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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое Centralized screening
  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.

Первичные конечные точки

• Screening completeness [Срок оценки: 120 days post screening initiation]

Вторичные конечные точки (5)

• Screening completeness 2 [Срок оценки: 60 days post screening initiation]
• Acceptability of the screening delivery strategy [Срок оценки: Baseline (screening)]
• Triage performance [Срок оценки: Baseline (screening)]
• Performance of urinary HPV test [Срок оценки: Baseline (screening)]
• Post treatment cervical lesion [Срок оценки: 12 months post screening]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

• menstrual bleeding
• Postpartum (<12 weeks after delivery)
• Clinical signs of cervical or pelvic infection

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Cameroon · 6 центров

• Bafoussam Baptist Hospital — Bafoussam
• Bingo Hospital — Bafoussam
• Centre Médical Spécialisé ACHA — Bafoussam
• Hôpital Régional Annexe — Bafoussam
• Bandjoun District Hospital — Bandjoun
• Foumbot District Hospital — Foumbot

Идентификаторы

NCT: NCT07181278 · IRD_2024_CEPED_OptiTri_mobileT · 22SANIC204 · ANRS 0467

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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