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

Study Overview
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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.

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.

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

Conditions
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HIV Infection

Intervention / Treatment
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* Other: Cytology Specimen Collection Procedure
* Other: Laboratory Biomarker Analysis
* Procedure: Medical Examination
* Procedure: Physical Examination
* Procedure: Proctoscopy with Biopsy
* Other: Questionnaire Administration


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (health information collection)<br>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: Cytology Specimen Collection Procedure<br>* Undergo blood, urethral swab, penile skin cell, and anal swab collection<br>* Other names: Cytologic Sampling;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Procedure: Medical Examination<br>* Undergo anal and penile clinical exam<br>* Other names: Medical Inspection;Procedure: Physical Examination<br>* Undergo targeted physical exam<br>* Other names: Physical Exam;Procedure: Proctoscopy with Biopsy<br>* Undergo HRA<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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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 |