Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya, the ENHANCE LINKAge Trial

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.

Conditions

• HIV Infection
• Human Papillomavirus-Related Cervical Carcinoma
• Screening Strategy

Interventions

OTHER

Best Practice

Receive standard care

OTHER

Health Promotion and Education

Receive instructions on how to use HPV self-testing kit

PROCEDURE

HPV Self-Collection

Undergo HPV self-collection

OTHER

Text Message-Based Navigation Intervention

Receive text messages for HPV testing results and triage and treatment reminders

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Michael Chung, MD, PhD · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2029-08-31

Completion

2030-08-31

Countries

• Kenya

Study Locations