Clinical trial NCT06708351: Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya, the ENHANCE LINKAge Trial
Official title: Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya (ENHANCE LINKAGE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Infection
Human Papillomavirus-Related Cervical Carcinoma
Screening Strategy
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-11-27
Enrollment: 2280
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: hybrid type 2 implementation-effectiveness cluster randomized clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background In sub-Saharan Africa (SSA), human papillomavirus (HPV) and HIV create a dual burden of disease that causes significant morbidity and mortality in the form of cervical cancer (CC). Women living with HIV (WLWH) have a six-fold higher risk of developing precancerous lesions that persist and progress to CC, which is the leading cause of cancer mortality among women in Kenya. Significant support from the Go Further campaign, represented by donors such as the President's Emergency Plan for AIDS Relief (PEPFAR), the George W. Bush Institute, UNAIDS, Merck, and Roche, to integrate CC screening into HIV clinics represents an exceptional opportunity to scale CC impact across SSA, but only if implementation science evidence is available to inform strategy. Currently, the impact of Go Further has been undermined by fractured linkages to care and insensitive screening methods; in Kenya, less than 2% of WLWH screened have received appropriate treatment. Implementation science studies are needed to better understand and surmount barriers to integrated care in publicly funded HIV clinics.

Broad objective This study seeks to explore and innovate strategies to overcome patient-, provider-, and system-level barriers to implementing CC screening and referral guidelines, link WLWH who require further diagnostic testing and/or treatment with effective and accessible care, and document services for accountability and quality improvement. In this proposal, our team will apply our extensive implementation science expertise and partnerships with Kenya Ministry of Health (MOH) to adapt and test evidence-based strategies (e.g., HPV self-testing, care navigators, and the WEMA mHealth app \[tested and scaled in Tanzania\]) that address key multi-level barriers identified through a formative, stakeholder-engaged research phase.

Methodology Using the EPIS framework to guide our project, we will: Aim 1a), Explore (engage a multi-disciplinary stakeholder advisory board to co-design the intervention package and prioritize implementation strategies that align with local capacity, opportunities, and motivations; Aim 1b), Prepare (develop tools and strengthen capacity at clinics to implement the strategies; Aim 2), Implement and evaluate the package of implementation strategies via a cluster-randomized stepped wedge trial in 9 clinics (assessing implementation \[provision of CC screening with HPV self-testing\] and effectiveness \[proportion of HPVpositive WLWH who receive subsequent diagnostic triage and/or treatment\] over months 0-12; and Aim 3), assess Sustainability (costs, cost-effectiveness, and transfer of delivery from study to local staff over months 13-18.

Significance of the study The overall goal of this study is to employ rigorous empirical methods to adapt and test implementation strategies that expand the scope of HIV care to screen for and treat early precancerous CC lesions in a sustainable, scalable way. Through partnering with Kenya's MOH, this project will have critical institutional support and dissemination capability, and will directly inform public health practice and policy.

Detailed description: Broad Objectives This study seeks to inform the effective and sustainable integration of early detection and successful treatment of precancerous cervical lesions among women living with HIV (WLWH) ages 25-49 years in HIV care clinics for women in Kenya.

Specific Objectives I. Identify and address barriers to integration and uptake of cervical cancer screening and treatment linkage in HIV care settings in Kenya.

II. Evaluate the implementation and effectiveness of ENHANCE LINKage (HPV self-testing, care navigators, and mHealth that supports screening and treatment linkage) in a hybrid type 2 study, a cluster randomized trial in 20 HIV care clinics.

III. Evaluate sustainability and economic impacts of ENHANCE LINKage.

Eligibility criteria: Inclusion Criteria:

* AIM 1 (PATIENTS): Aged 25-49 years
* AIM 1 (PATIENTS): Female
* AIM 1 (PATIENTS): Willing to participate in a 90-minute audio-recorded focus group discussion (FGD) and
* AIM 1 (PATIENTS): Speak English or Swahili
* AIM 1 (NURSES, CLINICAL STAFF, ADMINISTRATORS): Aged 18 years or older
* AIM 1 (NURSES, CLINICAL STAFF, ADMINISTRATORS): Involved in implementing intervention components
* AIM 1 (STAKEHOLDERS): Adults (aged \>= 18 years) who are healthcare system users, support persons, healthcare providers and administrators, representatives of the government, professional associations, and non-governmental and faith-based organizations
* AIMS 2 AND 3 (CLINIC PROVIDERS): Aged 18 years and older involved in CC screening, triage, and treatment
* AIMS 2 AND 3 (WOMEN LIVING WITH HIV): Ages 25-49 years

Exclusion Criteria:

* AIM 1: Stakeholder Advisory Board (SAB) members who are not engaged in CC work, individuals who have recently retired from the selected clinics, and patients who are attending the clinic for the first time will be excluded from the study
* AIMS 2 AND 3 (WOMEN LIVING WITH HIV): Pregnant women, women =\< 6 weeks postpartum, and women already confirmed to have cervical cancer will be excluded

Primary outcomes:
measure: IMPLEMENTATION OUTCOME: Difference in proportions in cervical cancer (CC) screening uptake between the intervention implementation versus control clinics
timeFrame: 1 to 12 months
measure: EFFECTIVENESS OUTCOME: Difference in the proportion of patients that received follow-up triage (with VIA) or treatment in the implementation intervention versus control clinics
timeFrame: 1 to 12 months
Secondary outcomes:
measure: Communication of human papillomavirus (HPV) test result to patients via mobile (m)Health messages
timeFrame: 1 to 12 months
measure: Receipt of HPV-negative result and guidance for next CC screening
timeFrame: 1 to 12 months
measure: Retention in HIV Care (>=2 visits per year)
timeFrame: 1 to 12 months
measure: HIV viral suppression (undetectable)
timeFrame: 1 to 12 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Michael Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: