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The cameroon mobile phone sms (CAMPS) trial: a protocol for a randomized controlled trial of mobile phone… Mbuagbaw, Lawrence; Thabane, Lahana; Ongolo-Zogo, Pierre; Lester, Richard T; Mills, Edward; Volmink, Jimmy; Yondo, David; Essi, Marie J; Bonono-Momnougui, Renée-Cecile; Mba, Robert; Ndongo, Jean S; Nkoa, Francois C; Ondoa, Henri A Jan 7, 2011

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STUDY PROTOCOL Open AccessThe cameroon mobile phone sms (CAMPS) trial:a protocol for a randomized controlled trial ofmobile phone text messaging versus usual carefor improving adherence to highly activeanti-retroviral therapyLawrence Mbuagbaw1*, Lahana Thabane2,3, Pierre Ongolo-Zogo1, Richard T Lester4,5, Edward Mills6,Jimmy Volmink7, David Yondo1, Marie José Essi1, Renée-Cecile Bonono-Momnougui1, Robert Mba1,Jean Serge Ndongo1, Francois C Nkoa1, Henri Atangana Ondoa1AbstractBackground: This trial aims at testing the efficacy of weekly reminder and motivational text messages, comparedto usual care in improving adherence to Highly Active Antiretroviral Treatment in patients attending a clinic inYaoundé, Cameroon.Methods and Design: This is a single-centered randomized controlled single-blinded trial. A central computergenerated randomization list will be generated using random block sizes. Allocation will be determined bysequentially numbered sealed opaque envelopes. 198 participants will either receive the mobile phone textmessage or usual care. Our hypothesis is that weekly motivational text messages can improve adherence to HighlyActive Antiretroviral Treatment and other clinical outcomes in the control group by acting as a reminder, a cue toaction and opening communication channels. Data will be collected at baseline, three months and six months.A blinded program secretary will send out text messages and record delivery.Our primary outcomes are adherence measured by the visual analogue scale, self report, and pharmacy refill data.Our secondary outcomes are clinical: weight, body mass index, opportunistic infections, all cause mortality andretention; biological: Cluster Designation 4 count and viral load; and quality of life. Analysis will be by intention-to-treat. Covariates and subgroups will be taken into account.Discussion: This trial investigates the potential of SMS motivational reminders to improve adherence to HighlyActive Antiretroviral Treatment in Cameroon. The intervention targets non-adherence due to forgetfulness andother forms of non-adherence.Trial Registration: Pan-African Clinical Trials Registry PACTR201011000261458http://clinicaltrials.gov/NCT01247181* Correspondence: mbuagbawl@yahoo.com1Centre for the Development of Best Practices in Health(CDBPH), YaoundéCentral Hospital, Avenue Henri Dunant, Messa, PO Box 87, Yaoundé,CameroonFull list of author information is available at the end of the articleMbuagbaw et al. Trials 2011, 12:5http://www.trialsjournal.com/content/12/1/5 TRIALS© 2011 Mbuagbaw et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.BackgroundMobile text messages using the short message service(SMS) are a cheap and non-invasive means of communi-cation that can be used to convey health related messagesto owners of mobile phones. There is contradictory evi-dence concerning the role of mobile phones in ameliorat-ing health outcomes, especially in less developedcountries where private ownership and use of mobilephones is not as widespread as in other more developedcountries [1]. Currently, Africa has the greatest uptake ofmobile phone technology [2].The advent of Highly Active Antiretroviral Therapy(HAART) has markedly reduced morbidity and mortalityassociated with the Human Immune deficiency Virus(HIV) [3]. Much effort has been put into the scaling upof access to HAART [4]. The efficacy of HAART dependslargely on compliance to treatment regimens. Pooradherence is associated with poor virological and immu-nological response. It is also responsible for the develop-ment of resistant strains [5]. Very high levels (> 95%) ofadherence are necessary for sustained clinical success [6].Our search for papers on the use of SMS technologyto improve adherence to HAART revealed two protocolsfor trials in Kenya (WelTel Kenya 1) [7] and India(HIVIND) [8]. The WelTel Kenya 1 trial reported signif-icant improvements in adherence and viral load [9].The World Health Organization (WHO) has prioritizedthe use of new technologies to assist health delivery inresource-limited settings [10]. The SMS is already used forbusiness transactions, personal communication, advertis-ing and betting. There is a potential for new benefits to bediscovered in the use of mobile phone technology inhealth interventions for resource- limited countries [11].In South Africa, the SMS has been demonstrated toimprove HIV health care service delivery by amelioratingcommunication between health workers and patients, andalso as an appointment reminder [12].Additionally, a Cochrane systematic review found thatmobile phone calls and reminders can improve adher-ence to tuberculosis care [13]. Another study investigat-ing the use of mobile phone technology to improveadherence to HAART discouraged the use of phonecalls as they are time and labor intensive [14]. A thirdstudy, investigating the use of text messaging to improveadherence to primary care found that it was more costeffective than phone calls[15]. The cost of phone callsmay also be a hindrance in developing countries. TheIndian trial [8] is testing automated phone calls coupledto picture messages. This may reduce the time andlabor costs involved. Another study reported high satis-faction with two way text messaging [16]. These findingssuggest that the more feasible application of the mobilephone in health would be the SMS.The goal of this trial is to assess whether sendingweekly motivational text messages via a mobile phoneversus no text messaging will improve adherence toHAART and clinical outcomes among HIV positivepatients over a 6 month period. We hypothesize thatsending one weekly motivational reminder will producea change in behavior to enhance drug or treatmentadherence and hence clinical outcomes. SMS-deliveredinterventions are capable of producing a positive beha-vior change [17].Participants will be selected from the AccreditedTreatment Centre (ACT) of the Yaoundé Central Hospi-tal (YCH).Methods and DesignThe trial is registered with the Pan-African Clinical TrialsRegistry http://pactr.org as PACTR201011000261458 andwith clinical trials.gov as NCT01247181.FundingPartial funding for this study was obtained from aninternational postdoctoral research fellowship awardedby the Canadian Institutes of Health Research (CIHR)HIV Clinical Trials Network (CTN) to the principalinvestigator.Study DesignUsing a 1:1 allocation ratio, patients at the YaoundéCentral Hospital (YCH) Accredited Treatment Centre(ATC) will be randomized to either receive a text mes-sage reminder to take their medication or not (Figure 1:Consolidated Standards of Reporting Trials-CONSORTdiagram of study design). Both groups of patients willbenefit from the usual care provided in this centrewhich includes adherence counseling and rarely, homevisits.RandomizationThis is a parallel group design evaluating the effects ofadding weekly SMS text messages using mobile phonesto usual care (intervention) versus usual care alone(control) among HIV positive patients on HAART. Eligi-ble and consenting patients will be randomized to inter-vention and control arms using 1:1 allocation ratio byopaque sealed envelope method. A computer generatedrandomization list will be generated using random blocksizes of 2, 4 and 6, by the Father Sean O’SullivanResearch Centre Biostatistics Unit at St Joseph’s Health-care/McMaster University. The allocation codes willthen be put in sequentially numbered opaque sealedenvelopes and administered by the trained ResearchStaff at YCH ATC centre. Trained interviewers - blindedto group allocation - will collect data using a pretestedMbuagbaw et al. Trials 2011, 12:5http://www.trialsjournal.com/content/12/1/5Page 2 of 8data collection form containing socio-demographic data,clinical information and adherence rates at baseline, 3and 6 months. The data analyst will also be blinded togroup allocation.Trial SettingCameroon is a sub-Saharan central African country, madeof ten provinces and a population of 18 million inhabitants[18]. The Centre and capital province has a population ofabout 3.2 million inhabitants. The adult prevalence rate ofHIV in the country is 5.1% [19]. Subjects will be recruitedfrom the YCH ACT. This is an urban centre in the heartof the capital city, Yaoundé. The adult prevalence of HIVin the Centre province is 4.7%. The YCH is a tertiary levelgeneral teaching hospital with a capacity of 381 beds. Itemploys nearly 800 staff including 95 doctors and 270nurses [20]. The ACT has a very high recruitment rate ofapproximately 40 new cases per week and caters for 6500regular clients. It is the largest HIV clinic in the countryand offers enormous potential for recruitment.Participants: inclusion/exclusion criteriaWe will include subjects who are aged above 21 years,own a mobile phone and can read text messages, andAssessedforeligibilityx >21x Ownsamobilephoneandcanreadtextmessagesx OnHAARTш1monthEnrolmentRandomizationInterventiongroupx Usualadherencecounsellingx WeeklymotivationaltextmessagesControlgroupx Usualadherencecounsellingx NotextmessagesBaselinedatacollectionx SocioͲdemographicx Clinical:WHO&CDCclassification,OI,Wt,BMIx Biological:CD4,Viralloadx Adherencex QualityoflifeFollowͲup(3monthsand6months)x Clinical:OI,Wt,BMIx Biological:CD4,Viralloadx Adherencex Qualityoflifex Allcausemortalityx RetentionFollowͲup(3monthsand6months)x Clinical:OI,Wt,BMIx Biological:CD4,Viralloadx Adherencex Qualityoflifex Allcausemortalityx RetentionBaselinedatacollectionx SocioͲdemographicx Clinical:WHO&CDCclassification,OI,Wt,BMIx Biological:CD4,Viralloadx Adherencex QualityoflifeTargetenrolment=198(Takingintoaccounta20%attrition)Exclusionx OnHAARTfor<1monthx Doesn’tfulfilleligibilitycriteriax RefusestotakepartFigure 1 Consolidated Standards of Reporting Trials-CONSORT diagram of study design.Mbuagbaw et al. Trials 2011, 12:5http://www.trialsjournal.com/content/12/1/5Page 3 of 8who have been on HAART for at least a month.Informed consent is a prerequisite for participating inthe study, and will be provided orally and in writing.We will exclude participants who have been onHAART for less than a month, are aged less than21 years. Participants who have used HAART for atleast one month are chosen so that we can calculate abaseline figure for adherence.InterventionWe will send a short text message to the participants inthe intervention group in both French and English. Thecontent of the message will be motivating and will actboth as a reminder and a cue to action (Figure 2: Exam-ple of a text message). The message will also contain aphone number they can call back if they need help. Thecontent will be varied so as to retain participants’ atten-tion throughout the period of the study and to explorethe various aspects of behavior change. The programsecretary will have a list of phone numbers to which he/she will send the messages every week and will use the‘delivery report’ function to ensure that the messageshave been delivered. One message will be sent per weekin the morning of a chosen day. The average cost fortext messages on any networks is 50 CFA Frs. CFA(≈0.1 USD). Text messaging will be provided as an add-on to usual care which includes regular HAART coun-seling and occasional home visits.ControlIn the control arm, patients will receive the usual careprovided to all patients of the ATC which includes regu-lar HAART counseling and occasional home visits. Theywill be given a number to call if they have questions.They will not receive any text messages, but they will beinterviewed at baseline, 3 months and 6 months.Study ObjectivesPrimary ObjectiveThe primary objective of this trial is to investigate theeffect of adding the SMS to usual care versus usual carealone in improving and maintaining adherence toHAART in HIV positive patients on HAART at 3 and6 months. There are several methods used to evaluateor measure adherence to medications, each with advan-tages and disadvantages [21,22]. Thus, there is no goldstandard in measuring medication adherence [21,23].The common approach is to use multiple methods tocompare or assess the robustness of the estimates ofadherence. For this study, we will use three commonlyused measures of adherence - namely Visual AnalogueScale (VAS), Pharmacy Refill Data (PRD), and SelfReport (SR). We will use VAS as the primary method ofmeasuring adherence. The VAS is highly correlated withmore objective methods like using MicroelectronicMonitoring System (MEMS) caps [24]. VAS method hasalso been widely used in several RCTs evaluating differ-ent interventions including mobile text messaging toenhance adherence to HAART [8,21]. PRD and SR willbe used to fill any missing data on VAS.Secondary objectivesThe secondary objectives include comparing clinical out-comes such as weight, body mass index (BMI), opportu-nistic infections (OI), Cluster Designation (CD) 4 count,viral load and quality of life between the groups. Thesecomparisons will be performed at 3 and 6 months.Outcome measuresOur primary outcome will be adherence rates, measuredusing VAS. SR and PRD will also be used to supplementVAS (Table 1).Our Secondary endpoints will be;• Clinical: Weight, BMI, opportunistic infections• Biological: CD4 count, viral load• Quality of life (QOL): Measured with the SF-12QOL assessment form [25].• All cause mortality• RetentionFigure 2 Example of a text message.Mbuagbaw et al. Trials 2011, 12:5http://www.trialsjournal.com/content/12/1/5Page 4 of 8DurationThe trial will run for six months, with outcome assess-ment at baseline, 3 months and 6 months.Sample sizeThe sample size calculation is based on the test of thenull hypothesis that the rates of adherence to HAARTin the two groups (intervention and control) are equal.The primary measure of effect is the rate of adherenceto ART treatment as measured by using the VAS over 6months. The criterion for significance (alpha) has beenset at 0.05. The test is 2-tailed, which means that aneffect in either direction will be interpreted. The samplesize was calculated using the WINPEPI (PEPI- for-win-dows) version 9.5 software [26]. With the proposed sam-ple size of 82 in each of the two groups (i.e. assuming a1:1 allocation ratio), the study will have power of 80% toyield a statistically significant result using a chi-squaredtest (assuming an intention-to-treat principle for theanalysis) of the relative risk at alpha = 0.05. This com-putation assumes an adherence rate of 80% (for theintervention group) versus 60% (for the control group)at 6 months. These estimates are reflective of estimatesfrom similar studies investigating SMS effect on drugadherences [27] and were modified to account for thetype of intervention and patients for this study. Weadjusted the sample size for a potential attrition rate of20% (due to drop-outs) based on attrition rates to carein this centre. Therefore, the required sample size is 198patients (99 per group). At the YCH ATC, on average,there are about 120 patients put on HAART per month.We estimate that about 90% will have mobile phonesand would be eligible to participate in the study. Ofthese, it is expected that approximately 75% would bewilling to participate in the study and will provide con-sent to participate in the trial. The expected period forrecruitment will be one month to obtain 198 patientsneeded for the trial. It is feasible to recruit 198 patientsin one month because we will also recruit from thelarge pool of old patients. Our study is designed todetect a 20% increase in adherence.Analysis planThe analysis and reporting of the results with follow theCONSORT guidelines [28]. The statistician/data analystwill be blinded to the study group. The process of patientselection and flow throughout the study will be summar-ized using a flow-diagram. The analysis results of patientdemographics and baseline outcome variables (both pri-mary and secondary) will be summarized using descrip-tive summary measures: expressed as mean (standarddeviation) or median (minimum-maximum) for continu-ous variables and number (percent) for categorical vari-ables. We will adopt an intention-to-treat principle toanalyze all outcomes, meaning that data from partici-pants will be analyzed according to the group to whichthey were randomized even if they do not receive theallocated intervention. We will also use multiple-imputa-tion [29] to handle missing data. We will use the T-testfor comparing groups on continuous outcomes and thechi-squared test for binary outcomes. All statistical testswill be performed using two-sided tests at the 0.05 levelof significance. The Bonferroni method will be used toadjust the level of significance for testing for secondaryTable 1 Overview of outcome measuresOutcome measures Scale Type Measure Analysis methodPrimaryAdherence at 6 months*VAS Ordinal Binary VAS percentage >95% Chi-squared testSelf report Ordinal Binary % adherence in last month >95% Chi-squared testPRD Ordinal Binary % of complete refills >95% Chi-squared testSecondaryWeight Ratio Continuous Change in weight T-testBMI Ratio Continuous Change in BMI T-testOI Nominal Binary Occurrence of new OI Chi-squared testMortality Nominal Binary All deaths Chi-squared testRetention Nominal Binary Number retained in care Chi-squared testCD4 count Ratio Continuous Change in CD4 count T-testViral load Ratio Continuous Change in viral load T-testSatisfaction with care Ordinal Categorical Change in satisfaction scores T-testQoL Ordinal Categorical Change in QoL scores T-testVAS: visual analogue scale, PRD: pharmacy refill data, BMI, body mass index, OI: opportunistic infection, CD4: Cluster Designation 4, QoL: Quality of Life.*All three measures of adherence will also be analyzed as continuous outcomes using T-test.Mbuagbaw et al. Trials 2011, 12:5http://www.trialsjournal.com/content/12/1/5Page 5 of 8outcomes to keep the overall level at alpha = 0.05. For allgroup comparisons, the results will be expressed as effect(or risk ratio for binary outcomes), corresponding two-sided 95% confidence intervals and associated p-values.P-values will be reported to three decimal places withvalues less than 0.001 reported as <0.001. Adjusted ana-lyses using the following baseline covariates (age, gender,education, duration on HAART, HIV staging, nutritionalstatus (BMI) and the presence or not of an opportunisticinfection (OI)) will be performed using regression techni-ques to investigate the residual impact of key baselinecharacteristics on the outcomes. Goodness-of-fit will beassessed by examining the residuals for model assump-tions and chi-squared test of goodness-of-fit. All analyseswill be performed using SPSS (Statistical Package for theSocial Sciences) version 16.0 for Windows.Adherence will be measured both as a continuous out-come (change in adherence) and as a binary outcome i.e.adherent (95% of pills taken) or non adherent (< 95% ofpills taken). In literature, adherence data can be handledin a number of ways. The measures can be reported asthe number of doses respected or can be combined into acomposite score [21]. Even though combined measuresare more correlated to clinical response, they are not verypractical [22]. The data from the various adherence mea-sures will not be merged. We will report the effects ofthe intervention on all the measures of adherence used,and compare them for discrepancies.Additional studies• Adherence rates: We will use this opportunity tocalculate the rates of adherence to HAART in theYCH ATC. The context of adherence to HAART inCameroon has changed greatly over time and the ratesreported in literature were subject to cost (which hasbeen dropping over time), availability, accessibility,study design, technique used to measure adherenceand study setting. These rates vary from 10% to 97%[30-32]. This study will provide a more accurate andcurrent estimate of adherence in Cameroon.• Safety: Data will be collected on issues that mayarise from the use of text messages to improveadherence.• Health worker experiences: Self-administeredquestionnaires will be used to assess health workerperceptions of the intervention in terms of longterm use, additional workload and benefits to care.The applicability of such an intervention will dependlargely on its acceptability by health workers.Ethical ConsiderationsThe trial will be conducted in compliance with the localprotocol and applicable regulatory requirements inCameroon. The study has been approved by CameroonNational Ethics Committee. Any deviations from theprotocol will be reported and explained. The study willbe conducted in accordance with the Helsinki declara-tion [33] and other established clinical practice guide-lines for research on human subjects. Researchpersonnel will approach all potentially eligible patientswho fulfill eligibility criteria for consent. All patientsmust sign a consent form to participate in the trial.DiscussionThe potential of mobile phone technology to improvehealth outcomes is a domain worth exploring, especiallyin this era of increased uptake and dependence onmobile phones. Studies investigating the use of textmessages to improve adherence have yielded variedresults [12,16,34].Improving adherence to HAART can play a key rolein reducing morbidity and mortality due to HIV, theoccurrence of drug resistant strains and the waste ofmedication in health systems that are already seriouslychallenged by the advent of HIV. Findings generatedfrom this trial may be generalized to other chronicillnesses.A major ethical consideration is the harm that mayarise due to accidental disclosure of status. This even-tuality will be properly explained to the participant,even though our message will neither disclose status normedication. In a study evaluating the use of mobilephones to improve attendance to an HIV clinic inUganda, privacy and confidentiality were not a problem[35]. Loss of privacy was not identified as a deterrent inthe HIVIND trial [8,36]. We are aware that most mobileoperators in Cameroon deliver mass text messages totheir clients for business, advertising, information andsometimes health. Our intervention will be an additionto an already existing system. Another concern is howto manage text messaging on a larger scale, knowingfully well that it cannot be left in the hands of mobileoperators, who will then be privy to the phone numbersof potentially identifiable individuals. In this trial, theoperators will not be used because a framework forcooperation that will not jeopardize confidentiality andanonymity hasn’t been established. A single phone withprepaid airtime will be used to deliver the text messages.This intervention centers on the Health Belief Modelof behavior change [37]. We will collect data on modify-ing factors (socio-demographic and disease related), per-ceived barriers to adherence and test the efficacy of theSMS reminder as a cue to action. Putting all these incontext will provide a better picture of who doesn’tadheres to HAART, why they don’t adhere and if textmessages can help. Applying the SMS not only as areminder, but as a cue to action permits it use to resolveMbuagbaw et al. Trials 2011, 12:5http://www.trialsjournal.com/content/12/1/5Page 6 of 8intentional and non-intentional non-adherence. In addi-tion, we will open channels for communication betweenappointments. Galovotti et al succinctly describe the keycomponents of an intervention aimed at bringing abouta change in behavior. The use of role models, affectiveimpact, and links to socio-cultural narratives, personali-zation and knowledge of impediments and facilitatorsare important features of successful behavioral interven-tions [38].Finally, this trial may contribute to the growing bodyof evidence on the use of mobile phone technology toimprove health outcomes in low resource settings.AbbreviationsATC: Accredited Treatment Centre; BMI: Body Mass Index; CD: ClusterDesignation; CIHR: Canadian Institutes for Health Research; CONSORT:Consolidated Standards for Reporting Trials; CTN: Canadian HIV TrialsNetwork; HAART: Highly Active Anti-Retroviral Therapy; HIV: Human ImmuneDeficiency Virus; MEMS: Micro-Electronic Monitoring System; OI:Opportunistic Infections; PRD: Pharmacy Refill Data; QOL: Quality of Life; SMS:Short Message Service; SPSS: Statistical Package for Social Sciences; SR: SelfReport; VAS: Visual Analogue Scale; WHO: World Health Organization; YCH:Yaoundé Central Hospital.AcknowledgementsThis study is support in part by Canadian Institutes of Health Research (CIHR)HIV Clinical Trials Network (CTN) in the form of international postdoctoralresearch fellowship award to the first author. Dr Thabane is a clinical trialsmentor for CIHR under the RCT Mentorship Programme.Author details1Centre for the Development of Best Practices in Health(CDBPH), YaoundéCentral Hospital, Avenue Henri Dunant, Messa, PO Box 87, Yaoundé,Cameroon. 2Department of Clinical Epidemiology and Biostatistics, McMasterUniversity, Hamilton, ON, Canada. 3Biostatistics Unit, Father Sean O’SullivanResearch Centre, St Joseph’s Healthcare, Hamilton, ON, Canada. 4Departmentof Medicine, Division of Infectious Diseases University of British Columbia,Vancouver, BC, Canada. 5British Columbia Centre for Disease Control,Vancouver, BC, Canada. 6Faculty of Health Sciences, University of Ottawa,Ottawa, ON, Canada. 7Faculty of Health Sciences Stellenbosch University,Capetown, South Africa.Authors’ contributionsLM conceived of the study. LT, POZ, RTL, EM, JV helped to draft themanuscript. DY, MJE, RCBM, RM, JSN, FN and HAO participated in its designand helped draft the manuscript. 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Am J PublicHealth 2001, 91:1602-1607.doi:10.1186/1745-6215-12-5Cite this article as: Mbuagbaw et al.: The cameroon mobile phone sms(CAMPS) trial: a protocol for a randomized controlled trial of mobilephone text messaging versus usual care for improving adherence tohighly active anti-retroviral therapy. Trials 2011 12:5.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitMbuagbaw et al. Trials 2011, 12:5http://www.trialsjournal.com/content/12/1/5Page 8 of 8


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