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

NCT04000503CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

University of British Columbia

Enrollment

2019

Start Date

2019-08-01

Completion Date

2021-07-31

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Self-collected HPV testing for cervical cancer screening

Conditions

Human Papillomavirus 16Human Papillomavirus 18Papillomavirus InfectionsCervical CancerPre-Cancerous Dysplasia

Eligibility

Age Range

25 Years – 49 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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

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

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

Secondary Outcomes

HPV prevalence

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

Time frame: Baseline

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

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

Time frame: Baseline

HPV and co-morbid conditions

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

Time frame: Baseline

Barriers and facilitators of engagement in care

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

Time frame: FGDs within 3 months of recruitment completion

Identify mediators of engagement of care

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

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

Locations

Uganda Cancer Institute, Kampala, Uganda

Linked Papers

2022-11-28

Experiences with thermal ablation for cervical precancer treatment after self‐collection HPV‐based screening in the ASPIRE Mayuge randomized trial

AbstractCervical cancer remains a significant public health burden in low‐resourced countries. Thus, the WHO prioritized cervix screening, and recently recommended thermal ablation treatment for cervical precancer. However, there is limited information on side effects during treatment and recovery, and acceptability among those treated. The ASPIRE Mayuge trial recruited women to participate in self‐collection cervix screening between 2019 and 2020 (N = 2019). Screen‐positive women (N = 531, 26.3%) were referred for visual inspection with acetic acid and thermal ablation treatment, per Uganda Ministry of Health recommendations; 71.2% of those referred attended follow‐up. Six months post‐screening, a subset of trial participants were recontacted. Those who received thermal ablation completed a survey assessing side effects during and after the procedure, and willingness to recommend the treatment to others. We summarized the results to describe the side effects and acceptability of thermal ablation treatment. Of 2019 participants, 349 (17%) received thermal ablation. A subset of 135 completed the follow‐up survey, where 90% reported pain during treatment; however, intensity and duration were low. Over a third of women reported problems with recovery for reasons including pain, discharge and bleeding. Regardless, 98% reported they would recommend the treatment to others. The use of thermal ablation to treat cervical precancer appears to be highly acceptable in this population. While many women reported side effects during the procedure and recovery, the majority said they would recommend the treatment to others. However, given the substantial proportion who reported problems with recovery, efforts should be made to provide additional resources to women after receiving thermal ablation treatment for cervical precancer.

2022-04-06

“We Shall Tell them with Love, Inform them what we have Learnt and then Allow them to go” - Men’s Perspectives of Self-Collected Cervical Cancer Screening in Rural Uganda: A Qualitative Inquiry

Uganda has high incidence rates of cervical cancer (47.5/100,000/year) due to limited screening access. In settings where men hold most of the decision-making power, they play an important role in women's uptake of cervical cancer screening. We aimed to capture men's knowledge, beliefs and perspectives about cervical cancer, community-based screening and health system barriers. Focus group discussions were conducted with men in rural Uganda. Data were verbatim translated and transcribed into English. Transcripts were analysed in ATLAS.ti using a deductive approach of thematic content analysis and applied to an implementation research framework. Twenty-three men participated in focus groups. Men held poor knowledge of cervical cancer, its causes and treatment. Men felt screening would be acceptable by women if men and women were educated. Men highlighted health system barriers to accessing screening including: 1) poor-quality health services, 2) large distances to facilities/lack of affordable transportation and 3) lack of health workers/mistreatment by health workers. Men described supporting women through assisting with transportation, psychosocial support and sharing information. They requested services for men to be decentralized alongside community outreaches for cervical cancer screening. Engaging men in the implementation, education and planning of community-based cervical cancer screening programs is critical. Not engaging men is a missed opportunity to provide them with services and education. Concerted efforts must be made in educating men and reducing health system barriers to ensure rural women receive cervical cancer screening and follow-up care in low-income settings. Clinicaltrials.gov, NCT04000503; Registered 27 June 2019.

2020-01-31

Integrated cervical cancer screening in Mayuge District Uganda (ASPIRE Mayuge): a pragmatic sequential cluster randomized trial protocol

AbstractBackgroundCervical cancer is almost entirely preventable through vaccination and screening, yet remains one of the ‘gravest threats to women’s lives’ according to the World Health Organization. Specific high-risk subtypes of human papillomavirus (HR-HPV) are well-established as the primary cause of cervical cancer. Uganda has one of the highest cervical cancer incidence rates in the world (54.8 per 100,000) as a result of limited screening access and infrastructure. The integration of a self-collected cervical cancer screening program using HPV testing within existing community-based primary health care services could increase access to screening and reduce cervical cancer rates among Ugandan women.MethodsUsing a pragmatic, sequential, cluster randomized trial design; we will compare the effectiveness of two cervical cancer screening models for self-collected HPV testing: 1) community health worker recruitment (door-to-door); and 2) community health meetings. In Mayuge district, Uganda, 31 villages are randomized to one of two treatment arms. Due to the nature of this trial, blinding is not possible. Women are eligible to participate if they have no previous history of hysterectomy or treatment for cervical cancer or pre-cancer and are aged 25–49 years old. All participants receive an integrated package of cervical cancer screening and education. Samples are tested for HPV using GeneXpert point of care testing. All women who test positive for HR-HPV types are referred to a designated health centre for follow-up inspection by Visual Inspection with Acetic acid (VIA) and treatment with thermal ablation. The primary outcome for the trial is the number of women who attend follow-up for VIA screening at a designated Health Centre after a positive HR-HPV test out of all women screened per arm. Secondary outcomes include: cervical cancer screening knowledge; patient-reported experience measures for self-collected cervical cancer screening; and HPV incidence.DiscussionResults from this study will inform the national scale-up of cervical cancer screening in Uganda, aligning with the World Health Organization’s target of achieving cervical cancer elimination through the pillar of increased HPV screening coverage.Trial registrationISRCTN,ISRCTN12767014. Registered 14 May 2019,10.1186/ISRCTN12767014;clinicaltrials.gov, NCT04000503; Registered 27 June 2019,https://clinicaltrials.gov/ct2/show/NCT04000503Protocol versionJanuary 8, 2020, version 1.

Linked Investigators

Gina S. Ogilvie

Gina Ogilvie is a Senior Scientist at BCCDC. She is also a Senior Advisor at BC Women's Hospital Health Centre, Assistant Director of the Women's Health Research Institute, and a professor in the UBC School of Population & Public Health. Research Dr. Ogilvie’s clinical and research focuses on both the public health and clinical aspects of reproductive health, human papillomavirus infection and vaccines, HIV in women and care for marginalized populations, and other sexually transmitted infections. She has been awarded with several recognitions and awards, including UBC’s Killam Faculty Research Prizes 2020, ASTDA Annual Legacy Awards 2021, American Sexually Transmitted Diseases Association (ASTDA) Achievement Award 2020, President’s Award, and Medical Staff Association of Children’s and Women’s Health Centre. Dr. Ogilvie is also a Tier 1 Canada Research Chair at Global Control of HPV Related Disease and Cancer. She is principal investigator on over 10 million dollars in research grants and has received funding from PHAC, CIHR, Michael Smith Foundation for Health Research, Canadian Foundation for Innovation and private foundations. Bio Dr. Ogilvie obtained her medical degree and family practice certification at McMaster University, and then did a fellowship in population health at McMaster University. She completed her Masters of Science (MSc) in clinical epidemiology at UBC, focusing on the care of HIV-positive women, and her Doctor of Public Health (DrPH) in HPV primary screening at the University of North Carolina at the Gillings School of Global Public Health. She has published over 150 peer reviewed manuscripts and provides advice and consultation to national and international institutions, including the Canadian Partnership Against Cancer, Public Health Agency of Canada, the World Health Organization (WHO), and Ministries of Health on STI, HIV and HPV vaccine policy and programming

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