HPV only at month 12

The goal of the optimization phase of MOST is to identify the most promising combination of experimental components in changing an outcome given a set of environmental constraints. Looking at effectiveness, efficiency, economy, and scalability criteria, we will focus on the proportion of anal HSIL identified (effectiveness), unit cost (efficiency and economy), and accumulating cost to the client over a 12-month period (economy). Meeting these criteria will likely imply scalability. The most appropriate anal HSIL screening algorithm would ideally be one which could

- identify anal HSIL in at least 20% of HIV-positive MSM and 10% of HIV-negative MSM at baseline and

OPTIMIZATION PHASE

Nittaya Phanuphak, MD,PhD.

Siriporn Nonenoy, RN.MPH.

Nittaya Phanuphak, MD.,Ph.D.

Napasawan Chinlaertworasiri

This the propose to use the Multiphase Optimization Strategy Trial (MOST) design to identify an anal HSIL screening algorithm which is most suitable in terms of effectiveness, efficiency, and economy. Specifically, The Investigators will use a factorial design as the main strategy in the MOST, as this allows the evaluation of multiple intervention components that are candidates for ultimate inclusion in the algorithm. The Investigators will then implement the most suitable anal HSIL screening algorithm in the clinic, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to guide its design, implementation, and evaluation. An interrupted time series will be used to compare anal HSIL screening uptake among men who have sex with men clients in the clinic, prior to and after the implementation of the new anal HSIL screening algorithm, and mixed-methods approaches will be used to evaluate components of the RE-AIM framework.

I. PREPARATION PHASE Purpose To lay groundwork for optimization of anal high-grade squamous intraepithelial lesion screening algorithm for MSM, and identify which test and component(s) should be included in the anal HSIL screening algorithm.

II. OPTIMIZATION PHASE Purpose To form an anal high-grade squamous intraepithelial lesion screening algorithm that meets the optimization criteria.

III. EVALUATION PHASE Purpose To establish whether the optimized anal high-grade squamous intraepithelial lesion screening algorithm has a statistically significant effect on service uptake among MSM compared to the standard of care.

Anal HSIL Screening Algorithm

Optimizing an Anal High-grade Squamous Intraepithelial Lesion Screening Algorithm for Thai Men Who Have Sex With Men and Transgender Women

identify anal HSIL in at least 20% of HIV-positive MSM/TGW and 10% of HIV-negative MSM/TGW within visit schedule.

Evaluate anal HSIL screening method uptake among MSM/TGW clients in the clinic compare to the implementation of the new anal HSIL screening method algorithm.

National Institutes of Health (NIH)

amfAR, The Foundation for AIDS Research

Institute of HIV Research and Innovation Foundation, Thailand

Infections

Immune System Diseases

Symptoms and General Pathology

Digestive System Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Sexually Transmitted Diseases

Virus Diseases

Anus Neoplasms

Syndrome

Communicable Diseases

Blood-Borne Infections

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

RNA Virus Infections

Slow Virus Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Anti-Infective Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Antineoplastic Agents

Micronutrients

Coagulants

Vitamins

Acetic Acid

Retinol acetate

Iodine

Lugol's solution

Cadexomer iodine

Participants will undergo a perianal and digital anorectal exam, a high resolution anoscopy, and cervical and anal swabs to determine the best method to identify women at high risk for anal cancer.

The physician will inspect the outside of the anus and use a gloved finger to feel the anus for any masses.

Perianal and Digital Anorectal Exam

A speculum will be inserted into the vagina to visualize the cervix. The sample for research tests will be collected with one ThinPrep cytobroom inserted into the cervix. Collection will be same for the sample to be paced in the RNA storage solution for future biomarker studies.

Cervical Swabs

The anal cytology specimen will be collected by inserting a saline moistened cotton-tipped swab into the anus, rotating it clock-wise for 20 seconds, and placed in SurePath. The first twenty participants will have anal cells collected in two different ways for validation/optimization: 1) saline moistened Dacron swab placed directly in ThinPrep medium and 2) Medscand Cytobrush Plus, a special brush, placed directly into ThinPrep medium. After validation/optimization is complete for up to 20 participants, the best collection method will be selected and will be used for all future enrolled participants.

Anal Swabs

High Resolution Anoscopy is a procedure that allows for examination and evaluation of the anal canal. Using a small thin round tube called an anoscope, the anal canal is examined with a high resolution magnifying instrument called a colposcope. Application of a mild acidic liquid (acetic acid or diluted vinegar) or a brown iodine-based solution (Lugol's) onto the anal canal facilitates evaluation of abnormal tissue such as anal dysplasia. If abnormal staining is seen using acetic acid (dense white lesion) or Lugol's solution (bright yellow lesion) a biopsy of that area will be obtained.

High Resolution Anoscopy (HRA)

Lisa Flowers, MD

The purpose of this research is to study different strategies to identify women at highest risk for anal cancer. Primarily, investigators want to study a risk assessment called the Anal Cancer Risk Index; it gives women an overall number score based on risk factors that they may have for anal cancer, such as age, number of sexual partners, or smoking. Investigators seek to understand whether women with higher Anal Cancer Risk Index scores are more likely to have abnormal results on anal pap smears, HPV tests, or anal biopsies. The study team will collect swabs of the cervix and the anus to study different laboratory tests that could identify women at highest risk of cervical and anal cancer. These laboratory tests include an anal pap smear, tests for markers of disease and tests that detect the HPV types most likely to cause cancer. The study team would like to see which of these laboratory tests do the best job at predicting precancerous lesions in the anus and are better indicators of risk for cancer. After collecting these swabs, women will have a procedure called high resolution anoscopy where investigators look closely at the anus and biopsy any suspicious areas. Finally, the study team will look for HPV proteins and changes that HPV can make in cells to see if these tests predict anal lesions.

Investigators seek to study different strategies to identify women at highest risk for anal cancer. Primarily, investigators want to study a risk assessment called the Anal Cancer Risk Index; it gives women an overall number score based on risk factors that they may have for anal cancer, such as age, number of sexual partners, or smoking. The study team would like to determine whether women with higher Anal Cancer Risk Index scores are more likely to have abnormal results on anal pap smears, HPV tests, or anal biopsies. Next, the team will collect a swab of the cervix and swabs of the anus to study different laboratory tests that could identify women at highest risk of anal cancer: these tests include an anal pap smear and tests that detect HPV types most likely to cause cancer. Investigators would like to see which of these laboratory tests do the best job at predicting precancerous lesions in the anus. After collecting these swabs, women will have a procedure called high resolution anoscopy where investigators will look closely at the anus and biopsy any suspicious areas. Finally, the study team will look for HPV proteins and changes that HPV can make in cells to see if these tests predict anal lesions. The HPV protein is called E6 and E7 and the cell change test is called CADM1/MAL/miR-124-2. Investigators will measure E6/E7 and CADM1/MAL/miR-124-2 in cervical and anal samples to see if women positive for this marker are more likely to have abnormal results on anal pap smears or anal biopsies.

New Strategies to Assess Anal Cancer Risk In Women

Assessment of anal cancer screening, risk factors for anal cancer, and its association with HPV using AIDS Risk Reduction Model Framework, that is a three stage model, including knowledge as a prerequisite to recognize risk and to take action to change or reduce the risk. Knowledge was measured with the Knowledge of Anal cancer and HPV, that is a 44-item knowledge multiple choice survey adapted from the Hild-Mosely, et al study, substituting "cervical" with "anal". A percentage score of correct responses was calculated and range from o to 100, being 100 the maximum correct result.

Assessment of high risk human papilloma virus in the anal cytology.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anal HSIL Screening Algorithm	NCT05531799	Anal High-grade...	OPTIMIZATION PH...	30 Years -	Institute of HIV Research and Innovation Foundation, Thailand
New Strategies to Assess Anal Cancer Risk In Women	NCT02873741	Human Immunodef... Human Papilloma...	Perianal and Di... Cervical Swabs Anal Swabs High Resolution...	18 Years -	Emory University
Anal HSIL Screening Algorithm	NCT05531799	Anal High-grade...	OPTIMIZATION PH...	30 Years -	Institute of HIV Research and Innovation Foundation, Thailand

Spots Global Cancer Trial Database for high resolution anoscopy (hra)