CHILI PROJECT
CHILI Project CHILI project which is Community Based HPV screening Implementation in Low- and middle-Income countries, started in 2021. This is a five-year study aimed to evaluate the acceptability, feasibility and cost-effectiveness of the Horizon 2020 ELEVATE cervical cancer screening tool in LMICs. The concept of the CHILI project is to design a multidisciplinary intervention to enhance screening coverage for cervical cancer, particularly for women in LMICs. The CHILI project supported by the European Union’s Horizon 2020 Framework Program for Research and Innovation Action, is based in Uganda, Mozambique, Ethiopia and Cambodia. For Uganda, the Project is made up of the Formative research component, the Adaptation Protocol that enrolled 112 participants, the Survey and Discrete Choice Experiment that enrolled 600 participants and Piloting of the ELEVATE tool, all from the age of 25 to 65 years and residents of Mukono and Wakiso districts. It is the intention of the CHILI consortium to develop a strategy that will bring cervical cancer screening to women, and not the other way around. Therefore, the device needs to be adapted and validated in these new contexts. Especially the cost of the device needs to be reduced as to afford scaling-up.
The approach of the CHILI project is three-fold. First, social science investigations will be conducted to understand current screening practices and to define a tailored strategy, including the new screening tool, that can be integrated in the current health system. Secondly, engineers will validate the HPV self-testing device and will adapt it to reduce the unit price and to enable large-scale manufacturing at an affordable cost. Finally, public health specialists and health economists will evaluate the implementation of the new screening tool during a pilot study to assess its appropriateness and cost-effectiveness.
Objectives of the study;
- To understand current cervical cancer screening practices and to define new strategies that include the ELEVATE self-sampling test and meet the conditions and requirements of the local context to increase screening coverage in the selected LMICs.
- To adapt and upscale the ELEVATE screening device to be used as a universal screening test in LMICs.
- To assess the adapted ELEVATE screening device, determining its user acceptability, uptake and cost effectiveness, by implementing and evaluating the new screening strategies in the selected LICs.
MAGY STUDY
MAGY which is a multi-site study for Adolescent Girls and Young Women for future HIV vaccines and antibodies for prevention started in 2023. The MAGY study in collaboration with IAVI is based in four countries namely Uganda (UVRI-IAVI), Zambia (CFHRZ), Kenya (KAVI-ICR) and South Africa (Aurum). The study focuses on AGYW from the ages of 15 to 24 years that are at risk of acquiring HIV and are living or working from around fishing communities. It is made up of a prevention package that is given to the AGYW in terms of HIV prevention, STI management, GBV management as well as Sexual Reproductive health services. This study aims to explore the participation of AGYW in future trials as it deals with Adolescent Girls and Young Women from fishing communities around Lake Victoria. On top of that, the AGYW are provided a skills training program such as hairdressing, computer skills and hand crafts as capacity building. The MAGY study along with the Social Behavioral Research component is as well made up of the clinical component that has mucosal sample collection; the use of soft cups, cytobrushes and vaginal swabs and Longitudinal Sub-study that includes Leukapheresis, Fine Needle Aspiration and Large Blood Draws.
The MAGY study has three main objectives;
- To investigate the factors that influence the design and participation in clinical trials of HIV vaccine and bnAb product candidates for AGYW.
- To establish AGYW clinical trial preparedness cohorts for the evaluation of enhanced broadly neutralizing antibodies as a long-acting injectable HIV prevention product.
- To characterize peripheral immune cells via the least invasive sampling approaches for assessment or prediction of the suitability of HIV vaccine candidates for AGYW.
PURPOSE 1 STUDY
PURPOSE 1 which stands for Phase 3, Double- Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long- Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/ Tenofovir Alafenamide for Pre- Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection started in 2022 and has the main objective of evaluating the efficacy of lenacapavir (LEN) and emitricitabine/ tenofovir alafenamide (F/TAF) in preventing the risk of HIV-1 infection relative to the background HIV-1 incidence rate. The PURPOSE 1 study includes a cross-sectional study which has the Incidence phase, the Randomized phase a LEN Open Label Extension phase and Pharmacokinetic Tail Phase.
The PURPOSE I study in partnership with Gilead Sciences, Inc. is based in approximately 25 centers in South Africa and Uganda. In Uganda there are three sites that work on the PURPOSE study namely; Makerere- Kalangala, AMBSO and MUJHU with each site recruiting a total number of 250 cisgender Adolescent Girls and Young Women at risk of acquiring HIV-1 infection from the age of 16 to 25 years.
The study objectives are;
- The primary objective of the Incidence phase of the study is to estimate the HIV-1 background incidence rate.
The primary objective of the Randomized phase of the study is;
- To evaluate the efficacy of LEN for HIV-1 pre-exposure prophylaxis (PrEP) in Adolescent girls and Young Women at risk of HIV-1 infection
- To evaluate the efficacy of F/TAF for HIV-1 PrEP in AGYW at risk of HIV-1 infection.
