An intervention delivered by text message to increase the acceptability of effective contraception among young women in Palestine: study protocol for a randomised controlled trial

Ona L McCarthy, Ola Wazwaz, Iman Jado, Baptiste Leurent, Phil Edwards, Samia Adada, Amina Stavridis, Caroline Free, Ona L McCarthy, Ola Wazwaz, Iman Jado, Baptiste Leurent, Phil Edwards, Samia Adada, Amina Stavridis, Caroline Free

Abstract

Background: Unintended pregnancy can negatively impact women's lives and is associated with poorer health outcomes for women and children. Many women, particularly in low- and middle-income countries, continue to face obstacles in avoiding unintended pregnancy. In the State of Palestine, a survey conducted in 2006 estimated that 38% of pregnancies are unintended. In 2014, unmet need for contraception was highest among young women aged 20-24 years, at 15%. Mobile phones are increasingly being used to deliver health support. Once developed, interventions delivered by mobile phone are often cheaper to deliver than face-to-face support. The London School of Hygiene and Tropical Medicine and the Palestinian Family Planning and Protection Association have partnered to develop and evaluate a contraceptive behavioural intervention for young women in Palestine delivered by mobile phone. The intervention was developed guided by behavioural science and consists of short, mobile phone text messages that contain information about contraception and behaviour change methods delivered over 4 months.

Methods: We will evaluate the intervention by conducting a randomised controlled trial. Five hundred and seventy women aged 18-24 years, who do not report using an effective method of contraception, will be allocated with a 1:1 ratio to receive the intervention text messages or control text messages about trial participation. The primary outcome is self-reported acceptability of at least one method of effective contraception at 4 months. Secondary outcomes include the use of effective contraception, acceptability of individual methods, discontinuation, service uptake, unintended pregnancy and abortion. Process outcomes include knowledge, perceived norms, personal agency and intervention dose received. Outcomes at 4 months will be compared between arms using logistic regression.

Discussion: This trial will determine the effect of the intervention on young women's attitudes towards the most effective methods of contraception. If the intervention is found to be effective, the intervention will be implemented widely across Palestine. The results could also be used to design a larger trial to establish its effect on unintended pregnancy.

Trial registration: ClinicalTrials.gov, ID: NCT02905461 . Registered on 14 September 2016.

Keywords: Cell phone; Mobile phone; Palestine. Contraception; Reproductive health; Young adults.

Conflict of interest statement

Ethics approval and consent to participate

The trial was granted ethical approval by the LSHTM Interventions Research Ethics Committee on 16 May 2016 and by the State of Palestine Ministry of Health Primary Health Care and Public Health Directorate on 9 May 2016.

Informed consent will be taken either by PFPPA recruitment staff or participants can read the Information Sheet (see Additional file 3) and provide informed consent (see Additional file 4) themselves online through the system.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) diagram
Fig. 2
Fig. 2
Schedule of enrolment, interventions and assessments. *Plus: if participants report using an effective method, where they obtained it; current pregnancy intention; whether they knew someone else that took part in the study and, if so, if they read each other’s messages (contamination); if they have experienced physical violence since being in the study and if anything good or bad happened as a result of receiving the messages

References

    1. Sedgh G, Singh S, Hussain R. Intended and unintended pregnancies worldwide in 2012 and recent trends. Stud Fam Plann. 2014;45(3):301–14. doi: 10.1111/j.1728-4465.2014.00393.x.
    1. Hardee K, Eggleston E, Wong EL, Irwanto, Hull TH. Unintended pregnancy and women’s psychological well-being in Indonesia. J Biosoc Sci. 2004;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;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;39(1):18–38. doi: 10.1111/j.1728-4465.2008.00148.x.
    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. doi: 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(3):231–57. doi: 10.2307/2676350.
    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;6(4):207–14.
    1. Lau Y, Keung DWF. Correlates of depressive symptomatology during the second trimester of pregnancy among Hong Kong Chinese. Soc Sci Med. 2007;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. doi: 10.1016/S1049-3867(96)00017-5.
    1. Cheng D, Schwarz EB, Douglas E, Horon I. Unintended pregnancy and associated maternal preconception, prenatal and postpartum behaviors. Contraception. 2009;79(3):194–8. doi: 10.1016/j.contraception.2008.09.009.
    1. Eggleston E. Unintended pregnancy and women’ use of prenatal care in Ecuador. Soc Sci Med. 2000;51(7):1011–8. doi: 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(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. doi: 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(4):551–61. doi: 10.1016/S0277-9536(99)00495-5.
    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;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;109(3):678–86. doi: 10.1097/01.AOG.0000255666.78427.c5.
    1. Carson C, Redshaw M, Sacker A, Kelly Y, Kurinczuk JJ, Quigley MA. Effects of pregnancy planning, fertility, and assisted reproductive treatment on child behavioral problems at 5 and 7 years: evidence from the Millennium Cohort Study. Fertil Steril. 2013;99(2):456–63. doi: 10.1016/j.fertnstert.2012.10.029.
    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. Sedgh G, Henshaw S, Singh S, Ahman E, Shah IH. Induced abortion: estimated rates and trends worldwide. Lancet. 2007;370(9595):1338–45. doi: 10.1016/S0140-6736(07)61575-X.
    1. Abortion U. Global and regional estimates of the incidence of unsafe abortion and associated mortality in 2008. Geneva, Switzerland: World Health Organization; 2011.
    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. 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. Giacaman R, Rabaia Y, Nguyen-Gillham V, Batniji R, Punamaki R-L, Summerfield D. Mental health, social distress and political oppression: the case of the occupied Palestinian territory. Glob Public Health. 2011;6(5):547–59. doi: 10.1080/17441692.2010.528443.
    1. Giacaman R, Mataria A, Nguyen-Gillham V, Safieh RA, Stefanini A, Chatterji S. Quality of life in the Palestinian context: an inquiry in war-like conditions. Health Policy. 2007;81(1):68–84. doi: 10.1016/j.healthpol.2006.05.011.
    1. Giacaman R, Abu-Rmeileh NME, Husseini A, Saab H, Boyce W. Humiliation: the invisible trauma of war for Palestinian youth. Public Health. 2007;121(8):563–71. doi: 10.1016/j.puhe.2006.10.021.
    1. Bosmans M, Nasser D, Khammash U, Claeys P, Temmerman M. Palestinian women’s sexual and reproductive health rights in a longstanding humanitarian crisis. Reprod Health Matters. 2008;16(31):103–11. doi: 10.1016/S0968-8080(08)31343-3.
    1. Giacaman R, Abu-Rmeileh NME, Mataria A, Wick L. Palestinian women’s pregnancy intentions: analysis and critique of the Demographic and Health Survey 2004. Health Policy. 2008;85(1):83–93. doi: 10.1016/j.healthpol.2007.06.006.
    1. Roudi-Fahimi F, Abdul Monem A. Unintended pregnancies in the Middle East and North Africa. In: Population Reference Bureau, editor; 2010.
    1. Cleland J, Ali MM. Reproductive consequences of contraceptive failure in 19 developing countries. Obstet Gynecol. 2004;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: twentieth revised edition. 20. New York: Ardent Media; 2011.
    1. Trussell J. Contraceptive efficacy: global library of women’s medicine. 2014. [26 September 2017]. Available from: .
    1. Palestinian Central Bureau of Statistics. Palestinian Family Health Survey 2006: Final Report. Ramallah, Palestine; 2007.
    1. Palestinian Central Bureau of Statistics. Palestinian Multiple Indicator Cluster Survey 2014: Final Report. Ramallah, Palestine; 2015.
    1. Imam A, Khatib S, Al-Hajar B, Qaraqra D, Al-Halaweh H, Salim M. Unmet needs for modern family planning in state of Palestine. Jerusalem, Palestine: School of Public Health/Al-Quds University; 2013.
    1. Memmi S. Contraceptive behaviour as a marital responsibility in the occupied Palestinian territory: a cross-sectional survey. Lancet. 2013;382:S26. doi: 10.1016/S0140-6736(13)62598-2.
    1. Roudi-Fahimi F, Abdul Monem A, Ashford L, El Adawy M. Women’s need for family planning in Arab countries. In: Population Reference Bureau, editor; 2012.
    1. Sayej S. Baseline survey on safe/unsafe abortion in selected refugee camps in West Bank Jerusalem: Palestinian Family Planning and Protection Association. 2007.
    1. AlRifai A. Safe and unsafe abortion among Palestinian women in Hebron Governorate in Southern West Bank-Palestine. Jerusalem: Palestinian Family Planning and Protection Association and the Safe Abortion Action Fund; 2015.
    1. Palestinian Central Bureau of Statistics. Final Report of the Palestinian Family Survey 2010. Ramallah, Palestine; 2013.
    1. Hammoudeh W. Addressing family planning delivery gaps in the Palestinian Territory. Washington, DC: Population Reference Bureau; 2014.
    1. Sayej S, Kokian V. Increasing access of the underserved areas in Palestine To SRH Services. 2014.
    1. Free C, Knight R, Robertson S, Whittaker R, Edwards P, Zhou W, et al. Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. Lancet. 2011;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, et al. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010;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, 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(6):825–34. doi: 10.1097/QAD.0b013e32834380c1.
    1. Zurovac D, Sudoi RK, Akhwale WS, Ndiritu M, Hamer DH, Rowe AK, 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(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;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. doi: 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. doi: 10.1186/1471-2458-14-188.
    1. Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, 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(1):e1001362. doi: 10.1371/journal.pmed.1001362.
    1. Head KJ, Noar SM, Iannarino NT, Grant Harrington N. Efficacy of text messaging-based interventions for health promotion: a meta-analysis. Soc Sci Med. 2013;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;36:393–415. doi: 10.1146/annurev-publhealth-031914-122855.
    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;138(3):e20160884.
    1. Berenson AB, Rahman M. A randomized controlled study of two educational interventions on adherence with oral contraceptives and condoms. Contraception. 2012;86(6):716–24. doi: 10.1016/j.contraception.2012.06.007.
    1. Castaño PM, Bynum JY, Andres R, Lara M, Westhoff C. Effect of daily text messages on oral contraceptive continuation: a randomized controlled trial. Obstet Gynecol. 2012;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;57(1):100–6. doi: 10.1016/j.jadohealth.2015.03.008.
    1. Hall KS, Westhoff CL, Castano PM. The impact of an educational text message intervention on young urban women’s knowledge of oral contraception. Contraception. 2013;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 of Systematic Reviews. 2015.
    1. Smith C, Ngo TD, Gold J, Edwards P, Vannak U, Sokhey L, et al. Effect of a mobile phone-based intervention on post-abortion contraception: a randomized controlled trial in Cambodia. Bull World Health Organ. 2015.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: new guidance. Medical Research Council.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013;50(5):587–92. doi: 10.1016/j.ijnurstu.2012.09.010.
    1. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:h1258. doi: 10.1136/bmj.h1258.
    1. Bartholomew Eldredge LK, Markham C, Ruiter R, Fernandez M, Kok G, Parcel G. Planning health promotion programs: an intervention mapping approach. 4th ed. San Francisco, CA: Jossey-Bass; 2016.
    1. Poushter J. Smartphone ownership and Internet usage continues to climb in emerging economies. Washington, DC: Pew Research Center; 2016.
    1. United Nations Department of Economic and Social Affairs. Definition of youth. [26 September 2017]. Available from: .
    1. Palestinian Family Planning and Protection Association (PFPPA) [26 September 2017]. Available from: .
    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. 5. San Francisco: Jossey-Bass; 2015. pp. 168–222.
    1. Kok G, Gottlieb N, Peters G, Mullen P, Parcel G, Ruiter R, et al. A taxonomy of behavior change methods; an intervention mapping approach. Health Psychol Rev. 2015.
    1. StataCorp . Stata Statistical Software: Release 15. College Station, TX: StataCorp LLC; 2017. p. 2017.
    1. O’Kelly M, Ratitch B. Clinical trials with missing data: a guide for practitioners. Chichester, UK: Wiley; 2014.
    1. European Medicines Agency. Guideline on Missing Data in Confirmatory Clinical Trials. London, UK; 2011.
    1. Schulz KF, Altman DG, Moher D, Group C, Altman DG, Barbour V, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. doi: 10.1136/bmj.c332.
    1. European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on adjustment for baseline covariates in clinical trials. London, UK. 2015.
    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;21(19):2917–30. doi: 10.1002/sim.1296.
    1. Kasenda B, Schandelmaier S, Sun X, von Elm E, You J, Blumle A, et al. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications. BMJ. 2014;349:g4539. doi: 10.1136/bmj.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;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;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;57(3):229–36. doi: 10.1016/j.jclinepi.2003.08.009.

Source: PubMed

3
S'abonner