HIV Infection Clinical Trial
Official title:
Investigating Human Papillomavirus (HPV) Infection and HPV-Associated Disease in Indian Men Who Have Sex With Men Who Are HIV-Positive
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 papilloma virus (HPV) infection and HPV-associated disease in screening Indian men who have sex with human immunodeficiency virus (HIV)-positive men. Gathering health information over time from Indian men who have sex with men (MSM) may help doctors determine how many HIV -positive MSM develop new HPV infections and how many HIV-positive MSM have HPV related disease.
Status | Not yet recruiting |
Enrollment | 246 |
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 positive, as documented by any licensed HIV test according to the Indian National acquired immune deficiency 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 - Participants 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) |
United States, India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of HPV-associated high-grade anal intraepithelial neoplasia (HGAIN) | The proportion of men with HPV 6, 11, 16, and/or 18-associated HGAIN will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs. | Baseline | |
Primary | Prevalence of premalignant lesions of the penis | Will be calculated using proportions and exact 95% binomial CI. | Baseline | |
Primary | Prevalence and incidence of human papillomavirus (HPV) | Will be estimated for specific types, and for all types combined using the life table approach for incidence. Separate estimates will be made for each anatomical site. Risk factors for site-specific incident infection will be evaluated using regression models for survival events observed in discrete time (e.g. pooled logistic regression), incorporating behavioral and biological predictors measured at baseline, and over time at study visits. Risk factors that will be assessed include behavioral and medical history, CD4+ level, and HIV viral load. | Up to 12 months | |
Secondary | The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18). | The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18) will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs . | Baseline | |
Secondary | The proportion of men with premalignant lesions of the penis at baseline according to reported number of sex partners in the last 6 months | The proportion of men with premalignant lesions of the penis at baseline according to number of sex partners in the last 6 months will be calculated. Premalignant lesions of the penis are determined by colposcopic magnification and HPV typing is based on concurrent DNA analysis of penile swabs. | baseline | |
Secondary | The proportion of men with HGAIN at baseline according to reported number of sex partners in the last 6 months | The proportion of men with HGAIN at baseline according to number of sex partners in the last 6 months will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs. | baseline | |
Secondary | The proportion of men with premalignant lesions of the penis at baseline according CD4+ level. | The proportion of men with premalignant lesions of the penis at baseline according to CD4+ level at baseline will be calculated. Premalignant lesions of the penis are determined by colposcopic magnification and HPV typing is based on concurrent DNA analysis of penile swabs . | baseline | |
Secondary | The proportion of men with HGAIN at baseline according CD4+ level. | The proportion of men with HGAIN at baseline according to CD4+ level at baseline will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs. | baseline | |
Secondary | The proportion of men with premalignant lesions of the penis at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18). | The proportion of men with premalignant lesions of the penis at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18) will be calculated. Premalignant lesions of the penis are determined by colposcopic magnification and HPV typing is based on concurrent DNA analysis of penile swabs . | Baseline |
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