To check the occurrence of Human Immunodeficiency Virus (HIV) among Indian Men who have Sex with Men(MSM)
- Conditions
- Men who are HIV sero-negative who has had sex with a man
- Registration Number
- CTRI/2022/09/045982
- Lead Sponsor
- Department of Health Research
- Brief Summary
It is well established that men who have sex with men (MSM) have a higher risk of acquiring HIV than othermen.This has been demonstrated through studies of both prevalence and incidence in the US, Africa andAsia. It is likely that MSM in India would have a similarly higher risk for infection. Prevalence studies havedemonstrated that the proportion of Indian MSM infected with HIV is high.The objective of the study is to evaluate the prevalence of anal and penile HPV infection and prevalence of HPV-associated lesions of the anus andpenis amongst men in India having high risk MSM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Male
- Target Recruitment
- 150
- 1.Men age 18 or older 2.HIV sero-negative, as documented by any licensed HIV test according to NACO guidelines.
- 3.Participants report any sex with a man in the past 6 months.
- 4.Participants must speak Hindi, Marathi, or English.
- 5.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.
- 1.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.
- 2.Participants with impairments that, in the opinion of the site Investigator, are temporary will be asked to return another day for enrollment.
- 3.Inability to provide informed consent.
- 4.History of a sex change operation that would preclude collection of penile or scrotal specimens.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the one-year incidence of HIV among high-risk MSM in India. 52 weeks
- Secondary Outcome Measures
Name Time Method 1.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.
Trial Locations
- Locations (1)
Tata Memorial Hospital
🇮🇳(Suburban), MAHARASHTRA, India
Tata Memorial Hospital🇮🇳(Suburban), MAHARASHTRA, IndiaDr Sharmila PimplePrincipal investigator9223207939pimplesa@tmc.gov.in