An interventional study of Best Practice and Health Promotion and Education in HIV Infection, Human Papillomavirus-Related Cervical Carcinoma and Screening Strategy, sponsored by Emory University. Not yet recruiting at 1 site in Kenya. Open to female participants aged 25 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Emory University · Not applicable, Interventional, and Health services research
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 2,280 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients undergo standard of care at clinics that have VIA testing
Other: Best Practice
Receive standard care
Also known as: standard of care, standard therapy
Receive instructions on how to use HPV self-testing kit
Undergo HPV self-collection
Also known as: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection
Receive text messages for HPV testing results and triage and treatment reminders
Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation
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.
Time frame: 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.
Time frame: 1 to 12 months
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.
Time frame: 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.
Time frame: 1 to 12 months
Retention in HIV Care (>=2 visits per year)
Between-arm comparison
Time frame: 1 to 12 months
HIV viral suppression (undetectable)
between-arm comparison
Time frame: 1 to 12 months
Plan to share: Undecided — Depends on regulations in Kenya regarding IPD
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Aug 2029, 32 months later.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 32 months is above that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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