Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)

ConditionsHIV Infections HPV Infection Cervical Cancer

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Screen, Triage, and Treat
Other intervention
A screening test is used to determine who is eligible for treatment, eliminating steps related to histological confirmation. Those who meet the HPV criteria will be immediately evaluated for suitability for on-site ablative treatment on the same day. Women not suitable for treatment will be referred for colposcopy and further management at the appropriate facility.

Treatment groups

600 Participants

are divided into 2 treatment groups

Group A: Standard of CareNo intervention 0 interventions

Group B: Screen, Triage, and TreatExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Percentage of Screen-positives Completing Full Screening Cascade

The investigators will calculate the percent of screen-positives who complete all follow-up steps in the screening cascade. For the iSTAR approach, this will include the percentage among those suitable for ablative therapy who undergo ablative therapy within 1 week of screening combined with the percentage of those not suitable for ablative therapy who complete all colposcopy referral steps which lead either to a treatment procedure or to a negative confirmatory diagnosis within 2 months. In the standard of care arm, this will include the percentage of all screen-positives who complete the colposcopy steps within 2 months.

Time frame

2 Months

Percentage of Women in the HPV+VL Triage Negative Group

The investigators will calculate the percentage of women with HPV+ by HPV VL triage negative who have abnormal pap results. Given the high specificity of cytology, this will quantify the extent of missed disease with the HPV VL triage approach.

Time frame

Day 1

Sponsors and contacts

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Columbia University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Clínica de Familia La Romana, Dominican Republic

Collaborator

Source ClinicalTrials.gov

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