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Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding… Zunza, Moleen; Cotton, Mark F; Mbuagbaw, Lawrence; Lester, Richard; Thabane, Lehana Jul 17, 2017

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STUDY PROTOCOL Open AccessInteractive weekly mobile phone textmessaging plus motivational interviewingin promotion of breastfeeding amongwomen living with HIV in South Africa:study protocol for a randomized controlledtrialMoleen Zunza1,2,3* , Mark F. Cotton4, Lawrence Mbuagbaw5,6, Richard Lester7 and Lehana Thabane5,6AbstractBackground: South Africa recently phased out access to free formula milk in the public sector in support ofbreastfeeding for women living with HIV. Few women living with HIV in South Africa choose breastfeeding andamong those who do, many stop breastfeeding early. We sought to explore the feasibility of using mobile phonetext messaging coupled with motivational interviewing to enhance adherence to breastfeeding practices.Methods and design: A randomized, parallel group, single-center pilot trial. Electronic sequence generation andrandom allocation will be done centrally. Women of low socioeconomic status, from Cape Town, South Africa willbe randomly assigned within 24 h of giving birth at a primary healthcare clinic to a structured weekly text messageplus motivational interviewing and usual standard of care, using a permutation of different block sizes. Criteria forfeasibility success will include: five participants recruited per week (over 12 weeks), about 75% of all eligibleparticipants consent for study participation, complete evaluation of outcomes in at least 70% of all recruitedparticipants, breastfeeding adherence rates of at least 70% in the intervention group, six months after delivery.Participants will be evaluated soon after giving birth and post-delivery at weeks 2, 6, 10, and 24. Primary analysiswill follow the “intention-to-treat” principle. Sub-group analysis will be used to assess sub-group effects.Discussion: This pilot trial will evaluate the feasibility of conducting a larger trial on communication and supportapproaches to improve adherence to breastfeeding by HIV-infected women. Text messaging and motivationalinterviewing are simple interventions which may allow participants to access personalized adherence advice andsupport.Trial registration: ClinicalTrials.gov: NCT02949713. Registered on 26 October 2016; Pan African Clinical Trial RegistryPACTR201611001855404. Registered on 8 November 2016.Keywords: HIV, infant feeding, mHealth, motivational interviewing, text messaging* Correspondence: moleenz@sun.ac.za1Faculty of Medicine and Health Sciences, Department of Global Health,Centre for Evidence Based Health Care, Stellenbosch University, Francie VanZyl Drive, PO Box 241, Cape Town 8000, South Africa2Research Institute, McGill University Health Centre, Montreal, QC, CanadaFull list of author information is available at the end of the article© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Zunza et al. Trials  (2017) 18:331 DOI 10.1186/s13063-017-2079-0BackgroundSince the detection of HIV transmission through breast-feeding, developed countries recommend formula feed-ing for HIV-infected women [1]. In resource-limitedsettings, where child mortality is mainly due to diarrhea,pneumonia, and malnutrition, the effectiveness of anti-retroviral treatment (ART) in reducing the risk of HIVtransmission through breastfeeding has largely resolvedthe dilemma on how HIV-infected women should feedtheir infants [2–4]. In such settings, the World HealthOrganization (WHO) recommends at least 12 months ofbreastfeeding with infant or maternal ART [5, 6]. Breast-feeding improves child health and development [7–17].South Africa, a country with a high prevalence of HIV,recently phased out access to free formula milk in thepublic sector in support of breastfeeding for women liv-ing with HIV. Despite the evidence showing reduced riskof infants dying from infections when breastfed, espe-cially in high HIV prevalence settings, breastfeedingrates remain low with challenges to promote breastfeed-ing by HIV-infected women [7–10]. We conducted aprospective cohort study in South Africa, when theWestern Cape prevention of mother-to-child transmis-sion program was phasing out access to free formulamilk [18]. We found that few HIV-infected womenchose to breastfeed; among those who did, many (50%)switched to formula feeding early (approximately fourmonths following delivery) [18]. Developing simple in-terventions to promote and sustain continued breast-feeding by women is a public health priority.Mobile phone text messaging (mHealth) is a simple,low-cost intervention that can promote health behaviorchange [19, 20]. Increasing mobile phone use in Africastimulated research efforts on how to leverage mobilephones as a communication tool in healthcare. Text mes-saging improves adherence to medication among HIV-infected, diabetes, and tuberculosis patients [21–23]. Textmessaging not only improves adherence to ART, but alsoreduces viral load and treatment interruptions [23, 24].These trials suggest that specific characteristics of the textmessages such as interactivity, timing, and content influ-ence text messaging efficacy. Interactive weekly text mes-saging was superior to interactive daily text messaging[25]. One similarity between adherence to ART and infantfeeding practice is that both have a strong behavioralmodification aspect: HIV-infected people have to takemedication to control the disease while breastfeedingwomen must modify their feeding practices to improvethe health outcomes of their infants. These similarities jus-tify applying information about text messaging from ARTadherence studies to infant feeding practices.Current research suggests that combining a number ofapproaches is more likely to influence behavior changethan an individual approach [26, 27]. Home visits bycommunity health workers and motivational interview-ing are interventions known to influence behaviorchange [28, 29]. However, the former requires consider-able human resources and may not be feasible in low-resource settings where the number of healthcareworkers is constrained. Patient-centered approaches fornegotiating behavior change outperform approaches thatinstruct patients to change behavior through providingadvice [30, 31]. Motivational interviewing is a patient-centered approach that is less coercive and explores thepatient’s readiness to change behavior and support theperson’s commitment to do so in the preferred direction[32, 33]. Motivational interviewing was of benefit acrossmany health problems, including HIV viral load suppres-sion, body weight, and alcohol and tobacco use [34].Motivational interviewing is more effective when com-bined with other interventions [35]. Little is knownabout the effect of mobile phone text messaging addedto motivational interviewing on supporting adherence tobreastfeeding among HIV-infected women.This pilot trial protocol was written following thestandard protocol items recommendations for interven-tional trials (SPIRIT) guidelines (see Additional file 1SPIRIT checklist) [36].Methods and designStudy designWe will assess the feasibility of the intervention at a sin-gle site: mother–infant pairs will be randomly assignedto interactive mobile phone text messaging plus motiv-ational interviewing or usual standard of care (seeFig. 1).Randomization schemeParticipants will be randomly assigned to study groupsusing a permuted block method. The randomization se-quence will be generated using a random number gener-ating program, with a 1:1 allocation ratio with blocks ofdifferent sizes to ensure a balanced allocation. Blocksizes will be randomly permuted. Electronic sequencegeneration and random allocation will be done centrally.Women meeting inclusion criteria who consent to par-ticipate will be enrolled and immediately assigned astudy arm in sequential order. The principal investigatorwill coordinate the procedures. Only data analysts willbe blinded to participant allocation.Setting and study populationWomen from peri-urban informal settlements will be in-vited to participate within 24 h of giving birth at a pri-mary healthcare clinic in Cape Town, South Africa.Zunza et al. Trials  (2017) 18:331 Page 2 of 8Inclusion criteriaHIV-infected mothers will be eligible for inclusion ifthey initiate breastfeeding within 24 h of giving birth,are on ART, are 18 years or older, own a mobile phone,and their infants are judged to be in good health (readyto be discharged soon after delivery).Exclusion criteriaParticipants will be excluded if inclusion criteria are notmet or if viral load is > 400 copies/mL, if they initiateformula feeding within 24 h of giving birth, gave birth tomore than one infant, or if the birth weight is < 2000 gor the gestational age is < 36 weeks. High viral load, mul-tiple birth, and low birth weight are associated with sub-optimal infant feeding practices and poor infantoutcomes.Study interventionsAll women and their infants, irrespective of their studyassignments, will receive health services and treatmentaccording to the respective provincial guidelines applic-able in the sector during the study. No deviation fromexisting guidelines will be caused by taking part in thisstudy. Participants will be evaluated soon after givingbirth and post delivery until cessation of breastfeedingor until end of the study. Children will be tested for HIVinfection at time points already in routine practice (i.e.at birth and ten weeks). We will extract information onthe children’s HIV status from the clinical and laboratoryrecords.Mobile phone text messagingConsented new mothers will register their phone num-bers into an automated text message (SMS) software(provided by WelTel.org). The first SMS will be sentwithin the first week following delivery. Every Mondaymorning, a text message will be sent to women in theintervention group encouraging them to exclusivelybreastfeed and inquire if they have any problems breast-feeding their infants. Participants will be asked torespond by text within 48 h, indicating that they eitherdo not have a problem or they have a problem and re-quire help. Participants may also use the free ‘call back’function to request a call from the nurse for complex is-sues or if cost or literacy is a problem. The researchnurse will review all the responses and then follow-upand provide triage to any participants who indicate aproblem or call participants who fail to respond within48 h. To preserve confidentiality, the content of the textmessages will not be related to the woman’s HIV status.Participants will be briefly trained on use of the phoneand the text messaging protocol.Motivational interviewingIn addition to text messaging, women will have individ-ual motivational interviews post delivery at weeks 2, 6,and 10. Study visits will be in line with the ExpandedProgram of Immunization routine schedule to maximizeparticipation [37]. We will train the research nurse inmotivational interviewing techniques, which include re-flective listening and expression of acceptance and af-firmation. These techniques will enable the researchnurse to understand participant’s frame of reference,reinforce participant’s own self-motivational statements,monitor the readiness to change, and affirm the partici-pant’s freedom of choice. Advice will be given with par-ticipant’s permission, and when given, the participantwill make her own choice. The research nurse will applythese techniques considering the participant’s readinessto change. The interviews will be recorded.Usual standard of careParticipants randomized to the usual standard of caregroup will be counselled by primary healthcare nursesand trained lay counsellors to exclusively breastfeed forthe first six months. They will be free to call the clinicstaff at any time on their own initiative. Women not re-ceiving motivational interviewing who report adherenceconcerns during study visits will receive adherenceFig. 1 Spirit figure of the pilot trialZunza et al. Trials  (2017) 18:331 Page 3 of 8counselling from the primary healthcare nurses and laycounsellors.All cell phone communications between providers andstudy participants, in both study arms, will be recordedin a study log.ObjectivesPrimary objectivesThis pilot study will determine the feasibility of conduct-ing a larger trial evaluating the effects of interactiveweekly mobile phone text messaging plus motivationalinterviewing versus usual care in promotion of breast-feeding by HIV-infected women. We will assess thefeasibility of the trial for participant recruitment, propor-tion of eligible participants consenting to participate,and proportion with complete outcome assessment.Secondary objectivesTo determine if there is a signal of intervention effecton adherence to breastfeeding that may inform largertrial design. We assume text messaging will remindwomen about the importance of breastfeeding andreinforce regular communication with clinic staff to ad-dress adherence related problems. Motivational inter-viewing may build confidence and motivate women tocontinue breastfeeding.Study endpointsSampling and enrolmentParticipants will be enrolled over a period of threemonths during weekdays.Primary endpointsThe primary feasibility outcomes will include the num-ber of participants invited to participate in the studywho consent to participate, number of participants withcomplete evaluation of infant feeding practices at allstudy visits as assessed by the infant feeding question-naire, and the number of involuntary disclosures of HIVstatus due to text messaging. Criteria for feasibility suc-cess will include: five participants recruited per week (i.e. 60participants over 12 weeks); about 75% of all eligible participants consent toparticipate; complete evaluation of outcomes in at least 70% ofall recruited participants; breastfeeding adherence rate of at least 70% in theintervention group, at 24 weeks post delivery; number of participants reporting involuntarydisclosure of HIV status due to text messaging lessthan 5%.Secondary endpointsSecondary outcomes include number of participantswho are exclusively breastfeeding 24 weeks post deliveryand number of participants who are breastfeeding. Thiswill be assessed using a questionnaire of food itemsgiven to the baby in the last 24 h and one week preced-ing inquiry. Participants will be considered either “ad-herent” to exclusive breastfeeding if babies receive onlybreastmilk and no other liquids or solids based foods or“non-adherent” if other foods are given. Breastfeedingwill be assessed by self-report of women who reportbreastfeeding in addition to giving other foods. Studyoutcomes will be evaluated at weeks 2, 6, 10, and 24.Sample sizeWe assume that a sample size of 60 participants is largeenough to determine feasibility [38]. The informationfrom this pilot trial will inform the design and provideinitial estimates of effect for sample size calculation forthe main trial.Data collection and managementData collection tools will include a baseline question-naire and a follow-up questionnaire (at weeks 2, 6, 10,and 24 post randomization). Our questionnaires weredeveloped using a validated WHO infant feeding ques-tionnaire [39]. The questionnaires will be used in Englishand will be administered by a research nurse orcounsellor fluent in the participant’s language. In in-stances where study participants speak only local lan-guages, the researcher nurse will translate questionsdirectly. We will inquire about feeding practices duringthe previous 24 h and during the prior week. Studyfollow-up, SMS messages, and responses will be re-corded on a study log weekly. Telephone communica-tions with participants in the usual care group notreceiving text messages will be recorded in a similarstudy log. Clinic records will be reviewed for clinicallyrelevant data. Study follow-up will continue untilcomplete cessation of breastfeeding or until end ofstudy.To maintain participant confidentiality, only a codednumber will identify all questionnaires, reports, andother records. A unique patient identification numberwill be used to link participant-specific data. All paperrecords will be kept in a locked file cabinet at the re-search site and at the Centre for Evidence Based HealthCare, Stellenbosch University. Access will be limited toresearch staff. Electronic files will be password-protected. Clinical information will not be released with-out written permission of the participant, except ifrequired by the ethics review committee. Participantnames will be stored separately. No reports will link in-dividual names with person level data. The researchZunza et al. Trials  (2017) 18:331 Page 4 of 8nurse or counsellor will receive training prior to begin-ning of the trial. A standard operations manual will beavailable to staff for reference on operational details.Data will be transcribed from the paper format into anelectronic database. We will check data to ensure thatentered values are acceptable, required fields are com-pleted, and items are consistent with other related itemsin the database. We will verify with source documentsfor any discrepant entries. A record of the database up-date will be kept, identifying information about the per-son who made the changes, date, changed values, andcomments.Analysis planPrimary outcomesAnalysis of baseline characteristics and feasibility out-comes will be based on descriptive statistics reported aspercentages (95% confidence intervals [CI]) for categor-ical variables and mean (standard deviation) or median(interquartile range) for continuous variables dependingon the distribution.Secondary outcomesWe will follow the Consolidated Standards of ReportingTrials (CONSORT) extension for reporting pilot trials[40]. We will use the intention-to-treat principle for sec-ondary outcome analysis, where all participants random-ized will be considered per group assignment. In thisanalysis, we will impute missing outcome data using boththe best-case and worst-case scenario. For adherence out-comes, missing data at study visits will be considered as“adherent” and “non-adherent,” respectively. For breast-feeding outcome, missing data at study visits will beconsidered as “stopped breastfeeding” and “still breast-feeding.” The study is not adequately powered to testintervention effects and these will be of secondary interestto assess potential trends. Logistic regression models willbe built for binary outcomes. For timed endpoints, the cu-mulative proportions of women stopping exclusivelybreastfeeding and cumulative proportions of those stop-ping any breastfeeding, we will use the Kaplan–Meier sur-vival analysis followed by multivariable Cox proportionalhazards model to adjust for possible baseline imbalances.We will report odds ratios and hazard ratios (95% CI) asinitial estimates of effect. Table 1 provides a summary ofmethods of analysis for each variable. Separately, we willconduct sub-analysis to assess subgroup effects, a sum-mary of this analysis follows below.Sub-group analysesAdditional analysis of secondary outcomes will includeonly participants who will be considered as active partic-ipants and another analysis of those who will be consid-ered non-active participants. The text messagingintervention requires active participation of study partic-ipants to be effective. Participants who respond to theweekly text messages > 80% of the time will be consid-ered as active respondents; those who respond ≤ 80% ofthe time will be considered as non-active respondents.The 80% cutoff may be revised as appropriate. Partici-pants who never respond to the text message, for what-ever reason, will be included in the usual care group.The sample size will be too small to perform furthersub-group analysis.The statistician under the guidance of a senior biostat-istician (LT), will conduct all analyses while blinded tostudy assignment. Stata 14 (StataCorp, College Station,TX, USA) will be used for analysis.Ethical aspectsThe study will be conducted according to the ethicalguidelines and principles of the International Declar-ation of Helsinki, South African Guidelines for GoodClinical Practice, and the Medical Research CouncilTable 1 Variables, measures, and methods of analysisVariable/Outcome Type Hypothesis Outcome measure Method of analysisl. Primarya. Participants recruited Count Percentage recruited Descriptive statisticsb. Participants consenting Count Percentage consenting Descriptive statisticsc. Completeness of evaluationof outcomesCount Percentage with completeoutcome evaluationDescriptive statisticsd. Cumulative breastfeedingadherence at six monthsBinary Percentage adherence inthe last 24 h and 1 weekDescriptive statistics2. Secondarya. Adherence to exclusivebreastfeedingBinary SMS +motivational interviewleads to better adherence tobreastfeeding than usual carePercentage adherence inthe last 24 h and 1 weekLogistic regressionb. Time to stoppingbreastfeedingTime-to-event SMS +motivational interviewprolongs time to stoppingbreastfeeding than usual careReporting of completecessation of breastfeedingKaplan–Meier survivalanalysisZunza et al. Trials  (2017) 18:331 Page 5 of 8Ethical Guidelines for Research [41, 42]. Participants willprovide written informed consent. Participants willreceive R150 (~US $10) for their participation time,transport, lunch on study visit days, and any otherstudy-related costs. There are no anticipated physicalrisks involved in participating in the study; however, par-ticipants will be insured by Stellenbosch University’s re-search policy in the event of some form of physicalinjury occurring as a direct result of taking part in thisstudy. The Stellenbosch University Human ResearchEthics Committee approved the study protocol (refer-ence no. N16/09/11). This pilot trial will not have a Dataand Safety Monitoring Board. The study will not have acodebreaking rule for randomization as the study is un-blinded, except for data analysts. All investigators de-clare no competing interests. If there are any protocolmodifications, the ethics committee, trial registry, andtrial participants will be informed. Study results will bepresented in aggregate format in technical reports andjournal publications.DiscussionThe pilot trial evaluates the feasibility of conducting alarger trial on communication and support approachesthat may improve adherence to exclusive and continuedbreastfeeding by HIV-infected women. Several clinicaltrials on mobile phone text messaging showed improvedtreatment adherence for chronic medication, includingdiabetes, HIV, and tuberculosis. Text messaging and mo-tivational interviewing will allow participants to accesspersonalized adherence advice and support. Text messa-ging is simple and popular among participants andhealthcare providers and this may maximize its use inreal practice settings. Additionally, our study is uniquein that it tests the ability to combine a number of ap-proaches to influence behavior change.The study will be conducted in a setting where adher-ence to breastfeeding is poor. This risks finding largerdifferences between the intervention and control groupsthan what could be found in settings with better baselineadherence to breastfeeding. However, we assume theintervention would show a similar trend in direction ofeffect, in settings with better adherence to breastfeeding.Another disadvantage of our study design is that bothhealthcare providers and the population whose behaviorwe are attempting to change (including those in theusual standard of care group) are sensitized to the po-tential benefits of the intervention during enrolment.We will record the frequency with which participants at-tend the primary healthcare clinics during follow inorder to identify any dose-response relationships be-tween interventions and behavior change.The design and analysis plan will allow us to assess theeffect of the intervention on secondary outcomes. Theresults of this pilot trial will inform further developmentof a larger trial on use of mobile phone text messagingplus motivational interviewing to improve breastfeedingpractices of HIV-infected women in resource-limitedsettings. While our measure of behavior change is basedon mothers’ self-report rather than more objective mea-sures that accurately predict infant feeding behavior, it isa widely used approach for measuring change in infantfeeding practices.Trial statusThe pilot trial is not yet recruiting participants. Protocolversion 1 25/06/2017.Additional fileAdditional file 1: SPIRIT 2013 Checklist: Recommended items to addressin a clinical trial protocol and related documents*. (DOC 118 kb)AbbreviationsAIDS: Acquired immunodeficiency syndrome; ART: Antiretroviral treatment;CONSORT: Consolidated Standards of Reporting Trials; HIV: Humanimmunodeficiency virus; SMS: Short message system; SPIRIT: Standardprotocol items recommendation for intervention trials; WHO: World HealthOrganizationAcknowledgementsThe authors thank Taryn Young for her input on funding applications for thestudy.FundingDr. Moleen Zunza is supported by Janssen/CTN Postdoctoral InternationalFellowship Award of the CIHR Canadian HIV Trials Network. We receivedfunds from Stellenbosch University (reference no. SU-PT-16/09-000054) andHarry Crossely Foundation to cover part of the project running costs. Thefunders will not have any role in study design, data collection, data analysis,interpretation, preparation of the manuscript, or decision to publish.Availability of data and materialsThe individual participant data will be available from the correspondingauthor on reasonable request.Authors’ contributionsMZ conceived the study and drafted the manuscript. MFC participated instudy design and helped to draft the manuscript. LM participated in studydesign and helped to draft the manuscript. RL participated in study designand helped to draft the manuscript. LT conceived the study, participated inits design, and helped to draft the manuscript. All authors read andapproved the final manuscript.Ethics approval and consent to participateParticipants will provide written informed consent. The StellenboschUniversity Human Research Ethics Committee approved the study protocol(reference no. N16/09/110).Consent for publicationNot applicable. Study results will be presented in aggregate format intechnical reports and journal publications.Competing interestsThe authors declare that they have no competing interests.Publisher’s NoteSpringer Nature remains neutral with regard to jurisdictional claims inpublished maps and institutional affiliations.Zunza et al. Trials  (2017) 18:331 Page 6 of 8Author details1Faculty of Medicine and Health Sciences, Department of Global Health,Centre for Evidence Based Health Care, Stellenbosch University, Francie VanZyl Drive, PO Box 241, Cape Town 8000, South Africa. 2Research Institute,McGill University Health Centre, Montreal, QC, Canada. 3CIHR Canadian HIVTrials Network, 588-1081 Burrard Street, Vancouver, BC V6B 3E6, Canada.4Faculty of Medicine and Health Sciences, Department of Paediatrics andChild Health, Stellenbosch University, Francie Van Zyl Drive, PO Box 241,Cape Town 8000, South Africa. 5Department of Clinical Epidemiology andBiostatistics, McMaster University, Hamilton, ON, Canada. 6Biostatistics Unit,Father Sean O’Sullivan Research Centre, St Joseph’s Healthcare, Hamilton, ON,Canada. 7Global Health, Division of Infectious Diseases, Faculty of Medicine,University of British Columbia, Vancouver General Hospital, Vancouver,Canada.Received: 7 December 2016 Accepted: 1 July 2017References1. 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Pretoria:Department of Health; 2006.•  We accept pre-submission inquiries •  Our selector tool helps you to find the most relevant journal•  We provide round the clock customer support •  Convenient online submission•  Thorough peer review•  Inclusion in PubMed and all major indexing services •  Maximum visibility for your researchSubmit your manuscript atwww.biomedcentral.com/submitSubmit your next manuscript to BioMed Central and we will help you at every step:Zunza et al. Trials  (2017) 18:331 Page 8 of 8

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