HIV InfectionNCT04142398
Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men
An observational study of HIV Infection and Human Papillomavirus Infection, run by AIDS Malignancy Consortium at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infection, Human Papillomavirus Infection, Human Papillomavirus-Related Carcinoma
- What is being tested?
- Cytology Specimen Collection Procedure, High Resolution Anoscopy with Biopsy and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Apr 2027to 31 Dec 2031
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: HIV-seropositive MSM in Mumbai, India
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States1 site
UCSF Medical Center-Parnassus
San Francisco, California, 94143
About this study
Official title: Investigating Human Papillomavirus (HPV) Infection and HPV-Associated Disease in Indian Men Who Have Sex With Men Who Are HIV-Positive
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the prevalence of HPV-associated premalignant lesions in the anus and penis in Indian HIV-seropositive men who have sex with men (MSM).
SECONDARY OBJECTIVES:
- Describe risk factors for prevalent premalignant lesions in the anus and penis in Indian HIV-seropositive MSM.
II. Describe the prevalence and incidence of penile and anal HPV infection in Indian HIV-seropositive MSM.
OUTLINE:
Participants receive a questionnaire and undergo a targeted physical and anal clinical exam at months 0, 6, and 12. Participants also undergo a penile skin cell and anal swab at months 0, 6, and 12 for cytology, HPV deoxyribonucleic acid (DNA), and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo high-resolution anoscopy (HRA) and penile clinical exam at month 12.
- Being tested
- Cytology Specimen Collection Procedure, High Resolution Anoscopy with Biopsy, Laboratory Biomarker Analysis, Medical Examination, Physical Examination
- Medical subject headings
- HIV Infections, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Undergo penile skin cell and anal swab collection
High Resolution Anoscopy with BiopsyProcedure or surgery
Also called High Resolution Anoscopy-Monitored Biopsy
Undergo HRA with biopsy
Laboratory Biomarker AnalysisOther
Correlative studies
Medical ExaminationProcedure or surgery
Also called Exam, Examination, Medical Assessment, Medical Exam
Undergo anal and penile clinical exam
Physical ExaminationProcedure or surgery
Also called Assessment, Physical, Physical Assessment, Physical Exam
Undergo targeted physical exam
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Screening (health information collection) | Participants receive a questionnaire and undergo a targeted physical and anal clinical exam at months 0, 6, and 12. Participants also undergo a penile skin cell and anal swab at months 0, 6, and 12 for cytology, HPV DNA, and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo HRA and penile clinical exam at month 12. Receives: Other: Cytology Specimen Collection Procedure; Procedure: High Resolution Anoscopy with Biopsy; Other: Laboratory Biomarker Analysis; Procedure: Medical Examination; Procedure: Physical Examination; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Prevalence of premalignant lesions of the penis
Will be calculated using proportions and exact 95% binomial CI.
Measured: Baseline
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.
Measured: Up to 12 months
Secondary outcomes (6)
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 .
Measured: Baseline
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.
Measured: baseline
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.
Measured: baseline
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 .
Measured: baseline
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.
Measured: baseline
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 .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start30 Apr 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Why it stopped: Closed due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joel Palefsky, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142398
- Sponsor's protocol ID
- AMC-094
- Other IDs
- NCI-2016-01347, AMC-094, AMC-094, AMC-094, R21CA167653, UM1CA121947
- Status last verified
- Jun 2025
- First submitted
- 29 Aug 2019
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Human Papillomavirus (HPV) Infection and HPV-Associated Disease in Indian Men Who Have Sex With Men Who Are HIV-Positive
- ClinicalTrials.gov ID
- NCT04142398
- Acronym / sponsor ID
- AMC-094
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Closed due to lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Apr 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Determine the prevalence of HPV-associated premalignant lesions in the anus and penis in Indian HIV-seropositive men who have sex with men (MSM).
SECONDARY OBJECTIVES:
- Describe risk factors for prevalent premalignant lesions in the anus and penis in Indian HIV-seropositive MSM.
II. Describe the prevalence and incidence of penile and anal HPV infection in Indian HIV-seropositive MSM.
OUTLINE:
Participants receive a questionnaire and undergo a targeted physical and anal clinical exam at months 0, 6, and 12. Participants also undergo a penile skin cell and anal swab at months 0, 6, and 12 for cytology, HPV deoxyribonucleic acid (DNA), and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo high-resolution anoscopy (HRA) and penile clinical exam at month 12.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (health information collection) | – | Other: Cytology Specimen Collection Procedure, Procedure: High Resolution Anoscopy with Biopsy, Other: Laboratory Biomarker Analysis, Procedure: Medical Examination, Procedure: Physical Examination, Other: Questionnaire AdministrationParticipants receive a questionnaire and undergo a targeted physical and anal clinical exam at months 0, 6, and 12. Participants also undergo a penile skin cell and anal swab at months 0, 6, and 12 for cytology, HPV DNA, and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo HRA and penile clinical exam at month 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-seropositive MSM in Mumbai, India
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- Inability to provide informed consent
- History of a sex change operation that would preclude collection of penile or scrotal specimens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo penile skin cell and anal swab collection | Other | Screening (health information collection) |
| High Resolution Anoscopy with BiopsyAlso: High Resolution Anoscopy-Monitored BiopsyUndergo HRA with biopsy | Procedure or surgery | Screening (health information collection) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Screening (health information collection) |
| Medical ExaminationAlso: Exam, Examination, Medical Assessment, Medical ExamUndergo anal and penile clinical exam | Procedure or surgery | Screening (health information collection) |
| Physical ExaminationAlso: Assessment, Physical, Physical Assessment, Physical ExamUndergo targeted physical exam | Procedure or surgery | Screening (health information collection) |
| Questionnaire AdministrationAncillary studies | Other | Screening (health information collection) |
Primary outcome
Prevalence of HPV-associated high-grade anal intraepithelial neoplasia (HGAIN)
Time frame: Baseline
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.
Prevalence of premalignant lesions of the penis
Time frame: Baseline
Will be calculated using proportions and exact 95% binomial CI.
Prevalence and incidence of human papillomavirus (HPV)
Time frame: Up to 12 months
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.
6 secondary outcomes
The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18).
Time frame: Baseline
The proportion of men with premalignant lesions of the penis at baseline according to reported number of sex partners in the last 6 months
Time frame: baseline
The proportion of men with HGAIN at baseline according to reported number of sex partners in the last 6 months
Time frame: baseline
The proportion of men with premalignant lesions of the penis at baseline according CD4+ level.
Time frame: baseline
The proportion of men with HGAIN at baseline according CD4+ level.
Time frame: baseline
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).
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Palefsky principal investigator
AIDS Malignancy Consortium
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and Human Papillomavirus Infection, run by AIDS Malignancy Consortium at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HPV-associated high-grade anal intraepithelial neoplasia (HGAIN) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.