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

NCT04142385 | Withdrawn

• 4 other identifiers: AMC-093NCI-2016-01358R21CA167652UM1CA121947
• Study Type: observational
• Target: N/A
• Locations: 2 countries
• Sites: 3

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.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Successful respondent-driven sampling (RDS)

  3 months

• Successful respondent-driven sampling (RDS)

  12 months

• Prevalence of penile human papillomavirus (HPV) infection, assessed by polymerase chain reaction (PCR)

  Up to 12 months

• Prevalence of human papillomavirus (HPV)-associated lesions of the penis

  Up to 12 months

• Prevalence of human papillomavirus (HPV)-associated lesions of the anus

  Up to 12 months

Study Arms (1)

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: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Procedure: Medical Examination; Procedure: Physical Examination; Procedure: Proctoscopy with Biopsy; Other: Questionnaire Administration

Interventions

Cytology Specimen Collection Procedure OTHER

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

Also known as: Cytologic Sampling

Observational (health information collection)

Laboratory Biomarker Analysis OTHER

Correlative studies

Observational (health information collection)

Medical Examination PROCEDURE

Undergo anal and penile clinical exam

Also known as: Exam, Examination, Medical Assessment, Medical Exam, Medical Inspection

Observational (health information collection)

Physical Examination PROCEDURE

Undergo targeted physical exam

Also known as: Assessment, Physical, Physical Assessment, Physical Exam

Observational (health information collection)

Proctoscopy with Biopsy PROCEDURE

Undergo HRA

Observational (health information collection)

Questionnaire Administration OTHER

Ancillary studies

Observational (health information collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-seronegative MSM in Mumbai, India

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• Tata Memorial Hospital: collaborator
• Udaan Trust: collaborator
• University of Arkansas: collaborator

Study Sites (3)

UCSF Medical Center-Parnassus

San Francisco, California, 94143, United States

Location

Tata Memorial Hospital

Mumbai, 400 012, India

Location

Udaan Trust

Mumbai, 401706, India

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Conditions

HIV Infections

Interventions

Independent Medical Evaluation; Restraint, Physical; Proctoscopy; Biopsy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling

Study Officials

• Joel Palefsky

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: October 29, 2019
• Study Start (Estimated): April 30, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

IN (2); US (1)