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

Withdrawn

• Conditions: HIV Infection

• Registration Number: NCT04142385
• Lead Sponsor: AIDS Malignancy Consortium

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.

Study Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-29
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-06
• Study Start: 2027-04-30
• Primary Completion: 2029-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of human immunodeficiency virus (HIV)	Up to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence of anal human papillomavirus (HPV) infection, assessed by polymerase chain reaction (PCR)	Up to 12 months	Summarized using proportions and exact 95% binomial confidence interval (CI). Will be estimated for specific types and for all combined.
Successful respondent-driven sampling (RDS)	12 months	Defined as more than 80% of participants recruited through RDS.
Prevalence of human papillomavirus (HPV)-associated lesions of the penis	Up to 12 months	Summarized using proportions and exact 95% binomial CI. Will be estimated for specific types and for all combined.
Prevalence of penile human papillomavirus (HPV) infection, assessed by polymerase chain reaction (PCR)	Up to 12 months	Summarized using proportions and exact 95% binomial confidence interval (CI). Will be estimated for specific types and for all combined.
Prevalence of human papillomavirus (HPV)-associated lesions of the anus	Up to 12 months	Summarized using proportions and exact 95% binomial CI. Will be estimated for specific types and for all combined.

Trial Locations

Locations (3)

UCSF Medical Center-Parnassus; 🇺🇸 San Francisco, California, United States

Tata Memorial Hospital; 🇮🇳 Mumbai, India

Udaan Trust; 🇮🇳 Mumbai, India