HIV Infection Clinical Trial
Official title:
Incidence of Human Immunodeficiency Virus (HIV) Among Indian Men Who Have Sex With Men (MSM)
Verified date | February 2024 |
Source | AIDS Malignancy Consortium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
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 |
Country | Name | City | State |
---|---|---|---|
India | Tata Memorial Hospital | Mumbai | |
India | Udaan Trust | Mumbai | |
United States | UCSF Medical Center-Parnassus | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
AIDS Malignancy Consortium | National Cancer Institute (NCI), Tata Memorial Hospital, Udaan Trust, University of Arkansas |
United States, India,
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 |
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