Actively Recruiting
Impact of a Single Versus Multiple Visits on the Cervical Cancer Screening Completeness, Feasibility and Acceptability Among Women Living With HIV in Cameroon
Led by Institut de Recherche pour le Developpement · Updated on 2025-09-16
1422
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
Sponsors
I
Institut de Recherche pour le Developpement
Lead Sponsor
E
Ecole Polytechnique Fédérale de Lausanne
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of a Single Versus Multiple Visits on the Cervical Cancer Screening Completeness, Feasibility and Acceptability Among Women Living With HIV in Cameroon
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HIV infection
- Receiving antiretroviral therapy
- Living in the department of the study hospital
- Aged between 25 and 49 years
- Eligible for cervical cancer screening
You will not qualify if you...
- Ongoing pregnancy
- History of hysterectomy
- Treatment of cervical lesion in the past 12 months
- Expected follow-up difficulties (e.g., planned travel, relocation, transfer)
- Any condition or treatment that prevents satisfactory participation as judged by investigators
- Menstrual bleeding at time of inclusion
- Post-partum period less than 12 weeks after delivery
- Clinical signs of cervical or pelvic infection
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Trial Site Locations
Total: 1 location
1
Foumban hospital
Foumban, Cameroon
Actively Recruiting
Research Team
A
Andre-Pascal Goura, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SCREENING
Number of Arms
2
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