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

NCT07177170 | Recruiting

• 3 other identifiers: IRD_2024_CEPED_OptiTri_GC22SANIC204ANRS-0467
• Study Type: interventional
• Target: 1,422
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cervical cancer; screening; HIV; differentiated prestation; implementation; resource-limited setting; thermal ablation; HPV test

Outcome Measures

Primary Outcomes (1)

• Screening completeness

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

  60 days post screening initiation

Secondary Outcomes (5)

• Screening completeness 2

  120 days post screening initiation

• Acceptability of the screening delivery strategy

  Baseline (screening)

• Triage performance

  Baseline (screening)

• Performance of urinary HPV test

  Baseline (screeening)

• Post treatment cervical lesion

  12 months

Study Arms (2)

Single visit

ACTIVE COMPARATOR

All women will be screened using a single-visit approach

Other: Single visit

Differentiated prestation

EXPERIMENTAL

A more flexible screening approach will be offered based on the participants preference. After counseling (following the decision aid approach), participants may decide to performed the screening in two visits.

Other: Differentiated screening delivery

Interventions

Differentiated screening delivery OTHER

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.

Differentiated prestation

Single visit OTHER

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

Single visit

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV infection
• receiving antiretroviral therapy
• living in the department of the study hospital

You may not qualify if:

• 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.);
• menstrual bleeding
• post-partum (\<12 weeks after delivery)
• clinicla signs of cervical or pelvic infection

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead
• 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

Study Sites (1)

Foumban hospital

Foumban, Cameroon

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Pierre Debeaudrap, MD, PhD

  Institut de Recherche pour le Développement (IRD)

  STUDY DIRECTOR

• Joëlle Sobngwi, MD, PhD

  RSD Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre-Pascal Goura, MD

CONTACT

+227679336464; cdpoptitri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Quasi-experimental design ("before - after") combined with a case study

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 16, 2025
• Study Start: December 12, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)