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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04142385
• Other study ID #: AMC-093
• Secondary ID: NCI-2016-01358AM
• Status: Not yet recruiting
• Start date: April 30, 2025
• Est. completion date: December 31, 2029

Study information

• Verified date: February 2024
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Infections

Intervention

Other:
• Cytology Specimen Collection Procedure
Undergo blood, urethral swab, penile skin cell, and anal swab collection
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Medical Examination
Undergo anal and penile clinical exam
• Physical Examination
Undergo targeted physical exam
• Proctoscopy with Biopsy
Undergo HRA

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai
India	Udaan Trust	Mumbai
United States	UCSF Medical Center-Parnassus	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI), Tata Memorial Hospital, Udaan Trust, University of Arkansas

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Successful respondent-driven sampling (RDS)	Defined as more than 80% of participants recruited through RDS.	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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