Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men

HIV Infection Clinical Trial

Official title:

Investigating Human Papillomavirus (HPV) Infection and HPV-Associated Disease in Indian Men Who Have Sex With Men Who Are HIV-Positive

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04142398
• Other study ID #: AMC-094
• Secondary ID: NCI-2016-01347AM
• Status: Not yet recruiting
• Start date: April 30, 2025
• Est. completion date: December 31, 2029

Study information

• Verified date: February 2024
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research trial studies the incidence of human papilloma virus (HPV) infection and HPV-associated disease in screening Indian men who have sex with human immunodeficiency virus (HIV)-positive men. Gathering health information over time from Indian men who have sex with men (MSM) may help doctors determine how many HIV -positive MSM develop new HPV infections and how many HIV-positive MSM have HPV related disease.

Description:

PRIMARY OBJECTIVES: I. Determine the prevalence of HPV-associated premalignant lesions in the anus and penis in Indian HIV-seropositive men who have sex with men (MSM). SECONDARY OBJECTIVES: I. Describe risk factors for prevalent premalignant lesions in the anus and penis in Indian HIV-seropositive MSM. II. Describe the prevalence and incidence of penile and anal HPV infection in Indian HIV-seropositive MSM. OUTLINE: Participants receive a questionnaire and undergo a targeted physical and anal clinical exam at months 0, 6, and 12. Participants also undergo a penile skin cell and anal swab at months 0, 6, and 12 for cytology, HPV deoxyribonucleic acid (DNA), and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo high-resolution anoscopy (HRA) and penile clinical exam at month 12.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 246
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV positive, as documented by any licensed HIV test according to the Indian National acquired immune deficiency syndrome (AIDS) Control Organization (NACO) guidelines
• Participants report any sex with a man in the past 6 months
• Participants must speak Hindi, Marathi, or English
• Participants should not have any plans to move out of the area in the next 12 months and commit to attending two additional visits one at 6 months and one at 12 months

Exclusion Criteria:

• Active drug or alcohol use or dependence, or other impairment that, in the opinion of the site investigator, would interfere with adherence to study requirements
• Participants with impairments that, in the opinion of the site investigator, are temporary, will be asked to return another day for enrollment
• Inability to provide informed consent
• History of a sex change operation that would preclude collection of penile or scrotal specimens

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infection
• Human Papillomavirus Infection
• Human Papillomavirus-Related Carcinoma
• Infections
• Papillomavirus Infections

Intervention

Other:
• Cytology Specimen Collection Procedure
Undergo penile skin cell and anal swab collection

Procedure:
• High Resolution Anoscopy with Biopsy
Undergo HRA with biopsy

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Medical Examination
Undergo anal and penile clinical exam
• Physical Examination
Undergo targeted physical exam

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai
India	Udaan Trust	Mumbai
United States	UCSF Medical Center-Parnassus	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of HPV-associated high-grade anal intraepithelial neoplasia (HGAIN)	The proportion of men with HPV 6, 11, 16, and/or 18-associated HGAIN will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs.	Baseline
Primary	Prevalence of premalignant lesions of the penis	Will be calculated using proportions and exact 95% binomial CI.	Baseline
Primary	Prevalence and incidence of human papillomavirus (HPV)	Will be estimated for specific types, and for all types combined using the life table approach for incidence. Separate estimates will be made for each anatomical site. Risk factors for site-specific incident infection will be evaluated using regression models for survival events observed in discrete time (e.g. pooled logistic regression), incorporating behavioral and biological predictors measured at baseline, and over time at study visits. Risk factors that will be assessed include behavioral and medical history, CD4+ level, and HIV viral load.	Up to 12 months
Secondary	The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18).	The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18) will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs .	Baseline
Secondary	The proportion of men with premalignant lesions of the penis at baseline according to reported number of sex partners in the last 6 months	The proportion of men with premalignant lesions of the penis at baseline according to number of sex partners in the last 6 months will be calculated. Premalignant lesions of the penis are determined by colposcopic magnification and HPV typing is based on concurrent DNA analysis of penile swabs.	baseline
Secondary	The proportion of men with HGAIN at baseline according to reported number of sex partners in the last 6 months	The proportion of men with HGAIN at baseline according to number of sex partners in the last 6 months will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs.	baseline
Secondary	The proportion of men with premalignant lesions of the penis at baseline according CD4+ level.	The proportion of men with premalignant lesions of the penis at baseline according to CD4+ level at baseline will be calculated. Premalignant lesions of the penis are determined by colposcopic magnification and HPV typing is based on concurrent DNA analysis of penile swabs .	baseline
Secondary	The proportion of men with HGAIN at baseline according CD4+ level.	The proportion of men with HGAIN at baseline according to CD4+ level at baseline will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs.	baseline
Secondary	The proportion of men with premalignant lesions of the penis at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18).	The proportion of men with premalignant lesions of the penis at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18) will be calculated. Premalignant lesions of the penis are determined by colposcopic magnification and HPV typing is based on concurrent DNA analysis of penile swabs .	Baseline