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

Incidence of Human Immunodeficiency Virus (HIV) Among Indian Men Who Have Sex With Men (MSM)

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.

Study Overview

• Status: Withdrawn
• Conditions: HIV Infection
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Procedure: Medical Examination; Procedure: Physical Examination; Other: Cytology Specimen Collection Procedure; Procedure: Proctoscopy with Biopsy

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• India
  • Mumbai, India, 400 012
    • Tata Memorial hospital
  • Mumbai, India, 401706
    • Udaan Trust
• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Medical Center-Parnassus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

HIV-seronegative MSM in Mumbai, India

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational (health information collection); 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.

Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary 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: Cytology Specimen Collection Procedure; Undergo blood, urethral swab, penile skin cell, and anal swab collection; Other Names: Cytologic Sampling; Procedure: Proctoscopy with Biopsy; Undergo HRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of human immunodeficiency virus (HIV)	The total number of participants with incident HIV divided by the total follow-up will be used to calculate the incidence per 100 person years. HIV status is determined by HIV rapid test and a confirmatory Western blot test.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful respondent-driven sampling (RDS)	Defined as half of the study sample enrolled and at least 50% of the responses to the questions of RDS acceptability are answered "Not at all embarrassed or burdened by RDS".	3 months
Successful respondent-driven sampling (RDS)	Defined as more than 80% of participants recruited through RDS.	12 months
Prevalence of penile human papillomavirus (HPV) infection, assessed by polymerase chain reaction (PCR)	Summarized using proportions and exact 95% binomial confidence interval (CI). Will be estimated for specific types and for all combined.	Up to 12 months
Prevalence of human papillomavirus (HPV)-associated lesions of the penis	Summarized using proportions and exact 95% binomial CI. Will be estimated for specific types and for all combined.	Up to 12 months
Prevalence of human papillomavirus (HPV)-associated lesions of the anus	Summarized using proportions and exact 95% binomial CI. Will be estimated for specific types and for all combined.	Up to 12 months
Prevalence of anal human papillomavirus (HPV) infection, assessed by polymerase chain reaction (PCR)	Summarized using proportions and exact 95% binomial confidence interval (CI). Will be estimated for specific types and for all combined.	Up to 12 months

Collaborators and Investigators

• Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI); University of Arkansas; Tata Memorial Hospital; Udaan Trust
• Investigators: Principal Investigator: Joel Palefsky, AIDS Malignancy Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Infections
• Other Study ID Numbers: AMC-093 (Other Identifier: CTEP); UM1CA121947 (U.S. NIH Grant/Contract); NCI-2016-01358 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R21CA167652 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No