HIV Infections(iSTAR)NCT07225530
Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)
A study testing Screen, Triage, and Treat in people with HIV Infections and HPV Infection, run by Columbia University at 1 site in Dominican Republic.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HPV Infection, Cervical Cancer
- What is being tested?
- Screen, Triage, and Treat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteDominican Republic
- Study dates
- 23 Feb 2026to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dominican Republic1 site, 1 recruiting
- Recruiting
Clínica de Familia La Romana
La Romana
Pamela Baez Caraballo, MD, MSc, 809-813-2934 ext. 130, pamela@clinicadefamilia.org.do
About this study
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.
Read the detailed description
The Dominican Republic (DR) has experienced a high burden of human immunodeficiency virus (HIV) over the last two decades. Unlike the United States, women are represented in almost equal numbers to men in the population living with HIV. Cervical cancer is the most common cancer among Women Living with HIV (WLH) and WLH are more likely to be infected with HPV and have persistent human papillomavirus (HPV) infection leading to precancer. Additionally, Latin America and the Caribbean are second only to sub-Saharan Africa in their cervical cancer burden. The DR has both a higher incidence of cervical cancer and a higher mortality rate from cervical cancer than the rest of the Caribbean. In fact, cervical cancer is the leading cause of cancer death for women 15-44 years of age in the DR. Cervical cancer persists in the DR largely because of the failure of routine screening. Coverage for cervical cancer screening is less than 50%, and fewer than 25% of the screen-positives complete the full round of follow-up care. Screening programs are critical so that every woman with precursor lesions is treated, and avoidable deaths are prevented. For a cervical cancer prevention and control program to have impact, retention in a full cycle of screening and treatment is fundamental.
The purpose of this randomized clinical trial (RCT) is to evaluate, through use of a clinical decision support system (CDSS), the effectiveness of primary screening for HPV using either the iSTAR approach with same day results return and same-day treatment for those eligible compared to standard of care (SOC). The iSTAR approach circumvents the multistep screening process by conducting the screening test (HPV), the triage step (HPV VL), and if suitable for ablative therapy, the treatment procedure (thermocoagulation) in a single visit. Those who are HPV positive and meet the HPV VL triage criteria but are not suitable for ablative therapy (large lesions, upper limit not seen, etc.) are referred to colposcopy services. This study will allow us to evaluate potential strategies for ensuring widespread implementation of Screen, Triage, and Treat in future work.
- Conditions
- HIV Infections, HPV Infection, Cervical Cancer
- Being tested
- Screen, Triage, and Treat
- Keywords
- People living with HIV (PLWH), Cervical cancer screening, Spanish speakers, HPV Infection
- Medical subject headings
- HIV Infections, Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screen, Triage, and TreatOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants randomized to the standard of care group will receive standard examinations and management of screen positives (ablative therapy or colposcopy referral at a follow-up visit). |
| Screen, Triage, and Treat | Experimental | Participants randomized to the screen, triage, and treat group will be examined using the screen and treat approach (same day results and ablative therapy or colposcopy referral, if applicable). Receives: Other: Screen, Triage, and Treat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start23 Feb 2026
- Primary completion1 May 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Clínica de Familia La Romana, Dominican Republic
- Responsible party
- Principal investigator, Rebecca Schnall, RN, MPH, PhD, Columbia University
- Investigators
- Rebecca Schnall, PhD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225530
- Sponsor's protocol ID
- AAAV3441
- Other IDs
- U01CA275110
- Acronym
- (iSTAR)
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)
- ClinicalTrials.gov ID
- NCT07225530
- Acronym / sponsor ID
- (iSTAR) / AAAV3441
- Conditions
- HIV Infections, HPV Infection, Cervical Cancer
- Keywords
- People living with HIV (PLWH), Cervical cancer screening, Spanish speakers, HPV Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Clínica de Familia La Romana, Dominican Republic
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 6 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Dominican Republic (DR) has experienced a high burden of human immunodeficiency virus (HIV) over the last two decades. Unlike the United States, women are represented in almost equal numbers to men in the population living with HIV. Cervical cancer is the most common cancer among Women Living with HIV (WLH) and WLH are more likely to be infected with HPV and have persistent human papillomavirus (HPV) infection leading to precancer. Additionally, Latin America and the Caribbean are second only to sub-Saharan Africa in their cervical cancer burden. The DR has both a higher incidence of cervical cancer and a higher mortality rate from cervical cancer than the rest of the Caribbean. In fact, cervical cancer is the leading cause of cancer death for women 15-44 years of age in the DR. Cervical cancer persists in the DR largely because of the failure of routine screening. Coverage for cervical cancer screening is less than 50%, and fewer than 25% of the screen-positives complete the full round of follow-up care. Screening programs are critical so that every woman with precursor lesions is treated, and avoidable deaths are prevented. For a cervical cancer prevention and control program to have impact, retention in a full cycle of screening and treatment is fundamental.
The purpose of this randomized clinical trial (RCT) is to evaluate, through use of a clinical decision support system (CDSS), the effectiveness of primary screening for HPV using either the iSTAR approach with same day results return and same-day treatment for those eligible compared to standard of care (SOC). The iSTAR approach circumvents the multistep screening process by conducting the screening test (HPV), the triage step (HPV VL), and if suitable for ablative therapy, the treatment procedure (thermocoagulation) in a single visit. Those who are HPV positive and meet the HPV VL triage criteria but are not suitable for ablative therapy (large lesions, upper limit not seen, etc.) are referred to colposcopy services. This study will allow us to evaluate potential strategies for ensuring widespread implementation of Screen, Triage, and Treat in future work.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants randomized to the standard of care group will receive standard examinations and management of screen positives (ablative therapy or colposcopy referral at a follow-up visit). |
| Screen, Triage, and Treat | Experimental | Other: Screen, Triage, and TreatParticipants randomized to the screen, triage, and treat group will be examined using the screen and treat approach (same day results and ablative therapy or colposcopy referral, if applicable). |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screen, Triage, and TreatA 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. | Other | Screen, Triage, and Treat |
Primary outcome
Percentage of Screen-positives Completing Full Screening Cascade
Time frame: 2 Months
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.
Percentage of Women in the HPV+VL Triage Negative Group
Time frame: Day 1
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Schnall, PhD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screen, Triage, and Treat in people with HIV Infections and HPV Infection, run by Columbia University at 1 site in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Schnall, PhD, MPH (212-342-6886, rb897@columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Screen-positives Completing Full Screening Cascade (time frame: 2 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.