Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25+
SponsorColumbia University
About this trial
This study aims to conduct a randomized controlled trial to evaluate the effectiveness of same-day HPV-based screen and treat among women living with HIV (WLH) in La Romana, Dominican Republic. With cervical cancer being a leading cause of cancer-related deaths in women living with HIV, and cervical cancer deaths being preventable through screening and early detection, this project seeks to identify factors associated with the successful implementation of the Screen, Triage, and Treat approach to inform future implementation and scale-up.
Eligibility criteria
Qualifiers
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
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Screen, Triage, and Treat
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Columbia University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Clínica de Familia La Romana, Dominican Republic
Collaborator
Source ClinicalTrials.gov