Clinical trial NCT04142398: Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men
Official title: Investigating Human Papillomavirus (HPV) Infection and HPV-Associated Disease in Indian Men Who Have Sex With Men Who Are HIV-Positive
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HIV Infection
Human Papillomavirus Infection
Human Papillomavirus-Related Carcinoma
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-10-29
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-seropositive MSM in Mumbai, India

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of HPV-associated high-grade anal intraepithelial neoplasia (HGAIN)
timeFrame: Baseline
measure: Prevalence of premalignant lesions of the penis
timeFrame: Baseline
measure: Prevalence and incidence of human papillomavirus (HPV)
timeFrame: Up to 12 months
Secondary outcomes:
measure: The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18).
timeFrame: Baseline
measure: The proportion of men with premalignant lesions of the penis at baseline according to reported number of sex partners in the last 6 months
timeFrame: baseline
measure: The proportion of men with HGAIN at baseline according to reported number of sex partners in the last 6 months
timeFrame: baseline
measure: The proportion of men with premalignant lesions of the penis at baseline according CD4+ level.
timeFrame: baseline
measure: The proportion of men with HGAIN at baseline according CD4+ level.
timeFrame: baseline
measure: 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).
timeFrame: Baseline
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center-Parnassus
state: California
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Mumbai
country: India
facility: Udaan Trust
Study officials:
affiliation: AIDS Malignancy Consortium
name: Joel Palefsky
role: PRINCIPAL_INVESTIGATOR
References: