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Completed

NCT Number: NCT04000503

Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge)

The purpose of this pragmatic cluster randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV testing in a rural, low-resource setting: 1) community health workers recruiting women door-to-door and 2) community health workers recruiting women at community health meetings.

This study will also help to further understand how current patient referral systems are working between health facilities, patient and provider preferences for integrated care and health system related barriers to integrated cervical cancer screening.

Hypothesis: More women will receive screening via the community health meeting but the engagement to care (i.e., visual inspection with acetic acid-our main outcome) will be greater in the door-to-door arm.

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Key information

Conditions

Human Papillomavirus 16 Cervical Cancer Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus 18 Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Cancerous Dysplasia Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

25 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Uganda Cancer Institute

Kampala, Uganda

About this study

A cluster randomized control trial will be conducted with the objective of understanding differences in the effectiveness of cervical cancer screening models using self-collected HPV testing on engagement in care. In 31 villages, women will be recruited for self-collected cervical cancer and sexually transmitted infection (STI) screening by: 1) Community health worker recruitment for self-collection (door-to-door), 2) community health meetings. Visual inspection with acetic acid (VIA), cryotherapy and thermocoagulation will be offered in local health facilities for all women who test positive for high-risk (HR)-HPV types. Women needing advanced cancer care will be referred to the Uganda Cancer Institute in Kampala.

The unit of randomization (2 arms) will be villages and the analysis will also account for clustering within this unit or randomization. All participants will receive an integrated package of cervical cancer screening and education and will participate in a survey at baseline. Samples will be tested using GeneXpert (XpertHPV) point of care testing at the Kigandalo health facility for HPV and high risk HPV (HR-HPV). Intervention arms will be implemented in phases by year to avoid temporal contamination.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with no previous history of hysterectomy
  • aged 25-49 years old
  • no previous history of treatment for cervical cancer
  • provided written informed consent.

Exclusion criteria

  • Women who are under 25 or over 49 years of age,
  • who have previously had a hysterectomy or been treated for cervical cancer
  • unable to provided informed consent.

Treatment and study plan

Self-collected HPV testing for cervical cancer screening

Behavioral

Self-collection cervical cancer screening, STI screening, and education on HIV by a community health worker. Women who test positive for high-risk HPV types will be referred to a designated health centre for VIA follow-up and treatment if indicated.

Primary outcomes

  1. VIA follow-up and treatment when indicated (screen and treat)

    Time frame: Outcome measured within 6 weeks of self-collection for HPV test

    Proportion of total screened women who complete VIA follow-up and treatment after testing positive for high-risk HPV type

Secondary outcomes

  1. HPV prevalence

    Time frame: Baseline

    Total number of women who test positive for HPV out of the total number of samples obtained

  2. STI-HPV co-infection rate (Gonorrhea, Syphilis, etc.)

    Time frame: Baseline

    Total number of women who test positive for STIs out of total number of women who test positive for HPV; total number of women who test negative for STIs out of total number of women who test positive for HPV; total number of women who test positive for STIs out of total number of women who test negative for HPV; total number of women who test negative for STIs out of total number of women who test negative for HPV

  3. HPV and co-morbid conditions

    Time frame: Baseline

    Association (adjusted OR) estimated between HPV and HIV; other STIs

  4. Barriers and facilitators of engagement in care

    Time frame: FGDs within 3 months of recruitment completion

    Semi-structured focus group discussions with women who did and did not attend follow-up screening in each study arm.

  5. Identify mediators of engagement of care

    Time frame: Outcome measured within 6 weeks of self-collection for HPV test

    Mediation analysis using counterfactual approach to assess mediating effect of patient reported experience, knowledge change and co-infection status with other STIs on engagement in care after positive HR-HPV test

Other outcomes

  1. Cost-effectiveness of each model of community-based cervical cancer screening

    Time frame: Modeled lifetime estimates after 1 year follow-up

    Measured using years of lives saved compared between each study arm and the ICER

  2. Process evaluation for integrated community-based cervical cancer screening

    Time frame: Within 6 months of final recruitment

    Evaluating reach, fidelity, barriers and facilitators of implementation in each arm from the community and health system perspective using mixed methods

  3. Male partner knowledge of cervical cancer screening

    Time frame: Baseline

    Assess men's knowledge level of HPV and cervical cancer and determine which factors impact the supportiveness towards a partner seeking screening.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Uganda Cancer Institute

Registry information

Official study title

Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge): A Pragmatic Cluster Randomized Control Trial

Acronym: ASPIRE

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 27, 2019
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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