Developing a screening algorithm for anal high-grade lesions in men who have sex with men
Optimizing an Anal High-grade Squamous Intraepithelial Lesion Screening Algorithm for Thai Men Who Have Sex With Men and Transgender Women
This study is testing a new way to screen for serious anal lesions in men who have sex with men and transgender women to see if it can improve detection and care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 950 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Institute of HIV Research and Innovation Foundation, Thailand Academic / other |
| Locations | 1 site (Pathum wan, Bangkok) |
| Trial ID | NCT05531799 on ClinicalTrials.gov |
What this trial studies
This study aims to create an optimized screening algorithm for anal high-grade squamous intraepithelial lesions (HSIL) specifically for men who have sex with men (MSM) and transgender women (TGW). Utilizing a Multiphase Optimization Strategy Trial (MOST) design, the researchers will evaluate various intervention components to determine the most effective and efficient screening approach. The implementation of the selected algorithm will be guided by the RE-AIM framework to ensure comprehensive evaluation and uptake in clinical settings. An interrupted time series analysis will compare screening uptake before and after the algorithm's implementation.
Who should consider this trial
Good fit: Ideal candidates include Thai MSM and TGW who are HIV-positive aged 30 years or older or HIV-negative aged 40 years or older.
Not a fit: Patients who are unable to perform study procedures or have anal cancer lesions at enrollment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the early detection and management of anal HSIL, leading to better health outcomes for MSM and TGW populations.
How similar studies have performed: While similar approaches have been explored, this specific optimization strategy for anal HSIL screening in MSM and TGW populations is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria Clients for MSM and TGW: * Thai nationality, men with self-identifies as MSM and/or TGW * HIV-positive MSM/TGW aged 30 years or older or * HIV-negative MSM/TGW aged 40 years or older Clinic staff: - Has worked in the study clinic during phase III Government stakeholders: - Involved in health policy development in Thailand Exclusion criteria Clients for MSM and TGW: * Unable to perform any study procedures, or unable to commit to attend all study visits. * Had Anal cancer lesion at enrollment visit, this exclusion for participation in phase II study. Clinic staff: - Not willing to participate in the evaluation Government stakeholders: - Not willing to participate in the evaluation
Where this trial is running
Pathum wan, Bangkok
- Institute of HIV Research and Innovation — Pathum wan, Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Nittaya Phanuphak, MD,PhD. — Institute of HIV Research and Innovation
- Study coordinator: Nittaya Phanuphak, MD,PhD.
- Email: nittaya.p@ihri.org
- Phone: 661 825 3544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.