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

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ClinicalTrials.gov Identifier: NCT04142398
Recruitment Status : Not yet recruiting
First Posted : October 29, 2019
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
HIV Infection Human Papillomavirus Infection Human Papillomavirus-Related Carcinoma Other: Cytology Specimen Collection Procedure Procedure: High Resolution Anoscopy with Biopsy Other: Laboratory Biomarker Analysis Procedure: Medical Examination Procedure: Physical Examination Other: Questionnaire Administration

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.

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Study Type : Observational
Estimated Enrollment : 246 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Human Papillomavirus (HPV) Infection and HPV-Associated Disease in Indian Men Who Have Sex With Men Who Are HIV-Positive
Estimated Study Start Date : September 30, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Screening (health information collection)
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.
Other: Cytology Specimen Collection Procedure
Undergo penile skin cell and anal swab collection
Other Name: Cytologic Sampling

Procedure: High Resolution Anoscopy with Biopsy
Undergo HRA with biopsy
Other Name: High Resolution Anoscopy-Monitored Biopsy

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Medical Examination
Undergo anal and penile clinical exam
Other Names:
  • Exam
  • Examination
  • Medical Assessment
  • Medical Exam
  • Medical Inspection

Procedure: Physical Examination
Undergo targeted physical exam
Other Names:
  • Assessment
  • Physical
  • Physical Assessment
  • Physical Exam

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Prevalence of HPV-associated high-grade anal intraepithelial neoplasia (HGAIN) [ Time Frame: 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.

  2. Prevalence of premalignant lesions of the penis [ Time Frame: Baseline ]
    Will be calculated using proportions and exact 95% binomial CI.

  3. Prevalence and incidence of human papillomavirus (HPV) [ Time Frame: 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.


Secondary Outcome Measures :
  1. The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18). [ Time Frame: 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 .

  2. The proportion of men with premalignant lesions of the penis at baseline according to reported number of sex partners in the last 6 months [ Time Frame: 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.

  3. The proportion of men with HGAIN at baseline according to reported number of sex partners in the last 6 months [ Time Frame: 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.

  4. The proportion of men with premalignant lesions of the penis at baseline according CD4+ level. [ Time Frame: 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 .

  5. The proportion of men with HGAIN at baseline according CD4+ level. [ Time Frame: 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.

  6. 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). [ Time Frame: 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 .


Biospecimen Retention:   Samples With DNA
Tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-seropositive MSM in Mumbai, India
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142398


Locations
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United States, California
UCSF Medical Center-Parnassus
San Francisco, California, United States, 94143
Contact: Joel Palefsky    877-827-3222    joel.palefsky@ucsf.edu   
Principal Investigator: Joel Palefsky         
India
Tata Memorial Hospital
Mumbai, India, 400 012
Contact: Sharmila A. Pimple    91-22-24154379    pimplesa@tmc.gov.in   
Principal Investigator: Sharmila A. Pimple         
Udaan Trust
Mumbai, India, 401706
Contact: Vijay Nair    91-22-3209-4538    airvijaynair@gmail.com   
Principal Investigator: Vijay Nair         
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Joel Palefsky AIDS Malignancy Consortium
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Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT04142398    
Other Study ID Numbers: AMC-094
NCI-2016-01347 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AMC-094
AMC-094 ( Other Identifier: AIDS Malignancy Consortium )
AMC-094 ( Other Identifier: CTEP )
R21CA167653 ( U.S. NIH Grant/Contract )
UM1CA121947 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Papillomavirus Infections
Virus Diseases
DNA Virus Infections
Tumor Virus Infections