Optimization of Cervical Cancer Screening Strategies Among Women Living With HIV: Effectiveness and Implementation of Decentralized Approach Using a Mobile Team With HPV Testing in the Western Region of Cameroon

NCT07181278 | Recruiting

• 3 other identifiers: IRD_2024_CEPED_OptiTri_mobileT22SANIC204ANRS 0467
• Study Type: interventional
• Target: 1,180
• Locations: 1 country
• Sites: 6

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 all the screening and treatment sequences 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. Different strategies for delivering screening with HPV testing for WLHIV are possible. A first approach ("centralized approach") consists of having well equipped reference centres with experienced health workers and referring women to these centers. An alternative consists of having a mobile unit who can bring equipment and health workers and perform the CC screening in the usual places of patient care ("decentralised" or mobile team approach). Each of these two approaches has advantages and limitations in terms of coverage, completeness, cost and quality of screening. It is necessary to evaluate them in real life to inform national decision-makers on the best strategy to use in their countries. The OptiTri-MU study aims to evaluate and compare the effectiveness of these two strategies for delivering CC screening ("centralized" screening versus "decentralized" screening). It will also assess the implementation of each strategy and 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. Design This is a trial in which the intervention (mobile team) will be implemented gradually. All sites starts with the centralized screening strategy. At each period, a new site is ransomly selected and start the the decentralized screening strategy. There will be 6 periods of 10 weeks. The effectiveness of the intervention will be assessed by comparing the outcomes at each site before and after implementation and by comparing the sites with each other. The primary outcome for effectiveness is the screening completeness 120 days after enrollment. 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) 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 Study population. 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; implementation; resource-limited setting; HPV test; decentralization; thermal ablation

Outcome Measures

Primary Outcomes (1)

• Screening completeness

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

  120 days post screening initiation

Secondary Outcomes (5)

• Screening completeness 2

  60 days post screening initiation

• Acceptability of the screening delivery strategy

  Baseline (screening)

• Triage performance

  Baseline (screening)

• Performance of urinary HPV test

  Baseline (screening)

• Post treatment cervical lesion

  12 months post screening

Study Arms (2)

Centralized screening

ACTIVE COMPARATOR

A self collected vaginal sample is collected onsite. All the other screening are performed in a reference centre.

Other: Centralized screening

Decentralized arm (mobile team)

EXPERIMENTAL

A mobile team consisting of midwives and lab technician with a Genexpert platform visits the health centres and perform CC screening with HPV testing and treament when required.

Other: Mobile unit with quasi point of care HPV testing and immediate triage + treatment

Interventions

Mobile unit with quasi point of care HPV testing and immediate triage + treatment OTHER

A mobile team consisting of one or two midwives and a lab technician with a Genexpert platform visits the health centres on a regular basis. After informed consent is granted, participants perform a vaginal self-sample, which is immediately analyzed with the Genexpert plateform. Participants who test HPV positive are invited for immediate triage and treatment if required.

Decentralized arm (mobile team)

Centralized screening OTHER

Self-collected samples are sent to a reference laboratory for HPV testing. Results are communicated to the participants and HPV positive women are invited to go to the reference centre where triage and treatment (when required) are performed.

Centralized screening

Eligibility Criteria

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

You may qualify if:

• Women
• HIV infection
• Age between 25 and 49 years old
• Receiving or starting ARV treatment
• Agreeing to participate in the study and having signed the consent

You may not qualify if:

• Current pregnancy
• Hysterectomy
• Treatment of cervical lesions within 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.);
• Any pathology or concomitant treatment which, in the opinion of the investigators, contraindicates participation or prevents satisfactory participation in the study
• menstrual bleeding
• Postpartum (\<12 weeks after delivery)
• Clinical signs of cervical or pelvic infection

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead
• International Agency for Research on Cancer: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Centre Pasteur du Cameroun: collaborator
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• Queen Mary University of London: collaborator
• Programme PACCI, Abidjan, Côte d'Ivoire: collaborator
• RSD Institute, Cameroon: collaborator
• Centre Hospitalier Simone VEIL de BEAUVAIS: collaborator

Study Sites (6)

Bafoussam Baptist Hospital

Bafoussam, Cameroon

RECRUITING

Bingo Hospital

Bafoussam, Cameroon

RECRUITING

Centre Médical Spécialisé ACHA

Bafoussam, Cameroon

RECRUITING

Hôpital Régional Annexe

Bafoussam, Cameroon

RECRUITING

Bandjoun District Hospital

Bandjoun, Cameroon

RECRUITING

Foumbot District Hospital

Foumbot, Cameroon

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Mobile Health Units; Therapeutics

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

Intervention Hierarchy (Ancestors)

Hospitals; Health Facilities; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Health Services

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: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Stepped-wedge cluster randomized clinical trial

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)