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.

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.

BACKGROUND:

Refill data are increasingly used to assess adherence in HIV-infected patients on combination antiretroviral therapy. However, it is not clear how feasible this method is when multiple pharmacies are involved. Also, the effects of inclusion of leftover medication from previous refills and prescribed treatment time on adherence calculations are unknown. We addressed these questions in the present study.

METHODS:

Adult HIV-1-infected patients were recruited at the outpatient clinic of the Academic Medical Centre in Amsterdam and asked for their pharmacies' names. Refill data were obtained from pharmacies. Percentages of patients misclassified as nonadherent when disregarding leftover medication and prescribed treatment interruptions were calculated. Finally, we investigated whether an average adherence calculation of all drugs or a calculation based on one drug in the regimen best predicted virological failure (plasma HIV-1 RNA >40 copies/mL).

RESULTS:

Two hundred one patients were included. Collecting data from multiple pharmacies (132) was found to be feasible. Forty-three percent of patients were misclassified as nonadherent when disregarding leftover medication and 2 percent when disregarding prescribed treatment time. There was no difference in predicting virological failure by different calculations of adherence.

CONCLUSIONS:

These findings suggest that studies using pharmacy refill data should include leftover medication.

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.

We compared adherence to cART and virological response between indigenous and immigrant HIV-infected patients in the Netherlands, and investigated if a possible difference was related to a difference in the psychosocial variables: HIV-stigma, quality-of-life, depression and beliefs about medications. Psychosocial variables were assessed using validated questionnaires administered during a face-to-face interview. Adherence was assessed trough pharmacy-refill monitoring. We assessed associations between psychosocial variables and non-adherence and having detectable plasma viral load using logistic regression analyses. Two-hundred-two patients participated of whom 112 (55%) were immigrants. Viral load was detectable in 6% of indigenous patients and in 15% of the immigrants (P < 0.01). In multivariate analyses, higher HIV-stigma and prior virological failure were associated with non-adherence, and depressive symptoms, prior virological failure and non-adherence with detectable viral load. Our findings suggest that HIV-stigma and depressive symptoms may be targets for interventions aimed at improving adherence and virological response among indigenous and immigrant HIV-infected patients.

BACKGROUND:

The interface between clinicians and laboratory staff is where the two meet and work together to provide quality care to their clients (patients). Effectiveness of the interface depends on the way the two groups of professionals relate to and communicate with each other. The number and type of tests requested and the use of the test results for clinical decision making can be influenced by the interfacebetween clinicians and laboratory staff. A model to understand the factors and dynamics around the interface is lacking.

OBJECTIVES:

To propose a new conceptual model to gain insight and analyse factors that influence the laboratory-clinical staff interface.

METHODS:

To develop the conceptual model, a literature study was performed, regulatory guidelines and standards for laboratories were analysed and discussions were held with experts on the topic.

RESULT:

A conceptual model and analytical framework provided good guidance in understanding and assessing the organisational and personal factors shaping the interface. The model was based on three elements: (1) the three phases of communication (pre-analytical, analytical and post-analytical); (2) the organisational and personal factors of interaction; and (3) the socio-political, economic and cultural context in which clinicians and laboratory staff operate.

CONCLUSION:

Assessment of the interface between clinicians and laboratory workers can be performed in a systematic way. Applying this model will provide information to managers of health institutions and heads of laboratories and clinical departments about what happens when clinicians and laboratory staff interact, thus aiding them in designing strategies to improve this interface.

In a multiple-dose-ranging trial, we previously evaluated higher doses of rifampin in patients for 2 weeks. The objectives of the current study were to administer higher doses of rifampin for a longer period to compare the pharmacokinetics, safety/tolerability, and bacteriological activity of such regimens. In a double-blind, randomized, placebo-controlled, phase II clinical trial, 150 Tanzanian patients with tuberculosis (TB) were randomized to receive either 600 mg (approximately 10 mg/kg of body weight), 900 mg, or 1,200 mg rifampin combined with standard doses of isoniazid, pyrazinamide, and ethambutol administered daily for 2 months. Intensive pharmacokinetic sampling occurred in 63 patients after 6 weeks of treatment, and safety/tolerability was assessed. The bacteriological response was assessed by culture conversion in liquid and solid media. Geometric mean total exposures (area under the concentration-versus-time curve up to 24 h after the dose) were 24.6, 50.8, and 76.1 mg · h/liter in the 600-mg, 900-mg, and 1,200-mg groups, respectively, reflecting a nonlinear increase in exposure with the dose (P < 0.001). Grade 3 adverse events occurred in only 2 patients in the 600-mg arm, 4 patients in the 900-mg arm, and 5 patients in the 1,200-mg arm. No significant differences in the bacteriological response were observed. Higher daily doses of rifampin (900 and 1,200 mg) resulted in a more than proportional increase in rifampin exposure in plasma and were safe and well tolerated when combined with other first-line anti-TB drugs for 2 months, but they did not result in improved bacteriological responses in patients with pulmonary TB. These findings have warranted evaluation of even higher doses of rifampin in follow-up trials. (This study has been registered at ClinicalTrials.gov under identifier NCT00760149.).

BACKGROUND:

Self-report is the most commonly used measure of adherence to highly active antiretroviral therapy, but typically shows weaker associations with virological treatment outcome than more objective adherence assessment methods. Socially desirable respondingmight hamper the validity of self-reported adherence. We investigated whether stratifying patients according to their socially desirableresponse set might improve the prediction of virological treatment response by self-reported adherence.

METHODS:

Patients enrolled in the focus group of the Dutch national cohort ATHENA completed a social desirability scale, four self-report adherence questions, and had their plasma HIV type-1 (HIV-1) RNA concentrations measured. We calculated odds ratios and 95% confidence intervals for self-reported non-adherence to predict HIV-1 RNA>50 copies/ml among patients with a lower or a higher tendencytowards socially desirable responding.

RESULTS:

A total of 331 patients were included. Self-reported non-adherence was significantly predictive of HIV-1 RNA>50 copies/ml on three out of four questions among patients with lower socially desirable responding (n=198). Self-reported non-adherence did not predict HIV-1 RNA>50 copies/ml among patients with higher socially desirable responding (n=132).

CONCLUSIONS:

Stratifying patients according to their socially desirable response set improved the prediction of virological treatmentresponse by self-reported adherence. This finding emphasizes the importance of discussing medication adherence with patients in a non-threatening and non-judgemental way that normalizes non-adherence in order to reduce socially desirable responding.

Background:

Mobile communication has been found to improve ART-adherence among people living with HIV (PLHIV). In our ongoing randomized clinical trial, we used two mobile communication strategies i.e., sending SMS and real-time medication monitoring (RTMM), to monitor adherence to ART and to intervene on adherence if indicated among PLHIV in Tanzania. We noticed a remarkable discrepancy between self-reported adherence and adherence recorded by SMS or RTMM among some of the first trial participants.

Objective:

Our objective was to explore reasons for those discrepancies.

Methods:

Adult PLHIV suspected of low levels of adherence were randomized to receiving adherence monitoring and reminders to take ART using 1) SMS versus 2) RTMM versus 3) a control group in two HIV treatment centers in Tanzania. During bi-monthly study visits PLHIV self-reported their level of adherence, received feedback about their level of adherence based on SMS or RTMM monitoring, and discussed strategies to overcome problems with adherence with HIV nurses. For this report, we selected PLHIV who had completed all follow-up visits and consistently self-reported a markedly different level of adherence to the nurse than was recorded by SMS or RTMM. These PLHIV were invited to a face-to-face interview to explore reasons for this discrepancy.

Results:

Twenty-six participants had completed follow-up. Six reported discrepancies and had an average of 46% adherence based on SMS/RTMM monitoring , while self-report recorded good adherence . Five participants insisted that their adherence to ART was good but four of them admitted that their adherence to properly using the monitoring device was low. Three participants mentioned concerns about involuntary disclosure of HIV status as main reason for low adherence to ART and/or device use. Two participants were still depending on other reminder cues despite receiving SMS or RTMM reminders. Poor network coverage caused apparently low adherence in one participant.

Conclusions:

Concerns about involuntary disclosure of HIV status was a main reason for low adherence to ART and/or proper adherence monitoring device use. Some participants still depended on reminders such as alarms despite receiving SMS or RTMM reminders illustrating the need for education and close monitoring when using new digital technologies in resource limited settings.

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.

BACKGROUND:

Previous studies have shown that health-related quality of life (HRQL) predicts survival in patients infected with human immunodeficiency virus (HIV). However, these studies predated the highly active antiretroviral therapy (HAART) era, included only a few patients receiving HAART, or had a limited duration of follow-up. This study investigates whether HRQL predicts survival among HIV-infectedpatients receiving HAART.

METHODS:

HIV-infected patients participating in the focus group of the AIDS Therapy Evaluation in the Netherlands (ATHENA) study and starting or already receiving HAART completed the Medical Outcomes Study HIV Health Survey at study entry (1 May 1998 through 31 December 2000). The physical health summary (PHS) and mental health summary (MHS) scores were calculated. All-cause mortality was established at 31 March 2008. Kaplan-Meier analysis and Cox regression models were performed to predict survival.

RESULTS:

The median follow-up was 8.4 years. Sixty-six patients (11.8%) died during follow-up. We found a significant relation between quartiles of PHS and survival (P < .001, log-rank test). Of patients with a PHS, 26 (20%) died in quartile 1 (indicating worst HRQL), 17 (13%) died in quartile 2, 10 (8%) died in quartile 3, and 5 (4%) died in quartile 4 (indicating best HRQL) (P< .001). The prediction of PHS on survivalwas independent of other (clinical) parameters (P< .001). No relation was found between MHS and survival (P= .13).

CONCLUSION:

Patient-reported HRQL predicted survival among HIV-infected patients receiving HAART. This information could be highlyuseful for physicians in determining the prognosis of their patients.

This study examines stigmatization among immigrant and indigenous (a person whose parents were both born in the Netherlands) HIV-infected patients in the Netherlands. We interviewed 90 indigenous Dutch and 112 immigrant HIV-infected patients using the personalized stigma and disclosure concerns subscales of the HIV Stigma Scale. Use of these scales with HIV-infected immigrant patients was feasible as we found adequate reliability and patients were able to answer the questions after explanation. Personalized stigma was significantly higher among HIV-infected immigrants. Disclosure concerns were significantly higher among persons with an HIV transmission route other than men having sex with men. In multivariate analyses adjusting for age, sex, and number of years being HIV positive, having an immigrant status remained significantly associated with personalized stigma and HIV transmission routes other than men having sex with men remained significantly associated with having more disclosure concerns. Our findings suggest that social workers and counselors should be especially attentive to experienced and perceived HIV stigma among HIV-infected persons from these particular populations. Future studies should explore the mechanisms underlying stigmatization in the different subgroups so interventions to decrease stigmatization can be developed and examined.

BACKGROUND:

Strengthening the communication and professional relationships between clinicians and laboratory workers is essential in order to positively change clinicians' attitudes about the reliability of diagnostic tests, enhancing the use of laboratory diagnostics and, ultimately, improving patient care. We developed an analytical framework to gain insight into the factors that influence communication amongst health professionals.

OBJECTIVE:

To explore whether the interaction between clinicians and laboratory workers influences the use of laboratory test results in clinical decision making.

METHODS:

Four health facilities in northern Tanzania were selected using convenience sampling, whereas study participants were selected using purposive sampling. The quantitative and qualitative data collection methods included self-administered questionnaires; semi-structured, individual interviews; in-depth, individual interviews; and/or focus group discussions with clinicians and laboratory workers. Thematic content analyses were performed on qualitative data based on the framework. Descriptive statistical analyses of quantitative data were conducted using Microsoft Excel.

RESULTS:

Contact between clinicians and laboratory professionals is seldom institutionalised and collaboration is rare. The clinicians believe collaboration with laboratory staff is a challenge because of the gap in education levels. Laboratory workers' education levels are often lower than their positions require, leading to clinicians' lack of respect for and confidence in laboratory professionals, which compromises the laboratory staff's motivation.

CONCLUSIONS:

Hospital managers, clinicians and laboratory workers need to recognise the critical and complementary roles each professional plays and the importance of addressing the gap between them. Field application of the framework proved successful, justifying the expansion of this study to a larger geographical area to include additional healthcare institutions.

In Tanzania sputum culture for tuberculosis (TB) is resource intensive and available only at zonal facilities. In this study overnight pooledsputum collection technique was compared with standard spot morning collection among pulmonary TB suspects at Kibong'oto National TB Hospital in Tanzania. A spot sputum specimen performed at enrollment, an overnight pooled sputum, and single morning specimen were collected from 50 subjects and analyzed for quality, quantity, and time to detection in Bactec MGIT system. Forty-six (92%) subjects' overnight pooled specimens had a volume ≥5 mls compared to 37 (37%) for the combination of spot and single morning specimens (P < 0.001). Median time to detection was 96 hours (IQR 87-131) for the overnight pooled specimens compared to 110.5 hours (IQR is 137 right 137-180) for the combination of both spot and single morning specimens (P = 0.001). In our setting of limited TB culture capacity, we recommend a single pooled sputum to maximize yield and speed time to diagnosis.

BACKGROUND:

HIV-infected patients on combination antiretroviral therapy (cART) may experience symptoms because of HIV disease or treatment. Symptoms might negatively affect quality of life, adherence, virological response, and survival. We investigated to what extent HIV-infected patients receiving cART experience symptoms with a median follow-up of 5.1 years. Additionally, we studied whether self-reportedsymptoms were related to concurrent quality of life and virological failure.

METHODS:

Patients from the ATHENA cohort completed questionnaires on self-reported symptoms and quality of life every 6 months (January 1998 to June 2005). Quality of life was measured with the Medical Outcomes Study HIV Health Survey (MOS-HIV), resulting in a physical health summary (PHS) score and a mental health summary (MHS) score. Growth curve models were conducted to investigate the course of symptoms. Random effect models were carried out to study the association with concurrent quality of life and virological response.

RESULTS:

We included 391 patients, completing 2,851 questionnaires. Symptoms that increased significantly over time were numb feeling in fingers or toes (P < .01), pain in legs (P < .01), pain when urinating (P < .01), sore muscles (P = .02), tingling of hands or feet (P = .06), and difficulties with seeing (P < .01). All self-reported symptoms were related to lower levels of PHS and MHS (P < .01). Trouble with sleeping (odds ratio [OR] 1.5; 95% Cl, 1.04-2.2), constipation (OR 2.8; 95% Cl, 1.7-1.8), pain in legs (OR 1.8; 95% Cl, 1.2-2.6), and numb feeling in fingers or toes (OR 1.7; 95% Cl, 1.1-2.7) were related to concurrent virological response.

CONCLUSION:

HIV-infected patients on cART report a large range of symptoms. Management of symptoms is relevant because a number of symptoms are related to poorer quality of life and virological failure.