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

NCT06708351 | Not Yet Recruiting DMC

• 5 other identifiers: STUDY00008289U01CA275120-01A1NCI-2024-08623EU6378-24P30CA138292
• Study Type: interventional
• Target: 2,280
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• IMPLEMENTATION OUTCOME: Difference in proportions in cervical cancer (CC) screening uptake between the intervention implementation versus control clinics

  Modified mixed effects Poisson models will be used to estimate prevalence ratios, including the effect of clinic-level intervention (no intervention versus intervention) with fixed effects for intervention exposure status, and a random effect for clinic. Imbalanced baseline demographic and clinical characteristics across clinics will be included as independent variables in an adjusted model. Statistical differences between intervention versus control clinics during each observation period in terms of indicators will be tested using X\^2 tests while mean differences and 95% confidence intervals (CI) will be tested using t-tests.

  1 to 12 months

• EFFECTIVENESS OUTCOME: Difference in the proportion of patients that received follow-up triage (with VIA) or treatment in the implementation intervention versus control clinics

  Modified mixed effects Poisson models will be used to estimate prevalence ratios, including the effect of clinic-level intervention (no intervention versus intervention) with fixed effects for intervention exposure status, and a random effect for clinic. Imbalanced baseline demographic and clinical characteristics across clinics will be included as independent variables in an adjusted model. Statistical differences between intervention versus control clinics during each observation period in terms of indicators will be tested using X\^2 tests while mean differences and 95% CI will be tested using t-tests.

  1 to 12 months

Secondary Outcomes (4)

• Communication of human papillomavirus (HPV) test result to patients via mobile (m)Health messages

  1 to 12 months

• Receipt of HPV-negative result and guidance for next CC screening

  1 to 12 months

• Retention in HIV Care (>=2 visits per year)

  1 to 12 months

• HIV viral suppression (undetectable)

  1 to 12 months

Study Arms (2)

Aim 2, Arm I (ENHANCE LINKAge)

EXPERIMENTAL

Patients receive HPV self-testing kit and instruction on how to perform HPV self-testing on study. Patients undergo vaginal self-swab and receive results by text message. Patients also receive mobile text message reminders for triage or treatment for women that test positive with HPV.

Other: Health Promotion and Education; Procedure: HPV Self-Collection; Other: Text Message-Based Navigation Intervention

Aim 2 (standard care)

ACTIVE COMPARATOR

Patients undergo standard of care at clinics that have VIA testing

Other: Best Practice

Interventions

Best Practice OTHER

Receive standard care

Also known as: standard of care, standard therapy

Aim 2 (standard care)

Health Promotion and Education OTHER

Receive instructions on how to use HPV self-testing kit

Aim 2, Arm I (ENHANCE LINKAge)

HPV Self-Collection PROCEDURE

Undergo HPV self-collection

Also known as: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection

Aim 2, Arm I (ENHANCE LINKAge)

Text Message-Based Navigation Intervention OTHER

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

Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation

Aim 2, Arm I (ENHANCE LINKAge)

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Kenya Medical Research Institute

Nairobi, Kenya

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Practice Guidelines as Topic; Standard of Care; Health Promotion; Educational Status

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Michael Chung, MD, PhD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandine Zoonekyndt-Ballart

CONTACT

404-727-1210; aballa3@emory.edu

Mohammed K Ali, MD, MSc, MBA

CONTACT

404-727-9776; mkali@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: hybrid type 2 implementation-effectiveness cluster randomized clinical trial

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: March 31, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2030
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

KE (1)