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.

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.

Feasibility of a pragmatic randomized adaptive clinical trial to evaluate a brief negotiational interview for harmful and hazardous alcohol use in Moshi, Tanzania.

INTRODUCTION: Low-resourced settings often lack personnel and infrastructure for alcohol use disorder treatment. We culturally adapted a Brief Negotiational Interview (BNI) for Emergency Department injury patients, the "Punguza Pombe Kwa Afya Yako (PPKAY)" ("Reduce Alcohol For Your Health") in Tanzania. This study aimed to evaluate the feasibility of a pragmatic randomized adaptive controlled trial of the PPKAY intervention. MATERIALS AND METHODS: This feasibility trial piloted a single-blind, parallel, adaptive, and multi-stage, block-randomized controlled trial, which will subsequently be used to determine the most effective intervention, with or without text message booster, to reduce alcohol use among injury patients. We reported our feasibility pilot study using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, with recruitment and retention rates being our primary and secondary outcomes. We enrolled adult patients seeking care for an acute injury at the Kilimanjaro Christian Medical Center in Tanzania if they (1) exhibited an Alcohol Use Disorder Identification Test (AUDIT) ≥8, (2) disclosed alcohol use prior to injury, or (3) had a breathalyzer ≥0.0 on arrival. Intervention arms were usual care (UC), PPKAY, PPKAY with standard text booster, or a PPKAY with a personalized text booster. RESULTS: Overall, 181 patients were screened and 75 enrolled with 80% 6-week, 82.7% 3-month and 84% 6-month follow-up rates showing appropriate Reach and retention. Adoption measures showed an overwhelmingly positive patient acceptance with 100% of patients perceiving a positive impact on their behavior. The Implementation and trial processes were performed with high rates of PPKAY fidelity (76%) and SMS delivery (74%). Intervention nurses believed Maintenance and sustainability of this 30-minute, low-cost intervention and adaptive clinical trial were feasible. CONCLUSIONS: Our intervention and trial design are feasible and acceptable, have evidence of good fidelity, and did not show problematic deviations in protocol. Results suggest support for undertaking a full trial to evaluate the effectiveness of the PPKAY, a nurse-driven BNI in a low-income country. TRIAL REGISTRATION: Trial registration number NCT02828267. https://classic.clinicaltrials.gov/ct2/show/NCT02828267.

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.

"The phone number tells us good things we didn't know before." Use of interactive voice response calling for improving knowledge and uptake of family planning methods among Maasai in Tanzania.

Maasai living in the Arusha region, Tanzania, face challenges in feeding their children because of decreasing grazing grounds for their cattle. Therefore, they requested birth control methods. Previous studies have shown that lack of knowledge about, and poor access to, family planning (FP) may worsen the situation. We developed an interactive voice response calling (IVRC) platform for Maasai and health care workers (HCW) to create a venue for communication about FP to increase knowledge and access to FP. The objective of this study was to explore the effect of the platform on knowledge, access and use of family planning methods. We applied a participatory action research approach using mixed methods for data collection to develop and pilot-test an mHealth-platform with IVRC using Maa language. We enrolled Maasai-couples and HCW in Monduli District (Esilalei ward), Arusha Region, and followed them for 20 months. A baseline assessment was done to explore knowledge about FP. Furthermore, we abstracted information on FP clinic visits. Based on that, we developed a system called Embiotishu. A toll-free number was provided to interact with the system by calling with their phone. The system offers pre-recorded voice messages with information about FP and reproductive health to educate Maasai. The system recorded the number of calls and the type of information accessed. We measured the outcome by (1) a survey investigating the knowledge of contraceptive methods before and after Embiotishu and (2) counting the number of clinic visits (2018-2020) from medical records and feedback from qualitative data for FP used among Maasai. The acceptability and feasibility were explored through focus group discussions (FGDs) with Maasai and in-depth interviews (IDIs) with HCW. We recruited 76 Maasai couples whom we interviewed during the baseline assessment. The overall knowledge of contraceptives increased significantly (p<0.005) in both men and women. The number of clinic visits rose from 137 in 2018 to 344 in 2019 and 228 in the first six months of 2020. Implants were the most prescribed family planning method, followed by injections and pills, as found in medical records. The number of incoming calls, missed calls, and questions were 24,033 over 20 months. Out of these calls, 14,547 topics were selected. The most selected topics were modern contraceptives (mainly implants, condoms, tubal ligation, and vasectomy). Natural methods of contraception (vaginal fluid observations, calendar, and temperature). Our study has shown that the IVRC system led to an improvement in knowledge about and access to contraceptives. Furthermore, it has potential to increase access to health information as well as improve dialogue between Health workers and Maasai.

Effect of a customized digital adherence tool on retention in care and adherence to antiretroviral treatment in breastfeeding women, children and adolescents living with HIV in Tanzania: a mixed-methods study followed by clinical trials.

BACKGROUND: Adherence to antiretroviral (ARV) treatment for HIV infection is challenging because of many factors. The World Health Organization (WHO) has recommended using digital adherence technologies (DATs). However, there is limited evidence on how DATs improve adherence. Wisepill® is an internet-enabled medication dispenser found feasible and acceptable in several studies. However, limited evidence is available on its effectiveness in improving ART adherence, specifically among children and adolescents. Furthermore, DATs are often developed without involving the target groups. We propose a two-stage project consisting of a formative study to customize an existing Wisepill DAT intervention and a randomized clinical trial to investigate the effectiveness of DAT combined with reminder cues and tailored feedback on adherence to ARV treatment among children and adolescents living with HIV and retention in care among breastfeeding women living with HIV in Kilimanjaro and Arusha Region, Tanzania. METHODS: We will conduct a formative mixed-methods study and three sub-trials in Kilimanjaro and Arusha Regions among (1) children aged 0-14 years and their caregivers, (2) adolescents aged 15-19 years and (3) breastfeeding women and their HIV-negative infants. In the formative study, we will collect and analyse data on needs and contents for DATs, including the contents of short message service (SMS) texts and tailored feedback. The results will inform the customization of the DAT to be tested in the sub-trials. In the trials, participants will be randomized in the intervention arm, where the DAT will be implemented or the control arm, where standard care will be followed. Participants in the intervention arm will take their medication from the Wisepill box and receive daily reminder texts and tailored feedback during clinic visits. DISCUSSION: If the intervention improves adherence to ART and the devices are acceptable, accurate and sustainable, the intervention can be scaled up within the National Aids Control Programmes. TRIAL REGISTRATION: PACTR202301844164954, date 27 January 2023.

Predicting viral load suppression by self-reported adherence, pharmacy refill counts and real time medication monitoring among people living with HIV in Tanzania.

INTRODUCTION: Monitoring of adherence to antiretroviral treatment (ART) is of utmost importance to prevent treatment failure. Several measures to monitor adherence have been applied in low-resource settings and they all have pros and cons. Our objective was to examine whether any of the following adherence measures is a better predictor of participants' viral load suppression: (1) self-report, (2) pharmacy refill count, (3) Real Time Medication Monitoring (RTMM), (4) a combination of self-report and pharmacy refill count or (5) all three adherence assessment methods combined. METHODOLOGY: This was a post-hoc analysis of data from our 48-week REMIND-HIV randomized controlled trial in which adherence to ART was measured using self-report, pharmacy refill counts and RTMM among ART-experienced adults living with HIV subjectively judged to be nonadherent to ART. For each adherence measure, we calculated sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for predicting virological failure defined as a viral load (VL) of > 20 copies/mL. To determine at which percentage of adherence the prediction was strongest, we evaluated adherence cut-offs of 80%, 85%, 90%, 95% and 100% using receiver operating characteristic (ROC) curves. VL data were obtained after 48 weeks of follow-up in the trial. RESULTS: A total of 233 people living with HIV (PLHIV) were included in this analysis. When comparing the ability of self-reported adherence with pharmacy refill count and RTMM adherence to predict viral load > 20 copies/ml, self-reported adherence had the lowest sensitivity, ranging from 6 to 17%, but the highest specificity, ranging from 100 to 86%, depending on cut-off values from 80 to 100%. Area under the ROC curves (AUC) were 0.54 for RTMM, 0.56 for pharmacy refill count and 0.52 for self-report, indicating low discriminatory capacity for each of the adherence measures. When we combined the self-report and pharmacy refill count measures, sensitivity increased, ranging from 28 to 57% but specificity decreased, ranging from 83 to 53%. When all three measures were combined, we observed the highest value of sensitivity, ranging from 46 to 92%, and PPV, ranging from 32 to 36%, at high cut-offs ranging from 80 to 100%. Upon combination of three adherence measures, the AUC increased to 0.59. CONCLUSION: Our results show that adherence assessed exclusively by self-report, pharmacy refill count or RTMM were insufficiently sensitive to predict virologic failure. Sensitivity markedly improved by combining all three measures, but the practical feasibility of such an approach would need to be studied.

Expanding access to rehabilitation using mobile health to address musculoskeletal pain and disability.

Introduction: Musculoskeletal (MSK) disorders such as low back pain and osteoarthritis are a leading cause of disability and the leading contributor to the need for rehabilitation services globally. This need has surpassed the availability of trained clinicians; even in urban areas where services and providers are thought to be more abundant, access can be challenged by transportation options and financial costs associated with travel, care and lost time from work. However, continuing standard of fully in-person rehabilitation care for MSK-associated pain and disability may no longer be necessary. With increased ownership or access to even a basic mobile phone device, and evidence for remote management by trained clinicians, some individuals with MSK disorders may be able to continue their rehabilitation regimen predominantly from home after initial evaluation in primary care or an outpatient clinic. Methods: This manuscript describes application of a framework we used to culturally and contextually adapt an evidence-based approach for leveraging digital health technology using a mobile phone (mHealth) to expand access to rehabilitation services for MSK-associated pain and disability. We then conducted a multi-level analysis of policies related to the adapted approach for rehabilitation service delivery to identify opportunities to support sustainability. Results: Our study was conducted in Tanzania, a lower-middle income country with their first National Rehabilitation Strategic Plan released in 2021. Lessons learned can be applied even to countries with greater infrastructure or fewer barriers. The seven-step adaptation framework used can be applied in other regions to improve the likelihood of local mHealth adoption and implementation. Our practice and policy assessment for Tanzania can be applied in other regions and used collaboratively with government officials in support of building or implementing a national rehabilitation strategic plan. Conclusion: The work described, lessons learned and components of the plan are generalizable globally and can improve access to rehabilitation services using mHealth to address the significant and increasing burden of disability.

Feasibility of SMS booster for alcohol reduction in injury patients in Tanzania.

Alcohol use is associated with 3 million annual deaths globally. Harmful alcohol use, which is associated with a high burden of disease in low- and middle-income countries (LMICs), often increases the probability of traumatic injury. Treatments for harmful alcohol use in LMICs, such as Tanzania, lack trained personnel and adequate infrastructure. The aim of this study was to assess the feasibility of using SMS boosters to augment a hospital based brief negotiational intervention (BNI) in this low resourced setting. We conducted a three stage, four arm feasibility trial of a culturally adapted BNI for injury patients with harmful and hazardous drinking admitted to Kilimanjaro Christian Medical Centre (KCMC) in Moshi, Tanzania. Post hospital discharge, two of the four arms included patients receiving either a standard or personalized short message service (SMS) booster to enhance and or perpetuate the effect of the in-hospital BNI. Text messages were sent weekly throughout a 3-month follow-up period. SMS feasibility was assessed according to the TIDier checklist evaluating what, when, how much, tailoring processes, modifications and how well (intervention fidelity). Data was collected with SMS logs and short answer surveys to participants. A total of 41 study participants were assigned to each receive 12 SMS over a three-month period; 38 received messages correctly, 3 did not receive intended messages, and 1 received a message who was not intended to. Of the 258 attempted texts, 73% were successfully sent through the messaging system. Of the messages that failed delivery, the majority were not able to be sent due to participants traveling out of cellular service range or turning off their phones. Participants interviewed in both booster arms reported that messages were appropriate, and that they would appreciate the continuation of such reminders. At 6-month follow-up, 100% (n = 11) of participants interviewed believed that the boosters had a positive impact on their behavior, with 90% reporting a large impact. This study demonstrated feasibility and acceptability of the integration of SMS mobile health technology to supplement this type of nurse-led BNI. SMS booster is a practical tool that can potentially prolong the impact of a brief hospital based intervention to enact behavioral change in injury patients with AUD.

Effect of Digital Adherence Tools on Adherence to Antiretroviral Treatment Among Adults Living With HIV in Kilimanjaro, Tanzania: A Randomized Controlled Trial.

BACKGROUND: Lifelong adherence to antiretroviral treatment remains challenging for people living with HIV (PLHIV). The aim of this study was to investigate whether any of 2 digital adherence tools could improve adherence among PLHIV in Kilimanjaro, Tanzania. METHODS: We performed a parallel 3-arm, nonblinded, randomized controlled trial with 1:1:1 allocation. We included adults aged between 18 and 65 years, living in Kilimanjaro region, and who were on antiretroviral treatment for at least 6 months. Their adherence, as judged by the study nurses, had to be suboptimal. In one arm, participants received reminder short message service (SMS) texts, followed by a question SMS. In the second arm, participants received a real-time medication monitoring (RTMM) device (Wisepill) with SMS reminders. In the third arm, participants received standard care only. The primary outcome of mean adherence over 48 weeks was compared between arms using between-group t tests in a modified intention-to-treat analysis. RESULTS: In each arm, we randomized 83 participants: data of 82 participants in the RTMM arm, 80 in the SMS arm, and 81 in the standard care arm were analyzed. The average (over 48 weeks) adherence in the SMS, RTMM, and control arms was 89.6%, 90.6%, and 87.9% for pharmacy refill; 95.9%, 95.0%, and 95.2% for self-report in the past week; and 97.5%, 96.6%, and 96.9% for self-report in the past month, respectively (P values not statistically significant). CONCLUSIONS: Receiving reminder SMS or RTMM combined with feedback about adherence levels and discussion of strategies to overcome barriers to adherence did not improve adherence to treatment and treatment outcome in PLHIV. CLINICAL TRIAL NUMBER: PACTR201712002844286.

"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.

Returning of antiretroviral medication dispensed over a period of 8 months suggests non-adherence despite full adherence according to real time medication monitoring.

Real-time medication monitoring (RTMM) may potentially enhance adherence to antiretroviral treatment (ART). We describe a participant in an ongoing trial who, shortly after completing trial participation, died of cryptococcal meningitis despite high levels of adherence according to self-report, pill-counts and RTMM (> 99%). However, she evidenced consistently high HIV viral load throughout the 48-week study follow-up. Subsequently, her relatives unsolicitedly returned eight months' dispensed ART medication that she was supposed to have taken. This brief report illustrates the challenges of adherence measurements including RTMM, and reinforces the need to combine adherence assessments with viral load monitoring in HIV care.

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.

Feasibility of SMS to remind pregnant and breastfeeding women living with HIV to take antiretroviral treatment in Kilimanjaro region, Tanzania: a pilot study.

BACKGROUND: Pregnant and breastfeeding Women Living with HIV (WLHIV) often have difficulties in reaching adequate levels of adherence (>95%) to Antiretroviral treatment. "Forgetting" is the most commonly mentioned reason. Sending reminders via SMS is expected to improve adherence. We conducted a pilot study to investigate acceptability, user experience and technical feasibility of sending reminder-SMS to WLHIV. METHODS: This was a 6-months observational pilot-study among WLHIV attending antenatal and postnatal care at Kilimanjaro Christian Medical Centre in Moshi, Tanzania. Women received a reminder-SMS 30 minutes before usual time of intake. One hour later, they received an SMS asking whether they took medication to which they could reply with 'Yes' or 'No'. Messages were sent 3 times a week on randomly chosen days to prevent reliance on daily messages. We calculated the percentage of number of SMS delivered, failed to be delivered, and replied to. We analysed feedback from exit-interviews about experience with the SMS-reminders. RESULTS: 25 women were enrolled (age 18-45), 2 were lost to follow up. 5,054 messages were sent of which 53 failed to be delivered (1%). 1,880 SMS were sent with a question if medication was taken; 1,012 (54%) messages were replied to, of which 1,003 (99%) were replied with 'YES' and closely to 'YES', and a total of 9 (1%) with 'NO' and 'closely to NO'. 868 messages (46%) were not responded to due to either dropout, change of phone number, loss of phone or network failure. Results from 18 interviews showed that 16 (89%) women were satisfied with SMS reminders. 2 (11%) were concerned about unwanted disclosure because of the content 'don't forget to take medication' and one reported other privacy issues (6%). 3 (17%) women experienced stigma. CONCLUSION: 99%of SMS being delivered indicates that SMS reminders in this resource-limited setting are technically feasible. However, concerns regarding privacy were noted, specifically the risk of unwanted disclosure and the experience of stigma. Participants indicated that being made aware of their adherence, motivated them to adhere better. However, personalised and more neutral content of the SMS might be a way to improving the intervention.

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.

Feasibility of Real Time Medication Monitoring Among HIV Infected and TB Patients in a Resource-Limited Setting.

HIV infected and tuberculosis (TB) patients need high levels of treatment adherence to achieve optimal treatment outcomes. We conducted a pilot-study on real time medication monitoring (RTMM) in a resource-limited setting. We enrolled five HIV infected and five TB patients from Kilimanjaro, Tanzania. They took their medication using RTMM. When the device was not opened on time, patients received a reminder SMS. After 3 months, we interviewed patients. Six patients (60 %) reached adherence of >95 %. Nine-hundred-twenty-two of 1104 intakes (84 %) were on time. Five-hundred reminders (45 %) were sent, of which 202 (40 %) were incorrect, because of an unstable mobile network. Nine patients found the device helpful and nine mentioned it keeps medication safe. Six patients reported that the size was too big. Five patients mentioned they received incorrect reminders. The device is considered useful in Kilimanjaro. Optimization of the device should consider network connectivity and the size of the device.