Efavirenz is related to neuropsychiatric symptoms among adults, but not among adolescents living with human immunodeficiency virus in Kilimanjaro, Tanzania.

OBJECTIVES: To explore the relationship between Efavirenz (EFV) and neuropsychiatric symptoms among adults and adolescents living with human immunodeficiency virus (HIV) in Kilimanjaro, Tanzania. METHODS: Cross-sectional study among HIV-infected adults (age 18-65) and adolescents (age 12-17) on antiretroviral treatment attending Kilimanjaro Christian Medical Centre, Moshi, Tanzania. Neuropsychiatric symptoms were measured using the Hospital Anxiety and Depression Scale (HADS), the Symptom Checklist 90 (SCL-90) and the Mini-International Neuropsychiatric Interview (MINI). manova and chi-squared tests were used to test differences between EFV and non-EFV-treated participants. RESULTS: A total of 215 adults and 150 adolescents participated. About 52% of adults and 37% of adolescents used EFV. Among adults, depression scores were higher for those on EFV (HADS (Cohen's D: 0.38; P = 0.02) and SCL-90 (Cohen's D: 0.24; P = 0.03). Among adolescents, those on EFV had lower scores on depression (HADS (Cohen's D: 0.3; P = 0.02) and SCL-90 (Cohen's D: 0.1; P = 0.02). About 10% of adults reported suicidal thoughts, but there was no difference between those on EFV and those without. Lastly, adults on EFV reported higher levels of problematic alcohol use (P = 0.003). CONCLUSIONS: In line with the previous studies, EFV is associated with depressive symptoms and problematic alcohol use among HIV-infected adults in Tanzania. In contrast, EFV was associated with lower levels of depressive symptoms in adolescents in Tanzania. Particularly among adults, close monitoring of depressive symptoms and alcohol use is indicated.

Implementation bottlenecks of real time medication monitoring (evriMED) for improving adherence to anti-TB drugs among people with tuberculosis in Kilimanjaro, Tanzania.

Introduction: Digital Adherence Tools (DATs), which include real-time medication monitoring and Short Message Service (SMS) reminders, have been reported to improve medication adherence among people with Tuberculosis (TB). Recently, in limited resource settings, DATs have been described as a promising tool to monitor patients' medication behaviour. We aimed to determine implementation bottlenecks of real-time medication monitoring using the evriMED device. Method: We conducted a research study using a mixed-methods approach, involving both people with TB s and directly observed treatment (DOT) providers who participated in the REMIND-TB trial and utilized the evriMED devices. EvriMED is a medication dispenser with internet connectivity that can send real-time SMS reminders. To gather data, we extracted reports from the Wisepill dashboard, specifically the client status report. This report documented the activity status of all devices, including communication and battery status. Additionally, we conducted in-depth interviews with people with TB and TB care providers who were involved in implementing the Remind TB trial in the Kilimanjaro region. These interviews were guided by the MIDI (Measurement Instrument for Determinants of Innovation), which helps identify the factors influencing the implementation of innovations such as evriMED. Results: Out of the initial 281 participants who were given devices, 245 completed the 6-month follow-up period. The findings indicate that at month 6, most of the devices (49%) reported battery-related challenges. Additionally, forty devices (14%) had reported more than one incidence of losing communication. Through interviews with participants, we observed that evriMED was perceived as user-friendly, and the people with TB reported high satisfaction as the device facilitated improved medication intake. TB care providers also said that evriMED was a relevant tool to be used by the people with TB. However, during the in-depth interview certain implementation bottlenecks were identified, including network issues, limited training, and low technology knowledge among TB care providers, who found the procedure of using the evriMED to be time-consuming. Conclusion: Implementation of evriMED was perceived as user-friendly and highly satisfactory by people with TB. Certain implementation bottlenecks were identified as potential barriers to the use of devices. These bottlenecks include network issues, limited training, battery-related challenges and low technological knowledge among TB care providers, which may have contributed to communication loss. Further research may be needed to address these limitations and develop effective strategies to facilitate the successful implementation of evriMED as a tool for improving medication intake among people with TB.

Acceptability of a Digital Adherence Tool Among Patients With Tuberculosis and Tuberculosis Care Providers in Kilimanjaro Region, Tanzania: Mixed Methods Study.

BACKGROUND: The World Health Organization has recommended digital adherence tools (DATs) as a promising intervention to improve antituberculosis drug adherence. However, the acceptability of DATs in resource-limited settings is not adequately studied. OBJECTIVE: We investigated the acceptability of a DAT among patients with tuberculosis (TB) and TB care providers in Kilimanjaro, Tanzania. METHODS: We conducted a convergent parallel mixed methods study among patients with TB and TB care providers participating in our 2-arm cluster randomized trial (REMIND-TB). The trial aimed to investigate whether the evriMED pillbox with reminder cues and adherence feedback effectively improves adherence to anti-TB treatment among patients with TB in Kilimanjaro, Tanzania. We conducted exit and in-depth interviews among patients as well as in-depth interviews among TB care providers in the intervention arm. We conducted a descriptive analysis of the quantitative data from exit interviews. Translated transcripts and memos were organized using NVivo software. We employed inductive and deductive thematic framework analysis, guided by Sekhon's theoretical framework of acceptability. RESULTS: Out of the 245 patients who completed treatment, 100 (40.8%) were interviewed during exit interviews, and 18 patients and 15 TB care providers were interviewed in-depth. Our findings showed that the DAT was highly accepted: 83% (83/100) expressed satisfaction, 98% (98/100) reported positive experiences with DAT use, 78% (78/100) understood how the intervention works, and 92% (92/100) successfully used the pillbox. Good perceived effectiveness was reported by 84% (84/100) of the participants who noticed improved adherence, and many preferred continuing receiving reminders through SMS text messages, indicating high levels of self-efficacy. Ethical concerns were minimal, as 85 (85%) participants did not worry about remote monitoring. However, some participants felt burdened using DATs; 9 (9%) faced difficulties keeping the device at home, 12 (12%) were not pleased with receiving daily reminder SMS text messages, and 30 (30%) reported challenges related to mobile network connectivity issues. TB care providers accepted the intervention due to its perceived impact on treatment outcomes and behavior change in adherence counseling, and they demonstrated high level of intervention coherence. CONCLUSIONS: DATs are highly acceptable in Tanzania. However, some barriers such as TB-related stigma and mobile network connectivity issues may limit acceptance. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-019-3483-4.

The effect of a customised digital adherence tool on HIV treatment outcomes in young people living with HIV (YPLHIV) in Blantyre, Malawi: a protocol for a randomised controlled trial.

BACKGROUND: People living with HIV (PLHIV) have to take lifelong antiretroviral treatment, which is often challenging. Young people living with HIV (YPLHIV) have the lowest viral load suppression rates in Malawi and globally, mostly due to poor treatment adherence. This is a result of complex interactions of multiple factors unique to this demographic group. The use of digital health interventions, such as real-time medication monitor (RTMM)-based digital adherence tools (DATs), could improve ART adherence in YPLHIV and subsequently improve viral load suppression which in turn could lead to reduced HIV-associated morbidity and mortality. AIM: To provide the evidence base for a digital adherence intervention to improve treatment outcomes in YPLHIV on ART. OBJECTIVES: 1. The primary objective is to determine the efficacy of a customised DAT compared to the standard of care in improving ART adherence in YPLHIV. 2. The secondary objective is to determine the efficacy of the customised DAT compared to the standard of care in improving viral load suppression in YPLHIV. METHODOLOGY: This will be a parallel open-label randomised control controlled two-arm trial in which non-adherent YPLHIV in selected ART facilities in Blantyre will be randomised in a 1:1 ratio to a customised DAT and standard care arms and followed up for 9 months. The primary outcome is the proportion adherent at 9 months (> = 95% by pill count), and the secondary outcome is the proportion with viral load suppressed at 9 months (< 200 copies/ml). DISCUSSION: There is a paucity of good quality evidence on effective digital health interventions to improve ART adherence and viral load suppression in YPLHIV globally and particularly in HIV high-burden settings like Malawi. This study will provide good-quality evidence on the effectiveness of a customised DAT in improving ART adherence and viral load suppression in this important demographic. TRIAL REGISTRATION: The trial has been registered in the Pan African Clinical Trials Registry number: PACTR202303867267716 on 23 March 2023 and can be accessed through the following URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25424 . All items from the WHO Trial Registration Data Set are described in this manuscript.

Developing contents for a digital adherence tool: A formative mixed-methods study among children and adolescents living with HIV in Tanzania.

Optimal adherence (>95%) to antiretroviral treatment (ART) remains a challenge among children and adolescents living with HIV (CALHIV). Digital adherence tools (DAT) with reminder cues have proven feasible among adult people living with HIV (PLHIV), with some concerns about the risk of HIV status disclosure. We aimed to assess the needs, contents and acceptability of an SMS-based DAT among CALHIV. We first conducted a survey to understand potential barriers to using DAT among CALHIV, then tested the DAT intervention among purposively selected participants. The DAT intervention included using the Wisepill device, receiving daily reminder SMS and receiving adherence reports on how they had taken medication in the past month. The content of the reminder SMS differed over time from asking if the medication was taken to a more neutral SMS like "take care". Afterwards, we conducted exit interviews, in-depth interviews, and focus-group discussions. We analysed quantitative findings descriptively and used thematic content analysis for qualitative data. We included 142 children and 142 adolescents in the survey, and 20 of each used the intervention. Eighty-five percent (121/142) of surveyed participants indicated they would like to receive reminder SMS. Most of them (97/121-80%) of children and 94/121(78%) of adolescents would prefer to receive daily reminders. Participants who used the DAT mentioned to be happy to use the device. Ninety percent of them had good experience with receiving reminders and agreed that the SMS made them take medication. However, 25% experienced network problems. Participants preferred neutral reminder SMSs that did not mention the word 'medication', but preserved confidentiality. The provided adherence reports inspired participants to improve their adherence. None of the participants experienced unwanted disclosure or stigmatisation due to DAT. However, 5% of adolescents were concerned about being monitored daily. This study showed that DAT is acceptable and provided insight of the needed SMS content for a customized DAT for CALHIV.

"I Wish to Continue Receiving the Reminder Short Messaging Service": A Mixed Methods Study on the Acceptability of Digital Adherence Tools Among Adults Living with HIV on Antiretroviral Treatment in Tanzania.

INTRODUCTION: Digital Adherence Tools (DAT) to promote adherence to antiretroviral treatment (ART) for HIV are being increasingly adopted globally, however their effectiveness and acceptability in limited resource settings has been challenging. In this study, we examine the acceptability of DATs to improve adherence to ART. METHODS: This study was part of a three-arm randomized controlled trial (REMIND) which investigated the effect of two different DAT's: SMS text messages (SMS) or real-time medication monitoring (RTMM) on treatment adherence; compared to standard of care. Exit interviews and in-depth interviews were conducted at 48 weeks follow-up, to collect data on their experiences (successes, challenges, and barriers) and behaviours regarding the implementation of the interventions. Translated transcripts, memos and field notes were imported to NVivo software version 12. We used a thematic framework analysis which drew from Sekhon's theoretical framework of acceptability (TFA), which comprises of seven constructs (affective attitude, perceived burden, perceived effectiveness, ethicality, self-efficacy, intervention coherence and opportunity costs). RESULTS: Of the 166 participants enrolled, 143 (86%) were interviewed (68 in the SMS arm and 75 in the RTMM arm). Participants were highly satisfied (98%) with the DAT system and the majority of them reported it motivated them to take their medication (99%). The majority of participants reported they were confident in their ability to comply with the intervention and understood how the intervention worked (97%). Very few reported negatively about the devices (carrying the device), with only 6% reporting that they did not feel comfortable and 8% had ethical concerns with the SMS-content A few participants reported challenges with their connectivity/network and that the visits were too time-consuming. A few participants reported that they incurred extra cost for the sake of the study. CONCLUSION: Overall, the acceptability of these DATs was high. However, several factors may hamper their acceptability including the content and number of SMS, carrying the devices and the network availability.

Protocol for establishing an Adaptive Diseases control Expert Programme in Tanzania (ADEPT) for integrating care of communicable and non-communicable diseases using tuberculosis and diabetes as a case study.

INTRODUCTION: Most sub-Saharan African countries endure a high burden of communicable infections but also face a rise of non-communicable diseases (NCDs). Interventions targeting particular epidemics are often executed within vertical programmes. We establish an Adaptive Diseases control Expert Programme in Tanzania (ADEPT) model with three domains; stepwise training approach, integration of communicable and NCDs and a learning system. The model aims to shift traditional vertical programmes to an adaptive diseases management approach through integrating communicable and NCDs using the tuberculosis (TB) and diabetes mellitus (DM) dual epidemic as a case study. We aim to describe the ADEPT protocol with underpinned implementation and operational research on TB/DM. METHODS AND ANALYSIS: The model implement a collaborative TB and DM services protocol as endorsed by WHO in Tanzania. Evaluation of the process and outcomes will follow the logic framework. A mixed research design with both qualitative and quantitative approaches will be used in applied research action. Anticipated implementation research outcomes include at the health facilities level for organising TB/DM services, pathways of patients with TB/DM seeking care in different health facilities, factors in service delivery that need deimplementation and the ADEPT model implementation feasibility, acceptability and fidelity. Expected operational research outcomes include additional identified patients with dual TB/DM, the prevalence of comorbidities like hypertension in patients with TB/DM and final treatment outcomes of TB/DM including treatment-related complications. Findings will inform the future policies and practices for integrating communicable and NCDs services. ETHICS AND DISSEMINATION: Ethical approval was granted by The National Research Health Ethical Committee (Ref-No. NIMR/HQ/R.8a/Vol.IX/2988) and the implementation endorsed by the government authorities. Findings will be proactively disseminated through multiple mechanisms including peer-reviewed journals, and engagement with various stakeholders' example in conferences and social media.

Technical and Psychosocial Challenges of mHealth Usage for Antiretroviral Therapy Adherence Among People Living With HIV in a Resource-Limited Setting: Case Series.

BACKGROUND: Mobile communication has been found to improve antiretroviral therapy (ART) adherence among people living with HIV. In an ongoing randomized clinical trial, 2 mobile communication strategies (ie, sending SMS text messages and real-time medication monitoring [RTMM]) were used to improve adherence to ART among people living with HIV in Tanzania. We noticed remarkable discrepancies between self-reported adherence and adherence recorded by SMS text messaging or RTMM among some of the first trial participants. OBJECTIVE: Our objective was to describe these cases and the observed discrepancies in more detail, to serve as a useful illustration of some of the challenges in using mobile health in resource-limited settings. METHODS: In an ongoing randomized trial, adults living with HIV from two HIV treatment centers in Tanzania who were suspected of low levels of adherence were randomly assigned in a 1:1:1 ratio to receive (1) SMS text message reminders, (2) an RTMM device, or (3) no additional intervention to standard HIV care. During bimonthly study visits, the participants self-reported their level of adherence, received feedback about their level of adherence based on SMS text messaging or RTMM, and discussed strategies to overcome adherence problems with nurses providing HIV care. For the purpose of this report, we selected people living with HIV who had completed 5 follow-up visits and consistently reported more than 95% adherence, while SMS text messaging or RTMM recorded lower than 75% adherence. The participants were invited for a short, face-to-face in-depth interview to explore reasons for this discrepancy. RESULTS: At the time of this analysis, 26 participants had completed follow-up. Six of these evidenced the above-mentioned discrepancies, with an average adherence of 46% based on SMS text messaging or RTMM, while self-reported adherence was 98%. Five of these 6 participants insisted that their adherence to ART was good, with 4 reporting that their adherence to properly using the monitoring device was low. Three participants mentioned concerns about involuntary disclosure of HIV status as a main reason for low adherence to using the device. Two participants were still depending on other reminder cues despite receiving SMS text message or RTMM reminders. Poor network coverage caused low adherence in 1 participant. CONCLUSIONS: Psychosocial barriers were reported as importantly contributing to low adherence, both with respect to use of ART and proper use of the adherence-monitoring device. This case series illustrates that when introducing new digital adherence monitoring technology, researchers should consider psychosocial barriers and distinguish between adherence to device use and adherence to treatment. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR201712002844286; https://tinyurl.com/y98q4p3l.

Implementation and effectiveness of evriMED with short messages service (SMS) reminders and tailored feedback compared to standard care on adherence to treatment among tuberculosis patients in Kilimanjaro, Tanzania: proposal for a cluster randomized controlled trial.

BACKGROUND: Adherence to tuberculosis (TB) treatment is challenging because of many factors. The World Health Organization has recommended the use of digital adherence monitoring technologies in its End TB Strategy. However, evidence on improving adherence is limited. EvriMED is a real-time medication-monitoring device which was found to be feasible and acceptable in a few studies in Asia. In Tanzania, however, there may be challenges in implementing evriMED due to stigmatization, network and power access, accuracy, and cost effectiveness, which may have implications for treatment outcome. We propose a pragmatic cluster randomized trial to investigate the effectiveness of evriMED with reminder cues and tailored feedback on adherence to TB treatment in Kilimanjaro, Tanzania. METHODS/DESIGN: We will create clusters in Kilimanjaro based on level of health care facility. Clusters will be randomized in an intervention arm, where evriMED will be implemented, or a control arm, where standard practice directly observed treatment will be followed. TB patients in intervention clusters will take their medication from the evriMED pillbox and receive tailored feedback. We will use the 'Stages of Change' model, which assumes that a person has to go through the stages of pre-contemplation, contemplation, preparation, action, and evaluation to change behavior for tailored feedback on adherence reports from the device. DISCUSSION: If the intervention shows a significant effect on adherence and the devices are accepted, accurate, and sustainable, the intervention can be scaled up within the National Tuberculosis Programmes. TRIAL REGISTRATION: Pan African Clinical Trials Registry, PACTR201811755733759 . Registered on 8 November 2018.

Feasibility of Using Short Message Service and In-Depth Interviews to Collect Data on Contraceptive Use Among Young, Unmarried, Sexually Active Men in Moshi, Tanzania, and Addis Ababa, Ethiopia: Mixed Methods Study With a Longitudinal Follow-Up.

BACKGROUND: Data on contraceptive needs and use among young unmarried men are limited. Conventional ways of data collection may lead to limited and unreliable information on contraceptive use due to sensitivity of the topic, as many young men feel ashamed to discuss their behavior of using contraceptives. As short message service (SMS) is anonymous and a commonly used means of communication, we believe that if deployed, it will create a promising user-friendly method of data collection. OBJECTIVE: The objective was to investigate the feasibility of using SMS to collect data on sexually active, young, unmarried men's sexual behavior and contraceptive preferences, practices, and needs in Addis Ababa, Ethiopia, and Moshi, Tanzania. METHODS: We enrolled men aged 18-30 years who were students (in Ethiopia and Tanzania), taxi or local bus drivers/assistants (Ethiopia and Tanzania), Kilimanjaro porters (Tanzania), or construction workers (Ethiopia). Young men were interviewed using a topic list on contraceptive use. They were followed up for 6 months by sending fortnightly SMS texts with questions about contraceptive use. If the young men indicated that they needed contraceptives during the reporting period or were not satisfied with the method they used, they were invited for a follow-up interview. At the end of the study, we conducted exit interviews telephonically using a semistructured questionnaire to explore the feasibility, acceptability, and accuracy of using SMS to validate the study findings in both countries. RESULTS: We enrolled 71 young unmarried men-35 in Tanzania and 36 in Ethiopia. In Moshi, 1908 messages were delivered to participants and 1119 SMS responses were obtained. In Ethiopia, however, only 525 messages were sent to participants and 248 replies were received. The question on dating a girl in the past weeks was asked 438 times in Tanzania and received 252 (58%) replies, of which 148 (59%) were "YES." In Ethiopia, this question was asked 314 times and received 64 (20%) replies, of which 52 (81%) were "YES" (P=.02 for difference in replies between Tanzania and Ethiopia). In Tanzania, the question on contraceptive use was sent successfully 112 times and received 108 (96%) replies, of which 105 (94%) were "YES." In Ethiopia, the question on contraceptive use was asked 17 times and received only 2 (11%) replies. Exit interviews in Tanzania showed that SMS was accepted as a means of data collection by 22 (88%) of the 25 interviewed participants. CONCLUSIONS: Despite network and individual challenges, the SMS system was found to be feasible in Moshi, but not in Addis Ababa. We recommend more research to scale up the method in different groups and regions.