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

Not yet recruiting

• Conditions: Human Papillomavirus Infection; Human Papillomavirus-Related Carcinoma; HIV Infection
• Interventions: Other: Cytology Specimen Collection Procedure; Procedure: High Resolution Anoscopy with Biopsy; Other: Laboratory Biomarker Analysis; Procedure: Medical Examination; Procedure: Physical Examination; Other: Questionnaire Administration

• Registration Number: NCT04142398
• Lead Sponsor: AIDS Malignancy Consortium

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Study Start: 2025-04-30
• Primary Completion: 2027-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 246

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening (health information collection)	Cytology Specimen Collection Procedure	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 DNA, and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo HRA and penile clinical exam at month 12.
Screening (health information collection)	Medical Examination	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 DNA, and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo HRA and penile clinical exam at month 12.
Screening (health information collection)	High Resolution Anoscopy with Biopsy	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 DNA, and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo HRA and penile clinical exam at month 12.
Screening (health information collection)	Laboratory Biomarker Analysis	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 DNA, and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo HRA and penile clinical exam at month 12.
Screening (health information collection)	Physical Examination	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 DNA, and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo HRA and penile clinical exam at month 12.
Screening (health information collection)	Questionnaire Administration	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 DNA, and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo HRA and penile clinical exam at month 12.

Primary Outcome Measures

Name	Time	Method
Prevalence of HPV-associated high-grade anal intraepithelial neoplasia (HGAIN)	Baseline	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.
Prevalence and incidence of human papillomavirus (HPV)	Up to 12 months	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.
Prevalence of premalignant lesions of the penis	Baseline	Will be calculated using proportions and exact 95% binomial CI.

Secondary Outcome Measures

Name	Time	Method
The proportion of men with HGAIN at baseline according CD4+ level.	baseline	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.
The proportion of men with premalignant lesions of the penis at baseline according to reported number of sex partners in the last 6 months	baseline	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.
The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18).	Baseline	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 .
The proportion of men with premalignant lesions of the penis at baseline according CD4+ level.	baseline	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 .
The proportion of men with HGAIN at baseline according to reported number of sex partners in the last 6 months	baseline	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.
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).	Baseline	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 .

Trial Locations

Locations (3)

Udaan Trust; 🇮🇳 Mumbai, India

UCSF Medical Center-Parnassus; 🇺🇸 San Francisco, California, United States

Tata Memorial Hospital; 🇮🇳 Mumbai, India