An interventional study of Differentiated screening delivery and Single visit in Cervical Cancer Screening and HIV, sponsored by Institut de Recherche pour le Developpement. Recruiting at 1 site in Cameroon. Open to female participants aged 25 Years to 49 Years. Per ClinicalTrials.gov, last updated 2025-09-16.
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 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 :
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 :
Other study objectives include :
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.
Context. Cervical cancer (CC) is a leading cause of death among women living with HIV (WLHIV) in resource-limited settings. There is compelling evidence that screening for human papillomavirus (HPV) infection by testing is a very sensitive method for identifying women at risk for precancerous lesions of the cervix. But since HPV infections are very common among WLHIV, it is necessary to have secondary triage to identify women who need to be treated.
The HPV-based screening approach includes multiple steps, and dropout may occur at these different steps, compromising the success of the CC elimination strategy. A single-visit screen and treat approach 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 often performed in multiple visites for logistical reasons, resulting in many dropouts. Strategies based on the differentiated prestation approach, 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 :
This will be a type 2 hybrid study that combines intervention research and implementation research. A quasi-experimental design ("before - after") combined with case study will be used for the effectiveness component of the research. 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 general objective of this research is to assess the (cost-)effectiveness and implementation of different the two screening delivery strategies.
Main specific objectives include:
To assess the implementation of each strategy in terms of :
Methodology. The implementation research will combine quantitative and qualitative methods and will be based on the i-PARHIS model. 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. Biomedical data will be collected prospectively. The implementation data will combine routine monitoring data, cross-sectional surveys, interviews and observations. The analysis will be sequential or convergent depending on the stages of the project.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 1,422 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:
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.
All women will be screened using a single-visit approach
Other: Single visit
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
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.
All the steps of the screening (using HPV test) and of the treatment will be performed in a single visit (when possible).
Screening completeness
Proportion of HPV+ participants completing all screening steps within 60 days of inclusion.
Time frame: 60 days post screening initiation
Screening completeness 2
Proportion of HPV+ participants completing all screening steps within 120 days of inclusion.
Time frame: 120 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 (screeening)
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
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Apr 2026, 16 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 16 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.
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