Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)
Recruiting · NCT07225530 · Interventional (participants receive a specific treatment) · Lead sponsor: Columbia University
View the official record on ClinicalTrials.gov →Interventions studied
Screen, Triage, and Treat
What this trial is about
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.
Who can take part
Age range
25 Years and older
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Clínica de Familia La Romana - La Romana, Dominican Republic