HIVACCESSNCT06128304
ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services
A study testing Core Implementation strategies and Core+ Enhanced Implementation Strategies in people with HIV and Cervical Cancer, run by University of California, San Diego at 2 sites in 2 countries.
Trial summary
While there has been a significant increase in the uptake of antiretroviral therapy among women living with HIV (WLHIV) in many low- and-middle income countries (LMICs), the coverage of cervical cancer screening and treatment (CCST) among WLHIV remains low. Read more about this study
- Who is it for?
- Ages 25 to 64 years, women only
- Conditions the study is for
- HIV, Cervical Cancer
- What is being tested?
- Core Implementation strategies and Core+ Enhanced Implementation Strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,436 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Nov 2023to 31 Aug 2027
- 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 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women living with HIV
Who cannot join
- -
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
UC San Diego
La Jolla, California, 92093
Joella Phillips, BA, 8589667703 ext. 2695, jiphillips@ucsd.edu
Nigeria1 site, 1 recruiting
- Recruiting
University of Nigeria, Nsukka
Enugu, Enugu State
Echezona Ezeanolue, MD, MPH, +1 7024991082, echezona.ezeanolue@unn.edu.ng
Tonia Onyeka, +234 806 356 3223, tonia.onyeka@unn.edu.ng
About this study
While there has been a significant increase in the uptake of antiretroviral therapy among women living with HIV (WLHIV) in many low- and-middle income countries (LMICs), the coverage of cervical cancer screening and treatment (CCST) among WLHIV remains low. This study aims to leverage the available infrastructure for HIV care and treatment programs in Nigeria to integrate cervical cancer screening and treatment and conduct a cluster randomized, hybrid type III trial design to assess the comparative effectiveness of a Core set of implementation strategies versus a Core+ (enhanced) set of implementation strategies to implement cervical cancer screening, onsite treatment, referral and referral completion, treatment, and retention in care among WLHIV. The overarching goal is to improve the health and life expectancy of WLHIV with co-occurring cervical cancer.
Read the detailed description
Nigeria has one of the largest HIV epidemics in the world with 1.8 million people living with HIV infection. With an estimated female population of 102 million and HIV prevalence of 1.6% among adult females, Nigeria has the largest population of women and the 4th largest number of women living with HIV (WLHIV) in Africa. Although access to antiretroviral therapy (ART) among WLHIV in Nigeria has increased over the years, with over 98% of the 960,000 WLHIV on ART, AIDS-related mortality remains high. In 2020, 16,000 WLHIV died from AIDS- related illnesses including cervical cancer. A pilot implementation program in Nigeria demonstrated that leveraging the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) supported HIV programs for the provision of evidence-based cervical cancer screen-and-treat interventions in WLHIV is feasible. The pilot program demonstrated, however, that tailored implementation strategies will be needed to address specific multilevel barriers along the cancer control continuum in order to address adoption, reach, and sustainability that are necessary for successful scale-up. However, in many African countries with a high burden of both HIV and cervical cancer, there is a paucity of evidence-based implementation strategies to inform effective integration of HIV and cervical cancer services delivery. Objectives of this proposal are to: 1) Refine strategies to integrate cervical cancer screening, treatment and management within existing comprehensive HIV treatment programs and determine implementation readiness; 2) Determine the comparative effectiveness of a Core set of implementation strategies versus Core+ enhanced implementation strategies; and 3) assess sustainment of the integration of cervical cancer screening, treatment, and management intervention into HIV programs. The investigators have assembled a strong team from University of California San Diego, the University of Nigeria, Nsukka, and Northeastern University with expertise in implementation science, HIV care and research, and cancer care and research. Our proposal is responsive to the NCI request for applications (RFA) and consistent with the World Health Organization global plan of elimination of cervical cancer by 2030. If effective, the proposed project will result in a set of feasible, culturally adaptable, and sustainable implementation strategies to integrate evidence-based cervical cancer screening and treatment into HIV programs in order to improve the health and life expectancy of WLHIV.
- Conditions
- HIV, Cervical Cancer
- Being tested
- Core Implementation strategies, Core+ Enhanced Implementation Strategies
- Keywords
- Implementation Science, Cluster randomized trial, Capacity building, Low and middle income countries, Research infrastructure, Exploration Preparation Implementation Sustainment (EPIS), EPIS Framework
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Implementation strategiesOther
Core Implementation Strategies
- Ongoing consultation
- Educational meetings
- Strengthen referral system
- Prepare patients to be active participants
Core+ Enhanced Implementation StrategiesOther
Includes all of the Core implementation strategies and adds:
- Community engagement using Health Beginning Initiative Model
- Smart Cards to facilitate patient engagement
| Study group | Role | What they receive |
|---|---|---|
| Core Implementation Strategies | Active comparator | Core Implementation Strategies
1. Ongoing consultation
2. Educational meetings
3. Strengthen referral system
4. Prepare patients to be active participants Receives: Other: Core Implementation strategies; Other: Core+ Enhanced Implementation Strategies |
| Core+ Enhanced Implementation Strategies | Experimental | Includes all of the Core implementation strategies and adds:
5. Community engagement using Health Beginning Initiative Model
6. Smart Cards to facilitate patient engagement Receives: Other: Core+ Enhanced Implementation Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
Percent of WLHIV who had cervical cancer (CC) screening
Measured: 12 months after enrollment
Sustainment
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.
Measured: 3 months prior to study completion
Secondary outcomes (1)
CCST Effectiveness
Percent of WLHIV treated for pre-invasive cancer who had negative post treatment follow-up screen
Measured: 15 months after treatment of pre-invasive cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start13 Nov 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nigeria Nsukka
- Responsible party
- Principal investigator, Gregory Aarons, University of California, San Diego
- Investigators
- Gregory Aarons, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128304
- Sponsor's protocol ID
- U01CA275118
- Acronym
- ACCESS
- Status last verified
- Jan 2026
- First submitted
- 7 Nov 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olakunde BO, Itanyi IU, Olawepo JO, Liu L, Bembir C, Idemili-Aronu N, Lasebikan NN, Onyeka TC, Dim CC, Chigbu CO, Ezeanolue EE, Aarons GA. Comparative effectiveness of implementation strategies for Accelerating Cervical Cancer Elimination through the integration of Screen-and-treat Services (ACCESS study): protocol for a cluster randomized hybrid type III trial in Nigeria. Implement Sci. 2024 Mar 11;19(1):25. doi: 10.1186/s13012-024-01349-9.
PubMed 38468266
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services
- ClinicalTrials.gov ID
- NCT06128304
- Acronym / sponsor ID
- ACCESS / U01CA275118
- Conditions
- HIV, Cervical Cancer
- Keywords
- Implementation Science, Cluster randomized trial, Capacity building, Low and middle income countries, Research infrastructure, Exploration Preparation Implementation Sustainment (EPIS), EPIS Framework
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,436 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of Nigeria Nsukka
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 13 Nov 2023 (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.
While there has been a significant increase in the uptake of antiretroviral therapy among women living with HIV (WLHIV) in many low- and-middle income countries (LMICs), the coverage of cervical cancer screening and treatment (CCST) among WLHIV remains low. This study aims to leverage the available infrastructure for HIV care and treatment programs in Nigeria to integrate cervical cancer screening and treatment and conduct a cluster randomized, hybrid type III trial design to assess the comparative effectiveness of a Core set of implementation strategies versus a Core+ (enhanced) set of implementation strategies to implement cervical cancer screening, onsite treatment, referral and referral completion, treatment, and retention in care among WLHIV. The overarching goal is to improve the health and life expectancy of WLHIV with co-occurring cervical cancer.
Detailed description
Nigeria has one of the largest HIV epidemics in the world with 1.8 million people living with HIV infection. With an estimated female population of 102 million and HIV prevalence of 1.6% among adult females, Nigeria has the largest population of women and the 4th largest number of women living with HIV (WLHIV) in Africa. Although access to antiretroviral therapy (ART) among WLHIV in Nigeria has increased over the years, with over 98% of the 960,000 WLHIV on ART, AIDS-related mortality remains high. In 2020, 16,000 WLHIV died from AIDS- related illnesses including cervical cancer. A pilot implementation program in Nigeria demonstrated that leveraging the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) supported HIV programs for the provision of evidence-based cervical cancer screen-and-treat interventions in WLHIV is feasible. The pilot program demonstrated, however, that tailored implementation strategies will be needed to address specific multilevel barriers along the cancer control continuum in order to address adoption, reach, and sustainability that are necessary for successful scale-up. However, in many African countries with a high burden of both HIV and cervical cancer, there is a paucity of evidence-based implementation strategies to inform effective integration of HIV and cervical cancer services delivery. Objectives of this proposal are to: 1) Refine strategies to integrate cervical cancer screening, treatment and management within existing comprehensive HIV treatment programs and determine implementation readiness; 2) Determine the comparative effectiveness of a Core set of implementation strategies versus Core+ enhanced implementation strategies; and 3) assess sustainment of the integration of cervical cancer screening, treatment, and management intervention into HIV programs. The investigators have assembled a strong team from University of California San Diego, the University of Nigeria, Nsukka, and Northeastern University with expertise in implementation science, HIV care and research, and cancer care and research. Our proposal is responsive to the NCI request for applications (RFA) and consistent with the World Health Organization global plan of elimination of cervical cancer by 2030. If effective, the proposed project will result in a set of feasible, culturally adaptable, and sustainable implementation strategies to integrate evidence-based cervical cancer screening and treatment into HIV programs in order to improve the health and life expectancy of WLHIV.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Implementation Strategies | Active comparator | Other: Core Implementation strategies, Other: Core+ Enhanced Implementation StrategiesCore Implementation Strategies 1. Ongoing consultation 2. Educational meetings 3. Strengthen referral system 4. Prepare patients to be active participants |
| Core+ Enhanced Implementation Strategies | Experimental | Other: Core+ Enhanced Implementation StrategiesIncludes all of the Core implementation strategies and adds: 5. Community engagement using Health Beginning Initiative Model 6. Smart Cards to facilitate patient engagement |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women living with HIV
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Core Implementation strategiesCore Implementation Strategies 1. Ongoing consultation 2. Educational meetings 3. Strengthen referral system 4. Prepare patients to be active participants | Other | Core Implementation Strategies |
| Core+ Enhanced Implementation StrategiesIncludes 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 Implementation Strategies, Core+ Enhanced Implementation Strategies |
Primary outcome
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.
1 secondary outcome
CCST Effectiveness
Time frame: 15 months after treatment of pre-invasive cancer
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 10 Feb 2026.
- Derived from this study: PubMed 38468266Olakunde BO, Itanyi IU, Olawepo JO, Liu L, Bembir C, Idemili-Aronu N, Lasebikan NN, Onyeka TC, Dim CC, Chigbu CO, Ezeanolue EE, Aarons GA. Comparative effectiveness of implementation strategies for Accelerating Cervical Cancer Elimination through the integration of Screen-and-treat Services (ACCESS study): protocol for a cluster randomized hybrid type III trial in Nigeria. Implement Sci. 2024 Mar 11;19(1):25. doi: 10.1186/s13012-024-01349-9.
- Individual participant dataSharing planned: No
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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.
Gregory Aarons, PhD principal investigator
University of California, San Diego
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Implementation strategies and Core+ Enhanced Implementation Strategies in people with HIV and Cervical Cancer, run by University of California, San Diego at 2 sites in 2 countries.
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 1 inclusion and 1 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 10 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 2 sites in United States, Nigeria. 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 Gregory Aarons, PhD (858-966-7703 ext. 90101, gaarons@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: 12 months after enrollment). 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?
On the ClinicalTrials.gov record for NCT06128304, which also lists 1 linked publication.
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 10 Feb 2026.