ENHANCE LINKage

ENHANcing CErvical cancer screening and treatment in women LIviNg with HIV in KenyA

Women living with HIV (WLWH) have a very high likelihood of developing and dying from cervical cancer due to the challenges they face in accessing care and treatment in low- and middle-income countries (LMIC) such as Kenya in sub-Saharan Africa (SSA). Despite support from the President’s Emergency Plan for AIDS Relief (PEPFAR) and other donor agencies (Go Further) to screen WLWH at HIV clinics, the number of WLWH identified as having pre-cancerous cervical lesions and successfully receiving treatment remains so low as to have a nearly insignificant impact on cervical cancer morbidity and mortality in LMIC and SSA. In this implementation science study, we propose to work with patients, clinicians, facility managers, communities, and government partners at publicly funded HIV clinics in Kenya to adapt and test methods to effectively screen WLWH for cervical cancer using World Health Organization guidelines, and link screen positive women to treatment in a sustainable manner that not only improves HIV care, but successfully prevents cancer.

Aims

1. Identify and address barriers to integration and uptake of CC screening, completion of triage (assessment for treatment), and treatment in HIV clinical care settings for WLWH in Kenya.
2. Evaluate the implementation and effectiveness of ENHANCE LINKAge in a type 2 hybrid stepped-wedge trial in 9 HIV clinics serving >5,500 patients in Nairobi.
3. Examine sustainability and economic impact(s) of ENHANCE LINKAge.

Approach

Using the Behavior Change Wheel, we will explore (a) the readiness of clinics, personnel, and administrators to adopt and implement CC screening and linkage to subsequent triage/treatment while improving HIV care, and (b) patients’ ability to and attitudes towards administering HPV self-testing at the clinic and completing follow-up VIA triage and treatment. We will use human-centered implementation research techniques to co-design contextually appropriate implementation strategies (the ENHANCE LINKAge package) for enhancing CC screening and completion of VIA triage and treatment in Nairobi, Kenya based on these data.

We will examine HPV self-testing, care navigators, and the WEMA mHealth platform, which supports CC screening and care navigation, in a type 2 hybrid stepped-wedge trial in 9 HIV clinics serving >5,500 patients in Nairobi. We will assess changes in the CC continuum within and between clinics. At 12 months post-initiation of ENHANCE LINKAge, we will assess completion of CC screening (primary implementation outcome) and the proportion of screen-positive WLWH who receive follow-up triage and treatment (primary effectiveness outcome), and secondary HIV outcomes.

Finally, we will use a mixed methods approach to measure sustainment indicators of the multi-component enhanced screening and triage/treatment linkage strategies for an additional 6 months (sustainment), estimate implementation costs, and use modeling to estimate cost-effectiveness of the strategies compared to standard of care in Kenya.

Funding

ENHANCE LINKage is funded through a US National Institutes of Health (NIH)/National Cancer Institute (NCI) grant: U01.