SMS messaging to improve retention and viral suppression in prevention of mother-to-child HIV transmission (PMTCT) programs in Kenya: A 3-arm randomized clinical trial

John Kinuthia, Keshet Ronen, Jennifer A Unger, Wenwen Jiang, Daniel Matemo, Trevor Perrier, Lusi Osborn, Bhavna H Chohan, Alison L Drake, Barbra A Richardson, Grace John-Stewart, John Kinuthia, Keshet Ronen, Jennifer A Unger, Wenwen Jiang, Daniel Matemo, Trevor Perrier, Lusi Osborn, Bhavna H Chohan, Alison L Drake, Barbra A Richardson, Grace John-Stewart

Abstract

Background: Pregnant and postpartum women living with HIV (WLWH) need support for HIV and maternal child health (MCH) care, which could be provided using short message service (SMS).

Methods and findings: We compared 2-way (interactive) and 1-way SMS messaging to no SMS in a 3-arm randomized trial in 6 MCH clinics in Kenya. Messages were developed using the Health Belief Model and Social Cognitive Theory; HIV messages were integrated into an existing MCH SMS platform. Intervention participants received visit reminders and prespecified weekly SMS on antiretroviral therapy (ART) adherence and MCH, tailored to their characteristics and timing. Two-way participants could message nurses as needed. Clinic attendance, viral load (VL), and infant HIV results were abstracted from program records. Primary outcomes were viral nonsuppression (VL ≥1,000 c/ml), on-time clinic attendance, loss to follow-up from clinical care, and infant HIV-free survival. Among 824 pregnant women randomized between November 2015 and May 2017, median age was 27 years, gestational age was 24.3 weeks, and time since initiation of ART was 1.0 year. During follow-up to 2 years postpartum, 9.8% of 3,150 VL assessments and 19.6% of women were ever nonsuppressed, with no significant difference in 1-way versus control (11.2% versus 9.6%, adjusted risk ratio (aRR) 1.02 [95% confidence interval (CI) 0.67 to 1.54], p = 0.94) or 2-way versus control (8.5% versus 9.6%, aRR 0.80 [95% CI 0.52 to 1.23], p = 0.31). Median ART adherence and incident ART resistance did not significantly differ by arm. Overall, 88.9% (95% CI 76.5 to 95.7) of visits were on time, with no significant differences between arms (88.2% in control versus 88.6% in 1-way and 88.8% in 2-way). Incidence of infant HIV or death was 3.01/100 person-years (py), with no significant difference between arms; risk of infant HIV infection was 0.94%. Time to postpartum contraception was significantly shorter in the 2-way arm than control. Study limitations include limited ability to detect improvement due to high viral suppression and visit attendance and imperfect synchronization of SMS reminders to clinic visits.

Conclusions: Integrated HIV/MCH messaging did not improve HIV outcomes but was associated with improved initiation of postpartum contraception. In programs where most women are virally suppressed, targeted SMS informed by VL data may improve effectiveness. Rigorous evaluation remains important to optimize mobile health (mHealth) interventions.

Trial registration: ClinicalTrials.gov number NCT02400671.

Conflict of interest statement

I have read the journal’s policy and the authors of this manuscript have the following competing interests: BR has been on a DSMB and mock FDA advisory panel for Gilead; and GJS reports financial support from NIH. All other authors declare no competing interests.

Figures

Fig 1. Participant flowchart. MCH, maternal child…
Fig 1. Participant flowchart. MCH, maternal child health; SMS, short message service; VL, viral load.
Fig 2. Effect of Mobile WACh-X on…
Fig 2. Effect of Mobile WACh-X on viral nonsuppression, loss to follow-up, infant HIV-free survival, and ART resistance.
aHR, adjusted hazard ratio; ART, antiretroviral therapy; SMS, short message service.

References

    1. Demena BA, Artavia-Mora L, Ouedraogo D, Thiombiano BA, Wagner N. A Systematic Review of Mobile Phone Interventions (SMS/IVR/Calls) to Improve Adherence and Retention to Antiretroviral Treatment in Low-and Middle-Income Countries. AIDS Patient Care STDS. 2020;34:59–71. doi: 10.1089/apc.2019.0181
    1. Shah R, Watson J, Free C. A systematic review and meta-analysis in the effectiveness of mobile phone interventions used to improve adherence to antiretroviral therapy in HIV infection. BMC Public Health. 2019;19:915. doi: 10.1186/s12889-019-6899-6
    1. Wald DS, Butt S, Bestwick JP. One-way Versus Two-way Text Messaging on Improving Medication Adherence: Meta-analysis of Randomized Trials. Am J Med. 2015;128:1139.e1–5. doi: 10.1016/j.amjmed.2015.05.035
    1. John-Stewart G. eHealth and Prevention of Mother-to-Child Transmission of HIV. Curr HIV/AIDS Rep. 2018;15:350–7. doi: 10.1007/s11904-018-0408-x
    1. Yotebieng M, Mpody C, Ravelomanana NLR, Tabala M, Malongo F, Kawende B, et al.. HIV viral suppression among pregnant and breastfeeding women in routine care in the Kinshasa province: a baseline evaluation of participants in CQI-PMTCT study. J Int AIDS Soc. 2019:22. doi: 10.1002/jia2.25376
    1. Matthews LT, Orrell C, Bwana MB, Tsai AC, Psaros C, Asiimwe S, et al.. Adherence to HIV antiretroviral therapy among pregnant and postpartum women during the Option B+ era: 12-month cohort study in urban South Africa and rural Uganda. J Int AIDS Soc. 2020:23. doi: 10.1002/jia2.25586
    1. Hosseinipour M, Nelson JAE, Trapence C, Rutstein SE, Kasende F, Kayoyo V, et al.. Viral suppression and HIV drug resistance at 6 months among women in Malawi’s option B+ program: Results from the PURE Malawi study. J Acquir Immune Defic Syndr. 2017;75:S149–55. doi: 10.1097/QAI.0000000000001368
    1. Fairbanks J, Beima-Sofie K, Akinyi P, Matemo D, Unger JA, Kinuthia J, et al.. You Will Know That Despite Being HIV Positive You Are Not Alone: Qualitative Study to Inform Content of a Text Messaging Intervention to Improve Prevention of Mother-to-Child HIV Transmission. JMIR Mhealth Uhealth. 2018;e10671:6. doi: 10.2196/10671
    1. Ware NC, Pisarski EE, Tam M, Wyatt MA, Atukunda E, Musiimenta A, et al.. The Meanings in the messages: How SMS reminders and real-time adherence monitoring improve antiretroviral therapy adherence in rural Uganda. AIDS. 2016;30. doi: 10.1097/QAD.0000000000001035
    1. Ronen K, Unger JA, Drake AL, Perrier T, Akinyi P, Osborn L, et al.. SMS messaging to improve ART adherence: perspectives of pregnant HIV-infected women in Kenya on HIV-related message content. AIDS Care. 2018;30:500–5. doi: 10.1080/09540121.2017.1417971
    1. Perrier T, Dell N, DeRenzi B, Anderson R, Kinuthia J, Unger J, et al.. Engaging pregnant women in Kenya with a hybrid computer-human SMS communication system. 33rd Annual ACM Conference. New York, New York, USA: ACM Press; 2015. pp. 1429–1438.
    1. Unger JA, Ronen K, Perrier T, DeRenzi B, Slyker J, Drake AL, et al.. Short message service communication improves exclusive breastfeeding and early postpartum contraception in a low- to middle-income country setting: a randomised trial. BJOG An Int J Obstet Gynaecol. 2018;125:1620–9. doi: 10.1111/1471-0528.15337
    1. Harrington EK, Drake AL, Matemo D, Ronen K, Osoti AO, John-Stewart G, et al.. An mHealth SMS intervention on Postpartum Contraceptive Use among Women and Couples in Kenya: A randomized controlled trial. Am J Public Health. 2019;109:934–41. doi: 10.2105/AJPH.2019.305051
    1. Drake AL, Unger JA, Ronen K, Matemo D, Perrier T, DeRenzi B, et al.. Evaluation of mHealth strategies to optimize adherence and efficacy of Option B+ prevention of mother-to-child HIV transmission: Rationale, design and methods of a 3-armed randomized controlled trial. Contemp Clin Trials. 2017;57:44–50. doi: 10.1016/j.cct.2017.03.007
    1. Lewis K, Harrington EK, Matemo D, Drake AL, Ronen K, O’Malley G, et al.. Utilizing perspectives from HIV-infected women, male partners and healthcare providers to design family planning SMS in Kenya: a qualitative study. BMC Health Serv Res. 2019;19:870. doi: 10.1186/s12913-019-4708-7
    1. Janz NK, Becker MH. The Health Belief Model: a decade later. Health Educ Q. 1984;11:1–47. doi: 10.1177/109019818401100101
    1. Bandura A. Social foundations of thought and action: A social cognitive theory. Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ, US: Prentice-Hall, Inc; 1986.
    1. Unger JA, Kinuthia J, John-Stewart G. Texting Condolences: Adapting mHealth Programs After Unexpected Pregnancy and Infant Outcomes. JMIR Mhealth Uhealth. 2017. doi: 10.2196/mhealth.8303
    1. Beck IA, Deng W, Payant R, Hall R, Bumgarner RE, Mullins JI, et al.. Validation of an Oligonucleotide Ligation Assay for Quantification of Human Immunodeficiency Virus Type 1 Drug-Resistant Mutants by Use of Massively Parallel Sequencing. J Clin Microbiol. 2014;52:2320–7. doi: 10.1128/JCM.00306-14
    1. WHO. WHO Guideline: recommendations on digital interventions for health system strengthening. WHO. World Health Organization; 2019. Available from: .
    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;376:1838–45. doi: 10.1016/S0140-6736(10)61997-6
    1. Lee SB, Valerius J. mHealth interventions to promote anti-retroviral adherence in HIV: Narrative review. JMIR Mhealth Uhealth. 2020;8:1–16. doi: 10.2196/14739
    1. Wang Z, Zhu Y, Cui L, Qu B. Electronic health interventions to improve adherence to antiretroviral therapy in people living with HIV: Systematic review and meta-analysis. JMIR Mhealth Uhealth. 2019;7. doi: 10.2196/14404
    1. Odeny TA, Bukusi EA, Cohen CR, Yuhas K, Camlin CS, McClelland RS. Texting improves testing: A randomized trial of two-way SMS to increase postpartum prevention of mother-to-child transmission retention and infant HIV testing. AIDS. 2014;28:2307–12. doi: 10.1097/QAD.0000000000000409
    1. Odeny TA, Hughes JP, Bukusi EA, Akama E, Geng EH, Holmes KK, et al.. Text messaging for maternal and infant retention in prevention of mother-to-child HIV transmission services: A pragmatic steppedwedge cluster-randomized trial in Kenya. PLoS Med. 2019;16:1–16. doi: 10.1371/journal.pmed.1002924
    1. van der Kop ML, Muhula S, Nagide PI, Thabane L, Gelmon L, Awiti PO, et al.. Effect of an interactive text-messaging service on patient retention during the first year of HIV care in Kenya (WelTel Retain): an open-label, randomised parallel-group study. Lancet Public Health. 2018;3:e143–52. doi: 10.1016/S2468-2667(17)30239-6
    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;25:825–34. doi: 10.1097/QAD.0b013e32834380c1
    1. Linnemayr S, Huang H, Luoto J, Kambugu A, Thirumurthy H, Haberer JE, et al.. Text Messaging for Improving Antiretroviral Therapy Adherence: No Effects After 1 Year in a Randomized Controlled Trial Among Adolescents and Young Adults. Am J Public Health. 2017;107:1944–50. doi: 10.2105/AJPH.2017.304089
    1. Mbuagbaw L, Thabane L, Ongolo-Zogo P, Lester RT, Mills EJ, Smieja M, et al.. The Cameroon Mobile Phone SMS (CAMPS) Trial: A Randomized Trial of Text Messaging versus Usual Care for Adherence to Antiretroviral Therapy. Gray RH, editor. PLoS ONE. 2012;7:e46909. doi: 10.1371/journal.pone.0046909
    1. Gross R, Ritz J, Hughes MD, Salata R, Mugyenyi P, Hogg E, et al.. Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial. Lancet Digit Heal. 2019;1:e26–34. doi: 10.1016/S2589-7500(19)30006-8
    1. Haberer JE, Sabin L, Amico KR, Orrell C, Galárraga O, Tsai AC, et al.. Improving antiretroviral therapy adherence in resource-limited settings at scale: A discussion of interventions and recommendations. J Int AIDS Soc. 2017. doi: 10.7448/IAS.20.1.21371
    1. Mills EJ, Lester R, Thorlund K, Lorenzi M, Muldoon K, Kanters S, et al.. Interventions to promote adherence to antiretroviral therapy in Africa: A network meta-analysis. Lancet HIV. 2014. doi: 10.1016/S2352-3018(14)00003-4
    1. Bauermeister JA, Golinkoff JM, Muessig KE, Horvath KJ, Hightow-Weidman LB. Addressing engagement in technology-based behavioural HIV interventions through paradata metrics. Curr Opin HIV AIDS. 2017;12:442–6. doi: 10.1097/COH.0000000000000396
    1. Fisher JD, Amico KR, Fisher WA, Cornman DH, Shuper PA, Trayling C, et al.. Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: The lifewindows project. AIDS Behav. 2011;15:1635–46. doi: 10.1007/s10461-011-9926-x
    1. Ronen K, Khasimwa B, Chohan B, Matemo D, Unger JA, Drake AL, et al.. Disparities in antenatal virologic failure among women receiving Option B+ in Kenya. Conference on Retroviruses and Opportunistic Infections. Boston, MA; 2018.
    1. Fisher JD, Fisher WA, Amico KR, Harman JJ. An information-motivation-behavioral skills model of adherence to antiretroviral therapy. Health Psychol. 2006. doi: 10.1037/0278-6133.25.4.462
    1. Graham SM, Micheni M, Chirro O, Nzioka J, Secor AM, Mugo PM, et al.. A Randomized Controlled Trial of the Shikamana Intervention to Promote Antiretroviral Therapy Adherence Among Gay, Bisexual, and Other Men Who Have Sex with Men in Kenya: Feasibility, Acceptability, Safety and Initial Effect Size. AIDS Behav. 2020. doi: 10.1007/s10461-020-02786-5
    1. Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, et al.. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018;52:446–62. doi: 10.1007/s12160-016-9830-8
    1. Flynn PM, Taha TE, Cababasay M, Fowler MG, Mofenson LM, Owor M, et al.. Prevention of HIV-1 transmission through breastfeeding: Efficacy and safety of maternal antiretroviral therapy versus infant nevirapine prophylaxis for duration of breastfeeding in HIV-1-infected women with high cd4 cell count (IMPAACT PROMISE): A randomi. J Acquir Immune Defic Syndr. 2018. doi: 10.1097/QAI.0000000000001612
    1. Fowler MG, Qin M, Fiscus SA, Currier JS, Flynn PM, Chipato T, et al.. Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention. N Engl J Med. 2016. doi: 10.1056/NEJMoa1511691

Source: PubMed

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