A randomised controlled trial of an intervention delivered by app instant messaging to increase the acceptability of effective contraception among young people in Tajikistan: study protocol

Ona McCarthy, Baptiste Leurent, Phil Edwards, Ravshan Tokhirov, Caroline Free, Ona McCarthy, Baptiste Leurent, Phil Edwards, Ravshan Tokhirov, Caroline Free

Abstract

Introduction: Women in lower income countries experience unintended pregnancies at a higher rate compared with women in higher income countries. Unintended pregnancy is associated with numerous poorer health outcomes for both women and their children. In Tajikistan, an estimated 26% of married individuals aged 15-24 years have an unmet need for contraception. The strong cultural value placed on childbearing and oppositional attitudes towards contraception are major barriers to contraceptive uptake in the country.Mobile phone ownership is widespread in Tajikistan. The option of receiving reproductive health support on your personal phone may be an appealing alternative to attending a clinic, particularly for young people. The London School of Hygiene & Tropical Medicine and the Tajik Family Planning Association have partnered to develop and evaluate a contraceptive behavioural intervention delivered by mobile phone. The intervention was developed in 2015-2016 guided by behavioural science. It consists of short instant messages sent through an app over 4 months, contains information about contraception and behaviour change methods.

Methods and analysis: This randomised controlled trial is designed to evaluate the effect of the intervention on self-reported acceptability of effective contraception at 4 months. 570 men and women aged 16-24 years will be allocated with a ratio of 1:1 to receive the intervention messages or the control messages about trial participation. The messages will be sent through the Tajik Family Planning Association's 'healthy lifestyles' app, which contains basic information about contraception.

Ethics and dissemination: The trial was granted ethical approval by the London School of Hygiene & Tropical Medicine Interventions Research Ethics Committee on 16 May 2016 and by the Tajik National Scientific and Research Centre on Paediatrics and Child Surgery on 15 April 2016. The results of the trial will be submitted for publication in peer-reviewed academic journals and disseminated to study stakeholders.

Trial registration number: Clinicaltrial.gov NCT02905513.

Date of registration: 14 September 2016. WHO TRIAL REGISTRATION DATASET: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02905513.

Keywords: young adults.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
CONSORT diagram.
Figure 2
Figure 2
Logic model of the problem.
Figure 3
Figure 3
Schedule of enrolment, interventions and assessments.

References

    1. Sedgh G, Singh S, Hussain R. Intended and unintended pregnancies worldwide in 2012 and recent trends. Stud Fam Plann 2014;45:301–14. 10.1111/j.1728-4465.2014.00393.x
    1. Brown SS, Eisenberg L, The Best Intentions: Unintended Pregnancy and the Well-Being of Children and Families. Washington D.C: National Academies Press, 1995.
    1. Hardee K, Eggleston E, Wong EL, et al. . Unintended pregnancy and women’s psychological well-being in Indonesia. J Biosoc Sci 2004;36:617–26. 10.1017/S0021932003006321
    1. Khajehpour M, Simbar M, Jannesari S, et al. . Health status of women with intended and unintended pregnancies. Public Health 2013;127:58–64. 10.1016/j.puhe.2012.08.011
    1. Gipson JD, Koenig MA, Hindin MJ. The effects of unintended pregnancy on infant, child, and parental health: a review of the literature. Stud Fam Plann 2008;39:18–38. 10.1111/j.1728-4465.2008.00148.x
    1. Najman JM, Morrison J, Williams G, et al. . The mental health of women 6 months after they give birth to an unwanted baby: a longitudinal study. Soc Sci Med 1991;32:241–7. 10.1016/0277-9536(91)90100-Q
    1. Barber JS, Axinn WG, Thornton A. Unwanted childbearing, health, and mother-child relationships. J Health Soc Behav 1999;40:231–57. 10.2307/2676350
    1. Nakku JE, Nakasi G, Mirembe F. Postpartum major depression at six weeks in primary health care: prevalence and associated factors. Afr Health Sci 2006;6:207–14. 10.5555/afhs.2006.6.4.207
    1. Lau Y, Keung DW. Correlates of depressive symptomatology during the second trimester of pregnancy among Hong Kong Chinese. Soc Sci Med 2007;64:1802–11. 10.1016/j.socscimed.2007.01.001
    1. Orr ST, Miller CA. Unintended pregnancy and the psychosocial well-being of pregnant women. Womens Health Issues 1997;7:38–46. 10.1016/S1049-3867(96)00017-5
    1. Cheng D, Schwarz EB, Douglas E, et al. . Unintended pregnancy and associated maternal preconception, prenatal and postpartum behaviors. Contraception 2009;79:194–8. 10.1016/j.contraception.2008.09.009
    1. Eggleston E. Unintended pregnancy and women’s use of prenatal care in Ecuador. Soc Sci Med 2000;51:1011–8. 10.1016/S0277-9536(00)00010-1
    1. Marston C, Cleland J. Do unintended pregnancies carried to term lead to adverse outcomes for mother and child? An assessment in five developing countries. Popul Stud 2003;57:77–93. 10.1080/0032472032000061749
    1. Kost K, Landry DJ, Darroch JE. Predicting maternal behaviors during pregnancy: does intention status matter? Fam Plann Perspect 1998;30:79–88. 10.2307/2991664
    1. Magadi MA, Madise NJ, Rodrigues RN. Frequency and timing of antenatal care in Kenya: explaining the variations between women of different communities. Soc Sci Med 2000;51:551–61. 10.1016/S0277-9536(99)00495-5
    1. Shah PS, Balkhair T, Ohlsson A, et al. . Intention to become pregnant and low birth weight and preterm birth: a systematic review. Matern Child Health J 2011;15:205–16. 10.1007/s10995-009-0546-2
    1. Mohllajee AP, Curtis KM, Morrow B, et al. . Pregnancy intention and its relationship to birth and maternal outcomes. Obstet Gynecol 2007;109:678–86. 10.1097/01.AOG.0000255666.78427.c5
    1. Singh S, Darroch J, Ashford L. Adding It Up: The Costs and Benefits of Investing in Sexual and Reproductive Health 2014. New York: Guttmacher Institute, 2014.
    1. Ulikpan A, Mirzoev T, Jimenez E, et al. . Central Asian Post-Soviet health systems in transition: has different aid engagement produced different outcomes? Glob Health Action 2014;7:24978 10.3402/gha.v7.24978
    1. Health care in Central Asia. Buckingham: Open University Press, 2002.
    1. Tajikistan Demographic and Health Survey 2012. Dushanbe, Tajikistan, and Calverton, Maryland, USA: SA, MOH, and ICF International. Statistical Agency under the President of the Republic of Tajikistan (SA), Ministry of Health [Tajikistan], and ICF International 2013.
    1. Cleland J, Ali MM. Reproductive consequences of contraceptive failure in 19 developing countries. Obstet Gynecol 2004;104:314–20. 10.1097/01.AOG.0000134789.73663.fd
    1. Trussell J. Contraceptive efficacy : Hatcher R, Trussell J, Nelson A, Contraceptive Technology: Twentieth Revised Edition. 20th ed New York: NY: Ardent Media, 2011.
    1. Trussell J. Contraceptive efficacy: Global library of women’s medicine. 2014. Available from .
    1. World Health Organization. Medical eligibility criteria for contraceptive use. 5th edn, 2015.
    1. Sedgh G, Ashford L, Hussain R. Unmet Need for Contraception in Developing Countries: Examining Women’s Reasons for Not Using a Method. New York: Guttmacher Institute, 2016.
    1. Free C, Knight R, Robertson S, et al. . Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. Lancet 2011;378:49–55. 10.1016/S0140-6736(11)60701-0
    1. Lester RT, Ritvo P, Mills EJ, et al. . Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet 2010;376:1838–45. 10.1016/S0140-6736(10)61997-6
    1. Pop-Eleches C, Thirumurthy H, Habyarimana JP, et al. . Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS 2011;25:825–34. 10.1097/QAD.0b013e32834380c1
    1. Zurovac D, Sudoi RK, Akhwale WS, et al. . The effect of mobile phone text-message reminders on Kenyan health workers’ adherence to malaria treatment guidelines: a cluster randomised trial. Lancet 2011;378:795–803. 10.1016/S0140-6736(11)60783-6
    1. Orr JA, King RJ. Mobile phone SMS messages can enhance healthy behaviour: a meta-analysis of randomised controlled trials. Health Psychol Rev 2015;9:397–416. 10.1080/17437199.2015.1022847
    1. Hall CS, Fottrell E, Wilkinson S, et al. . Assessing the impact of mHealth interventions in low- and middle-income countries - what has been shown to work? Glob Health Action 2014;7:25606 10.3402/gha.v7.25606
    1. Aranda-Jan CB, Mohutsiwa-Dibe N, Loukanova S. Systematic review on what works, what does not work and why of implementation of mobile health (mHealth) projects in Africa. BMC Public Health 2014;14:188 10.1186/1471-2458-14-188
    1. Free C, Phillips G, Galli L, et al. . The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS Med 2013;10:e1001362 10.1371/journal.pmed.1001362
    1. Head KJ, Noar SM, Iannarino NT, et al. . Efficacy of text messaging-based interventions for health promotion: a meta-analysis. Soc Sci Med 2013;97:41–8. 10.1016/j.socscimed.2013.08.003
    1. Hall AK, Cole-Lewis H, Bernhardt JM. Mobile text messaging for health: a systematic review of reviews. Annu Rev Public Health 2015;36:393–415. 10.1146/annurev-publhealth-031914-122855
    1. L’Engle KL, Mangone ER, Parcesepe AM, et al. . Mobile phone interventions for adolescent sexual and reproductive health: a systematic review. Pediatrics 2016;138:e20160884 10.1542/peds.2016-0884
    1. Berenson AB, Rahman M. A randomized controlled study of two educational interventions on adherence with oral contraceptives and condoms. Contraception 2012;86:716–24. 10.1016/j.contraception.2012.06.007
    1. Castaño PM, Bynum JY, Andrés R, et al. . Effect of daily text messages on oral contraceptive continuation: a randomized controlled trial. Obstet Gynecol 2012;119:14–20. 10.1097/AOG.0b013e31823d4167
    1. Trent M, Thompson C, Tomaszewski K. Text Messaging Support for Urban Adolescents and Young Adults Using Injectable Contraception: Outcomes of the DepoText Pilot Trial. J Adolesc Health 2015;57:100–6. 10.1016/j.jadohealth.2015.03.008
    1. Hall KS, Westhoff CL, Castaño PM. The impact of an educational text message intervention on young urban women’s knowledge of oral contraception. Contraception 2013;87:449–54. 10.1016/j.contraception.2012.09.004
    1. Smith C, Gold J, Ngo TD, et al. . Mobile phone-based interventions for improving contraception use. Cochrane Database Syst Rev 2015:CD011159 10.1002/14651858.CD011159.pub2
    1. Higgins JP, Altman DG, Gøtzsche PC, et al. . The cochrane collaboration’s tool for assessing risk of bias in randomised trials. BMJ 2011;343:d5928 10.1136/bmj.d5928
    1. Smith C, Ngo TD, Gold J, et al. . Effect of a mobile phone-based intervention on post-abortion contraception: a randomized controlled trial in Cambodia. Bull World Health Organ 2015;93:842–50. 10.2471/BLT.15.160267
    1. Mobile cellular subscriptions per 100 people: World Bank (International Telecommunication Union, World Telecommunication/ICT Development Report and database. 2015. (20 Feb 2017).
    1. Study on the use of mobile technologies in Tajikistan. 2015. ICT4D .
    1. Bartholomew Eldredge LK, Markham C, Ruiter R, et al. . Planning Health Promotion Programs: An Intervention Mapping Approach. 4th edn, 2016.
    1. Montaño D, Kasprzyk D. Theory of Reasoned Action, Theory of Planned Behavior, and the Integrated Behavioral Model : Glanz K, Rimer BK, Viswanath K, Health behaviour: Theory, research and practice. 5th ed San Francisco: Jossey-Bass, 2015:168–222.
    1. Kok G, Gottlieb NH, Peters GJ, et al. . A taxonomy of behaviour change methods: an Intervention Mapping approach. Health Psychol Rev 2016;10:297–312. 10.1080/17437199.2015.1077155
    1. Francis JJ, Eccles MP, Johnston M, et al. . Constructing questionnaires based on the theory of planned behaviour. A manual for health services researchers 2010;2004:2–12.
    1. Montaño DE, Kasprzyk D, Hamilton DT, et al. . Evidence-based identification of key beliefs explaining adult male circumcision motivation in Zimbabwe: targets for behavior change messaging. AIDS Behav 2014;18:885–904. 10.1007/s10461-013-0686-7
    1. O’Kelly M, Ratitch B. Clinical trials with missing data: A guide for practitioners. John Wiley & Sons, Ltd, 2014.
    1. Schulz KF, Altman DG, Moher D, et al. . CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332 10.1136/bmj.c332
    1. Guideline on adjustment for baseline covariates in clinical trials. European Medicines Agency CfMPfHU, 2015.
    1. Pocock SJ, Assmann SE, Enos LE, et al. . Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med 2002;21:2917–30. 10.1002/sim.1296
    1. Kasenda B, Schandelmaier S, Sun X, et al. . Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications. BMJ 2014;349:g4539 10.1136/bmj.g4539
    1. Gabler NB, Duan N, Liao D, et al. . Dealing with heterogeneity of treatment effects: is the literature up to the challenge? Trials 2009;10:43 10.1186/1745-6215-10-43
    1. Kent DM, Rothwell PM, Ioannidis JP, et al. . Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal. Trials 2010;11:85 10.1186/1745-6215-11-85
    1. Brookes ST, Whitely E, Egger M, et al. . Subgroup analyses in randomized trials: risks of subgroup-specific analyses; power and sample size for the interaction test. J Clin Epidemiol 2004;57:229–36. 10.1016/j.jclinepi.2003.08.009

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