Clinical trial · Interventional
Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HIV Infections | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Screen, Triage, and Treat | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- 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).
- type
- EXPERIMENTAL
- label
- Screen, Triage, and Treat
- description
- 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).
- interventionNames
- Other: Screen, Triage, and Treat
Primary outcomes (2)
- measure
- Percentage of Screen-positives Completing Full Screening Cascade
- timeFrame
- 2 Months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available