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BackgroundIn many low-resourced settings, self-collected HPV-based cervical cancer screening (SCS) is being rolled out through task shifting to community health workers (CHWs). Process evaluations are needed to ensure SCS programs are effective and translate to community-based contexts.MethodsThe Advances in Screening and Prevention in Reproductive Cancers (ASPIRE) study in Mayuge, Uganda was a two-arm, pragmatic randomized trial comparing two SCS implementation strategies facilitated by CHWs: Door-to-door and Community health day recruitment. This adjunct study uses the RE-AIM evaluation framework to assess the Reach, Efficacy, Adoption, Implementation and Maintenance of each implementation strategy in a subpopulation using process data collected throughout the trial.ResultsOf the trial population (n=2019), 781 women participated in both the baseline and exit surveys (door-to-door: n=406; community health day: n=375) and are included in this analysis. Both implementation strategies demonstrated high Reach, Efficacy, Adoption, Implementation and Maintenance. Trial consent rate was high and 100% of consenting participants in both arms participated in SCS (Reach). Follow-up rates among HPV positive participants were also high in both arms (door-to-door: 84% and community health day: 74%) (Efficacy). The intervention employed 61 CHWs, 7 nurses, 3 health facilities and other local staff within the health system to implement the intervention (Adoption). The community health day arm received HPV screening results and visual inspection with acetic acid (VIA) quicker than the door-to-door arm, but reported higher dissatisfaction with wait times (Implementation). While women had knowledge of cervical cancer symptoms and prevention measures at six-months post-intervention, no one in either arm recalled that cervical cancer could be asymptomatic (Maintenance).ConclusionBoth SCS implementation strategies performed well, demonstrating high Reach, Efficacy, Adoption, Implementation and Maintenance throughout participating communities. Implementing pragmatic approaches including task-shifting to CHWs can reduce health worker burden and improve screening access in low-resourced, community-based settings.

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.

BACKGROUND In Uganda, cervical cancer (CaCx) is the leading cancer, accounting for 35.7% of all cancer cases in females and 20.5% of all cancer cases overall. While CaCx is preventable, human papillomavirus vaccination rates in Uganda are OBJECTIVE To describe the implementation and experiences of a telemedicine system for improving CaCx screening in Uganda. METHODS The study was conducted between 2019 and 2021 at the Uganda Cancer Institute in Kampala and at its four satellite clinics in Arua, Mayuge, Mbarara, and Jinja districts. We implemented a mobile phone-based telemedicine system to support data capture and sharing for remote consultation, monitoring, and development of artificial intelligence (AI) models for automatic analysis of cervicographs. We conducted focus group discussions with staff at the screening clinics (n=27) and women undergoing screening (n=15) about their experiences and perceptions of the system, as well as taking field observations of the screening process and utilization of the telemedicine system. RESULTS The system consisted of the Gynocular portable colposcope coupled with a Samsung smartphone with the open-source data capture app Open Data Kit (ODK), and a centralized ODK Aggregate server which the consultant gynecologists would log in, view the data dashboard, and give a second opinion when requested. We also made a custom mobile app into which the AI model was deployed for testing. We screened 2682 women, with VIA positivity of 12%. Qualitative findings show that the patients and health workers were positive about the system, highlighting the following benefits: better visualization on the smartphone screen, ability to get a second opinion, and ease of communication among the nurses to discuss cases, and with patients to explain the findings or treatment by showing them the pictures of their cervix. Other perceived benefits included improved clinical data management, supporting performance monitoring and feedback, and “modernization” of screening and thus increased trust in the otherwise simple VIA procedure. We also observed that the time needed to train the nurses on the system was short, about 2-3 days, but ongoing supervision was needed to ensure the VIA assessments were correct. Only a few patients expressed concern about the privacy of their information, but these concerns were easily allayed with explanations of the data collection and handling. CONCLUSIONS This study demonstrates the feasibility and value of digital health tools in cervical cancer screening in Uganda, especially with regards to improving patient experience, and the quality of screening services.

Cervical 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.

To understand the relationship between informed choice and long-acting reversible contraceptive (LARC) use among women aged 15-49 years in Uganda after adjusting for potential confounding.This cross-sectional study uses data from the 2016 Uganda Standard Demographic and Health Survey. Thomas-Rao corrections to a χIn all, 3646 women were included in the analysis and 975 reported using a LARC. In the design-adjusted multivariable analysis, the odds of reporting LARC usage were 1.98 (95% confidence interval 1.61-2.43) times higher among women who reported informed choice compared with those who did not. The subsequent propensity score analysis reported similar findings.Providing informed choice can help to increase the number of women who use LARC in Uganda. As such, the Ugandan Ministry of Health should further expand access to family planning counseling as it could contribute to the reduction of unplanned pregnancies across Uganda with the use of LARC.

Objective To understand the knowledge, preferences, and barriers for self-collected cervical cancer screening (SC-CCS) and follow-up care at the individual and health system level to inform the implementation of community-based SC-CCS. Methods Surveys and focus group discussions (FGDs) with women and FGDs with healthcare providers were conducted in Uganda. Survey data were analyzed using frequencies and FGD data were analyzed using thematic content analysis. Data were triangulated between methods. Results Sixty-four women were surveyed and 58 participated in FGDs. Facilitators to screening access included decentralization, convenience, privacy, confidentiality, knowledge, and education. Barriers to accessing screening included lack of transportation and knowledge, long wait times, difficulty accessing health care, and lack of trust in the health system. Additional implementation challenges included insufficiently trained human resources and lack of infrastructure. Conclusion Integrating SC-CCS within rural health systems in low-resource settings has been under-evaluated. Community-based SC-CSS could prevent high cervical cancer-related mortalities while working within the human and financial resource limitations of rural health systems. SC-CCS is acceptable to women and healthcare providers. By addressing rural women's preferences and barriers to care, decision-makers can build health systems that provide community-centered care close to women's homes across the care continuum.

IntroductionLong-acting reversible contraceptive (LARC) methods are superior to other modern birth control methods in preventing pregnancy as they are highly effective and have a low failure rate. The Ugandan Ministry of Health has prioritized providing long-acting reversible contraception (LARC) and ensuring informed choice within the context of family planning. This study aims to understand the relationship between informed choice and LARC use among women aged 15-49 in Uganda after adjusting for potential confounding.MethodsThis cross-sectional study utilizes data from the 2016 Uganda Standard Demographic and Health Survey. Thomas-Rao corrections to a chi-square test were used for the bivariable analysis. A design-adjusted multivariable logistic regression was used to estimate the association between informed choice and LARC use. Propensity score matching was conducted as a sensitivity analysis.ResultsIn all, 3,646 women were included in the analysis and 975 reported using a LARC. In the design- adjusted multivariable analysis, the odds of reporting LARC usage were 1.98 (95% CI 1.61 - 2.43) times higher among women who reported informed choice compared to those who did not. The subsequent propensity score analysis reported similar findings.DiscussionProviding informed choices can help increase the number of women who utilize LARCs in Uganda. As such, the Ugandan Ministry of Health should further expand access to family planning counselling as it could contribute to the reduction of unplanned pregnancies across Uganda through the use of LARCs.Significance: There is currently no research on the association between informed choice and long-term reversible contraception (LARC) use in Uganda. More broadly, research in relation to informed choice and LARC use in sub-Saharan Africa is largely descriptive. This association is important to understand because Uganda has one of the highest unplanned pregnancy and fertility rates in the world. The study will contribute to a better understanding of family planning counselling in Uganda, which may be useful in developing future family planning programs and interventions. As such, this will help reduce the overall unplanned pregnancy rate in Uganda.

ObjectiveUnderstanding the side effects and acceptability of thermal ablation (TA) is necessary before large-scale application in screen-and-treat programmes can be justified in low-income and middle-income countries (LMICs).DesignArticles were selected for inclusion by two independent reviewers. Risk of bias was assessed using the Downs and Black’s criteria. Summary data were extracted, and authors contacted for data when necessary. Proportions of interest and 95% CIs were estimated using a random effects model. Subgroup analysis was performed based on place of treatment and timing of post-treatment follow-up. Heterogeneity was estimated using the I2.Eligibility criteriaStudies that reported one or more side effects or patient acceptability measures after treatment of the cervix using TA in women living in LMICs who completed a cervical cancer screening test. Included articles were clinical trials or observational studies available in English and published before 18 December 2020.Information sourcesOvid MEDLINE, EMBASE, CINAHL, CAB Global Health and WHO Global Index Medicus were searched for this systematic review and meta-synthesis.ResultsA total of 1590 abstracts were screened, 84 full text papers reviewed and 15 papers selected for inclusion in the qualitative review, 10 for meta-synthesis (N=2039). Significant heterogeneity was found in screening tests used to identify women eligible for TA and in methods to ascertain side effects. The most commonly reported side effect during treatment was pain (70%, 95% CI 52% to 85%; I2=98.01%) (8 studies; n=1454). No women discontinued treatment due to pain. At treatment follow-up, common side effects included vaginal discharge (72%, 95% CI 18% to 100%; I2=99.55%) (5 studies; n=771) and bleeding (38%, 95% CI 15% to 64%; I2=98.14%) (4 studies; n=856). Satisfaction with treatment was high in 99% (95% CI 98% to 100%; I2=0.00%) of women (3 studies; n=679).ConclusionsTA results in a number of common side effects, though acceptability remains high among women treated in LMICs. Standardised side effect and acceptability reporting are needed as TA becomes more readily available.PROSPERO registration numberCRD42020197605.

Cervical cancer is the most common cancer affecting sub-Saharan African women and is prevalent among HIV-positive (HIV+) individuals. No comprehensive profiling of cancer genomes, transcriptomes or epigenomes has been performed in this population thus far. We characterized 118 tumors from Ugandan patients, of whom 72 were HIV+, and performed extended mutation analysis on an additional 89 tumors. We detected human papillomavirus (HPV)-clade-specific differences in tumor DNA methylation, promoter- and enhancer-associated histone marks, gene expression and pathway dysregulation. Changes in histone modification at HPV integration events were correlated with upregulation of nearby genes and endogenous retroviruses.

BackgroundCervical 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.

Highlights • This is one of the first studies on cervical cancer survival in a low-income country. • In Uganda, cervical cancer is often incompletely treated and survival remains poor. • HIV infection in this cohort was not associated with stage at diagnosis. • HIV was weakly associated with shorter survival., Our objective was to determine how HIV infection impacts cervical cancer stage at presentation and overall survival (OS) among Ugandan women. This was a prospective study of 149 women diagnosed with cervical cancer from 2013 to 2015 at the Uganda Cancer Institute. Poisson regression models were fit to calculate prevalence ratios (PR) for the association between HIV infection and late stage at cancer diagnosis. The association between HIV infection and OS after cervical cancer diagnosis was evaluated using Cox proportional hazards models. The cohort included 53 HIV-positive and 96 HIV-negative participants. Median age at diagnosis was 44 years for HIV-positive and 54 years for HIV-negative participants. Seventy-seven percent of HIV-positive participants received antiretroviral therapy. Median baseline CD4 count was 373 cells/mm3 for HIV-positive participants versus 926 cells/mm3 for HIV-negative participants. Thirty-two percent of HIV-positive participants were diagnosed with late stage cervical cancer (III-IV) versus 39% of HIV-negative participants. No association was found between late stage at cancer diagnosis and HIV infection (PR adjusted for age, parity and transport cost 1.0, 95%CI 0.6–1.8). Most women presenting for care received cancer treatment, though almost half who received radiotherapy did not complete treatment. The median OS was 13.7 months for HIV-positive participants and 24.3 months for HIV-negative participants. After adjusting for age and stage, HIV infection was weakly associated with OS (HR 1.3, 95%CI 0.8–2.2). In Uganda, cervical cancer is often incompletely treated and survival remains poor. HIV infection was not associated with cervical cancer stage at diagnosis, but may be weakly associated with shorter survival.

Purpose To provide evidence-based, resource-stratified global recommendations to clinicians and policymakers on the management and palliative care of women diagnosed with invasive cervical cancer. Methods ASCO convened a multidisciplinary, multinational panel of cancer control, medical and radiation oncology, health economic, obstetric and gynecologic, and palliative care experts to produce recommendations reflecting resource-tiered settings. A systematic review of literature from 1966 to 2015 failed to yield sufficiently strong quality evidence to support basic- and limited-resource setting recommendations; a formal consensus-based process was used to develop recommendations. A modified ADAPTE process was also used to adapt recommendations from existing guidelines. Results Five existing sets of guidelines were identified and reviewed, and adapted recommendations form the evidence base. Eight systematic reviews, along with cost-effectiveness analyses, provided indirect evidence to inform the consensus process, which resulted in agreement of 75% or greater. Recommendations Clinicians and planners should strive to provide access to the most effective evidence-based antitumor and palliative care interventions. If a woman cannot access these within her own or neighboring country or region, she may need to be treated with lower-tier modalities, depending on capacity and resources for surgery, chemotherapy, radiation therapy, and supportive and palliative care. For women with early-stage cervical cancer in basic settings, cone biopsy or extrafascial hysterectomy may be performed. Fertility-sparing procedures or modified radical or radical hysterectomy may be additional options in nonbasic settings. Combinations of surgery, chemotherapy, and radiation therapy (including brachytherapy) should be used for women with stage IB to IVA disease, depending on available resources. Pain control is a vital component of palliative care. Additional information is available at www.asco.org/rs-cervical-cancer-treatment-guideline and www.asco.org/guidelineswiki . It is the view of ASCO that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines.

Although human papillomavirus (HPV) vaccines offer enormous promise for the ultimate control and possible elimination of cervical cancer, barriers to uptake and coverage of the vaccine both in high- and low/middle-income settings mean that advances in secondary prevention continue to be essential to prevent unnecessary deaths and suffering from cervical cancer for decades to come. While cytology (the Pap smear) has reduced cervical cancer incidence and prevalence in jurisdictions where it has been systematically implemented in population-based programs-mainly in high-income settings-limitations inherent to this method, and to program delivery, leave many women still vulnerable to cervical cancer. Recent evidence has confirmed that screening based on HPV testing prevents more invasive cervical cancer and precancerous lesions, and offers innovative options such as self-collection of specimens to improve screening uptake broadly. In this paper, we review key advances, future opportunities, and ongoing challenges for secondary prevention of cervical cancer using HPV-based testing.

Background High-risk human papillomavirus (hrHPV) testing has been recommended by the World Health Organization as the primary screening test in cervical screening programs. The option of self-sampling for this screening method can potentially increase women’s participation. Designing screening programs to implement this method among underscreened populations will require contextualized evidence. Methods PREvention and SCReening Innovation Project Toward Elimination of Cervical Cancer (PRESCRIP-TEC) will use a multi-method approach to investigate the feasibility of implementing a cervical cancer screening strategy with hrHPV self-testing as the primary screening test in Bangladesh, India, Slovak Republic and Uganda. The primary outcomes of study include uptake and coverage of the screening program and adherence to follow-up. These outcomes will be evaluated through a pre-post quasi-experimental study design. Secondary objectives of the study include the analysis of client-related factors and health system factors related to cervical cancer screening, a validation study of an artificial intelligence decision support system and an economic evaluation of the screening strategy. Discussion PRESCRIP-TEC aims to provide evidence regarding hrHPV self-testing and the World Health Organization’s recommendations for cervical cancer screening in a variety of settings, targeting vulnerable groups. The main quantitative findings of the project related to the impact on uptake and coverage of screening will be complemented by qualitative analyses of various determinants of successful implementation of screening. The study will also provide decision-makers with insights into economic aspects of implementing hrHPV self-testing, as well as evaluate the feasibility of using artificial intelligence for task-shifting in visual inspection with acetic acid. Trial registration ClinicalTrials.gov, NCT05234112. Registered 10 February 2022