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

Summary

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.

Conditions

• Cervical Cancer Screening
• HIV

Interventions

OTHER

Differentiated screening delivery

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.

OTHER

Single visit

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

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne

  collaborator OTHER

• Centre Pasteur du Cameroun

  collaborator OTHER

• Centre Hospitalier Simone Veil

  collaborator UNKNOWN

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Queen Mary University of London

  collaborator OTHER

• Hôpitaux Universitaire de Genève

  collaborator UNKNOWN

• International Agency for Research on Cancer

  collaborator OTHER

• Programme PACCI, Abidjan, Côte d'Ivoire

  collaborator UNKNOWN

• RSD Institute, Cameroon

  collaborator UNKNOWN

• Institut de Recherche pour le Developpement

  lead OTHER_GOV

Principal Investigators

• Pierre Debeaudrap, MD, PhD · Institut de Recherche pour le Développement (IRD)

• Joëlle Sobngwi, MD, PhD · RSD Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

25 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-12

Primary Completion

2026-04-30

Completion

2027-05-31

Countries

• Cameroon

Study Locations