Cervical Cancer ScreeningOptiTri_MTNCT07181278
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
A study testing Mobile unit with quasi point of care HPV testing and immediate triage + treatment and Centralized screening in people with Cervical Cancer Screening and HIV, run by Institut de Recherche pour le Developpement at 6 sites in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 49 years, women only
- Conditions the study is for
- Cervical Cancer Screening, HIV
- What is being tested?
- Mobile unit with quasi point of care HPV testing and immediate triage + treatment and Centralized screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,180 participants
- Where
- 6 sitesCameroon
- Study dates
- 28 Apr 2025to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- Deferred inclusion if
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- menstrual bleeding
- Postpartum (<12 weeks after delivery)
- Clinical signs of cervical or pelvic infection
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Cameroon6 sites, 6 recruiting
- Recruiting
Bafoussam Baptist Hospital
Bafoussam
Director
- Recruiting
Bingo Hospital
Bafoussam
Director
- Recruiting
Centre Médical Spécialisé ACHA
Bafoussam
Director
- Recruiting
Hôpital Régional Annexe
Bafoussam
Director
- Recruiting
Bandjoun District Hospital
Bandjoun
Director
- Recruiting
Foumbot District Hospital
Foumbot
Director
About this study
Official title: Optimization of HPV-based 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
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.
Read more
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.
Read the detailed description
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 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
- Cervical Cancer Screening, HIV
- Being tested
- Mobile unit with quasi point of care HPV testing and immediate triage + treatment, Centralized screening
- Keywords
- cervical cancer, screening, HIV, implementation, resource-limited setting, HPV test, decentralization, thermal ablation
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile unit with quasi point of care HPV testing and immediate triage + treatmentOther
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 screeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Centralized screening | Active comparator | A self collected vaginal sample is collected onsite. All the other screening are performed in a reference centre. Receives: 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. Receives: Other: Mobile unit with quasi point of care HPV testing and immediate triage + treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening completeness
Proportion of HPV+ participants completing all screening steps within 60 days of inclusion.
Measured: 120 days post screening initiation
Secondary outcomes (5)
Screening completeness 2
Proportion of HPV+ participants completing all screening steps within 60 days of inclusion.
Measured: 60 days post screening initiation
Acceptability of the screening delivery strategy
Questionnaire assessing the acceptability and using a 4 point Likert scale
Measured: Baseline (screening)
Triage performance
Sensitivity, specificity of the triage option to detect CIN2+ and CIN3+ lesion
Measured: Baseline (screening)
Performance of urinary HPV test
Concordance between HPV test results from urine samples and those from cervical specimen collected by the clinician
Measured: Baseline (screening)
Post treatment cervical lesion
Frequency of CIN2+ lesion 12 months after treatment and performance of the markers of cure (sensitivity and specificity)
Measured: 12 months post screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start28 Apr 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 1,180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- International Agency for Research on Cancer, Institut National de la Santé Et de la Recherche Médicale, France, Centre Pasteur du Cameroun, Ecole Polytechnique Fédérale de Lausanne, Queen Mary University of London, Programme PACCI, Abidjan, Côte d'Ivoire, RSD Institute, Cameroon, Centre Hospitalier Simone VEIL de BEAUVAIS
- Responsible party
- Sponsor
- Investigators
- Pierre Debeaudrap, MD, PhD, Study director, Institut de Recherche pour le Développement (IRD)Joëlle Sobngwi, MD, PhD, Principal investigator, RSD Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181278
- Sponsor's protocol ID
- IRD_2024_CEPED_OptiTri_mobileT
- Other IDs
- 22SANIC204, ANRS 0467
- Acronym
- OptiTri_MT
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of HPV-based 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
- ClinicalTrials.gov ID
- NCT07181278
- Acronym / sponsor ID
- OptiTri_MT / IRD_2024_CEPED_OptiTri_mobileT
- Conditions
- Cervical Cancer Screening, HIV
- Keywords
- cervical cancer, screening, HIV, implementation, resource-limited setting, HPV test, decentralization, thermal ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,180 participants (estimated)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- International Agency for Research on Cancer, Institut National de la Santé Et de la Recherche Médicale, France, Centre Pasteur du Cameroun, Ecole Polytechnique Fédérale de Lausanne, Queen Mary University of London, Programme PACCI, Abidjan, Côte d'Ivoire, RSD Institute, Cameroon, Centre Hospitalier Simone VEIL de BEAUVAIS
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Centralized screening | Active comparator | Other: Centralized screeningA self collected vaginal sample is collected onsite. All the other screening are performed in a reference centre. |
| Decentralized arm (mobile team) | Experimental | Other: Mobile unit with quasi point of care HPV testing and immediate triage + treatmentA 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. |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile unit with quasi point of care HPV testing and immediate triage + treatmentA 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. | Other | Decentralized arm (mobile team) |
| Centralized screeningSelf-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. | Other | Centralized screening |
Primary outcome
Screening completeness
Time frame: 120 days post screening initiation
Proportion of HPV+ participants completing all screening steps within 60 days of inclusion.
5 secondary outcomes
Screening completeness 2
Time frame: 60 days post screening initiation
Acceptability of the screening delivery strategy
Time frame: Baseline (screening)
Triage performance
Time frame: Baseline (screening)
Performance of urinary HPV test
Time frame: Baseline (screening)
Post treatment cervical lesion
Time frame: 12 months post screening
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Debeaudrap, MD, PhD study director
Institut de Recherche pour le Développement (IRD)
Joëlle Sobngwi, MD, PhD principal investigator
RSD Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile unit with quasi point of care HPV testing and immediate triage + treatment and Centralized screening in people with Cervical Cancer Screening and HIV, run by Institut de Recherche pour le Developpement at 6 sites in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andre-Pascal Goura, MD (+227679336464, cdpoptitri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening completeness (time frame: 120 days post screening initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.