Optimizing the efficiency and implementation of cash transfers to improve adherence to antiretroviral therapy: study protocol for a cluster randomized controlled trial

Laura Packel, Prosper Njau, Carolyn Fahey, Angela Ramadhani, William H Dow, Nicholas P Jewell, Sandra McCoy, Laura Packel, Prosper Njau, Carolyn Fahey, Angela Ramadhani, William H Dow, Nicholas P Jewell, Sandra McCoy

Abstract

Background: Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve HIV care and treatment outcomes, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. To address these questions and begin to bridge the "know-do gap" with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based intervention to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone region, Tanzania.

Methods: We will conduct a type I hybrid implementation-effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with a mobile health technology (mHealth) system. Specifically, our team will expand the intervention to 32 clinics and enroll 1984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome and (b) evaluate the implementation challenges and successes at multiple levels (patient, provider, clinic).

Discussion: This trial will provide evidence not only about the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond.

Trial registration: ClinicalTrials.gov NCT04201353 . Registered on December 17, 2019.

Keywords: ART adherence; Cash transfer; Cluster randomized trial; HIV; Implementation–effectiveness hybrid design; Tanzania.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Cluster randomized hybrid effectiveness–implementation trial study design

References

    1. Avert. Global information and education on HIV and AIDS. Available from: . Cited 2019 Dec 1.
    1. UNAIDS D . Update AE. Geneva: Joint United Nations Programme on HIV. AIDS; 2019.
    1. HIV/AIDS JUNP on et al. Fast-track: ending the AIDS epidemic by 2030. Geneva: UNAIDS; 2014.
    1. McCoy SI. Improving the efficiency of HIV testing with peer recruitment, financial incentives, and the involvement of persons living with HIV infection. J Acquir Immune Defic Syndr. 2013;63(2):e56–e63. doi: 10.1097/QAI.0b013e31828a7629.
    1. Björkman-Nyqvist M. Evaluating the impact of short term financial incentives on HIV and STI incidence among youth in Lesotho: a randomized trial. In: 7th IAS Conference on HIV Pathogenesis, Treatment, and Prevention. Kuala Lumpur; 2013.
    1. de Walque D. Incentivising safe sex: a randomised trial of conditional cash transfers for HIV and sexually transmitted infection prevention in rural Tanzania. BMJ Open. 2012;2:000747. doi: 10.1136/bmjopen-2011-000747.
    1. Galarraga O, Genberg BL, Martin RA, Barton Laws M, Wilson IB. Conditional economic incentives to improve HIV treatment adherence: literature review and theoretical considerations. AIDS Behav. 2013;17(7):2283–92. doi: 10.1007/s10461-013-0415-2.
    1. Solomon S. Chennai, India in 19th Conference on Retroviruses and Opportunistic Infections. 2012. The impact of voucher incentives on linkage to care and ART initiation among drug users.
    1. Haukoos JS. The effect of financial incentives on adherence with outpatient human immunodeficiency virus testing referrals from the emergency department. Acad Emerg Med. 2005;12(7):617–621. doi: 10.1197/j.aem.2005.02.016.
    1. Thornton R. The demand for and impact of learning HIV status: evidence from a field experiment. Am Econ Rev. 2008;98:1829–1863. doi: 10.1257/aer.98.5.1829.
    1. Cluver L. Child-focused state cash transfers and adolescent risk of HIV infection in South Africa: a propensity-score-matched case-control study. Lancet Glob Health. 2013;1(6):362–370. doi: 10.1016/S2214-109X(13)70115-3.
    1. Handa S. The government of Kenya’s cash transfer program reduces the risk of sexual debut among young people age 15–25. PLoS One. 2014;9:85473. doi: 10.1371/journal.pone.0085473.
    1. Singer AW, Weiser SD, McCoy SI. Does food insecurity undermine adherence to antiretroviral therapy? A systematic review. AIDS Behav. 2015;19(8):1510–26. doi: 10.1007/s10461-014-0873-1.
    1. Young S, Wheeler AC, McCoy SI, Weiser SD. A review of the role of food insecurity in adherence to care and treatment among adult and pediatric populations living with HIV and AIDS. AIDS Behav. 2014;18(5):505–15. doi: 10.1007/s10461-013-0547-4.
    1. Buzdugan R, Bautista-Arredondo S, McCoy SI. The promise of behavioral economics for HIV/AIDS treatment and care. In: 21th international AIDS conference. Durban; 2016.
    1. Chaiyachati KH. Interventions to improve adherence to antiretroviral therapy: a rapid systematic review. AIDS. 2014;2:187–204. doi: 10.1097/QAD.0000000000000252.
    1. El-Sadr WM. HPTN 065 in Conference on Retroviruses and Opportunistic Infections. 2015. Effect of financial incentives on linkage to care and viral suppression.
    1. Galarraga O, Sosa-Rubi SG. Conditional economic incentives to improve HIV prevention and treatment in low-income and middle-income countries. Lancet HIV. 2019;6(10):e705–e714. doi: 10.1016/S2352-3018(19)30233-4.
    1. Fahey CA, Njau PF, Katabaro E, Mfaume RS, Ulenga N, Mwenda N, et al. Financial incentives to promote retention in care and viral suppression in adults with HIV initiating antiretroviral therapy in Tanzania: a three-arm randomised controlled trial. Lancet HIV. 2020; Available from: . Cited 2020 Oct 7.
    1. McCoy SI, Njau PF, Fahey C, Kapologwe N, Kadiyala S, Jewell NP, et al. Cash vs. food assistance to improve adherence to antiretroviral therapy among HIV-infected adults in Tanzania. AIDS Lond Engl. 2017;31(6):815–825. doi: 10.1097/QAD.0000000000001406.
    1. Linnemayr S, Stecher C, Mukasa B. Behavioral economic incentives to improve adherence to antiretroviral medication. AIDS Lond Engl. 2017;31(5):719–726. doi: 10.1097/QAD.0000000000001387.
    1. Yotebieng M, Thirumurthy H, Moracco KE, Edmonds A, Tabala M, Kawende B, et al. Conditional cash transfers to increase retention in PMTCT care, antiretroviral adherence, and postpartum virological suppression: a randomized controlled trial. J Acquir Immune Defic Syndr. 2016;72(Suppl 2):S124–S129. doi: 10.1097/QAI.0000000000001062.
    1. Yotebieng M, Thirumurthy H, Moracco KE, Kawende B, Chalachala JL, Wenzi LK, et al. Conditional cash transfers and uptake of and retention in prevention of mother-to-child HIV transmission care: a randomised controlled trial. Lancet HIV. 2016;3(2):e85–e93. doi: 10.1016/S2352-3018(15)00247-7.
    1. McCoy SI. Rationale and design of a randomized study of short-term food and cash assistance to improve adherence to antiretroviral therapy among food insecure HIV-infected adults in Tanzania. BMC Infect Dis. 2015;15:490. doi: 10.1186/s12879-015-1186-3.
    1. McMahon JH. Pharmacy adherence measures to assess adherence to antiretroviral therapy: review of the literature and implications for treatment monitoring. Clinical infectious diseases. Off Publ Infect Dis Soc Am. 2011;52(4):493–506. doi: 10.1093/cid/ciq167.
    1. Messou E. Association between medication possession ratio, virologic failure and drug resistance in HIV-1-infected adults on antiretroviral therapy in Cote d’Ivoire. J Acquir Immune Defic Syndr. 2011;56:356–364. doi: 10.1097/QAI.0b013e3182084b5a.
    1. Goldman JD. Simple adherence assessments to predict virologic failure among HIV-infected adults with discordant immunologic and clinical responses to antiretroviral therapy. AIDS Res Hum Retrovir. 2008;24(8):1031–1035. doi: 10.1089/aid.2008.0035.
    1. Hong SY. Medication possession ratio associated with short-term virologic response in individuals initiating antiretroviral therapy in Namibia. PLoS One. 2013;8:56307. doi: 10.1371/journal.pone.0056307.
    1. Czaicki NL, Mnyippembe A, Blodgett M, Njau P, McCoy SI. It helps me live, sends my children to school, and feeds me: a qualitative study of how food and cash incentives may improve adherence to treatment and care among adults living with HIV in Tanzania. AIDS Care. 2017;29(7):876–884. doi: 10.1080/09540121.2017.1287340.
    1. Kadota J, Fahey C, Njau P, Kapologwe N, Padian NS, Dow W, et al. Conditional food or cash transfers do not increase purchase of temptation goods among adults living with HIV infection in Shinyanga, Tanzania. 2017.
    1. Garcia M, Moore CM. Sub-Saharan Africa, in Directions in Development. Washington, D.C: The World Bank; 2012. The cash dividend: the rise of cash transfer programs.
    1. Fahey CA, Mwenda N, Bhattarai PR, Mneney J, Katabaro E, Njau PF, et al. Feasibility and acceptability of a biometric mHealth system for monitoring retention in HIV services and delivering financial incentives to adults initiating antiretroviral therapy in Tanzania. 2019.
    1. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs. Med Care. 2012;50(3):217–226. doi: 10.1097/MLR.0b013e3182408812.
    1. Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health Ment Health Serv Res. 2009;36(1):24–34. doi: 10.1007/s10488-008-0197-4.
    1. Deci E, Ryan RM. Facilitating optimal motivation and psychological well-being across life’s domains. Can Psychol. 2008;49:14–23. doi: 10.1037/0708-5591.49.1.14.
    1. Nechyba T. Microeconomics. Mason: Cengage Learning; 2010.
    1. Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007;298(20):2415. doi: 10.1001/jama.298.20.2415.
    1. O’Donoghue T, Rabin M. Doing it now or later. Am Econ Rev. 1999;89:103–124. doi: 10.1257/aer.89.1.103.
    1. Tversky A, Kahneman D. Judgment under uncertainty: heuristics and biases. Science. 1974;185(4157):1124–1131. doi: 10.1126/science.185.4157.1124.
    1. Codagnone C. The challenges and opportunities of “nudging”. J Epidemiol Community Health. 2014;68(10):909–911. doi: 10.1136/jech-2014-203948.
    1. Susnstein CR, Thaler RH. Nudge: improving decisions about health, wealth, and happiness. New Haven: Yale University Press; 2008.
    1. Gardner B. A review and analysis of the use of ‘habit’ in understanding, predicting and influencing health-related behaviour. Health Psychol Rev. 2015;9(3):277–295. doi: 10.1080/17437199.2013.876238.
    1. National AIDS Control Programme . National guidelines for the management of HIV and AIDS. Tanzania: National AIDS Control Programme; 2017.
    1. Ministry of Health and Social Welfare . Tanzania national eHealth strategy 2012–2018. Tanzania: Ministry of Health, Community Development, Gender, Elderly and Children, National AIDS Control Programme; 2013.
    1. Silver L, Johnson C. Internet Connectivity Seen as Having Positive Impact on Life in Sub-Saharan Africa: But Digital Divides Persist. Pew Research Center; 2018.
    1. Yu H, Li F, Gallis JA, Turner EL. cvcrand: Efficient design and analysis of cluster randomized trials [Internet]. 2020. Available from: .
    1. Moulton L. Covariate-based constrained randomization of group-randomized trials. Clin Trials. 2004;1(3):297–305. doi: 10.1191/1740774504cn024oa.
    1. World Health Organization . Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. 2013.
    1. President’s Emergency Plan for AIDS Relief . PEPFAR monitoring, evaluation, and reporting indicator reference guide. Washington (DC): PEPFAR; 2019.
    1. Brooke J. SUS-A quick and dirty usability scale. In: Jordan PW, Thomas B, Weerdmeester BA, McClelland AL, editors. Usability evaluation in industry. London: Taylor and Francis; 1996.
    1. Schnall R, Cho H, Liu J. Health information technology usability evaluation scale (health-ITUES) for usability assessment of Mobile health technology: validation study. JMIR MHealth UHealth. 2018;6(1):e4. doi: 10.2196/mhealth.8851.
    1. Taljaard M, Donner A, Villar J, Wojdyla D, Velazco A, Bataglia V, et al. Intracluster correlation coefficients from the 2005 WHO Global Survey on Maternal and Perinatal Health: implications for implementation research. Paediatr Perinat Epidemiol. 2008;22(2):117–125. doi: 10.1111/j.1365-3016.2007.00901.x.
    1. Little RJ, Rubin DB. Causal effects in clinical and epidemiological studies via potential outcomes: concepts and analytical approaches. Annu Rev Public Health. 2000;21:121–145. doi: 10.1146/annurev.publhealth.21.1.121.
    1. Greenland S. An introduction to instrumental variables for epidemiologists. Int J Epidemiol. 2000;29(6):1102. doi: 10.1093/oxfordjournals.ije.a019909.
    1. Gertler PJ, Martinez S, Premand P, Rawlings LB, Vermeersch CM. Impact evaluation in practice. The World Bank; 2016.
    1. Miles MB, Huberman AM, Huberman MA, Huberman M. Qualitative data analysis: an expanded sourcebook: Sage; 1994. p. 69–104.
    1. Ulin PR, Robinson ET, Tolley EE. Qualitative methods in public health: a field guide for applied research: Wiley; 2012. p. 179–89.
    1. Maxwell JA. Qualitative research design: an interactive approach, vol. 41: Sage publications; 2012. p. 104–20.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever