An interventional study of Mobile unit with quasi point of care HPV testing and immediate triage + treatment and Centralized screening in Cervical Cancer Screening and HIV, sponsored by Institut de Recherche pour le Developpement. Recruiting at 6 sites in Cameroon. Open to female participants aged 25 Years to 49 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Institut de Recherche pour le Developpement · Not applicable, Interventional, and Screening
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 study will also assess the implementation of each screening strategy in terms of :
Other study objectives include :
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 study will also assess the implementation of each screening strategy in terms of :
Other study objectives include :
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 1,180 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Institut de Recherche pour le Developpement is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Deferred inclusion if
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A self collected vaginal sample is collected onsite. All the other screening are performed in a reference centre.
Other: Centralized screening
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
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.
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.
Screening completeness
Proportion of HPV+ participants completing all screening steps within 60 days of inclusion.
Time frame: 120 days post screening initiation
Screening completeness 2
Proportion of HPV+ participants completing all screening steps within 60 days of inclusion.
Time frame: 60 days post screening initiation
Acceptability of the screening delivery strategy
Questionnaire assessing the acceptability and using a 4 point Likert scale
Time frame: Baseline (screening)
Triage performance
Sensitivity, specificity of the triage option to detect CIN2+ and CIN3+ lesion
Time frame: Baseline (screening)
Performance of urinary HPV test
Concordance between HPV test results from urine samples and those from cervical specimen collected by the clinician
Time frame: Baseline (screening)
Post treatment cervical lesion
Frequency of CIN2+ lesion 12 months after treatment and performance of the markers of cure (sensitivity and specificity)
Time frame: 12 months post screening
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Jul 2027, 26 months after the start.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's planned 26 months is below that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Institut de Recherche pour le Developpement