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.

Training of healthcare providers and use of long-acting reversible contraception in low- and middle-income countries: A systematic review.

INTRODUCTION: Unintended pregnancy, a major global health issue resulting in unsafe terminations of pregnancy and maternal deaths in low- and middle-income countries, could be significantly reduced through increased use of modern contraception, including long-acting reversible contraceptives (LARC). Training of healthcare providers to administer such contraceptives may improve uptake. We conducted a systematic review to collate the end-user uptake data following training of healthcare providers in low- and middle-income countries. MATERIAL AND METHODS: We searched PubMed, Embase, the Global Health Library and the Cochrane Library up to 23 May 2020. The review was restricted to low- and middle-income countries and focused on healthcare providers who had received training in LARC. Studies that reported contraceptive uptake among women, preference of LARC among healthcare workers and/or women, and unplanned pregnancies within 12 months of LARC initiation were included. All included studies underwent quality assessment using either the Cochrane Risk of Bias Tool or the Newcastle-Ottawa Scale. PROSPERO registration number CRD42020185291. RESULTS: A total of 28 studies (end-users n = 6 112 544) were included (27 cohort studies and one randomized trial). Nineteen studies were set in Africa, five in Asia, one in Central America and four were multi-country studies. Twenty-eight studies reported LARC use among women, and 25 studies found an increase in uptake of LARC by women using short-acting methods switching to longer-acting methods or by recruiting new users of LARC. The randomized controlled trial was assessed as high quality and reported positive findings; however, there was great heterogeneity in the type of intervention and of how outcomes were measured among the other included studies. Further, the quality of these studies varied, although it should be noted that the poor-quality studies reflected the trends of those of higher quality. CONCLUSIONS: Despite heterogeneity, current evidence indicates that training of healthcare providers in LARC may increase the uptake among women in low- and middle-income countries. More robust studies are warranted to inform policy.

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.

Quality of life after maternal near miss: A systematic review.

INTRODUCTION: Maternal near miss is a major global health issue; approximately 7 million women worldwide experience it each year. Maternal near miss can have several different health consequences and can affect the women's quality of life, yet little is known about the size and magnitude of this association. The aim of this study was to assess the evidence of the association between women who have experienced maternal near miss and quality of life and women who had an uncomplicated pregnancy and delivery. MATERIAL AND METHODS: Cochrane library, Embase, CINAHL, Web of Science, MEDLINE, Scopus and PubMed were searched for published studies. Studies were selected according to the PECO model (population, exposure, control and outcome) and were included if they investigated quality of life as an outcome after maternal near miss among women of all ages with no limitation on country or time (up to June 2020). Maternal near miss was defined as a life-threatening condition arising from complications related to pregnancy and/or childbirth. The quality of the studies was assessed according to the Newcastle-Ottawa scale and a Forest plot was constructed based on quality of life outcomes and study quality. PROSPERO registration number: CRD42020169232. RESULTS: Fifteen studies were included in the review with a total of 31 558 women. Quality of life was reported in various ways, and 25 different confounders were controlled for. Compared with women who did not experience maternal near miss, women exposed to maternal near miss had an overall lower quality of life (n = 2/2), had poorer mental (n = 6/10) and social health (n = 2/3), and maternal near miss had negative economic consequences (n = 4/4). Maternal near miss was not associated with sexual dysfunction (n = 1/5). Ten of 15 studies were assessed as being of poor quality. CONCLUSIONS: Evidence shows that maternal near miss is negatively associated with various aspects of quality of life. This highlights the importance of addressing the adverse effects associated with maternal near miss and follow up maternal near miss after discharge. Quality of life is a multidimensional concept that is assessed in various ways, and the literature on the field is heterogeneous. More high-quality studies are needed.

"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.

Intimate Partner Violence and Electronic Health Interventions: Systematic Review and Meta-Analysis of Randomized Trials.

BACKGROUND: Intimate partner violence (IPV) is a major public health concern. eHealth interventions may reduce exposure to violence and health-related consequences as the technology provides a safe and flexible space for the target population. However, the evidence is unclear. OBJECTIVE: The goal of the review is to examine the effect of eHealth interventions compared with standard care on reducing IPV, depression, and posttraumatic stress disorder (PTSD) among women exposed to IPV. METHODS: We searched EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials, PsycInfo, Scopus, Global Health Library, ClinicalTrials.gov, and International Clinical Trials Registry Platform for published and unpublished trials from inception until April 2019. Trials with an eHealth intervention targeting women exposed to violence were included. We assessed risk of bias using the Cochrane Risk of Bias Tool. Trials that reported effect estimates on overall IPV; physical, sexual, and psychological violence; depression; or posttraumatic stress disorder were included in meta-analyses. RESULTS: A total of 14 trials were included in the review; 8 published trials, 3 unpublished trials and 3 ongoing trials. Of the 8 published trials, 2 were judged as overall low risk of bias trials. The trials reported 23 types of outcomes, and 7 of the trials had outcomes that were eligible for meta-analyses. Our pooled analyses found no effect of eHealth interventions on any of our prespecified outcomes: overall IPV (SMD -0.01; 95% CI -0.11 to 0.08; I2=0%; 5 trials, 1668 women); physical violence (SMD 0.01; 95% CI -0.22 to 0.24; I2=58%; 4 trials, 1128 women); psychological violence (SMD 0.07; 95% CI -0.12 to 0.25; I2=40%; 4 trials, 1129 women); sexual violence (MD 0.36; 95% CI -0.18 to 0.91; I2=0%; 2 trials, 1029 women); depression (SMD -0.13; 95% CI -0.37 to 0.11; I2=78%; 5 trials, 1600 women); and PTSD (MD -0.11; 95% CI -1.04 to 0.82; I2=0%; 5 trials, 1267 women). CONCLUSIONS: There is no evidence from randomized trials of a beneficial effect of eHealth interventions on IPV. More high-quality trials are needed, and we recommend harmonizing outcome reporting in IPV trials by establishing core outcome sets. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42019130124; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=130124.

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.

Attitudes towards and health consequences of female genital mutilation/cutting: A qualitative study among Somali and Kurdish immigrants and descendants in Denmark.

Objectives: There is lack of in-depth knowledge of how immigrants who originate from countries where female genital mutilation/cutting (FGM/C) historically is practiced, perceive the practice after migrating to Europe. The aim of this study was to explore the attitude towards FGM/C among immigrants and descendants and the health consequences of living with FGM/C. Study design: Qualitative methods were used in the form of semi-structured interviews and focus group discussions. Female and male immigrants and descendants in Denmark from Somalia or Kurdish of Iraq/Iran participated in the study. The interview/focus group discussion guides were developed by the European Institute for Gender Equality. Purposely sampling was used, and participants were recruited by use of snowballing through gatekeepers and women's societies working within the Somali and Kurdish communities. Results: Sixteen persons participated in the study. No descendants had been cut, but all female immigrants had been cut prior to migrating and did not wish to pass on the practice. FGM/C was perceived as a harmful practice with severe sexual and mental health consequences. Women with Somali origin experienced that the practice was falsely associated with their origin, which led to stigmatisation. Women with Kurdish origin lacked healthcare support when suffering sexual consequences of FGM/C. It was generally perceived that the Danish healthcare system lacked cultural sensitivity. Conclusion: FGM/C is negatively perceived among Somali and Kurdish immigrants and descendants in Denmark and not practiced among these groups. The Danish healthcare system should adopt a more culturally sensitive approach when addressing sexual health among immigrants and descendants. Denmark and other European countries should work towards destigmatising the immigrant communities when it comes to FGM/C. Larger European studies with primary data are needed to generalise the findings of this study.

Video Consultations and Safety App Targeting Pregnant Women Exposed to Intimate Partner Violence in Denmark and Spain: Nested Cohort Intervention Study (STOP Study).

BACKGROUND: Intimate partner violence (IPV) during pregnancy is a public health issue with wide-ranging consequences for both the mother and fetus, and interventions are needed. Therefore, the Stop Intimate Partner Violence in Pregnancy (STOP) cohort was established with the overall aim to identify pregnant women exposed to IPV through digital screening and offer women screening positive for IPV a digital supportive intervention. OBJECTIVE: The aim of this study was to (1) introduce the design and profile of the STOP cohort study, (2) assess the feasibility of implementing digital IPV screening among pregnant women, and (3) assess the feasibility of implementing a digital supportive intervention targeting pregnant women exposed to IPV. METHODS: Pregnant women attending antenatal care in the Region of Southern Denmark and in Andalucía, Spain were offered digital screening for IPV using validated scales (Abuse Assessment Screen and Women Abuse Screening Tool). Women who screened positive were eligible to receive a digital supportive intervention. The intervention consisted of 3-6 video consultations with an IPV counselor and a safety planning app. In Denmark, IPV counselors were antenatal care midwives trained by a psychologist specialized in IPV, whereas in Spain, the counselor was a psychologist. RESULTS: Data collection started in February 2021 and was completed in October 2022. Across Denmark and Spain, a total of 19,442 pregnant women were invited for IPV screening and 16,068 women (82.65%) completed the screening. More women in Spain screened positive for exposure to IPV (350/2055, 17.03%) than in Denmark (1195/14,013, 8.53%). Among the women who screened positive, only 31.39% (485/1545) were eligible to receive the intervention with only 104 (21.4%) of these women ultimately receiving it. CONCLUSIONS: Digital screening for IPV among pregnant women is feasible in an antenatal care context in Denmark and Spain; however, a digital supportive intervention during pregnancy appears to have limited feasibility as only a minor subgroup of women who screened positive for eligibility received the intervention. More research is needed on how to best support pregnant women exposed to IPV if universal IPV screening is to be implemented in antenatal care.

Two-way text message interventions and healthcare outcomes in Africa: Systematic review of randomized trials with meta-analyses on appointment attendance and medicine adherence.

BACKGROUND: The growing access to mobile phones in Africa has led to an increase in mobile health interventions, including an increasing number of two-way text message interventions. However, their effect on healthcare outcomes in an African context is uncertain. This systematic review aims to landscape randomized trials involving two-way text message interventions and estimate their effect on healthcare outcomes. METHODS: We searched Medline, Embase, Cochrane Central Register of Controlled Trials, The Global Health Library (up to 12 August 2021) and trial registries (up to 24 April 2020). Published and unpublished trials conducted in Africa comparing two-way text message interventions with standard care and/or one-way text message interventions were included. Trials that reported dichotomous effect estimates on healthcare appointment attendance and/or medicine adherence were assessed for risk of bias and included in meta-analyses. Results of other outcomes were reported descriptively. RESULTS: We included 31 trials (28,563 participants) all set in Sub-Saharan Africa with a wide range of clinical conditions. Overall, ten different trials were included in the primary meta-analyses, and two of these had data on both medicine adherence and appointment attendance. An additional two trials were included in sensitivity analyses. Of the 12 included trials, three were judged as overall low risk of bias and nine as overall high risk of bias trials. Two-way text messages did not improve appointment attendance, RR: 1.03; 95% CI: 0.95-1.12, I2 = 53% (5 trials, 4374 participants) but improved medicine adherence compared to standard care, RR: 1.14, 95% CI: 1.07-1.21, I2 = 8% (6 trials, 2783 participants). CONCLUSION: Two-way text messages seemingly improve medicine adherence but has an uncertain effect on appointment attendance compared to standard care. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020175810.

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.

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.

One-way SMS and healthcare outcomes in Africa: Systematic review of randomised trials with meta-analysis.

BACKGROUND: The impact of one-way SMS on health outcomes in Africa is unclear. We aimed to conduct a systematic review of one-way SMS randomised trials in Africa and a meta-analysis of their effect on healthcare appointments attendance and medicine adherence. METHODS: PubMed, Embase, CENTRAL, The Global Health Library, ClinicalTrials.gov, ICTRP, and PACTR were searched for published and unpublished trials in Africa without language restriction (up to April 2018). Trials reporting effect estimates on healthcare appointment attendance and medicine adherence were assessed for risk of bias and included in meta-analyses using random-effects models. Other outcomes were reported descriptively. The protocol is registered in PROSPERO, ID:CRD42018081062. RESULTS: We included 38 one-way SMS trials conducted in Africa within a broad range of clinical conditions. Eighteen trials were included in the meta-analyses, and four were assessed as overall low risk of bias. One-way SMS improved appointment attendance, OR:2·03; 95% CI:1·40-2·95 (12 trials, 6448 participants), but not medicine adherence, RR:1·10; 95% CI:0·98-1·23 (nine trials, 4213 participants). Subgroup analyses showed that one-way SMS had the highest impact on childhood immunization attendance, OR:3·69; 95% CI:1·67-8·13 (three trials, 1943 participants). There was no clear evidence of one-way SMS improving facility delivery, knowledge level (reproductive/antenatal health, hypertension), diabetes- and hypertension management. CONCLUSION: In an African setting, the clinical effect of one-way SMS is uncertain except for appointment attendance where the effect seems to vary depending on which clinical condition it is used in.

Text messages to increase attendance to follow-up cervical cancer screening appointments among HPV-positive Tanzanian women (Connected2Care): study protocol for a randomised controlled trial.

BACKGROUND: Cervical cancer is a major health concern in Tanzania, caused by poor attendance for cervical cancer screening and follow-up of women at risk. Mobile telephone health interventions are proven effective tools to improve health behaviour in African countries. So far, no knowledge exists on how such interventions may perform in relation to cervical cancer screening in low-income settings. This study aims to assess the degree to which a Short Message Service (SMS) intervention can increase attendance at appointments among women who have tested positive for high-risk (HR) Human Papillomavirus (HPV) during cervical cancer screening. METHODS/DESIGN: Connected2Care is a non-blinded, multicentre, parallel-group, randomised controlled trial. Tanzanian women testing positive to HR HPV at inclusion are randomly assigned in an allocation ratio of 1:1 to the SMS intervention or the control group (standard care). In a period of 10 months, the intervention group will receive 15 one-directional health educative text messages and SMS reminders for their appointment. The total sample size will be 700 with 350 women in each study arm. Primary outcome is attendance rate for follow-up. Secondary objectives are cost-effectiveness, measured through incremental ratios, and knowledge of cervical cancer by a 16-item true/false scale questionnaire at baseline and follow-up. Barriers against implementing the intervention will be assessed in a mixed-methods sub-population study. DISCUSSION: This study may provide information on the potential effects, costs, and barriers in implementing an SMS intervention targeting a group of women who are followed up after testing positive for HR HPV and are, therefore, at increased risk of developing cervical cancer. This can guide decision-makers on the effective use of mobile technology in a low-income setting. Trial status: recruiting. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02509702 . Registered on 15 June 2015.