HIV InfectionNCT06708351
Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya, the ENHANCE LINKAge Trial
A study testing Best Practice, Health Promotion and Education and HPV Self-Collection in people with HIV Infection and Human Papillomavirus-Related Cervical Carcinoma, run by Emory University at 1 site in Kenya.
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). Read more about this study
- Who is it for?
- Ages 25 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Human Papillomavirus-Related Cervical Carcinoma, Screening Strategy
- What is being tested?
- Best Practice, Health Promotion and Education and HPV Self-Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,280 participants
- Where
- 1 siteKenya
- Study dates
- 31 Dec 2026to 31 Aug 2030
- Phase
- Interventional
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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site
Kenya Medical Research Institute
Nairobi
Nelly Rwamba Mugo, 254 20 2720030, rwamba@uw.edu
Nelly Rwamba Mugo
About this study
Official title: Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya (ENHANCE LINKAGE)
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.
Read more
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.
Read the 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.
- Being tested
- Best Practice, Health Promotion and Education, HPV Self-Collection, Text Message-Based Navigation Intervention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard care
Health Promotion and EducationOther
Receive instructions on how to use HPV self-testing kit
HPV Self-CollectionProcedure or surgery
Also called At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection
Undergo HPV self-collection
Text Message-Based Navigation InterventionOther
Also called Automated Text Message-Based Navigation, Text Message-Based Navigation
Receive text messages for HPV testing results and triage and treatment reminders
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 to 12 months
Secondary outcomes (4)
Communication of human papillomavirus (HPV) test result to patients via mobile (m)Health messages
Based on confirmation of HPV test results being sent to the participant's phone via two-way text message or mHealth application.
Measured: 1 to 12 months
Receipt of HPV-negative result and guidance for next CC screening
Based on participants responding with a text to indicate that they have received their HPV results.
Measured: 1 to 12 months
Retention in HIV Care (>=2 visits per year)
Between-arm comparison
Measured: 1 to 12 months
HIV viral suppression (undetectable)
between-arm comparison
Measured: 1 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start31 Dec 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- hybrid type 2 implementation-effectiveness cluster randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 2,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michael H Chung, Emory University
- Investigators
- Michael Chung, MD, PhD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708351
- Sponsor's protocol ID
- STUDY00008289
- Other IDs
- U01CA275120-01A1, NCI-2024-08623, EU6378-24, STUDY00008289, P30CA138292
- Status last verified
- Sep 2026
- First submitted
- 25 Nov 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depends on regulations in Kenya regarding IPD