The effect of weekly short message service communication on patient retention in care in the first year after HIV diagnosis: study protocol for a randomised controlled trial (WelTel Retain)

Mia L van der Kop, David I Ojakaa, Anik Patel, Lehana Thabane, Koki Kinagwi, Anna Mia Ekström, Kirsten Smillie, Sarah Karanja, Patricia Awiti, Edward Mills, Carlo Marra, Lennie Bazira Kyomuhangi, Richard T Lester, Mia L van der Kop, David I Ojakaa, Anik Patel, Lehana Thabane, Koki Kinagwi, Anna Mia Ekström, Kirsten Smillie, Sarah Karanja, Patricia Awiti, Edward Mills, Carlo Marra, Lennie Bazira Kyomuhangi, Richard T Lester

Abstract

Introduction: Interventions to improve retention in care after HIV diagnosis are necessary to optimise the timely initiation of antiretroviral therapy (ART) and HIV/AIDS control outcomes. Widespread mobile phone use presents new opportunities to engage patients in care. A randomised controlled trial (RCT), WelTel Kenya1, demonstrated that weekly text messages led to improved ART adherence and viral load suppression among those initiating ART. The aim of this study was to determine whether the WelTel intervention is an effective and cost-effective method of improving retention in care in the first year of care following HIV diagnosis.

Methods and analysis: WelTel Retain is an open, parallel group RCT that will be conducted at the Kibera Community Health Centre in Nairobi, Kenya. Over a 1-year period, we aim to recruit 686 individuals newly diagnosed with HIV who will be randomly allocated to an intervention or control arm (standard care) at a 1:1 ratio. Intervention arm participants will receive the weekly WelTel SMS 'check-in' to which they will be instructed to respond within 48 h. An HIV clinician will follow-up and triage any problems that are identified. Participants will be followed for 1 year, with a primary endpoint of retention in care at 12 months. Secondary outcomes include retention in stage 1 HIV care (patients return to the clinic to receive their first CD4 results) and timely ART initiation. Cost-effectiveness will be analysed through decision-analytic modelling.

Ethics and dissemination: Ethical approval has been obtained from the University of British Columbia and the African Medical and Research Foundation. This trial will test the effectiveness and cost-effectiveness of the WelTel intervention to engage patients during the first year of HIV care. Trial results and economic evaluation will help inform policy and practice on the use of WelTel in the early stages of HIV care.

Trial registration: ClinicalTrials.gov NCT01630304.

Keywords: Health Economics; Public Health.

Figures

Figure 1
Figure 1
HIV cascade of care.
Figure 2
Figure 2
WelTel intervention.
Figure 3
Figure 3
Flow of participants.

References

    1. Rosen S, Fox MP. Retention in HIV care between testing and treatment in sub-Saharan Africa: a systematic review. PLoS Med 2011;8:e1001056.
    1. Kohler PK, Chung MH, McGrath CJ, et al. Implementation of free cotrimoxazole prophylaxis improves clinic retention among antiretroviral therapy-ineligible clients in Kenya. AIDS 2011;25:1657–61
    1. Ford N, Kranzer K, Hilderbrand K, et al. Early initiation of antiretroviral therapy and associated reduction in mortality, morbidity and defaulting in a nurse-managed, community cohort in Lesotho. AIDS 2010;24:2645–50
    1. Boyles TH, Wilkinson LS, Leisegang R, et al. Factors influencing retention in care after starting antiretroviral therapy in a rural South African programme. PLoS ONE 2011;6:e19201.
    1. Communications Commission of Kenya Quarterly sector statistics report. Nairobi: Communications Commission of Kenya, 2012
    1. Wesolowski A, Eagle N, Noor AM, et al. Heterogeneous mobile phone ownership and usage patterns in Kenya. PLoS ONE 2012;7:e35319.
    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
    1. Kenya National Bureau of Statistics Kenya Population and Housing Census 2009. Nairobi: Government Printer, 2010
    1. Dalal W, Feikin DR, Amolloh M, et al. Home-based HIV testing and counseling in rural and urban Kenyan communities. J Acquir Immune Defic Syndr 2013;62:e47–54
    1. Fox M, Larson B, Rosen S. Defining retention and attrition in pre-antiretroviral HIV care: proposals based on experience in Africa. Boston, MA: Center for Global Health and Development, Boston University, 2012
    1. Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med 1991;32:705–14
    1. Geng EH, Nash D, Kambugu A, et al. Retention in care among HIV-infected patients in resource-limited settings: emerging insights and new directions. Curr HIV/AIDS Rep 2010;7:234–44
    1. Geng EH, Glidden DV, Bwana MB, et al. Retention in care and connection to care among HIV-infected patients on antiretroviral therapy in Africa: estimation via a sampling-based approach. PLoS ONE 2011;6:e21797.
    1. Ryan P. Random allocation of treatment in blocks. Stata J 2008;8:146
    1. Hedeker D, Mermelstein RJ, Demirtas H. Analysis of binary outcomes with missing data: missing=smoking, last observation carried forward, and a little multiple imputation. Addiction 2007;102:1564–73
    1. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 1976;34:585–612
    1. Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol 1971;44:793–7
    1. U.S. Department of Health & Human Services Guidance on reviewing and reporting unanticipated problems involving risks to subjects or others and adverse events. Washington, DC: U.S. Department of Health & Human Services, 2007
    1. Padgett DK. Qualitative and mixed methods in public health. Los Angeles: Sage Publications Incorporated, 2011
    1. Kaplan RS, Anderson SR. Time-driven activity-based costing. Harv Bus Rev 2004;82:131–8
    1. Edejer Tan-Torres T, Baltussen R, Adam T, et al. Making choices in health: WHO guide to cost-effectiveness analysis. Geneva: World Health Organization, 2003
    1. Hardy H, Kumar V, Doros G, et al. Randomized controlled trial of a personalized cellular phone reminder system to enhance adherence to antiretroviral therapy. AIDS Patient Care STDs 2011;25:153–61
    1. Simoni JM, Huh D, Frick PA, et al. Peer support and pager messaging to promote antiretroviral modifying therapy in Seattle: a randomized controlled trial. J Acquir Immune Defic Syndr 2009;52:465–73
    1. Franklin VL, Greene A, Waller A, et al. Patients’ engagement with “Sweet Talk”—a text messaging support system for young people with diabetes. J Med Internet Res 2008;10:e20.
    1. van der Kop ML, Karanja S, Thabane L, et al. In-depth analysis of patient-clinician cell phone communication during the WelTel Kenya1 antiretroviral adherence trial. PLoS ONE 2012;7:25

Source: PubMed

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