ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services (ACCESS)
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ClinicalTrials.gov Identifier: NCT06128304 |
Recruitment Status :
Recruiting
First Posted : November 13, 2023
Last Update Posted : January 3, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Cervical Cancer | Other: Core Implementation strategies Other: Core+ Enhanced Implementation Strategies | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2436 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services |
Actual Study Start Date : | November 13, 2023 |
Estimated Primary Completion Date : | August 31, 2026 |
Estimated Study Completion Date : | August 31, 2027 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Core Implementation Strategies
Core Implementation Strategies
|
Other: Core Implementation strategies
Core Implementation Strategies
Other: Core+ Enhanced Implementation Strategies Includes all of the Core implementation strategies and adds: 5. Community engagement using Health Beginning Initiative Model 6. Smart Cards to facilitate patient engagement |
Experimental: Core+ Enhanced Implementation Strategies
Includes all of the Core implementation strategies and adds: 5. Community engagement using Health Beginning Initiative Model 6. Smart Cards to facilitate patient engagement |
Other: Core+ Enhanced Implementation Strategies
Includes all of the Core implementation strategies and adds: 5. Community engagement using Health Beginning Initiative Model 6. Smart Cards to facilitate patient engagement |
- Reach [ Time Frame: 12 months after enrollment ]Percent of WLHIV who had cervical cancer (CC) screening
- Sustainment [ Time Frame: 3 months prior to study completion ]Provider Report of Sustainment Scale (PRESS; Moullin et al., 2021). The PRESS has 3-items scored from 0 "not at all" to 4 "to a very great extent" where higher scores indicate better evidence-based practice sustainment.
- CCST Effectiveness [ Time Frame: 15 months after treatment of pre-invasive cancer ]Percent of WLHIV treated for pre-invasive cancer who had negative post treatment follow-up screen
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Ages Eligible for Study: | 25 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women living with HIV
Exclusion Criteria:
-
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06128304
Contact: Gregory Aarons, PhD | +1 8583350700 | gaarons@health.ucsd.edu | |
Contact: Echezona Ezeanolue, MD, MPH | +234 803 773 9972 | echezona.ezeanolue@unn.edu.ng |
United States, California | |
UC San Diego | Recruiting |
La Jolla, California, United States, 92093 | |
Contact: Joella Phillips, BA 858-966-7703 ext 2695 jiphillips@ucsd.edu | |
Nigeria | |
University of Nigeria, Nsukka | Recruiting |
Enugu, Nigeria | |
Contact: Echezona Ezeanolue, MD, MPH +1 7024991082 echezona.ezeanolue@unn.edu.ng | |
Contact: Tonia Onyeka +234 806 356 3223 tonia.onyeka@unn.edu.ng |
Principal Investigator: | Gregory Aarons, PhD | University of California, San Diego |
Responsible Party: | Gregory Aarons, Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT06128304 |
Other Study ID Numbers: |
U01CA275118 ( U.S. NIH Grant/Contract ) |
First Posted: | November 13, 2023 Key Record Dates |
Last Update Posted: | January 3, 2024 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Implementation Science Cluster randomized trial Capacity building Low and middle income countries |
Research infrastructure Exploration Preparation Implementation Sustainment (EPIS) EPIS Framework |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases |
Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases |