Text messaging for maternal and infant retention in prevention of mother-to-child HIV transmission services: A pragmatic stepped-wedge cluster-randomized trial in Kenya

English version

Autoři: Thomas A. Odeny ^aff001; James P. Hughes ^aff004; Elizabeth A. Bukusi ^aff002; Eliud Akama ^aff002; Elvin H. Geng ^aff007; King K. Holmes ^aff003; R. Scott McClelland ^aff003
Působiště autorů: Department of Medicine, University of Missouri-Kansas City, Kansas City, Missouri, United States of America ^aff001; Center for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya ^aff002; Department of Epidemiology, University of Washington, Seattle, Washington, United states of America ^aff003; Department of Biostatistics, University of Washington, Seattle, Washington, United States of America ^aff004; Department of Global Health, University of Washington, Seattle, Washington, United states of America ^aff005; Department of Obstetrics and Gynecology, University of Washington, Seattle, Washington, United States of America ^aff006; University of California San Francisco, San Francisco, California, United States of America ^aff007; Department of Medicine, University of Washington, Seattle, Washington, United States of America ^aff008; Center for AIDS Research, University of Washington, Seattle, Washington, United States of America ^aff009; Department of Microbiology, University of Washington, Seattle, Washington, United states of America ^aff010; Institute of Tropical and Infectious Diseases, University of Nairobi, Nairobi, Kenya ^aff011
Vyšlo v časopise: Text messaging for maternal and infant retention in prevention of mother-to-child HIV transmission services: A pragmatic stepped-wedge cluster-randomized trial in Kenya. PLoS Med 16(10): e32767. doi:10.1371/journal.pmed.1002924
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pmed.1002924

Souhrn

Background

Timely diagnosis of infant HIV infection is essential for antiretroviral therapy (ART) initiation. In a randomized controlled trial, we found the Texting Improves Testing (TextIT) intervention (a theory-based text messaging system) to be efficacious for improving infant HIV testing rates and maternal retention in prevention of mother-to-child HIV transmission (PMTCT) programs. Using an implementation science approach, we aimed to evaluate real-world effectiveness of the intervention.

Methods and findings

In a pragmatic, cluster-randomized, stepped-wedge trial with 2 time periods of observation, we randomly allocated 10 clinics to begin implementing the intervention immediately and 10 clinics to begin implementing 6 months later. To approximate real-world conditions, inclusion criteria were broad. Women at clinics implementing the intervention received up to 14 text messages during pregnancy and after delivery and had the option to respond to text messages, call, or send inquiry text messages to a designated clinic phone. The primary outcomes were infant HIV testing and maternal retention in care during the first 8 weeks after delivery. We used modified Poisson regression with robust variance estimation to estimate the relative risk and 95% confidence intervals (CIs). Generalized estimating equations were applied on individual-level data to account for clustering by site. Between February 2015 and December 2016, 4,681 women were assessed for study participation, and 2,515 were included. Participant characteristics at enrollment did not differ by study arm. Overall median age was 27 years (interquartile range [IQR] 23–30), median gestational age was 30 weeks (IQR 28–34), 99% were receiving ART, and 87% who enrolled during intervention phases owned a phone. Of 2,326 infants analyzed, 1,466 of 1,613 (90.9%) in the intervention group and 609 of 713 (85.4%) in the control group met the primary outcome of HIV virologic testing performed before 8 weeks after birth (adjusted relative risk [aRR] 1.03; 95% CI 0.97–1.10; P = 0.3). Of 2,472 women analyzed, 1,548 of 1,725 (90%) in the intervention group and 571 of 747 (76%) in the control group met the primary outcome of retention in care during the first 8 weeks after delivery (aRR 1.12; 95% CI 0.97–1.30; P = 0.1). This study had two main limitations. Staff at all facilities were aware of ongoing observation, which may have contributed to increased rates of infant HIV testing and maternal retention in care at both intervention and control facilities, and programmatic initiatives to improve maternal and infant retention in care were ongoing at all facilities at the time of this study, which likely limited the ability to demonstrate effectiveness of the trial intervention.

Conclusions

In this study, a larger proportion of infants in the intervention group received HIV testing compared with the control group, but the difference was small and not statistically significant. There was also a nonsignificant increase in maternal postpartum retention in the intervention periods. Despite the lack of a significant effect of the intervention, key lessons emerged, both for strengthening PMTCT and for implementation research in general. Perhaps most important, improving the implementation of usual care may have been sufficient to substantially improve infant HIV testing rates.

Trial registration

ClinicalTrials.gov Trial Number NCT02350140.

Klíčová slova:

HIV diagnosis and management – HIV prevention – Infants – Kenya – Labor and delivery – Pregnancy

Zdroje

1. Cotton MF, Rabie H. Impact of earlier combination antiretroviral therapy on outcomes in children. Curr Opin HIV AIDS. 2015;10(1):12–7. Epub 2014/11/13. doi: 10.1097/COH.0000000000000117 25389804.

2. Joint United Nations Programme on HIV/AIDS (UNAIDS). On the Fast-Track to an AIDS Free Generation. UNAIDS, Geneva, Switzerland; 2016.

3. Psaros C, Remmert JE, Bangsberg DR, Safren SA, Smit JA. Adherence to HIV Care after Pregnancy among Women in Sub-Saharan Africa: Falling Off the Cliff of the Treatment Cascade. Curr HIV/AIDS Rep. 2015;12(1):1–5. doi: 10.1007/s11904-014-0252-6 25620530

4. Odeny TA, Newman M, Bukusi EA, McClelland RS, Cohen CR, Camlin CS. Developing content for a mHealth intervention to promote postpartum retention in prevention of mother-to-child HIV transmission programs and early infant diagnosis of HIV: a qualitative study. PLoS ONE. 2014;9(9):e106383. doi: 10.1371/journal.pone.0106383 25181408

5. 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(15):2307–12. Epub 2014/10/15. doi: 10.1097/QAD.0000000000000409 25313586

6. Odeny TA, Padian N, Doherty MC, Baral S, Beyrer C, Ford N, et al. Definitions of implementation science in HIV/AIDS. Lancet HIV. 2015;2(5):e178–e80. doi: 10.1016/S2352-3018(15)00061-2 26423000

7. Kimanga DO, Ogola S, Umuro M, Ng’ang’a A, Kimondo L, Murithi P, et al. Prevalence and incidence of HIV infection, trends, and risk factors among persons aged 15–64 years in Kenya: results from a nationally representative study. J Acquir Immune Defic Syndr. 2014;66 Suppl 1(Suppl 1):S13–S26. doi: 10.1097/QAI.0000000000000124 24445338.

8. National Guidelines for PMTCT Peer Education and Psychosocial Support in Kenya: The Kenya Mentor Mother Program. Nairobi, Kenya: Kenya Ministry of Health, 2012.

9. O’Farrell D, Nichols K, Harrison K, Lutukai M, Lewis-Kulzer J, Agengo G, et al. Increasing health system efficiency: use of motorcycles for patient outreach in Kisumu, Nyanza province. 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention; Kuala Lumpur, Malaysia 2013.

10. Tuller D. Following Trail of Lost AIDS Patients in Africa. The New York Times. 2010 2010/10/25/.

11. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–91. Epub 2006/07/11. doi: 10.1016/j.cct.2006.05.007 16829207.

12. Kahan BC, Morris TP. Reporting and analysis of trials using stratified randomisation in leading medical journals: review and reanalysis. BMJ. 2012;345:e5840. Epub 2012/09/18. doi: 10.1136/bmj.e5840 22983531

13. Yelland LN, Salter AB, Ryan P. Performance of the modified Poisson regression approach for estimating relative risks from clustered prospective data. Am J Epidemiol. 2011;174(8):984–92. Epub 2011/08/16. doi: 10.1093/aje/kwr183 21841157.

14. Kenya Strategic Framework for Elimination of Mother-to-Child Transmission of HIV and Keeping Mothers Alive 2012–2015. Kenya Ministry of Health, 2012.

15. Turan JM, Onono M, Steinfeld RL, Shade SB, Owuor K, Washington S, et al. Implementation and Operational Research: Effects of Antenatal Care and HIV Treatment Integration on Elements of the PMTCT Cascade: Results From the SHAIP Cluster-Randomized Controlled Trial in Kenya. J Acquir Immune Defic Syndr. 2015;69(5):e172–81. Epub 2015/05/15. doi: 10.1097/QAI.0000000000000678 25967269

16. Aliyu MH, Blevins M, Audet CM, Kalish M, Gebi UI, Onwujekwe O, et al. Integrated prevention of mother-to-child HIV transmission services, antiretroviral therapy initiation, and maternal and infant retention in care in rural north-central Nigeria: a cluster-randomised controlled trial. Lancet HIV. 2016;3(5):e202–11. Epub 2016/04/30. doi: 10.1016/S2352-3018(16)00018-7 27126487

17. Kenya National Bureau of Statistics, Ministry of Health, National AIDS Control Council, Kenya Medical Research Institute, National Council for Population Development. Kenya Demographic and Health Survey 2014. Rockville, MD, USA: 2015.

18. Koepsell TD, Zatzick DF, Rivara FP. Estimating the population impact of preventive interventions from randomized trials. Am J Prev Med. 2011;40(2):191–8. Epub 2011/01/18. doi: 10.1016/j.amepre.2010.10.022 21238868

19. Hallfors D, Cho H, Sanchez V, Khatapoush S, Kim HM, Bauer D. Efficacy vs effectiveness trial results of an indicated "model" substance abuse program: implications for public health. Am J Public Health. 2006;96(12):2254–9. Epub 2006/07/01. doi: 10.2105/AJPH.2005.067462 16809591

20. Geng EH, Peiris D, Kruk ME. Implementation science: Relevance in the real world without sacrificing rigor. PLoS Med. 2017;14(4):e1002288. doi: 10.1371/journal.pmed.1002288 28441435

21. Dillabaugh LL, Lewis Kulzer J, Owuor K, Ndege V, Oyanga A, Ngugi E, et al. Towards Elimination of Mother-to-Child Transmission of HIV: The Impact of a Rapid Results Initiative in Nyanza Province, Kenya. AIDS Res Treat. 2012;2012. doi: 10.1155/2012/602120 22548155

22. Akama E, Mburu M, Mutegi E, Nyanaro G, Otieno JP, Ndolo S, et al. Impact of a Rapid Results Initiative Approach on Improving Male Partner Involvement in Prevention of Mother to Child Transmission of HIV in Western Kenya. AIDS Behav. 2018;22(9):2956–65. Epub 2018/06/28. doi: 10.1007/s10461-018-2140-3 29948337