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      Scaled-Up Mobile Phone Intervention for HIV Care and Treatment: Protocol for a Facility Randomized Controlled Trial

      , MPH,PhD 1 , , , MA 2 , , MPH, PMP 3 , , MPH,PhD 4 , , MPH 2
      (Reviewer), (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications Inc.
      implementation science, mobile phones, mHealth, HIV, AIDS, HIV care and treatment, cluster-RCT, Ghana

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          Adherence to prevention, care, and treatment recommendations among people living with HIV (PLHIV) is a critical challenge. Yet good clinical outcomes depend on consistent, high adherence to antiretroviral therapy (ART) regimens. Mobile phones offer a promising means to improve patient adherence and health outcomes. However, limited information exists on the impact that mobile phones for health (mHealth) programs have on ART adherence or the behavior change processes through which such interventions may improve patient health, particularly among ongoing clients enrolled in large public sector HIV service delivery programs and key populations such as men who have sex with men (MSM) and female sex workers (FSW).


          Our aim is to evaluate an mHealth intervention where text message reminders are used as supportive tools for health providers and as motivators and reminders for ART clients to adhere to treatment and remain linked to care in Ghana. Using an implementation science framework, we seek to: (1) evaluate mHealth intervention effects on patient adherence and health outcomes, (2) examine the delivery of the mHealth intervention for improving HIV care and treatment, and (3) assess the cost-effectiveness of the mHealth intervention.


          The 36-month study will use a facility cluster randomized controlled design (intervention vs standard of care) for evaluating the impact of mHealth on HIV care and treatment. Specifically, we will look at ART adherence, HIV viral load, retention in care, and condom use at 6 and 12-month follow-up. In addition, participant adoption and satisfaction with the program will be measured. This robust methodology will be complemented by qualitative interviews to obtain feedback on the motivational qualities of the program and benefits and challenges of delivery, especially for key populations. Cost-effectiveness will be assessed using incremental cost-effectiveness ratios, with health effects expressed in terms of viral load suppression and costs of resources used for the intervention.


          This study and protocol was fully funded, but it was terminated prior to review from ethics boards and study implementation.


          This cluster-RCT would have provided insights into the health effects, motivational qualities, and cost-effectiveness of mHealth interventions for PLHIV in public sector settings. We are seeking funding from alternate sources to implement the trial.

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          Most cited references25

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          World Health Organization.

          Ala Alwan (2007)
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            Mobile phone text messaging for promoting adherence to antiretroviral therapy in patients with HIV infection.

            More than 34 million people are presently living with HIV infection. Antiretroviral therapy (ART) can help these people to live longer, healthier lives, but adherence to ART can be difficult. Mobile phone text-messaging has the potential to help promote adherence in these patients. To determine whether mobile phone text-messaging is efficacious in enhancing adherence to ART in patients with HIV infection. Using the Cochrane Collaboration's validated search strategies for identifying randomised controlled trials and reports of HIV interventions, along with appropriate keywords and MeSH terms, we searched a range of electronic databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), MEDLINE (via PubMed), PsycINFO, Web of Science, and the World Health Organization (WHO) Global Index Medicus. The date range was from  01 January 1980 to 01 November 2011. There were no limits to language or publication status. Randomised controlled trials (RCTs) in which patients or their caregivers (in the case of infants and children) of any age, in any setting, and receiving ART were provided with mobile phone text messages as a means of promoting adherence to ART. Two authors independently examined the abstracts of all identified trials. We initially identified 243 references. Seventeen full-text articles were closely reviewed. Both authors abstracted data independently, using a pre-designed, standardised data collection form. When appropriate, data were combined in meta-analysis. Two RCTs from Kenya were included in the review. One trial compared short weekly text messages against standard care. The other trial compared short daily, long daily, short weekly and long weekly messages against standard care. Both trials were with adult patients.In the trial comparing only short weekly messages to standard care, text messaging was associated with a lower risk of non-adherence at 12 months (RR 0.77, 95% CI 0.63 to 0.93) and with the non-occurrence of virologic failure at 12 months (RR 0.83, 95% CI 0.69 to 0.99).In the trial that compared different intervals and lengths for text-messaging to standard care, long weekly text-messaging was not significantly associated with a lower risk of non-adherence compared to standard care (RR 0.79, 95% CI 0.60 to 1.04). Patients receiving weekly text-messages of any length were at lower risk of non-adherence at 48 weeks than were patients receiving daily messages of any length (RR 0.79, 95% CI 0.64 to 0.99). There were no significant differences between weekly text-messaging of any length (RR 1.01, 95% CI 0.75 to 1.37) and between short or long messaging at either interval (RR 0.99, 95% CI 0.78 to 1.27). Compared to standard care, any daily text-messaging, whether short or long, did not reduce the risk for non-adherence (RR 0.99, 95% CI 0.82 to 1.20).In meta-analysis of both trials, any weekly text-messaging (i.e. whether short or long messages) was associated with a lower risk of non-adherence at 48-52 weeks (RR 0.78, 95% CI 0.68 to 0.89). The effect of short weekly text-messaging was also significant (RR 0.77, 95% CI 0.67 to 0.89). There is high-quality evidence from the two RCTs that mobile phone text-messaging at weekly intervals is efficacious in enhancing adherence to ART, compared to standard care. There is high quality evidence from one trial that weekly mobile phone text-messaging is efficacious in improving HIV viral load suppression. Policy-makers should consider funding programs proposing to provide weekly mobile phone text-messaging as a means for promoting adherence to antiretroviral therapy. Clinics and hospitals should consider implementing such programs. There is a need for large RCTs of this intervention in adolescent populations, as well as in high-income countries.
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              Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome.

              Many questionnaires on adherence to antiretroviral therapy are in use, but the validity of patients' responses has not been tested. The Medication Adherence Self-Report Inventory (MASRI) has been developed and tested for its validity against objective measures and treatment outcome. Prospective study comparing questionnaire responses with MEMS TrackCap (MC, a medication event monitoring system), pill count (PC) and plasma HIV viraemia in a publicly funded specialist HIV clinic. Patients self-medicating antiretroviral therapy who were not cognitively impaired and were able to read and understand English. Mean adherence by MC of the 78 subjects was 92.9% (SE, 1.8%) and by PC 96.8% (SE, 1.4%). Agreement between MC and responses to items about doses missed 1, 2 or 3 days ago was low (kappa = 0.23 (P < 0.03), 0.44 (P < 0.001) and 0.28 (P < 0.01) respectively). This improved when these responses were summated (kappa = 0.46;P < 0.001) and was similar to that for recall of non-adherence over the preceding 2 weeks (kappa = 0.54; P < 0.001). Mean self-reported adherence by visual analogue scale (VAS) over the preceding month was 93.3% (SE, 1.2%). This was strongly associated with both MC (r = 0.63; P < 0.001) and PC (r = 0.75; P < 0.001). On multivariate analysis, the strongest association between a MASRI item and MC was for the VAS. Both the 2 week recall and VAS items were inversely associated with viral load (P = 0.01). There was no association between dose timing (measured MC or questionnaire) or 3 day self-report and viral load. The MASRI provides a means of measuring patient adherence that is valid when compared with objective measures.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications Inc. (Toronto, Canada )
                Jan-Mar 2015
                23 January 2015
                : 4
                : 1
                : e11
                [1] 1FHI 360 Social and Behavioral Health Sciences Durham, NCUnited States
                [2] 2FHI 360 Ghana AccraGhana
                [3] 3FHI 360 Scientific Affairs Durham, NCUnited States
                [4] 4School of Public Health University of Ghana AccraGhana
                Author notes
                Corresponding Author: Kelly L L'Engle klengle@ 123456fhi360.org
                Author information
                ©Kelly L L'Engle, Kimberly Green, Stacey M Succop, Amos Laar, Samuel Wambugu. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 23.01.2015.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 29 June 2014
                : 10 August 2014
                : 28 September 2014

                implementation science,mobile phones,mhealth,hiv,aids,hiv care and treatment,cluster-rct,ghana


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