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Context. Cervical cancer (CC) is a leading cause of death among women living with HIV (WLHIV) in resource-limited settings. Yet, effective methods for screening and preventing CC are available. The recommanded approach for CC screening is based on multiple steps, including initial test to detect human papillomavirus (HPV) infection, visual inspection to identify women with HPV at risk for precancerous lesion and treatment when required.
Dropout may occur at these different steps, compromising the success of the CC elimination strategy. Performing the all screening and treatment sequence in a single visit has been recommanded based on the results of a large South African trial. Yet, in many contexts, including those with limited resources, the screening and treatment activities are performed in multiple visites for logistical reasons, resulting in many dropouts. Strategies based on the differentiated prestation approaches, which propose a simplified management centered on the patients preferences, could guide the adaptation of the single-visit approach to account for contextual constraints while maintaining high effectiveness.
The OptiTri-GC study aims to design and assess the impact of a differentiated CC screen and treat strategy in a district hospital; It will assess both its implementation and its effectiveness based on the completeness at each stage of the screening cascade. In addition, it will also include three sub-studies designed to evaluate :
This study has two periods. During the first period, a single visit approach will be used while differentiated approach will be prepared using participatory research. During the second period, the differentiated approach will be implemented. The screening overall completeness will be compared between the two periods to assess the differentiated approach effectiveness.
The study will also assess the implementation of each screening strategy in terms of :
Other study objectives include :
Methodology. Participants will be WLHIV aged 25 to 49 and eligible for CC screening. Health care workers will also be invited to participate to the implementation research. The data collected will be quantitative and qualitative.
Full description
Context. Cervical cancer (CC) is a leading cause of death among women living with HIV (WLHIV) in resource-limited settings. There is compelling evidence that screening for human papillomavirus (HPV) infection by testing is a very sensitive method for identifying women at risk for precancerous lesions of the cervix. But since HPV infections are very common among WLHIV, it is necessary to have secondary triage to identify women who need to be treated.
The HPV-based screening approach includes multiple steps, and dropout may occur at these different steps, compromising the success of the CC elimination strategy. A single-visit screen and treat approach has been recommanded based on the results of a large South African trial. Yet, in many contexts, including those with limited resources, the screening and treatment activities are often performed in multiple visites for logistical reasons, resulting in many dropouts. Strategies based on the differentiated prestation approach, which propose a simplified management centered on the patients preferences, could guide the adaptation of the single-visit approach to account for contextual constraints while maintaining high effectiveness.
The OptiTri-GC study aims to design and assess the impact of a differentiated CC screen and treat strategy in a district hospital; It will assess both its implementation and its effectiveness based on the completeness at each stage of the screening cascade. In addition, it will also include three sub-studies designed to evaluate :
This will be a type 2 hybrid study that combines intervention research and implementation research. A quasi-experimental design ("before - after") combined with case study will be used for the effectiveness component of the research. During the first period, a single visit approach will be used while differentiated approach will be prepared using participatory research. During the second period, the differentiated approach will be implemented.
The general objective of this research is to assess the (cost-)effectiveness and implementation of different the two screening delivery strategies.
Main specific objectives include:
To assess the effectiveness of each implementation strategy (in terms of cascade completeness)
To assess the implementation of each strategy in terms of :
To assess the participants' stress levels during the screening process and to identify potential psychosocial support strategies
To document the experience of WLHIV and health workers during the screening process and the post-treatment follow-up.
To assess the performance of different triage methods among HPV+ participants (partial genotyping, simple or aided visual inspection, S5 methylation)
To assess the performance of HPV testing on a urine sample compared with vaginal self-collected or cervical (clinician-collected) samples
To assess the efficacy of thermal ablation treatment in terms of post-treatment cervical lesions
Methodology. The implementation research will combine quantitative and qualitative methods and will be based on the i-PARHIS model. Participants will be WLHIV aged 25 to 49 and eligible for CC screening. Health care workers will also be invited to participate to the implementation research. The data collected will be quantitative and qualitative. Biomedical data will be collected prospectively. The implementation data will combine routine monitoring data, cross-sectional surveys, interviews and observations. The analysis will be sequential or convergent depending on the stages of the project.
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1,422 participants in 2 patient groups
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Andre-Pascal Goura, MD
Data sourced from clinicaltrials.gov
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