Mobile phone text messages for improving adherence to antiretroviral therapy (ART): a protocol for an individual patient data meta-analysis of randomised trials

IntroductionMobile phone text messaging is emerging as an important tool in the care of people living with HIV; however, reports diverge on its efficacy in improving adherence to antiretroviral therapy (ART), and little is known about which patient groups may benefit most from phone-based adherence interventions. We will conduct an individual patient data meta-analysis to investigate the overall and subgroup effects of text messaging in three recently published text-messaging randomised controlled trials.Methods and analysisData from two Kenyan and one Cameroonian trial will be verified, reformatted and merged. We will determine pooled effect sizes for text messaging versus standard care for improving adherence to ART using individual patient random-effects meta-analysis. We will test for the interaction effects of age, gender, level of education and duration on ART. Sensitivity analyses will be conducted with regard to thresholds for adherence, methods of handling missing data and fixed-effects meta-analysis. Only anonymised data will be collected from the individual studies.Ethics and disseminationEthical approval was obtained for the individual studies. The results of this paper will be disseminated as peer-reviewed publications, at conferences and as part of a doctoral thesis. This individual patient data meta-analysis may provide important insights into the effects of text messaging on ART adherence in different subpopulations, with important implications for programme implementation involving such interventions and future research

Mobile phone text messages for improving adherence to antiretroviral therapy (ART): an individual patient data meta-analysis of randomised trials

ObjectivesOur objectives were to analyse the effects of text messaging versus usual care in improving adherence to antiretroviral therapy (ART) in people living with HIV using individual patient data meta-analysis. Adjusted, sensitivity and subgroup analyses were conducted.Setting3 randomised controlled trials conducted between 2010 and 2012 in rural and urban centres in Cameroon and Kenya (two studies) were used.ParticipantsA total of 1166 participants were included in this analysis (Cameroon=200; Kenya=428 and 538).Primary and secondary outcomesThe primary outcome was adherence to ART >95%. The secondary outcomes were mortality, losses to follow-up, transfers and withdrawals.ResultsText messaging improved adherence to ART (OR 1.38; 95% CIs 1.08 to 1.78; p=0.012), even after adjustment for baseline covariates (OR 1.46; 95% CI 1.13 to 1.88; p=0.004). Primary education (compared with no formal education) was associated with a greater intervention effect on adherence (OR 1.65; 95% CI 1.10 to2.48; p=0.016) and also showed a significant subgroup effect (p=0.039). In sensitivity analysis, our findings were robust to a modified threshold of adherence, multiple imputation for missing dataand aggregate level data pooling, but not to fixed-effects meta-analyses using generalised estimation equations. There was a significant subgroup effect for long weekly (p=0.037), short weekly text messages (p=0.014) and interactive messaging (p=0.010). Text messaging did not significantly affect any of the secondary outcomes.ConclusionsText messaging has a significant effect on adherence to ART, and this effect is influenced by level of education, gender, timing (weekly vs daily) and interactivity. We recommend the use of interactive weekly text messaging to improve adherence to ART, which is most effective in those with at least a primary level of education

Advanced HIV disease at presentation to care in Nairobi, Kenya: late diagnosis or delayed linkage to care?—a cross-sectional study

Background: Presenting to care with advanced HIV is common in sub-Saharan Africa and increases the risk of severe disease and death; however, it remains unclear whether this is a consequence of late diagnosis or a delay in seeking care after diagnosis. The objectives of this cross-sectional study were to determine factors associated with advanced HIV at presentation to care and whether this was due to late diagnosis or delays in accessing care. Methods: Between 2013 and 2015, adults presenting to care were recruited at two clinics in low-income areas of Nairobi, Kenya. Participants were considered to have advanced HIV if their CD4 count was below 200 cells/μL, or they were in WHO stage 4. Information on previous HIV diagnoses was collected using interviewer-administered questionnaires. Logistic regression was used to determine the association between clinical and socio-demographic factors and advanced HIV. Results: Of 753 participants presenting to HIV care, 248 (33 %) had advanced HIV. Almost 60 % (146/248) of those presenting with advanced HIV had been previously diagnosed, most of whom (102/145; 70 %) presented to care within three months of their initial diagnosis. The median time to presentation to HIV care after an initial diagnosis was 22 days (IQR 6-147) for those with advanced HIV, compared to 19 days (IQR 4-119) for those with non-advanced HIV (p = 0.716). Clinic (adjusted odds ratio [AOR] 1.55, 95 % CI 1.09–2.20) and age (AOR 1.72 per unit increase in age category, 95 % CI 1.45–2.03) were associated with presenting with advanced HIV. Conclusions: Presentation to care with advanced HIV was primarily due to delayed diagnosis, rather than delayed linkage to care after diagnosis. Variation by clinic suggests that outreach and other community-based efforts may drive earlier testing and linkage to care. Our findings highlight the ongoing importance of implementing strategies to encourage earlier HIV diagnosis, particularly among adults 30 years and older.Medicine, Faculty ofNon UBCMedicine, Department ofReviewedFacult

In-depth analysis of patient-clinician cell phone communication during the WelTel Kenya1 antiretroviral adherence trial.

The WelTel Kenya1 trial demonstrated that text message support improved adherence to antiretroviral therapy (ART) and suppression of HIV-1 RNA load. The intervention involved sending weekly messages to patients inquiring how they were doing; participants were required to respond either that they were well or that there was a problem.1) Describe problems participants identified through mobile phone support and reasons why participants did not respond to the messages; 2) investigate factors associated with indicating a problem and not responding; and 3) examine participant perceptions of the intervention.Secondary analysis of WelTel Kenya1 trial data.Reasons participants indicated a problem or did not respond were extracted from the study log. Negative binomial regression was used to determine participant characteristics associated with indicating a problem and non-response. Data from follow-up questionnaires were used to describe participant perceptions of the intervention.Between 2007 and 2009, 271 participants generated 11,873 responses; 377 of which indicated a problem. Health issues were the primary reason for problem responses (72%). Rural residence (adjusted incidence rate ratio [IRR] 1.96; 95%CI 1.19-3.25; p=0.009 and age were associated with indicating a problem (adjusted IRR 0.63 per increase in age group category; 95%CI 0.50-0.80; p<0.001). Higher educational level was associated with a decreased rate of non-response (adjusted IRR 0.81; 95%CI 0.69-0.94; p=0.005). Of participants interviewed, 62% (n=129) stated there were no barriers to the intervention; cell phone issues were the most common barrier. Benefits included reminding patients to take medication and promoting a feeling that "someone cares".The WelTel intervention enabled frequent communication between clinicians and patients during the WelTel Kenya1 trial. Many patients valued the service for the support it provided, with health-related concerns comprising the majority of problems identified by participants. Few sociodemographic characteristics were associated with participant engagement in the intervention

The validity of the SF-12 and SF-6D instruments in people living with HIV/AIDS in Kenya

Background: Health-related quality of life (HRQoL) and health state utility value (HSUV) measurements are vital components of healthcare clinical and economic evaluations. Accurate measurement of HSUV and HRQoL require validated instruments. The 12-item Short-Form Health Survey (SF-12) is one of few instruments that can evaluate both HRQoL and HSUV, but its validity has not been assessed in people living with HIV/AIDS (PLWHA) in east Africa, where the burden of HIV is high. Methods: This cross-sectional study used baseline data from a randomized trial involving PLWHA in Kenya. Data included responses from a translated and adapted SF-12 survey as well as key demographic and clinical data. Construct validity of the survey was examined by testing the SF-12’s ability to distinguish between groups known in advance to have differences in their health based on their disease severity. We classified disease severity based on established definitions from the US Center for Disease Control (CDC) and WHO, as well as a previously studied viral load threshold. T-tests and ANOVA were used to test for differences in HRQoL and HSUV scores. Area under the receive operator curve (AUC) was used to test the discriminative ability of the HRQoL and HSUV instruments. Results: Differences in physical component scores met the minimum clinically important difference among participants with more advanced HIV when defined by CD4 count (4.3 units) and WHO criteria (compared to stage 1, stages 2, 3 and 4 were 2.0, 7.2 and 9.8 units lower respectively). Mental score differences met the minimum clinically important difference between WHO stage 1 and stage 4 patients (4.4). Differences in the HSUV were statistically lower in more advanced HIV by all three definitions of severity. The AUC showed poor to weak discriminatory ability in most analyses, but had fair discriminatory ability between WHO clinical stage 1 and clinical stage 4 individuals (AUC = 0.71). Conclusion: Our findings suggest that the Kiswahili translated and adapted version of the SF-12 could be used as an assessment tool for physical health, mental health and HSUV for Kiswahili-speaking PLHWA. Trial registration Clinical trials.gov identifier: NCT00830622 . Registered 26 January 2009.Medicine, Faculty ofPharmaceutical Sciences, Faculty ofOther UBCNon UBCMedicine, Department ofReviewedFacult

Multiple Sclerosis in Older Adults: The Clinical Profile and Impact of Interferon Beta Treatment

Background. We examined (1) patient characteristics and disease-modifying drug (DMD) exposure in late-onset (LOMS, ≥50 years at symptom onset) versus adult-onset (AOMS, 18–<50 years) MS and (2) the association between interferon-beta (IFNβ) and disability progression in older relapsing-onset MS adults (≥50 years). Methods. This retrospective study (1980–2004, British Columbia, Canada) included 358 LOMS and 5627 AOMS patients. IFNβ-treated relapsing-onset MS patients aged ≥50 (regardless of onset age, 90) were compared with 171 contemporary and 106 historical controls. Times to EDSS 6 from onset and from IFNβ eligibility were examined using survival analyses. Results. LOMS patients (6%) were more likely to be male, with motor onset and a primary-progressive course, and exhibit faster progression and were less likely to take DMDs. Nonetheless, 57% were relapsing-onset, of which 31% were prescribed DMDs, most commonly IFNβ. Among older relapsing-onset MS adults, no significant association between IFNβ exposure and disability progression was found when either the contemporary (hazard ratio [HR]: 0.46; 95% CI: 0.18–1.22) or historical controls (HR: 0.54; 95% CI: 0.20–1.42) were considered. Conclusion. LOMS differed clinically from AOMS. One-third of older relapsing-onset MS patients were prescribed a DMD. IFNβ exposure was not significantly associated with reduced disability in older MS patients

Mobile phone text messages for improving adherence to antiretroviral therapy (ART): a protocol for an individual patient data meta-analysis of randomised trials

INTRODUCTION: Mobile phone text messaging is emerging as an important tool in the care of people living with HIV; however, reports diverge on its efficacy in improving adherence to antiretroviral therapy (ART), and little is known about which patient groups may benefit most from phone-based adherence interventions. We will conduct an individual patient data meta-analysis to investigate the overall and subgroup effects of text messaging in three recently published text-messaging randomised controlled trials. METHODS AND ANALYSIS: Data from two Kenyan and one Cameroonian trial will be verified, reformatted and merged. We will determine pooled effect sizes for text messaging versus standard care for improving adherence to ART using individual patient random-effects meta-analysis. We will test for the interaction effects of age, gender, level of education and duration on ART. Sensitivity analyses will be conducted with regard to thresholds for adherence, methods of handling missing data and fixed-effects meta-analysis. Only anonymised data will be collected from the individual studies. ETHICS AND DISSEMINATION: Ethical approval was obtained for the individual studies. The results of this paper will be disseminated as peer-reviewed publications, at conferences and as part of a doctoral thesis. This individual patient data meta-analysis may provide important insights into the effects of text messaging on ART adherence in different subpopulations, with important implications for programme implementation involving such interventions and future research

Mobile phone text messages for improving adherence to antiretroviral therapy (ART): an individual patient data meta-analysis of randomised trials

INTRODUCTION: Mobile phone text messaging is emerging as an important tool in the care of people living with HIV; however, reports diverge on its efficacy in improving adherence to antiretroviral therapy (ART), and little is known about which patient groups may benefit most from phone-based adherence interventions. We will conduct an individual patient data meta-analysis to investigate the overall and subgroup effects of text messaging in three recently published text-messaging randomised controlled trials. METHODS AND ANALYSIS: Data from two Kenyan and one Cameroonian trial will be verified, reformatted and merged. We will determine pooled effect sizes for text messaging versus standard care for improving adherence to ART using individual patient random-effects meta-analysis. We will test for the interaction effects of age, gender, level of education and duration on ART. Sensitivity analyses will be conducted with regard to thresholds for adherence, methods of handling missing data and fixed-effects meta-analysis. Only anonymised data will be collected from the individual studies. ETHICS AND DISSEMINATION: Ethical approval was obtained for the individual studies. The results of this paper will be disseminated as peer-reviewed publications, at conferences and as part of a doctoral thesis. This individual patient data meta-analysis may provide important insights into the effects of text messaging on ART adherence in different subpopulations, with important implications for programme implementation involving such interventions and future research