Same-day HPV screen-and-treat for women with HIV in La Romana

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares an iSTAR same-day HPV-based screen-and-treat approach supported by a clinical decision support system (CDSS) against standard care among women living with HIV at Clínica de Familia La Romana. Eligible participants are Spanish-speaking people assigned female at birth, age 25 or older, living with HIV and not pregnant or recently treated for cervical precancer. Participants who screen positive for high-risk HPV will receive same-day triage and treatment per protocol, and key outcomes include treatment completion, retention in care, and implementation factors affecting scale-up. The study will identify facilitators and barriers to implementing single-visit screen-and-treat in a high-burden, low-resource setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 25 years of age;
* female sex assigned at birth (any gender identity);
* HIV-positive;
* women who have had cervical cancer precursor lesions which were removed more than 6 months ago; and
* understand Spanish

Exclusion Criteria:

* ages outside of the specified inclusion criteria;
* women who are pregnant, less than 6 weeks postpartum, or in whom pregnancy cannot be excluded;
* history of a Loop Electrosurgical Excision Procedure (LEEP) procedure in the last 6 months;
* history of a hysterectomy;
* previous diagnosis of gynecological cancer;
* history of cancer of the anogenital tract; or
* unable or unwilling to provide informed consent

Where it's running

• Clínica de Familia La Romana
  La Romana, Dominican Republic Recruiting

Study contacts

• Principal investigator: Rebecca Schnall, PhD, MPH — Columbia University
• Study coordinator: Rebecca Schnall, PhD, MPH
• Email: rb897@columbia.edu
• Phone: 212-342-6886

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• At-home HPV self-collection kits for cervical cancer screening

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• Comparing clinic-only versus clinic plus community outreach to offer HPV self-collection for cervical screening in women with HIV

  This project will test whether adding community health worker outreach to clinic services helps more women living with HIV complete HPV self-collection for cervical screening.

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• CHW4CervixHealth: HPV self-collection kits with community health workers

  This project will test whether giving self-collection HPV kits during community workshops led by community health workers helps increase screening among under-screened women aged 25–65 and will first compare kit results to clinical Pap smears.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07336134

• Mail-delivered mouth rinse and saliva kits for HPV testing in people with HIV

  This project tests whether people living with HIV can collect mouth rinse and saliva samples at home, mail them in, and get HPV test results that match clinic-collected samples.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07087145

• Using a portable colposcope for cervical cancer screening

  This study is testing a portable device to help screen women for cervical cancer and HPV in Kenya, aiming to improve diagnosis and treatment options.

  Recruiting Duke University · Nairobi · NCT06458062

• Comparing two treatments for cervical cancer risk reduction in women living with HIV in Mozambique

  This study is testing two different treatments for pre-cancerous cervical lesions in women living with HIV in Mozambique to see which one works better in getting rid of high-risk HPV.

  Recruiting Instituto Nacional de Saúde, Mozambique · Maputo · NCT06326294

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.