Clinical trial NCT04142385: Incidence of HIV Infection in Screening Indian Men Who Have Sex With Men
Official title: Incidence of Human Immunodeficiency Virus (HIV) Among Indian Men Who Have Sex With Men (MSM)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HIV Infection
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Tata Memorial Hospital
name: Udaan Trust
name: University of Arkansas
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-seronegative MSM in Mumbai, India

Brief summary: This research trial studies the incidence of human immunodeficiency virus (HIV) infection in screening Indian men who have sex with men (MSM). Gathering health information over time from Indian MSM may help doctors determine how many Indian MSM develop new cases of HIV infection.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the one-year incidence of HIV among high-risk MSM in India.

SECONDARY OBJECTIVES:

I. To test the feasibility and acceptability of recruiting a sample of 150 high-risk HIV-uninfected MSM using respondent-driven sampling (RDS) and following them every six months for one year.

II. To produce preliminary descriptive data on the prevalence and incidence of human papillomavirus (HPV) infection and HPV-associated disease and sexually transmitted infections (STIs) other than HPV in HIV-seronegative MSM in India.

III. To produce preliminary descriptive data on sexual risk behaviors with men and women, as well as data on other potential confounders.

OUTLINE:

Participants receive a questionnaire, undergo a targeted physical and anal clinical exam, undergo blood collection and urethral swab for STIs, and a penile skin cell and anal swab for cytology and HPV deoxyribonucleic acid (DNA) at months 0, 6, and 12. Participants also undergo high-resolution anoscopy (HRA) and penile clinical exam at month 12.

Eligibility criteria: Inclusion Criteria:

* HIV seronegative, as documented by any licensed HIV test according to National Acquired Immunodeficiency 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
* Participant 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: Incidence of human immunodeficiency virus (HIV)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Successful respondent-driven sampling (RDS)
timeFrame: 3 months
measure: Successful respondent-driven sampling (RDS)
timeFrame: 12 months
measure: Prevalence of penile human papillomavirus (HPV) infection, assessed by polymerase chain reaction (PCR)
timeFrame: Up to 12 months
measure: Prevalence of human papillomavirus (HPV)-associated lesions of the penis
timeFrame: Up to 12 months
measure: Prevalence of human papillomavirus (HPV)-associated lesions of the anus
timeFrame: Up to 12 months
measure: Prevalence of anal human papillomavirus (HPV) infection, assessed by polymerase chain reaction (PCR)
timeFrame: Up to 12 months
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: