Impact of a Single Versus Multiple Visits on the Cervical Cancer Screening Completeness, Feasibility and Acceptability Among Women Living With HIV in Cameroon

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-49
SponsorInstitut de Recherche pour le Developpement

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Differentiated screening delivery

    Other intervention

    More 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 intervention

    All the steps of the screening (using HPV test) and of the treatment will be performed in a single visit (when possible).

Treatment groups

1,422 Participants
are divided into 2 treatment groups
Group A: Single visitActive comparator 1 intervention
Group B: Differentiated prestationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Screening completeness

Proportion of HPV+ participants completing all screening steps within 60 days of inclusion.

Time frame
60 days post screening initiation

Secondary outcomes

1

Screening completeness 2

Proportion of HPV+ participants completing all screening steps within 120 days of inclusion.

Time frame
120 days post screening initiation
2

Acceptability of the screening delivery strategy

Questionnaire assessing the acceptability and using a 4 point Likert scale

Time frame
Baseline (screening)
3

Triage performance

Sensitivity, specificity of the triage option to detect CIN2+ and CIN3+ lesion

Time frame
Baseline (screening)
4

Performance of urinary HPV test

Concordance between HPV test results from urine samples and those from cervical specimen collected by the clinician

Time frame
Baseline (screeening)

Other outcomes

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