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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2027-04-30

Study Completion Date

2031-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cytology Specimen Collection Procedure

Intervention Type OTHER

Undergo blood, urethral swab, penile skin cell, and anal swab collection

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Medical Examination

Intervention Type PROCEDURE

Undergo anal and penile clinical exam

Physical Examination

Intervention Type PROCEDURE

Undergo targeted physical exam

Proctoscopy with Biopsy

Intervention Type PROCEDURE

Undergo HRA

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Cytology Specimen Collection Procedure

Undergo blood, urethral swab, penile skin cell, and anal swab collection

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Medical Examination

Undergo anal and penile clinical exam

Intervention Type PROCEDURE

Physical Examination

Undergo targeted physical exam

Intervention Type PROCEDURE

Proctoscopy with Biopsy

Undergo HRA

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Cytologic Sampling Exam Examination Medical Assessment Medical Exam Medical Inspection Assessment Physical Physical Assessment Physical Exam

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No