Clinical trial · Observational
Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men
Investigating Human Papillomavirus (HPV) Infection and HPV-Associated Disease in Indian Men Who Have Sex With Men Who Are HIV-Positive
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed due to lack of funding.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infection | — | UNRESOLVED | — |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
| Human Papillomavirus-Related Carcinoma | Human Papillomavirus-Related Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| High Resolution Anoscopy with Biopsy | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Medical Examination | Procedure | — | UNRESOLVED |
| Physical Examination | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Screening (health information collection)
- description
- 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.
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Procedure: High Resolution Anoscopy with Biopsy
- Other: Laboratory Biomarker Analysis
- Procedure: Medical Examination
- Procedure: Physical Examination
- Other: Questionnaire Administration
Primary outcomes (3)
- measure
- Prevalence of HPV-associated high-grade anal intraepithelial neoplasia (HGAIN)
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available