Incidence of HIV Infection in Screening Indian Men Who Have Sex With Men

AIDS Malignancy Consortium

Status: Begins enrollment in 7 months

Conditions: HIV Infection

Treatments: Procedure: Medical Examination; Other: Cytology Specimen Collection Procedure; Procedure: Physical Examination; Procedure: Proctoscopy with Biopsy; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: Other; NETWORK; NIH

Identifiers

NCT04142385

NCI-2016-01358 (Registry Identifier)

UM1CA121947 (U.S. NIH Grant/Contract)

AMC-093

R21CA167652 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Observational (health information collection)

Description:

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 DNA at months 0, 6, and 12. Participants also undergo HRA and penile clinical exam at month 12.

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Proctoscopy with Biopsy

Procedure: Physical Examination

Other: Cytology Specimen Collection Procedure

Procedure: Medical Examination

Other: Questionnaire Administration