An Intervention Delivered by App Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Protocol of a Randomized Controlled Trial

Ona L McCarthy, Veronica Osorio Calderon, Shelly Makleff, Silvia Huaynoca, Baptiste Leurent, Phil Edwards, Jhonny Lopez Gallardo, Caroline Free, Ona L McCarthy, Veronica Osorio Calderon, Shelly Makleff, Silvia Huaynoca, Baptiste Leurent, Phil Edwards, Jhonny Lopez Gallardo, Caroline Free

Abstract

Background: Unintended pregnancy is associated with numerous poorer health outcomes for both women and their children. Fulfilling unmet need for contraception is essential in avoiding unintended pregnancies, yet millions of women in low- and middle-income countries continue to face obstacles in realizing their fertility desires. In Bolivia, family planning progress has improved in recent decades but lags behind other countries in the region. Unmet need for contraception among women aged 15 to 19 years is estimated to be 38%, with the adolescent fertility rate at 70 per 1000 women. Mobile phones are an established and popular mode in which to deliver health behavior support. The London School of Hygiene & Tropical Medicine and the Centro de Investigación, Educación y Servicios in Bolivia have partnered to develop and evaluate a contraceptive behavioral intervention for Bolivian young women delivered by mobile phone. The intervention was developed guided by behavioral science and consists of short instant messages sent through an app over 4 months.

Objective: The objective of this study is to evaluate the effect of the intervention on young women's use of and attitudes toward the most effective contraceptive methods.

Methods: We will allocate 1310 women aged 16 to 24 years with an unmet need for contraception in a 1:1 ratio to receive the intervention messages or the control messages about trial participation. The messages are sent through the Tú decides app, which contains standard family planning information. Coprimary outcomes are use and acceptability of at least one effective contraceptive method, both measured at 4 months.

Results: Recruitment commenced on March 1, 2017 and was completed on July 29, 2017. We estimate that the follow-up period will end in January 2018.

Conclusions: This trial will evaluate the effect of the intervention on young women's use of and attitudes toward the (nonpermanent) effective contraception methods available in Bolivia.

Trial registration: ClinicalTrials.gov NCT02905526; https://ichgcp.net/clinical-trials-registry/NCT02905526 (Archived by WebCite at http://www.webcitation.org/6vT0yIFfN).

Keywords: Bolivia; adolescent; behavior change; cell phone; contraception behavior; reproductive health; smartphone; young adult.

Conflict of interest statement

Conflicts of Interest: None declared.

©Ona L McCarthy, Veronica Osorio Calderon, Shelly Makleff, Silvia Huaynoca, Baptiste Leurent, Phil Edwards, Jhonny Lopez Gallardo, Caroline Free. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.12.2017.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials (CONSORT) flow diagram.
Figure 2
Figure 2
Schedule of enrollment, interventions, and assessments.

References

    1. Darroch JE. Trends in contraceptive use. Contraception. 2013 Mar;87(3):259–63. doi: 10.1016/j.contraception.2012.08.029.
    1. Brown S, Eisenberg L, editors. The Best Intentions: Unintended Pregnancy and the Well-Being of Children and Families. Washington, DC: National Academies Press; 1995.
    1. Hardee K, Eggleston E, Wong EL, Irwanto. Hull TH. Unintended pregnancy and women's psychological well-being in Indonesia. J Biosoc Sci. 2004 Sep;36(5):617–26.
    1. Khajehpour M, Simbar M, Jannesari S, Ramezani-Tehrani F, Majd HA. Health status of women with intended and unintended pregnancies. Public Health. 2013 Jan;127(1):58–64. doi: 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 Mar;39(1):18–38.
    1. Najman JM, Morrison J, Williams G, Andersen M, Keeping JD. The mental health of women 6 months after they give birth to an unwanted baby: a longitudinal study. Soc Sci Med. 1991;32(3):241–7.
    1. Barber JS, Axinn WG, Thornton A. Unwanted childbearing, health, and mother-child relationships. J Health Soc Behav. 1999 Sep;40(3):231–57.
    1. Nakku JEM, Nakasi G, Mirembe F. Postpartum major depression at six weeks in primary health care: prevalence and associated factors. Afr Health Sci. 2006 Dec;6(4):207–14. doi: 10.5555/afhs.2006.6.4.207.
    1. Lau Y, Keung DWF. Correlates of depressive symptomatology during the second trimester of pregnancy among Hong Kong Chinese. Soc Sci Med. 2007 May;64(9):1802–11. doi: 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(1):38–46.
    1. Cheng D, Schwarz EB, Douglas E, Horon I. Unintended pregnancy and associated maternal preconception, prenatal and postpartum behaviors. Contraception. 2009 Mar;79(3):194–8. doi: 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 Oct;51(7):1011–8.
    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 (Camb) 2003;57(1):77–93. doi: 10.1080/0032472032000061749.
    1. Kost K, Landry DJ, Darroch JE. Predicting maternal behaviors during pregnancy: does intention status matter? Fam Plann Perspect. 1998;30(2):79–88.
    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 Aug;51(4):551–61.
    1. Shah PS, Balkhair T, Ohlsson A, Beyene J, Scott F, Frick C. Intention to become pregnant and low birth weight and preterm birth: a systematic review. Matern Child Health J. 2011 Feb;15(2):205–16. doi: 10.1007/s10995-009-0546-2.
    1. Mohllajee AP, Curtis KM, Morrow B, Marchbanks PA. Pregnancy intention and its relationship to birth and maternal outcomes. Obstet Gynecol. 2007 Mar;109(3):678–86. doi: 10.1097/01.AOG.0000255666.78427.c5.
    1. Sedgh G, Henshaw S, Singh S, Ahman E, Shah IH. Induced abortion: estimated rates and trends worldwide. Lancet. 2007 Oct 13;370(9595):1338–45. doi: 10.1016/S0140-6736(07)61575-X.
    1. World Health Organization . Unsafe Abortion. Global and Regional Estimates of the Incidence of Unsafe Abortion and Associated Mortality in 2008. 6th edition. Geneva, Switzerland: WHO; 2011.
    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, NY: Guttmacher Institute; 2016. [2017-10-20]. .
    1. World Bank Bolivia World Development Indicators 2015. [2017-12-06]. .
    1. Patrinos H, Skoufias E, Lunde T. Indigenous Peoples in Latin America: Economic Opportunities and Social Networks. World Bank Policy Research Working Paper 4227. Washington, DC: World Bank; 2007.
    1. Bertrand J. USAID graduation from family planning assistance: implications for Latin America. New Orleans, LA: Tulane University School of Public Health and Tropical Medicine; 2011. Oct, [2017-12-07]. .
    1. Cleland J, Ali MM. Reproductive consequences of contraceptive failure in 19 developing countries. Obstet Gynecol. 2004 Aug;104(2):314–20. doi: 10.1097/01.AOG.0000134789.73663.fd.
    1. Trussell J. Contraceptive efficacy. In: Hatcher R, Trussell J, Nelson A, Cates W, Kowal D, Policar M, editors. Contraceptive Technology. New York, NY: Ardent Media; 2011.
    1. Trussell J. Global Library of Women’s Medicine. 2014. Feb, [2017-12-07]. Contraceptive efficacy .
    1. UNFPA Independent Country Programme Evaluation-Bolivia. 2012. [2017-10-20]. .
    1. Encuesta Nacional de Demografía y Salud 2008. 2009. [2017-10-20]. .
    1. Center for Reproductive Rights Bolivia's abortion provisions. Penal Code (1972), Title VIII, Chapter II, Articles 263–269. 2017. [2017-10-20]. .
    1. Free C, Knight R, Robertson S, Whittaker R, Edwards P, Zhou W, Rodgers A, Cairns J, Kenward MG, Roberts I. Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. Lancet. 2011 Jul 2;378(9785):49–55. doi: 10.1016/S0140-6736(11)60701-0.
    1. Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W, Habyarimana J, Sadatsafavi M, Najafzadeh M, Marra CA, Estambale B, Ngugi E, Ball TB, Thabane L, Gelmon LJ, Kimani J, Ackers M, Plummer FA. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010 Nov 27;376(9755):1838–45. doi: 10.1016/S0140-6736(10)61997-6.
    1. Pop-Eleches C, Thirumurthy H, Habyarimana JP, Zivin JG, Goldstein MP, de Walque D, MacKeen L, Haberer J, Kimaiyo S, Sidle J, Ngare D, Bangsberg DR. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS. 2011 Mar 27;25(6):825–34. doi: 10.1097/QAD.0b013e32834380c1.
    1. Zurovac D, Sudoi RK, Akhwale WS, Ndiritu M, Hamer DH, Rowe AK, Snow RW. The effect of mobile phone text-message reminders on Kenyan health workers' adherence to malaria treatment guidelines: a cluster randomised trial. Lancet. 2011 Aug 27;378(9793):795–803. doi: 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 Dec;9(4):397–416. doi: 10.1080/17437199.2015.1022847.
    1. Hall CS, Fottrell E, Wilkinson S, Byass P. Assessing the impact of mHealth interventions in low- and middle-income countries--what has been shown to work? Glob Health Action. 2014;7:25606.
    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. doi: 10.1186/1471-2458-14-188.
    1. Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, Patel V, Haines A. 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(1):e1001362. doi: 10.1371/journal.pmed.1001362.
    1. Head KJ, Noar SM, Iannarino NT, Grant HN. Efficacy of text messaging-based interventions for health promotion: a meta-analysis. Soc Sci Med. 2013 Nov;97:41–8. doi: 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 Mar 18;36:393–415. doi: 10.1146/annurev-publhealth-031914-122855.
    1. World Health Organization . mHealth: New Horizons for Health Through Mobile Technologies: Second Global Survey on eHealth. Geneva, Switzerland: World Health Organization; 2011.
    1. L'Engle KL, Mangone ER, Parcesepe AM, Agarwal S, Ippoliti NB. Mobile phone interventions for adolescent sexual and reproductive health: a systematic review. Pediatrics. 2016 Sep;138(3) doi: 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 Dec;86(6):716–24. doi: 10.1016/j.contraception.2012.06.007.
    1. Castaño PM, Bynum JY, Andrés R, Lara M, Westhoff C. Effect of daily text messages on oral contraceptive continuation: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):14–20. doi: 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 Jul;57(1):100–6. doi: 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 Apr;87(4):449–54. doi: 10.1016/j.contraception.2012.09.004.
    1. Smith C, Gold J, Ngo TD, Sumpter C, Free C. Mobile phone-based interventions for improving contraception use. Cochrane Database Syst Rev. 2015 Jun 26;(6):CD011159. doi: 10.1002/14651858.CD011159.pub2.
    1. Smith C, Ngo TD, Gold J, Edwards P, Vannak U, Sokhey L, Machiyama K, Slaymaker E, Warnock R, McCarthy O, Free C. Effect of a mobile phone-based intervention on post-abortion contraception: a randomized controlled trial in Cambodia. Bull World Health Organ. 2015 Dec 01;93(12):842–50A. doi: 10.2471/BLT.15.160267.
    1. World Bank International Telecommunication Union, World Telecommunication/ICT Development Report and database. 2015. [2017-12-06]. Mobile cellular subscriptions per 100 people .
    1. Montaño D, Kasprzyk D. Theory of reasoned action, theory of planned behavior, and the integrated behavioral model. In: Glanz K, Rimer BK, Viswanath K, editors. Health Behaviour: Theory, Research and Practice. 5th edition. San Francisco, CA: Jossey-Bass; 2015.
    1. Kok G, Gottlieb N, Peters G, Mullen P, Parcel G, Ruiter R, Fernández ME, Markham C, Bartholomew L. A taxonomy of behaviour change methods: an intervention mapping approach. Health Psychol Rev. 2016 Sep;10(3):297–312. doi: 10.1080/17437199.2015.1077155.
    1. Bartholomew Eldredge LK, Markham C, Ruiter R, Fernandez M, Kok G, Parcel G. Planning Health Promotion Programs: An Intervention Mapping Approach. 4th edition. San Francisco, CA: John Wiley & Sons; 2016.
    1. Francis J, Eccles M, Johnston M, Walker A, Grimshaw J, Foy R, Kaner E, Smith L, Bonetti D. Constructing Questionnaires Based on the Theory of Planned Behaviour. A Manual for Health Services Researchers. Newcastle upon Tyne, UK: Centre for Health Services Research, University of Newcastle upon Tyne; 2004.
    1. Montaño DE, Kasprzyk D, Hamilton DT, Tshimanga M, Gorn G. Evidence-based identification of key beliefs explaining adult male circumcision motivation in Zimbabwe: targets for behavior change messaging. AIDS Behav. 2014 May;18(5):885–904. doi: 10.1007/s10461-013-0686-7.
    1. Unidad de Análisis de Políticas Sociales y Económicas Encuesta de evaluación de salud y nutrición 2012: informe de resultados. 2014. [2017-12-06]. .
    1. O'Kelly M, Ratitch B. Clinical Trials With Missing Data: A Guide for Practitioners. Chichester, UK: John Wiley & Sons, Ltd; 2014.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.
    1. European Medicines Agency. Committee for Medicinal Products for Human Use . Guideline on adjustment for baseline covariates in clinical trials. London, UK: EMA; 2015. [2017-10-20]. .
    1. Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med. 2002 Oct 15;21(19):2917–30. doi: 10.1002/sim.1296.
    1. Kasenda B, Schandelmaier S, Sun X, von Elm E, You J, Blümle A, Tomonaga Y, Saccilotto R, Amstutz A, Bengough T, Meerpohl JJ, Stegert M, Olu KK, Tikkinen KAO, Neumann I, Carrasco-Labra A, Faulhaber M, Mulla SM, Mertz D, Akl EA, Bassler D, Busse JW, Ferreira-González I, Lamontagne F, Nordmann A, Gloy V, Raatz H, Moja L, Rosenthal R, Ebrahim S, Vandvik PO, Johnston BC, Walter MA, Burnand B, Schwenkglenks M, Hemkens LG, Bucher HC, Guyatt GH, Briel M, DISCO Study Group Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications. BMJ. 2014 Jul 16;349:g4539.
    1. Gabler NB, Duan N, Liao D, Elmore JG, Ganiats TG, Kravitz RL. Dealing with heterogeneity of treatment effects: is the literature up to the challenge? Trials. 2009 Jun 19;10:43. doi: 10.1186/1745-6215-10-43.
    1. Kent DM, Rothwell PM, Ioannidis JPA, Altman DG, Hayward RA. Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal. Trials. 2010 Aug 12;11:85. doi: 10.1186/1745-6215-11-85.
    1. Brookes ST, Whitely E, Egger M, Smith GD, Mulheran PA, Peters TJ. Subgroup analyses in randomized trials: risks of subgroup-specific analyses; power and sample size for the interaction test. J Clin Epidemiol. 2004 Mar;57(3):229–36. doi: 10.1016/j.jclinepi.2003.08.009.

Source: PubMed

Подписаться