Adherence to support pessary in the treatment of pelvic organ prolapse: a retrospective study conducted among 1,371 women.

INTRODUCTION AND HYPOTHESIS: The objective was to investigate the adherence to pessary treatment in women with pelvic organ prolapse (POP) who were found eligible for this treatment by the urogynecologist, at the first visit at the Department of Gynecology and Obstetrics, Odense University Hospital. METHODS: Data were extracted from the women's medical records. Frequency tabulations were performed to describe the women's reasons for pessary discontinuation by age group. Binominal logistic regression analysis was conducted to investigate how women's age, POP characteristics, urogynecological history, and their pessary experience and management were associated with continued pessary use. RESULTS: This study included 1,371 women treated with support pessary. Of these, 850 women continued pessary treatment and 521 women underwent surgical treatment. A history of hysterectomy (OR: 0.68, 95% CI: 0.51-0.90, p = 0.008), urinary incontinence (OR: 0.71, 95% CI: 0.56-0.89, p = 0.003), and previous pessary use (OR: 0.75, 95% CI: 0.56-0.99, p = 0.047) were significant factors associated with discontinuation. Further, women aged 81-99 years were significantly more likely to continue pessary treatment (OR: 1.77, 95% CI: 1.15-2.74, p = 0.009). "POP surgery," "prolapse stage," and "prolapse predominant compartment" were not associated with discontinuation. Approximately 38% of women aged 26-54 years discontinued owing to personal preference. CONCLUSIONS: Hysterectomy, incontinence, and previous pessary use are significant predictors of pessary discontinuation. Increasing age is significantly associated with pessary continuation.

Knowledge on human papilloma virus and experience of getting positive results: a qualitative study among women in Kilimanjaro, Tanzania.

BACKGROUND: Human papilloma virus (HPV) is a sexually transmitted infection causing more than 80% of cervical cancers. WHO recommends using of sensitive screening methods like HPV-testing to timely prevent future morbidity and mortality from cervical cancer. Pilot studies have shown that HPV-testing is feasible and can be scaled in developing country like Tanzania. However, there is limited information on women understanding, reactions and psychological challenges following diagnosis of high risk HPV (HR-HPV). This study explored the knowledge of women on HPV and their experience after HPV positive results in Kilimanjaro, Tanzania. METHODS: The study was part of a larger study that assessed incidence and persistence of HR-HPV among women aged 18 years and above in Kilimanjaro. This was a cross sectional study conducted in Moshi municipal council among women who had HR-HPV positive results at enrollment. In-depth interviews were conducted with 13 randomly selected women who were attending for follow-up after enrollment. Interviews were conducted at the health facility and Atlas.ti.8 was used to analyze the data using thematic framework analysis. RESULTS: Women had knowledge on HPV infection but they had different reactions following receiving positive HPV results. Reaction toward the positive HPV results had two extremes; some women had psychological effect (hopeless, death sentence, having cancer, being shocked, failure to disclose and psychosexual effects) while others women explained positive results is good as they are identified earlier, will be followed up and it has made them plan to continue with cervical cancer screening in future. CONCLUSION: Women had knowledge on HPV, but positive results lead to negative and positive experiences by women. Clinicians and programs need to develop interventions and good strategies to minimize the psychological and social burden of testing positive for HPV.

Comparison of human papillomavirus-based cervical cancer screening strategies in Tanzania among women with and without HIV.

Cervical cancer is the most common female cancer in Eastern Africa, and the World Health Organization (WHO) recommends human papillomavirus (HPV)-based screening as a key element to eliminate the disease. In this cross-sectional study from Tanzania, we compared nine HPV-based cervical cancer screening strategies, including HPV testing at standard cut-off; HPV testing at increased viral load cut-offs; HPV testing with partial/extended genotyping, and HPV testing with visual inspection with acetic acid (VIA). We pooled data collected during 2008 to 2009 and 2015 to 2017 from 6851 women aged 25 to 65. Cervical cytology samples were HPV tested with Hybrid Capture 2, and HPV positive samples were genotyped with INNO-LiPA Extra II. Human immunodeficiency virus (HIV) testing and VIA were done according to local standards. We calculated sensitivity, specificity, positive and negative predictive value of screening strategies, with high-grade cytological lesions as reference, separately for women with and without HIV. HPV testing at standard cut-off (1.0 relative light units [RLU]) had highest sensitivity (HIV+: 97.8%; HIV-: 91.5%), but moderate specificity (HIV+: 68.1%; HIV-: 85.7%). Increasing the cut-off for HPV positivity to higher viral loads (5.0/10.0 RLU) increased specificity (HIV+: 74.2%-76.5%; HIV-: 89.5%-91.2%), with modest sensitivity reductions (HIV+: 91.3%-95.7%; HIV-: 83.5%-87.8%). Limiting test positivity to HPV types 16/18/31/33/35/45/52/58 improved specificity while maintaining high sensitivity (HIV+: 90.2%; HIV-: 81.1%). Triage with VIA and/or partial genotyping for HPV16/18 or HPV16/18/45 had low sensitivities (≤65%). In conclusion, HPV testing alone, or HPV testing with extended genotyping or increased viral load cut-offs, may improve cervical cancer screening in Sub-Saharan Africa.

Performance of HPV testing, Pap smear and VIA in women attending cervical cancer screening in Kilimanjaro region, Northern Tanzania: a cross-sectional study nested in a cohort.

OBJECTIVE: There is a concern about performance of the screening approaches, where information on the quality of novel and affordable screening approaches that will perform well in remote areas is warranted. This lack of information makes it difficult to prioritise resource use in efforts to improve cervical cancer outcomes. We aimed to compare the diagnostic value of human papillomavirus (HPV) testing on self-collected samples, Pap smear and visual inspection of the cervix with acetic acid (VIA) tests for detection of high-grade cervical intraepithelial neoplasia or worse (CIN2+). DESIGN: A combined cross-sectional and cohort study. SETTING: Three primary healthcare centres in Kilimanjaro region, Tanzania. PARTICIPANTS: 1620 women undergoing cervical cancer screening from December 2018 to September 2021. Inclusion criteria were being aged 25-60 years, and no history of premalignant or cervical cancer. Exclusion criteria were overt signs of cancer and previous hysterectomy. INTERVENTIONS: Participants underwent HPV self-sampling with Evalyn Brush and Care HPV kit assay was used to determine prevalence of high-risk HPV infection. Women with positive HPV test were together with a random sample of HPV negative women scheduled for follow-up where VIA was performed, and Pap smear and cervical biopsies obtained. RESULTS: Of 1620 women enrolled, 229 (14.1%) were HPV positive and 222 of these attended follow-up together with 290 (20.8%) women with negative HPV test. On VIA, 17.6% were positive. On Pap smear, 8.0% were classified as high-grade squamous intraepithelial lesion. The sensitivity and specificity, respectively, of the various tests, compared with histopathology for the detection of CIN2+ were: HPV test 62.5%, 59.3%; Pap smear 82.8%, 82.1% and; VIA 48.4%, 56.8%. When combined, the sensitivity and specificity for HPV and Pap smear were 90.6%, 70.6% while HPV and VIA were 65.6% and 75.5% for the detection of CIN2+. CONCLUSIONS: The performance of care HPV testing on self-collected samples opens the possibility of increasing coverage and early detection in resource-constrained settings.

Acceptability of text messages and knowledge change for cervical cancer screening: a Tanzanian mixed methods study.

OBJECTIVES: To investigate the acceptability of a text message intervention and evaluate if text messages could increase knowledge of cervical cancer and screening. DESIGN: This study was a substudy of a randomised controlled trial that used a mixed methods research design combining a quantitative questionnaire dataset and qualitative interview data. A before and after assessment was made of questionnaire responses. Acceptability was measured on a 6-point Likert scale and knowledge was measured through 16 binary true/false knowledge questions concerning cervical cancer and screening. Qualitative data were coded using a combined inductive-deductive approach. SETTING: Ocean Road Cancer Institute in Dar es Salaam as well as Kilimanjaro Christian Medical Center and Mawenzi Regional hospital in the Kilimanjaro Region in Tanzania. PARTICIPANTS: Human papillomavirus (HPV) positive women who had been randomised to the intervention group and received educative and reminder messages. Qualitative interviews were conducted with a subgroup of women in the intervention group. INTERVENTIONS: 15 one-way educative and reminder text messages. RESULTS: A total of 115 women in the intervention group responded to both the baseline and follow-up questionnaire. Overall, women found it highly acceptable to receive text messages, and there was a trend towards acceptability rising between baseline and follow-up (mean: 0.22; 95% CI 0.00 to 0.44; p=0.05; t-statics=1.96). A significant increase in acceptability was found among the lowest educated and those who had not previously been screened. The qualitative interviews showed that the underlying reasons for the high acceptability rate were that the women felt someone cared for them and that the text messages were for their own benefits. The text messages did not improve the women's knowledge on cervical cancer and screening. CONCLUSIONS: Educative and reminder text messages are highly acceptable among HPV-positive Tanzanian women; however, they do not increase the women's knowledge of cervical cancer and screening. TRIAL REGISTRATION NUMBER: clingov (NCT02509702).

Persistence and risk factors of high-risk human papillomavirus infection among HIV positive and HIV negative tanzanian women: a cohort study.

BACKGROUND: High-risk (HR) human papillomavirus (HPV) persistence is the most important risk factor for cervical cancer. We have assessed the type-specific HR HPV persistence among HIV positive and HIV negative Tanzanian women and factors associated with HR HPV persistence. METHODS: In a cohort study including 4080 Tanzanian women, 3074 attended follow-up examination (up to 32 months after enrollment). Cervical samples were obtained for liquid-based cytology and HPV DNA testing using Hybrid Capture 2 and Inno-Lipa Extra II. Information on lifestyle factors was collected through a personal interview. The probability of HR HPV persistence at a given time point since enrollment was estimated non-parametrically using the EMICM algorithm. RESULTS: Among the 462 women HR HPV positive at enrollment, 158 had at least one identical type detected at follow-up. The probability of persistence at 18 months after enrollment was 34.2 (95% CI 29.0-39.4). Stratifying by HIV status, the persistence probability was 42.9% (95% CI 33.5-51.9) among HIV positive, and 28.0% (95% CI 22.1-34.2) among HIV negative. Overall, HR HPV persistence was most common for HPV58, 35, 16, 31, and 52. Among HIV positive women it was HPV45, and HPV16, followed by HPV58 and HPV18, and among HIV negative women it was HPV31, HPV33 and HPV58. Risk factors associated with persistence of HR HPV were older age, longer interval between enrollment and follow-up, binge drinking, and HIV status. CONCLUSIONS: HR HPV persistence was common in Tanzania, and most common among HIV positive women. Overall, persistence was most frequent for HPV 58, 35, 16, 31 and 52. The nonavalent HPV vaccine should be considered.

The role of telepathology in diagnosis of pre-malignant and malignant cervical lesions: Implementation at a tertiary hospital in Northern Tanzania.

INTRODUCTION: Adequate and timely access to pathology services is a key to scale up cancer control, however, there is an extremely shortage of pathologists in Tanzania. Telepathology (scanned images microscopy) has the potential to increase access to pathology services and it is increasingly being employed for primary diagnosis and consultation services. However, the experience with the use of telepathology in Tanzania is limited. We aimed to investigate the feasibility of using scanned images for primary diagnosis of pre-malignant and malignant cervical lesions by assessing its equivalency to conventional (glass slide) microscopy in Tanzania. METHODS: In this laboratory-based study, assessment of hematoxylin and eosin stained glass slides of 175 cervical biopsies were initially performed conventionally by three pathologists independently. The slides were scanned at x 40 and one to three months later, the scanned images were reviewed by the pathologists in blinded fashion. The agreement between initial and review diagnoses across participating pathologists was described and measured using Cohen's kappa coefficient (κ). RESULTS: The overall concordance of diagnoses established on conventional microscopy compared to scanned images across three pathologists was 87.7%; κ = 0.54; CI (0.49-0.57).The overall agreement of diagnoses established by local pathologist on conventional microscopy compared to scanned images was 87.4%; κ = 0.73; CI (0.65-0.79). The concordance of diagnoses established by senior pathologist compared to local pathologist on conventional microscopy and scanned images was 96% and 97.7% respectively. The inter-observer agreement (κ) value were 0.93, CI (0.87-1.00) and 0.94, CI (0.88-1.00) for conventional microscopy and scanned images respectively. CONCLUSIONS: All κ coefficients expressed good intra- and inter-observer agreement, suggesting that telepathology is sufficiently accurate for primary diagnosis in surgical pathology. The discrepancies in interpretation of pre-malignant lesions highlights the importance of p16 immunohistochemistry in definitive diagnosis in these lesions. Sustainability factors including hardware and internet connectivity are essential components to be considered before telepathology may be deemed suitable for widely use in Tanzania.

Incident detection of human papillomavirus - a prospective follow-up study among Tanzanian women with a focus on HIV status.

BACKGROUND: The causative role of human papillomavirus (HPV) in cervical carcinogenesis is well established; however, prospective studies examining high-risk(HR)-HPV acquisition among adult women in HIV-prevalent settings are limited. METHODS: We conducted a prospective study among women (25-60 years) attending cervical cancer screening in Tanzania. Cervical specimens obtained at enrolment and follow-up were tested for HPV. Participants were interviewed on lifestyle and tested for HIV. RESULTS: Among 3805 eligible women, 3074 (80.8%) attended follow-up (median time between the 2 examinations, 17.3 months); 307 had missing HPV results at enrolment or follow-up, leaving 2767 study participants. Among 2253 women initially HR-HPV negative, 184 acquired HR-HPV-incidence: 54.5 per 1000 person-years (95% CI:47.1-62.9); among HIV-positive women 75.2 per 1000 person-years (95% CI:54.5-103.7), HIV-negative 50.9 per 1000 person-years (95% CI:43.3-60.0). HPV52 and HPV16 were the most frequently acquired types. In multivariable regression analysis, HIV positivity, low CD4 count, younger age, and multiple sexual partners were associated with increased odds of HPV acquisition. CONCLUSION: HPV acquisition was higher among HIV-positive than HIV-negative women, especially women with low CD4 counts. Improvement of immune status among HIV-positives may decrease HPV acquisition. Nonavalent HPV vaccination should be considered given the pattern of HR-HPV types acquired.

Concordance in HPV Detection Between Self-Collected and Health Provider-Collected Cervicovaginal Samples Using careHPV in Tanzanian Women.

PURPOSE: Cervical cancer screening is one of the strategies to prevent the disease among women at risk. Human papillomavirus (HPV) DNA testing is increasingly used as the cervical cancer screening method because of its high sensitivity. Self-collection of cervical specimens has the potential to improve participation. However, there is only limited information on comparison between self-collected and provider-collected samples with regard to detection of high-risk HPV using the careHPV method. The study aimed to compare HPV detection by careHPV in self-collected and provider-collected cervical samples and to assess the acceptability of self-collection techniques. MATERIAL AND METHODS: Women attending cervical cancer screening clinics at Ocean Road Cancer Institute, Kilimanjaro Christian Medical Centre or Mawenzi Hospital in Tanzania were included in the study. They underwent a face-to-face interview, HIV testing, and collected a self-sample using Evalyn Brush. Subsequently, they had a cervical sample taken by a health provider. Both samples were tested for high-risk HPV DNA using careHPV. RESULTS: Overall, 464 women participated in the study. The high-risk HPV prevalence was 19.0% (95% CI, 15.6 to 22.9) in the health provider samples, but lower (13.8%; 95% CI, 10.9 to 17.3) in the self-collected samples. There was a good overall agreement 90.5% (95% CI, 87.5 to 93.0) and concordance (κ = 0.66; 95% CI, 0.56 to 0.75) between the two sets of samples. Sensitivity and specificity were 61.4% (95% CI, 50.4 to 71.6) and 97.3% (95% CI, 95.2 to 98.7), respectively, varying with age. Most women preferred self-collection (79.8%). CONCLUSION: Overall, self-sampling seems to be a reliable alternative to health-provider collection and is acceptable to the majority of women. However, instructions on proper procedures for sample collection to the women are important.

Acceptability and feasibility of self-sampling and follow-up attendance after text message delivery of human papillomavirus results: A cross-sectional study nested in a cohort in rural Tanzania.

INTRODUCTION: The objective was to determine if self-collection of vaginal samples for human papillomavirus (HPV) testing was acceptable and feasible in rural Tanzania and to assess the extent of attendance at a follow-up appointment among women who tested HPV-positive after delivery of HPV results via text messages. MATERIAL AND METHODS: A combined cross-sectional and cohort study was conducted among women aged 25-60 years from rural Kilimanjaro, Tanzania. Women were offered HPV self-sampling or traditional visual inspection of the cervix with acetic acid. If HPV self-sampling was preferred, participants received instructions on self-collection with an Evalyn Brush. A questionnaire was used to assess the acceptability and feasibility of the self-sampling procedure for the participants and delivery of HPV results via text messages. A mobile text message platform was used to send private text messages with the screening results to the participants. RESULTS: A total of 1108 women were enrolled and self-collected an HPV sample; 11.8% tested positive for high-risk HPV. The majority (98.9%) agreed that they had no trouble in understanding the instructions on how to perform the self-collection and that they would recommend it to a friend (94.5%) or as a standard screening method in Tanzania (95.5%). A minority of women experienced bleeding (2.4%) or pain (6%) while collecting the sample, while some were worried that they would get hurt (12.7%) or felt embarrassed (3.5%). The majority (98.4%) of women would like to receive the screening test results via text messages. Eighty-two per cent of those who tested positive for high-risk HPV attended the follow-up appointment after receiving a text message reminder and an additional 16% attended after receiving both a text message and a phone call reminder whereas 2% did not attend follow up at all. Attendance was not influenced by age, marital status, education level, parity, or HIV status. CONCLUSIONS: Human papillomavirus self-sampling and text-message feedback delivery are generally well-perceived and accepted among rural Tanzanian women, and the majority of HPV-positive women attended a follow-up appointment after receiving their HPV results and follow-up appointment via text messages. This screening method may have potential to be transferrable to other low-income countries with a high incidence of cervical cancer and so improve cervical cancer screening attendances.

The association between human papillomavirus and cervical high-grade cytology among HIV-positive and HIV-negative Tanzanian women: A cross-sectional study.

INTRODUCTION: Human papillomavirus (HPV) is the causative agent of precancerous lesions and cervical cancer, cervical cancer being the leading cause of deaths in Tanzanian women. Early detection and treatment of precancerous lesions are important in the prevention of cervical cancer cases. MATERIAL AND METHODS: We conducted a cross-sectional study among 3390 Tanzanian women aged 25-60 years. Information on lifestyle habits was collected, and women underwent gynecological examination with collection of cervical cells for conventional cytological and HPV testing. Blood samples were tested for HIV. The association between cervical high-grade cytology (HGC) and potential risk factors was examined using multivariable logistic regression adjusting for age and high-risk HPV (HR-HPV). RESULTS: The prevalence of HGC was 3.6% and of low-grade cytology was 8.3%. In women who were both HR-HPV-positive and HIV-positive, the prevalence of HGC was 28.3%. It increased by age and was 47% among women aged 50-60 years. Women, who had their sexual debut at age 9-15 years and 16-18 years, respectively, had 2.5 and 2.4 times increased odds of HGC compared with women whose sexual debut was at age 21 years and older. HIV-positive women had increased odds of HGC in comparison with HIV-negative women after adjustment for age (odds ratio [OR] 2.95, 95% CI 1.92-4.54). HR-HPV-positive women had nearly 100-fold increased odds of HGC compared with HR-HPV-negative women (OR 96.6, 95% CI 48.0-194), and this estimate was higher among HIV-positive women (OR 152.2, 95% CI 36.1-642.0). CONCLUSIONS: Increasing age, early age at first intercourse, HR-HPV, and HIV infections were associated with a substantially increased risk of HGC.

Agreement between careHPV and hybrid capture 2 in detecting high-risk HPV in women in Tanzania.

INTRODUCTION: Visual inspection of the cervix with acetic acid is used to control the burden of cervical cancer in low- and middle-income countries. This method has some limitations and HPV DNA testing may be an alternative, but it is expensive and requires a laboratory setup. Cheaper and faster HPV tests have been developed. This study describe the agreement between a fast HPV test (careHPV) and hybrid capture 2 (HC2) in detection of high-risk HPV among Tanzanian women. MATERIAL AND METHODS: The study involved women attending routine cervical cancer screening at the Ocean Road Cancer Institute and Kilimanjaro Christian Medical Centre in Tanzania. The women were offered HIV testing. Two cervical samples were subsequently obtained; the first sample was processed at the clinics using careHPV and the second sample was transported to Denmark and Germany for cytology and HC2 analysis. Kappa statistic was calculated to assess the agreement between careHPV and HC2. The sensitivity, specificity and predictive values of careHPV were calculated using HC2 as reference. The analyses were done for the overall study population and stratified by testing site and HIV status. RESULTS: A total of 4080 women were enrolled, with 437 being excluded due to invalid information, lack of careHPV or HC2 results. Overall agreement between the tests was substantial with a kappa value of 0.69 (95% confidence interval [CI] 0.66-0.72). The sensitivity and specificity of careHPV was 90.7% (95% CI 89.6-91.8) and 84.2% (95% CI 81.2-86.8), respectively. The agreement was similar in the stratified analyses where the kappa values were 0.75 (95% CI 0.70-0.79) in women aged 25-34, 0.66 (95% CI 0.62-0.70) in women aged 35-60, 0.73 (95% CI 0.70-0.77) at the Ocean Road Cancer Institute, 0.64 (95% CI 0.60-0.69) at the Kilimanjaro Christian Medical Center, 0.73 (95% CI 0.68-0.79) in HIV-positive and 0.66 (95% CI 0.63-0.70) in HIV-negative women. The kappa value of 0.64 (95% CI 0.39-0.88) for cervical high-grade lesions indicates a substantial agreement between careHPV and HC2 in detecting HPV among women with cervical high-grade lesions. CONCLUSIONS: A substantial agreement was found between careHPV and HC2 in detecting HPV overall as well as detecting HPV among women with cervical high-grade lesions. However, given the limited resources available in low and middle-income countries, the HPV testing assay should be weighed against the cost-effectiveness of the test.

HPV types, cervical high-grade lesions and risk factors for oncogenic human papillomavirus infection among 3416 Tanzanian women.

OBJECTIVE: The objective of the present study was to assess the prevalence and type-specific distribution of cervical high-risk (HR) human papillomavirus (HPV) among women with normal and abnormal cytology, and to describe risk factors for HR HPV among HIV-positive and HIV-negative women in Tanzania. METHODOLOGY: A cross-sectional study was conducted in existing cervical cancer screening clinics in Kilimanjaro and Dar es Salaam. Cervical specimens were obtained from women aged 25-60 years. Samples were shipped to Denmark for cytological examination, and to Germany for HR HPV testing (using Hybrid Capture 2) and genotyping (using LiPaExtra). Risk factors associated with HPV were assessed by multivariable logistic regression analysis. RESULT: Altogether, 4080 women were recruited with 3416 women contributing data for the present paper, including 609 HIV-positive women and 2807 HIV-negative women. The overall HR HPV prevalence was 18.9%, whereas the HR HPV prevalence in women with high-grade squamous intraepithelial lesions (HSILs) was 92.7%. Among HPV-positive women with HSIL, HPV16 (32.5%) and HPV58 (19.3%) were the the most common types followed by HPV18 (16.7%) and HPV52 (16.7%). Factors associated with HR HPV included younger age, increasing number of partners and early age at first intercourse. Similar risk factors were found among HIV-positive and HIV-negative women. In addition, among HIV-positive women, those with CD4 counts <200 cells/mm3 had an increased risk of HR HPV (OR 2.2; 95% CI 1.2 to 4.8) compared with individuals with CD4 count ≥500 cells/mm3. CONCLUSION: Given the HPV distribution among Tanzanian women, the current HPV vaccination in Tanzania using quadrivalent vaccine may be considered replaced by the nonavalent vaccine in the future. In addition, appropriate antiretroviral treatment management including monitoring of viremia may decrease the burden of HR HPV in HIV-positive women.

Comprehensive Cervical Cancer Prevention in Tanzania (CONCEPT) study: Cohort profile.

PURPOSE: Cervical cancer is a major cause of death among women in Eastern Africa, and the distribution of human papillomavirus (HPV) according to HIV status is inadequately characterised in this region. In order to guide future cervical cancer preventive strategies that involve HPV testing, the Comprehensive Cervical Cancer Prevention in Tanzania (CONCEPT) study was established in 2015. The CONCEPT cohort aims to investigate the natural history of HPV and determine acquisition and persistence patterns of high-risk (HR) HPV among HIV-positive and HIV-negative women. Further, the influence of lifestyle and sexual/reproductive factors will be investigated. The main objective of this article is to describe how the CONCEPT cohort was established. PARTICIPANTS: Women aged 25-60 years were enrolled from cervical cancer screening clinics in Dar-es-Salaam and Moshi, Tanzania. Data were collected at baseline, at 14 months (first follow-up) and at 28 months (second follow-up). Biological samples included two cervical swabs for careHPV DNA testing, cytology, Hybrid Capture 2, genotyping and blood samples for HIV. Visual inspection with acetic acid was performed, and sociodemographic, lifestyle and sexual/reproductive characteristics were collected through a standardised questionnaire. FINDINGS TO DATE: 4043 women were included in the cohort from August 2015 to May 2017. At baseline, 696 (17.1%) women were HR HPV positive, and among these, 31.6% were HIV positive; 139 women (3.4%) had high-grade squamous intraepithelial lesions. 3074 women (81%) attended the first follow-up. The majority attended after receiving a phone call reminder (35%) or from home via self-samples (41%). At first follow-up, 438 (14.4%) were HR HPV positive and 30.4% of these were HIV positive. FUTURE PLANS: A second follow-up is underway (17 December 2018-October 2020). We plan to integrate our data with a previous cross-sectional HPV study from Tanzania to increase the power of our findings. Researchers interested in collaborating are welcomed, either by extracting data or jointly requesting further investigation from the cohort.

Effectiveness of One-Way Text Messaging on Attendance to Follow-Up Cervical Cancer Screening Among Human Papillomavirus-Positive Tanzanian Women (Connected2Care): Parallel-Group Randomized Controlled Trial.

BACKGROUND: Rapid human papillomavirus (HPV) DNA testing is an emerging cervical cancer screening strategy in resource-limited countries, yet it requires follow-up of women who test HPV positive. OBJECTIVE: This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women. METHODS: This multicenter, parallel-group randomized controlled trial was conducted at 3 hospitals in Tanzania. Eligible participants were aged between 25 and 60 years, had tested positive to a rapid HPV test during a patient-initiated screening, had been informed of their HPV result, and had a private mobile phone with a valid number. Participants were randomly assigned in a 1:1 ratio to the intervention or control group through an incorporated algorithm in the text message system. The intervention group received one-way text messages, and the control group received no text messages. The primary outcome was attendance at a 14-month health provider-initiated follow-up screening. Participants were not blinded, but outcome assessors were. The analysis was based on intention to treat. RESULTS: Between August 2015 and July 2017, 4080 women were screened for cervical cancer, of which 705 were included in this trial-358 women were allocated to the intervention group, and 347 women were allocated to the control group. Moreover, 16 women were excluded before the analysis because they developed cervical cancer or died (8 from each group). In the intervention group, 24.0% (84/350) women attended their follow-up screening, and in the control group, 23.8% (80/335) women attended their follow-up screening (risk ratio 1.02, 95% CI 0.79-1.33). CONCLUSIONS: Attendance to a health provider-initiated follow-up cervical cancer screening among HPV-positive women was strikingly low, and one-way text messages did not improve the attendance rate. Implementation of rapid HPV testing as a primary screening method at the clinic level entails the challenge of ensuring a proper follow-up of women. TRIAL REGISTRATION: ClinicalTrials.gov NCT02509702; https://clinicaltrials.gov/ct2/show/NCT02509702. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10.2196/15863.

"The best thing is that you are doing it for yourself" - perspectives on acceptability and feasibility of HPV self-sampling among cervical cancer screening clients in Tanzania: a qualitative pilot study.

BACKGROUND: Cervical cancer is the most common type of cancer in sub-Saharan Africa, and it is also the cancer disease that most women die from. The high mortality rate is partly due to low attendance rates to screening services and low sensitivity of visual inspection with acetic acid, which is the standard screening method used in screening programs in sub-Saharan Africa. In order to overcome of the burden of disease new screening strategies and methods are warranted. This study aims to explore the acceptability and feasibility of HPV self-sampling compared to provider-based sampling among cervical cancer screening clients living in Dar es Salaam. METHODS: Women attending cervical cancer screening at Ocean Road Cancer Institute in Dar es Salaam, Tanzania between February - April 2017 were invited into the study. The participants had (1) a provider-collected sample, and (2) a self-sample for HPV on top of the regular cervical cancer screening. 50% of the participants conducted the self-sample after receiving a written instruction guide of how to collect the sample (written). The other 50% received both the written and an oral introduction to self-sampling (written+). All participants could ask for nurse assistance during self-sample collection if needed. Individual semi-structured interviews were conducted with the participants post sample collection. Data collection stopped when saturation was reached. Data were analysed using a thematic content analysis. RESULTS: Twenty-one women participated in the study. Regardless of how women were introduced to the self-sample (written or written+), there was a high demand for nurse presence as they felt uncertain of their personal capabilities to collect the self-sample correctly. However, as long as nurse assistance was an option most women perceived self-sampling as easy and comfortable though few experienced bleeding and pain. The majority of women preferred self-sampling over provider-sampling primarily due to the method being more private than the provider-sampling. CONCLUSIONS: HPV self-sampling was well-perceived and accepted, however, for the method to be feasible a nurse needed to be present. HPV Self-sampling may be an alternative method to increase uptake of cervical cancer screening. Larger quantitative studies are recommended to support the study findings.

Performance of careHPV, hybrid capture 2 and visual inspection with acetic acid for detection of high-grade cervical lesion in Tanzania: A cross-sectional study.

OBJECTIVE: To examine the test performance of careHPV, Hybrid Capture2 (HC2) and visual inspection with acetic acid (VIA) for detection of cytologically diagnosed high-grade cervical lesions or cancer (HSIL+). DESIGN: Cross-sectional study. SETTING: Ocean Road Cancer Institute (ORCI) and Kilimanjaro Christian Medical Center (KCMC), Tanzania. POPULATION: Women attending routine cervical cancer screening. METHOD: We enrolled 4080 women (25-60 years) in the study. The women were interviewed on lifestyle habits, and tested for HIV. A cervical specimen for careHPV testing (performed at ORCI and KCMC), and a liquid-based cytology sample for HPV DNA detection using HC2 (performed at Tuebingen University Hospital, Germany) and for cytology assessment (performed at Vejle Hospital, Denmark) were obtained at a gynecological examination. Subsequently, VIA was performed. With cytology as gold standard, the sensitivity and specificity of careHPV, HC2, and VIA for detection of HSIL+ were calculated. RESULTS: Altogether, 23.6% had a positive careHPV test, 19.1% had positive HC2 test, and 6.3% had a positive VIA test. The sensitivity/specificity was 88.9%/78.9% for careHPV and 91.1%/83.7%, for HC2. VIA showed a low sensitivity of 31.1% but a high specificity (94.6%) for detection of HSIL+. The sensitivity of careHPV, HC2 and VIA was higher among younger women, and among HIV positive women. VIA triage of careHPV positive women improved specificity, but sensitivity dropped to 27%. CONCLUSION: Our results confirm the low sensitivity of VIA for detection of HSIL+ and further document that careHPV test is promising as a primary screening method for cervical-cancer prevention in low-resource regions. A suitable triage test has to be identified.

Competing needs: a qualitative study of cervical cancer screening attendance among HPV-positive women in Tanzania.

OBJECTIVES: The aim of this study was to understand causes of attendance and non-attendance to a follow-up cervical cancer screening among human papillomavirus (HPV)-positive women. DESIGN: Semistructured, individual interviews with HPV-positive women and cervical cancer screening nurses. The interview guide and initial data analysis were guided by existing health behaviour theories. However, as the theories limited the potential of the data material, a grounded theory framework guided the final data analysis. SETTING: Interviews were conducted in Dar es Salaam, Tanzania, at Ocean Road Cancer Institute (ORCI) or in the homes of screening clients. PARTICIPANTS: 15 interviews were conducted with women who had tested HPV-positive during a patient-initiated screening and been appointed for a follow-up screening 14 months later. Nine women had not attended the follow-up appointment, four had delayed attendance and two had attended on the scheduled date. Further, individual interviews were conducted with the two nurses working at ORCI's screening clinic. RESULTS: Perceived benefits for attending a patient-initiated screening include treatment of gynaecological symptoms and prevention of disease. The key perceived benefit of a health provider-initiated follow-up screening is prevention, which is challenged by the circumstance that it is seen by women as having merely potential benefit and therefore can be postponed when competing needs are present. Perceived challenges for screening attendance include emotional costs, in the form of fear of the disease, fear of the gynaecological examination as well as direct and indirect economic costs, such as transportation costs, lost income and waiting time. CONCLUSION: Cervical cancer screening is one among many tasks that women living in a low-income setting must attend to. Since health provider-initiated follow-up screening is seen as having only potential benefit, attendance can be postponed when competing needs exist. TRIAL REGISTRATION NUMBER: NCT02509702.

Vaginal pessaries in the management of symptomatic pelvic organ prolapse in rural Kilimanjaro, Tanzania: a pre-post interventional study.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to evaluate the outcomes of vaginal pessaries in managing symptomatic pelvic organ prolapse (POP) in a low-income setting. METHODS: A pre-post interventional study was conducted in the Kilimanjaro region, Tanzania. Seventy-one women with symptoms and a POP stage II or more on the POP quantification test were fitted with a vaginal pessary. Pelvic examination, POP Distress Inventory (POPDI-6) and POP Impact Questionnaire (POPIQ-7) were completed at baseline, after 3 months and after 12-18 months. Changes in the POPDI-6 and POPIQ-7 scores, complications and satisfaction associated with pessary use before and after the intervention were obtained. RESULTS: Pessary treatment was associated with a reduction in the overall POPDI score from 55.0 (50.0, 60.0) at baseline to 25.0 (25.0, 30.0) after 12-18 months' use. The overall POPIQ score was reduced from 54.2 (41.7, 66.7) at baseline to 25.0 (25.0, 29.2) after 12-18 months' use of the pessary. Vaginal discharge was reported in 72.4 and 32.4% of the women after 3 and 12-18 months' use respectively, whereas 72.4 and 25% of the women had some degree of granuloma, erosion or infection at 3 and 12-18 months respectively. Despite the reported complications, 78% of the women were satisfied with the pessary when interviewed after 12-18 months and 81% wanted to continue using it. CONCLUSIONS: Vaginal pessary improves symptoms and quality of life associated with symptomatic POP. Therefore, it may be a treatment option in managing POP in low-income countries such as Tanzania.