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Using the Screen, Triage, and Treat (iSTAR) Approach in Primary Care Clinics Specializing in HIV Care to Improve Cervical Cancer Screening and Treatment in Women Living with HIV
Trial Status: active
This clinical trial studies whether the Screen, Triage, and Treat (iSTAR) approach can be used in primary care clinics specializing in HIV care to improve cervical cancer screening and treatment in women living with HIV (WLH) in the Dominican Republic. Cervical cancer is the leading cause of cancer-related deaths in WLH. The Dominican Republic has a higher incidence of cervical cancer and a higher death rate from cervical cancer than the rest of the Caribbean. This is largely due to the failure of routine screening as well as losing contact with patients during follow-up for treatment once screening is completed. Cervical cancer is often a result of the common sexually transmitted human papillomavirus (HPV) infection. If the HPV infection persists, it results in the formation of a precancerous lesion. If this lesion is left untreated, it results in cervical cancer. The iSTAR approach conducts HPV screening, triaging, and if suitable, treatment in a single visit. During the visit, patients are screened for HPV, the screening results are assessed and triaged to determine who is eligible for treatment, and those eligible patients then undergo same day treatment. Using the iSTAR approach in primary care clinics specializing in HIV care may be an effective way to improve cervical cancer screening and treatment in WLH.
Inclusion Criteria
USABILITY TESTING: Staff and clinicians who provide direct care at Clínica de Familia or Columbia University
HEURISTIC EVALUATIONS: Usability experts
IMPLEMENTATION INTERVENTION (PRACTICE FACILITATION): Confirmed to be clinical staff or implementation staff at Clínica de Familia
IMPLEMENTATION INTERVENTION (PRACTICE FACILITATION): ≥ 18 years old
IMPLEMENTATION INTERVENTION (PRACTICE FACILITATION): Cognitively able to complete the required survey or interview activities
COGNITIVE INTERVIEWS: Participants from Clínica de Familia
COGNITIVE INTERVIEWS: Participants will be WLH and/or providers
WORKSHOPS: Participants from Clinica de Familia
RCT: ≥ 25 years of age
RCT: Female sex assigned at birth (any gender identity)
RCT: HIV-positive
RCT: Women who have had cervical cancer precursor lesions which were removed more than 6 months ago
RCT: Understand Spanish
Exclusion Criteria
IMPLEMENTATION INTERVENTION (PRACTICE FACILITATION): Providers and clinic staff are ineligible to participate in the implementation intervention if they fail to meet any of the above criteria
RCT: Ages outside of the specified inclusion criteria
RCT: Women who are pregnant, less than 6 weeks postpartum, or in whom pregnancy cannot be excluded
RCT: History of a LEEP procedure in the last 6 months
RCT: History of a hysterectomy
RCT: Previous diagnosis of gynecological cancer
RCT: History of cancer of the anogenital tract
RCT: Unable or unwilling to provide informed consent
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07225530.
Locations matching your search criteria
United States
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
I. Engage the target population to refine implementation strategies (mobile health [mHealth] clinical decision support tool, practice facilitation, patient education material) to integrate cervical cancer screening and treatment within a community-based primary care clinic specializing in HIV care in the Dominican Republic.
II. Conduct an randomized controlled trial (RCT) to assess the effectiveness of the bundle of strategies for implementing iSTAR in improving cervical cancer control when introduced to WLH attending Clínica de Familia.
III. Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, identify multi-level factors associated with the successful implementation of iSTAR to inform future implementation and scale-up.
OUTLINE: Participants are assigned to 1 of 2 aims.
AIM 1: Participants are assigned to 1 of 5 groups.
GROUP I: Participants complete usability testing and a survey on study in support of the refinement of the implementation strategies to integrate cervical cancer screening and treatment within the community-based primary care clinic specializing in HIV care in the Dominican Republic.
GROUP II: Participants complete heuristic evaluations on study in support of the refinement of the implementation strategies to integrate cervical cancer screening and treatment within the community-based primary care clinic specializing in HIV care in the Dominican Republic.
GROUP III: Participants attend practice facilitation sessions over 90 minutes-3 hours as well as monthly teleconference sessions and complete surveys and an interview over 30-45 minutes on study in support of the refinement of the implementation strategies to integrate cervical cancer screening and treatment within the community-based primary care clinic specializing in HIV care in the Dominican Republic.
GROUP IV: Participants complete a cognitive interview over 1 hour on study in support of the refinement of the implementation strategies to integrate cervical cancer screening and treatment within the community-based primary care clinic specializing in HIV care in the Dominican Republic.
GROUP V: Participants attend an educational workshop over 30-45 minutes and complete surveys on study in support of the refinement of the implementation strategies to integrate cervical cancer screening and treatment within the community-based primary care clinic specializing in HIV care in the Dominican Republic.
AIM 2: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo visualization of cervix with and without acetic acid and cervical sample collection with on-site HPV deoxyribonucleic acid (DNA) testing at baseline. Approximately two hours later, patients with a positive HPV result undergo automated triaging of results within the mHealth clinical decision support system (CCDS). Patients meeting the triage step (HPV VL) criteria then undergo visual assessment for treatment (VAT). Patients found suitable for treatment during VAT undergo immediate thermoablation treatment on study. Patients found not suitable for treatment during VAT receive referral for follow-up colposcopy, loop electrosurgical excision procedure (LEEP), or cancer treatment on study. Patients with a positive baseline HPV result who do not meet HPV VL criteria receive instructions to undergo re-screen pap smear in 12 months. Patients with a negative baseline HPV result receive instructions to undergo routine screening during follow up.
ARM II: Patients undergo visualization of cervix with and without acetic acid and cervical sample collection with batched HPV DNA testing at baseline. Following HPV DNA testing, patients return to office and receive HPV DNA results and undergo colposcopy biopsy on study. Within three weeks of colposcopy biopsy, patients receive biopsy results and undergo thermoablation treatment or receive referrals for further management as needed on study.
After completion of study intervention, patients are followed up at 1 year.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
