About this trial
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 :
* The performance of urinary HPV testing. * The performance of different methods to identify women requiring a treatment. * The risk of post-treatment cervical disease.
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 :
* Success through the measure of fidelity, reach and completeness * Identification of adaptation, barriers and facilitating/leverage factors * Perception, feasibility and acceptability of the screening strategies (by patients and health care workers) It will assess the participants' stress levels during the screening process and to identify potential psychosocial support strategies and document the experience of WLHIV and health workers during the screening process and the post-treatment follow-up.
Other study objectives include :
* To assess the performance of different methods to identify women requiring a treatment * 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 treatment in terms of post-treatment cervical lesions
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HIV infection
receiving antiretroviral therapy
living in the department of the study hospital
Disqualifiers
ongoing pregnancy
hysterectomy
treatment of cervical lesion in the past 12 months
Expected follow-up difficulties: planned absence that could interfere with the participation in the study (e.g., travel abroad, relocation, imminent transfer, etc.);
Trial design
Sequential
Treatments tested in this trial
Differentiated screening delivery
Other interventionMore flexibility in the screening delivery will be offered. A decision aid process will be implemented to help the participants deciding between the two options.
Single visit
Other interventionAll the steps of the screening (using HPV test) and of the treatment will be performed in a single visit (when possible).
Treatment groups
Trial outcomes
Primary outcomes
Screening completeness
Proportion of HPV+ participants completing all screening steps within 60 days of inclusion.
Secondary outcomes
Screening completeness 2
Proportion of HPV+ participants completing all screening steps within 120 days of inclusion.
Acceptability of the screening delivery strategy
Questionnaire assessing the acceptability and using a 4 point Likert scale
Triage performance
Sensitivity, specificity of the triage option to detect CIN2+ and CIN3+ lesion
Performance of urinary HPV test
Concordance between HPV test results from urine samples and those from cervical specimen collected by the clinician
Sponsors and contacts
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Institut de Recherche pour le Developpement
Lead sponsor
Ecole Polytechnique Fédérale de Lausanne
Collaborator
Centre Pasteur du Cameroun
Collaborator
Centre Hospitalier Simone VEIL de BEAUVAIS
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Queen Mary University of London
Collaborator
Hôpitaux Universitaire de Genève
Collaborator
International Agency for Research on Cancer
Collaborator
Programme PACCI, Abidjan, Côte d'Ivoire
Collaborator
RSD Institute, Cameroon
Collaborator