ClinicalTrials.gg
RecruitingNCT07177170OptiTri_GCUpdated Sep 16, 2025

Impact of a Single Versus Multiple Visits on the Cervical Cancer Screening Completeness, Feasibility and Acceptability Among Women Living With HIV in Cameroon

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

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as recruiting.
  • Registered 8 months after the study started (first participant enrolled Dec 2024, registered Aug 2025).
  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,422
Allocation
Non-randomized
Ages
25 Years to 49 Years
Sex
Female
01

Study 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 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 :

  • The performance of urinary HPV testing.
  • The performance of different methods to identify women requiring a treatment.
  • The risk of post-treatment cervical disease.

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 :

  • 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) It will assess the participants' stress levels during the screening process and to identify potential psychosocial support strategies and document the experience of WLHIV and health workers during the screening process and the post-treatment follow-up.

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

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.

Read the detailed description

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 :

  • the performance of urinary HPV testing.
  • the performance of different post-HPV test triage options (partial genotyping, simple or Artifical Intelligence assisted visual inspection, methylation markers)
  • the risk of post-treatment cervical disease and the performance of different cure markers.

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 effectiveness of each implementation strategy (in terms of cascade completeness)
  • To assess the implementation of each 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)
  • To assess the participants' stress levels during the screening process and to identify potential psychosocial support strategies
  • To document the experience of WLHIV and health workers during the screening process and the post-treatment follow-up.
  • To assess the performance of different triage methods among HPV+ participants (partial genotyping, simple or aided visual inspection, S5 methylation)
  • 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 thermal ablation treatment in terms of post-treatment cervical lesions

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.

02

Conditions studied

  • Cervical Cancer Screening
  • HIV

Keywords

  • cervical cancer
  • screening
  • HIV
  • differentiated prestation
  • implementation
  • resource-limited setting
  • thermal ablation
  • HPV test
03

In context

Uterine Cervical Neoplasms

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
25 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.

Inclusion criteria

  • infection
  • receiving antiretroviral therapy
  • living in the department of the study hospital

Exclusion criteria

Exclusion Criteria:

  • ongoing pregnancy
  • hysterectomy
  • treatment of cervical lesion in the past 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 Inclusion deferred if
  • menstrual bleeding
  • post-partum (\<12 weeks after delivery)
  • clinicla signs of cervical or pelvic infection
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
1,422 participants (estimated)

Study arms

  • Active comparator
    Single visit

    All women will be screened using a single-visit approach

    Other: Single visit

  • Experimental
    Differentiated prestation

    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

Interventions

  • OtherDifferentiated 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.

  • OtherSingle visit

    All the steps of the screening (using HPV test) and of the treatment will be performed in a single visit (when possible).

06

What researchers measure

Primary outcomes

  1. Screening completeness

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

    Time frame: 60 days post screening initiation

Secondary outcomes

  1. Screening completeness 2

    Proportion of HPV+ participants completing all screening steps within 120 days of inclusion.

    Time frame: 120 days post screening initiation

  2. Acceptability of the screening delivery strategy

    Questionnaire assessing the acceptability and using a 4 point Likert scale

    Time frame: Baseline (screening)

  3. Triage performance

    Sensitivity, specificity of the triage option to detect CIN2+ and CIN3+ lesion

    Time frame: Baseline (screening)

  4. 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)

  5. 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

07

Study locations

1 of 1 sites recruiting
  • Foumban hospital
    Foumban, Cameroon
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Aug 22, 2025
First posted
Sep 16, 2025
StartActual
Dec 12, 2024
Primary completionEst.
Apr 2026
CompletionEst.
May 2027
Last update
Sep 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07177170
Lead sponsor
Institut de Recherche pour le Developpement
Collaborators
Ecole Polytechnique Fédérale de Lausanne, Centre Pasteur du Cameroun, Centre Hospitalier Simone VEIL de BEAUVAIS, Institut National de la Santé Et de la Recherche Médicale, France, Queen Mary University of London, Hôpitaux Universitaire de Genève, International Agency for Research on Cancer, Programme PACCI, Abidjan, Côte d'Ivoire, RSD Institute, Cameroon
Responsible party
Sponsor
First posted
Sep 16, 2025
Start date
Dec 12, 2024
Primary completion
Apr 2026 (estimated)
Completion
May 2027 (estimated)
Last update
Sep 16, 2025

Study contacts

Andre-Pascal Goura, MD
Contact
cdpoptitri@gmail.com
+227679336464
Pierre Debeaudrap, MD, PhD
study director · Institut de Recherche pour le Développement (IRD)
Joëlle Sobngwi, MD, PhD
principal investigator · RSD Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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