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
NCT ID: NCT07181278
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1180 participants
INTERVENTIONAL
2025-04-28
2028-08-01
Brief Summary
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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.
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Detailed Description
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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 It is a stepped-wedge cluster randomized trial with primary HIV care unit as clusters and 6 periods of 10 weeks. All sites starts with the centralized screening strategy. At each period, a new site is randomized to the decentralized screening strategy. 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
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Study Design
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RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
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Centralized screening
A self collected vaginal sample is collected onsite. All the other screening are performed in a reference centre.
Centralized screening
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.
Decentralized arm (mobile team)
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.
Mobile unit with quasi point of care HPV testing and immediate triage + treatment
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.
Interventions
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Mobile unit with quasi point of care HPV testing and immediate triage + treatment
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.
Centralized screening
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
Deferred inclusion if
* menstrual bleeding
* Postpartum (\<12 weeks after delivery)
* Clinical signs of cervical or pelvic infection
25 Years
49 Years
FEMALE
No
Sponsors
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International Agency for Research on Cancer
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Centre Pasteur du Cameroun
OTHER
Ecole Polytechnique Fédérale de Lausanne
OTHER
Queen Mary University of London
OTHER
Programme PACCI, Abidjan, Côte d'Ivoire
UNKNOWN
RSD Institute, Cameroon
UNKNOWN
Centre Hospitalier Simone Veil
UNKNOWN
Institut de Recherche pour le Developpement
OTHER_GOV
Responsible Party
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Principal Investigators
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Pierre Debeaudrap, MD, PhD
Role: STUDY_DIRECTOR
Institut de Recherche pour le Développement (IRD)
Joëlle Sobngwi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
RSD Institute
Locations
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Bafoussam Baptist Hospital
Bafoussam, , Cameroon
Bingo Hospital
Bafoussam, , Cameroon
Centre Médical Spécialisé ACHA
Bafoussam, , Cameroon
Hôpital Régional Annexe
Bafoussam, , Cameroon
Bandjoun District Hospital
Bandjoun, , Cameroon
Foumbot District Hospital
Foumbot, , Cameroon
Countries
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Central Contacts
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Facility Contacts
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Director
Role: primary
Director
Role: primary
Director
Role: primary
Director
Role: primary
Director
Role: primary
Director
Role: primary
Other Identifiers
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IRD_2024_CEPED_OptiTri_mobileT
Identifier Type: -
Identifier Source: org_study_id
22SANIC204
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ANRS 0467
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
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