An observational study in HIV Infection, sponsored by AIDS Malignancy Consortium. Withdrawn at 3 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by AIDS Malignancy Consortium · Observational
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.
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.
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HIV-seronegative MSM in Mumbai, India
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 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 · Other: Laboratory Biomarker Analysis · Procedure: Medical Examination · Procedure: Physical Examination · Procedure: Proctoscopy with Biopsy · Other: Questionnaire Administration
Undergo blood, urethral swab, penile skin cell, and anal swab collection
Also known as: Cytologic Sampling
Correlative studies
Undergo anal and penile clinical exam
Also known as: Exam, Examination, Medical Assessment, Medical Exam, Medical Inspection
Undergo targeted physical exam
Also known as: Assessment, Physical, Physical Assessment, Physical Exam
Undergo HRA
Ancillary studies
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.
Time frame: Up to 12 months
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".
Time frame: 3 months
Successful respondent-driven sampling (RDS)
Defined as more than 80% of participants recruited through RDS.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months
Plan to share: Undecided
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This study is withdrawn, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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AIDS Malignancy Consortium