scholarly journals Efficacy of Mobile phone use on adherence to Nevirapine prophylaxis and retention in care among the HIV-exposed infants in prevention of mother to child transmission of HIV: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lilian M. N. Kebaya ◽  
Dalton Wamalwa ◽  
Nyambura Kariuki ◽  
Bashir Admani ◽  
Philip Ayieko ◽  
...  

Abstract Background HIV is a major contributor to infant mortality. A significant gap remains between the uptake of infant and maternal antiretroviral regimens and only a minority of HIV-exposed infants receives prophylaxis and safe infant feeding. Losses to follow-up of HIV-exposed infants are associated with shortcomings of facility-based PMTCT models with weak community support of linkages. Use of mobile phones offers an opportunity for improving care and promoting retention assessed by timely attendance of scheduled appointments for the mother-baby pairs and achievement of an HIV-free generation. The objective of this study was to compare self-reported adherence to infant Nevirapine (NVP) prophylaxis and retention in care assessed by timely attendance of scheduled appointments over 10 weeks in HIV exposed infants randomized to 2-weekly mobile phone calls (intervention) versus no phone calls (control). Methods In this open label randomized controlled study, one hundred and fifty HIV infected women drawn from 3 health facilities in Western Kenya and their infants were randomly assigned to receive either phone-based reminders on PMTCT messages or standard health care messages (no calls) within 24 h of delivery. Women in the intervention arm continued to receive fortnightly phone calls. At 6- and 10-weeks following randomization we collected data on infant adherence to Nevirapine, mode of infant feeding, early HIV testing and retention in care in both study arms. All analyses were intention to treat. Results At 6 weeks follow-up, 90.7% (n = 68) of participants receiving phone calls reported adherence to infant NVP prophylaxis, compared with 72% (n = 54) of participants in the control group (p = 0.005). Participants in the intervention arm were also significantly more likely to remain in care than participants in the control group [78.7% (n = 59) vs. 58.7% (n = 44), p = 0.009 at 6 weeks and 69.3% (n = 52) vs. 37.3% (n = 28), p < 0.001 at 10 weeks]. Conclusions These results suggest that phone calls are potentially an important tool to improve adherence to infant NVP prophylaxis and retention in care for HIV-exposed infants. Trial registration PACTR202007654729602. Registered 6 June 2018 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3449

2020 ◽  
Author(s):  
Lilian Maureen Nyatichi Kebaya ◽  
Dalton Wamalwa ◽  
Nyambura Kariuki ◽  
Bashir Admani ◽  
Philip Ayieko ◽  
...  

Abstract Background: HIV is a major contributor to infant mortality. A significant gap remains between the uptake of infant and maternal antiretroviral regimens and only a minority of HIV-exposed infants receives prophylaxis and safe infant feeding. Losses to follow-up of HIV-exposed infants are associated with shortcomings of facility-based PMTCT models with weak community support of linkages. Use of mobile phones offers an opportunity to improving care and promoting retention for the mother-baby pairs and achievement of an HIV-free generation.Objectives: To compare self-reported adherence to infant Nevirapine (NVP) prophylaxis and retention in care over 10 weeks in HIV exposed infants randomized to 2-weekly mobile phone calls (intervention) versus no phone calls (control).Design: Open label Randomized controlled trial Methods: One hundred and fifty HIV infected women drawn from 3 health facilities in Western Kenya and their infants were randomly assigned to receive either phone-based reminders on PMTCT messages or standard health care messages (no calls) within 24 hours of delivery. Women in the intervention arm continued to receive fortnightly phone calls. At 6- and 10-weeks following randomization we collected data on infant adherence to Nevirapine, mode of infant feeding, early HIV testing and retention in care in both study arms. All analyses were intention to treat.Results: At 6 weeks follow-up, 90.7% (n = 68) of participants receiving phone calls reported adherence to infant NVP prophylaxis, compared with 72% (n = 54) of participants in the control group (p = 0.005). Participants in the intervention arm were also significantly more likely to remain in care than participants in the control group [78.7% (n = 59) vs. 58.7% (n = 44), p = 0.009 at 6 weeks and 69.3% (n = 52) vs. 37.3% (n = 28), p < 0.001 at 10 weeks].Conclusions: These results suggest that phone calls are potentially an important tool to improve adherence to infant NVP prophylaxis and retention in care for HIV-exposed infants.Trial registration: PACTR202007654729602. Registered 6 June 2018 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3449


2020 ◽  
Author(s):  
Lilian Maureen Nyatichi Kebaya ◽  
Dalton Wamalwa ◽  
Nyambura Kariuki ◽  
Bashir Admani ◽  
Philip Ayieko ◽  
...  

Abstract Background: HIV is a major contributor to infant mortality. A significant gap remains between the uptake of infant and maternal antiretroviral regimens and only a minority of HIV-exposed infants receives prophylaxis and safe infant feeding. Losses to follow-up of HIV-exposed infants are associated with shortcomings of facility-based PMTCT models with weak community support of linkages. Use of mobile phones offers an opportunity for improving care and promoting retention assessed by timely attendance of scheduled appointments for the mother-baby pairs and achievement of an HIV-free generation.Objectives: To compare self-reported adherence to infant Nevirapine (NVP) prophylaxis and retention in care assessed by timely attendance of scheduled appointments over 10 weeks in HIV exposed infants randomized to 2-weekly mobile phone calls (intervention) versus no phone calls (control).Design: Open label Randomized controlled trialMethods: One hundred and fifty HIV infected women drawn from 3 health facilities in Western Kenya and their infants were randomly assigned to receive either phone-based reminders on PMTCT messages or standard health care messages (no calls) within 24 hours of delivery. Women in the intervention arm continued to receive fortnightly phone calls. At 6- and 10-weeks following randomization we collected data on infant adherence to Nevirapine, mode of infant feeding, early HIV testing and retention in care in both study arms. All analyses were intention to treat.Results: At 6 weeks follow-up, 90.7% (n = 68) of participants receiving phone calls reported adherence to infant NVP prophylaxis, compared with 72% (n = 54) of participants in the control group (p = 0.005). Participants in the intervention arm were also significantly more likely to remain in care than participants in the control group [78.7% (n = 59) vs. 58.7% (n = 44), p = 0.009 at 6 weeks and 69.3% (n = 52) vs. 37.3% (n = 28), p < 0.001 at 10 weeks].Conclusions: These results suggest that phone calls are potentially an important tool to improve adherence to infant NVP prophylaxis and retention in care for HIV-exposed infants.Trial registration: PACTR202007654729602. Registered 6 June 2018 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3449


2016 ◽  
Vol 27 (08) ◽  
pp. 661-668 ◽  
Author(s):  
Eveling Rojas-Roncancio ◽  
Richard Tyler ◽  
Hyung-Jin Jun ◽  
Tang-Chuan Wang ◽  
Haihong Ji ◽  
...  

Background: Several tinnitus sufferers suggest that manganese has been helpful with their tinnitus. Purpose: We tested this in a controlled experiment where participants were committed to taking manganese and Lipoflavonoid Plus® to treat their tinnitus. Research Design: Randomized controlled trial. Study Sample: 40 participants were randomized to receive both manganese and Lipoflavonoid Plus® for 6 months, or Lipoflavonoid Plus® only (as the control). Data Collection and Analysis: Pre- and postmeasures were obtained with the Tinnitus Handicap Questionnaire, Tinnitus Primary Functions Questionnaire, and tinnitus loudness and annoyance ratings. An audiologist performed the audiogram, the tinnitus loudness match, and minimal masking level. Results: Twelve participants were dropped out of the study because of the side effects or were lost to follow-up. In the manganese group, 1 participant (out of 12) showed a decrease in the questionnaires, and another showed a decrease in the loudness and annoyance ratings. No participants from the control group (total 16) showed a decrease in the questionnaires ratings. Two participants in the control group reported a loudness decrement and one reported an annoyance decrement. Conclusions: We were not able to conclude that either manganese or Lipoflavonoid Plus® is an effective treatment for tinnitus.


2019 ◽  
Vol 10 (2) ◽  
pp. 60
Author(s):  
Arsene Florent Hobabagabo ◽  
Rex Wong ◽  
Soha El-Halabi ◽  
Edison Rwagasore ◽  
Simon-Pierre Niyonsenga ◽  
...  

Effective management of Type 1 Diabetes Mellitus (T1DM) requires that people living with the condition attend regular clinical visits. The Rwanda Diabetes Association (RDA) asks young T1DM patients to attend quarterly outreach visits, and prior to the visits, RDA issues reminders via local radio stations. However, adherence in attending clinical appointments has remained low.Since Rwanda has a high mobile phone penetration rate, a pilot intervention study was conducted exploring the use of mobile phone call reminders and Short Message Service (SMS) messages to increase T1DM patients’ attendance of RDA’s quarterly outreach visits. The control group was exposed to only the regular radio broadcast, while the intervention group received reminder phone calls or SMS messages 72 hours prior to their appointments in addition to the regular radio broadcast.The attendance rate was significantly different between the 14 control patients and 35 intervention patients, with 23.3% (3/14) and 76.7% (27/35) attending visits, respectively (P=0.048). The results suggest that using mHealth methods (phone call/SMS reminders) can be effective in improving health outcomes, improving the adherence of T1DM patients to follow-up visits with minimal added cost. The total cost was 0.37 USD per person, compared to potential 672.40 USD for each lost treatment, indicating the intervention is cost-effective in that it minimizes loss to follow up in resource-limited settings. Further research is needed to evaluate the feasibility of scaling up the pilot project and to understand whether improved attendance is sustained long-term.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1870-1870
Author(s):  
Kaini Shen ◽  
Yujun Dong ◽  
Weijun Fu ◽  
Yu Wu ◽  
Zhongxia Huang ◽  
...  

【Introduction 】There is ongoing unmet need for effective therapies in Mayo 2004 stage II-III amyloid light-chain (AL) amyloidosis patients, who undergo early death due to cardiac dysfunction. Lately, in vitro studies demonstrated that doxycycline could induce disruption of fibril formation in transgenic mouse model of AL amyloidosis. Matched case-control study of standard chemotherapy with or without doxycycline confirmed higher hematological response, cardiac responses and superior survival with doxycycline in AL patients. However, the possible advantage of doxycycline on lower early mortality and better long-term survival has not been evaluated in a randomized controlled clinical trial. We designed a randomized unblinded controlled study to investigate the efficacy and safety of co-administration of oral doxycycline with bortezomib-cyclophosphamide-dexamethasone (BCD) regimen in treatment-naïve AL amyloidosis patients with Mayo 2004 stage II-III disease. 【Methods 】The randomized unblinded controlled study took place in 12 hospitals in China. Eligible participants were adults with a confirmed diagnosis of AL amyloidosis, whose Mayo 2004 stage were II or III. Enrolled patients were randomly allocated to receive either doxycycline combined with BCD or BCD alone as initial treatment. We chose stratified blocked randomization (block size of 4) to ensure Mayo stage II and III were evenly distributed between doxycycline group and control group. For both two groups, patients will receive 1.3mg/m2of subcutaneous bortezomib and 40mg of oral or intravenous dexamethasone on days 1, 8, 15 and 22, and 300mg/m2oral or intravenous cyclophosphamide on days 1, 8 and 15 of a 35-day cycle. This process was repeated for 9 cycles. Doxycycline was given orally 100mg twice daily for the experimental group. The primary endpoint is progression-free survival. Secondary endpoints include overall survival, adverse events, hematological response, organ response and safety of treatment. This trial has been registered with ClinicalTrials.gov (number NCT03401372) and recruitment and follow-up are ongoing. We planned to enroll a total of 140 participants. 【Results 】Between April 21st, 2018 and June 30th, 2019, 111 patients were enrolled and randomly assigned to receive doxycycline plus BCD (n=56) or BCD alone (n=55) (Figure 1). The baseline characteristics were shown in Table 1. The median age was 61 (range, 41-78) years with a male: female ratio of 1.64:1. Mayo 2004 stage II disease was present in 28 patients in the control group and 29 patients in the doxycycline group. Mayo 2004 stage III disease was present in 27 patients in the control group and 27 patients in the doxycycline group. The median cTnI was 0.10 (range, 0-1.92) μg/L, NT-proBNP 3647 (range, 271-20507) pg/mL, and dFLC 205.30 (50.28-791.90) mg/L, with no significant difference between either group. Organ involvement included the heart (100%), kidney (61.3%), liver (14.4%), peripheral nerves (10.8%) and gastrointestinal tract (5.4%). The percentage of hepatic involvement and 24-hour urine protein were higher in the doxycycline group. The median duration of doxycycline was 5.9 months. Only one patient discontinued doxycycline due to toxicity (Grade 2 rash). Till now, the median follow-up time was 6.1 months and no patients were lost to follow-up. Fourteen patients have completed 9 cycles of chemotherapy. In total, 22 patients died and disease progression occurred in 3 patients. Two patients discontinued treatment due to withdrawal of consent and one of them proceeded to autologous stem cell transplantation. Three patients discontinued study drug owing to unacceptable diarrhea and received second-line treatment based on ixazomib or melphalan afterwards. The grade 3/4 adverse effects were developed in 8 patients (1 infection, 1 mucositis and 6 diarrhea) in the control group and 6 patients (1 infection, 1 arrhythmia, 1 kidney dysfunction and 3 diarrhea) in the doxycycline group. 【Conclusions 】Our data suggested that addition of doxycycline to standard bortezomib-based chemotherapy was an tolerable regimen for treating patients with AL amyloidosis. If this protocol could significantly improve survival and organ response needs to be confirmed with further follow-up. Disclosures No relevant conflicts of interest to declare.


Author(s):  
Dong Yuan ◽  
Jing Zhang ◽  
Xiaoxue Wang ◽  
Su Chen ◽  
Yue Wang

In this pilot, single-blind, randomized controlled trial, we investigated the effects of intensified oral hygiene care (IOHC) on reducing stroke-associated pneumonia (SAP) incidence. Patients admitted within 24 hours of stroke onset were recruited and randomized to receive IOHC or routine oral hygiene care. The occurrence of SAP was checked and oral swabs were obtained during the 7-day follow-up. The SAP incidence was lower, though not significantly, in the IOHC group than in the control group. IOHC successfully decreased SAP incidence among patients who were male, had higher National Institutes of Health Stroke Scale and Debris Index scores, and lower Glasgow Coma Scale and Gugging Swallowing Screen scores. Furthermore, IOHC significantly decreased the prevalence of oral suspected SAP pathogens. These results suggest that IOHC can decrease the incidence of SAP in the most vulnerable patient groups and lower the prevalence of suspected oral SAP pathogens.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Alla Machulska ◽  
Kristian Kleinke ◽  
Tanja Joan Eiler ◽  
Armin Grünewald ◽  
Rainer Brück ◽  
...  

Abstract Background Automatic tendencies to approach drug-related cues have been linked to the development and maintainance of harmful drug-taking behavior. Recent studies have demonstrated that these automatic approach tendencies can be targeted directly by means of cognitive bias modification (CBM). Moreover, changing those approach tendencies may enhance treatment outcomes. However, training and therapy effects tend to be rather small and adherence to the training might be impaired by time-consuming multiple laboratory training sessions. Here, we present a protocol for a randomized controlled design to improve CBM training efficiency and facilitate access to the training by providing mobile-phone-based training sessions at home to current smokers motivated to quit smoking. Methods Participants (n = 100) are current smokers who smoke at least six cigarettes per day for at least 6 months and are willing to quit smoking. All participants attend a brief behavioral smoking cessation intervention (TAU) and are randomly assigned either to an experimental (TAU + training) or a control group. Participants in the experimental condition are given access to a training application (app) aimed at retraining automatic approach biases for smoking cues. Participants are instructed to perform the app training outside the laboratory context on a daily basis for 14 consecutive days. Participants in the control group do not receive the training. Primary outcome measures are changes in smoking-related approach biases and reductions in daily nicotine consumption as assessed at baseline, post-training and at 6-week follow up. Secondary outcome measures include approach biases for alternative stimuli or smoking stimuli to which participants were not exposed during training, attentional and association biases, biochemical outcomes, and self-reported smoking behavior, also measured at three different time points (baseline, post-training, and follow up). After completion of the study, smokers in the control condition will receive access to the training app. Discussion This randomized controlled trial is the first to test the effectiveness of an app-based CBM intervention as an adjunct to a brief smoking cessation intervention in smokers motivated to quit smoking. The results of this study can inform future research in the optimization and advancement of CBM treatment for addiction. Trial registration Current Controlled Trials, ISRCTN15690771. Registered on 20 November 2018.


2016 ◽  
Vol 19 (10) ◽  
pp. 1893-1903 ◽  
Author(s):  
Jaden Bendabenda ◽  
Lotta Alho ◽  
Ulla Ashorn ◽  
Yin Bun Cheung ◽  
Kathryn G Dewey ◽  
...  

AbstractObjectiveSafety of home fortificants in children is uncertain in areas where infections are common. We tested the hypothesis that provision of lipid-based nutrient supplements (LNS) containing Fe does not increase infectious morbidity in children.DesignRandomized controlled trial. Infants were randomised to receive 10, 20 or 40 g LNS/d; or no supplement until age 18 months. All LNS contained 6 mg Fe/d. Morbidity outcomes (serious adverse events, non-scheduled visits and guardian-reported morbidity episodes) were compared between control and intervention groups using a non-inferiority margin of 20 %.SettingNamwera and Mangochi catchment areas in rural Malawi.SubjectsInfants aged 6 months (n1932).ResultsThe enrolled 1932 infants contributed 1306 child-years of follow-up. Baseline characteristics were similar across groups. Compared with the control group, the relative risk (95 % CI) of serious adverse events was 0·71 (0·48, 1·07), 0·67 (0·48, 0·95) and 0·91 (0·66, 1·25) in 10, 20 and 40 g LNS/d groups, respectively. The incidence rate ratio (95 % CI) of non-scheduled visits due to malaria was 1·10 (0·88, 1·37), 1·08 (0·89, 1·31) and 1·21 (1·00, 1·46), and of guardian-reported morbidity episodes was 1·04 (0·96, 1·11), 1·03 (0·97, 1·10) and 1·04 (0·97, 1·10), in the respective LNS groups.ConclusionsProvision of 10 and 20 g LNS/d containing 6 mg Fe/d did not increase morbidity in the children. Provision of 40 g LNS/d did not affect guardian-reported illness episodes but may have increased malaria-related non-scheduled visits.


2018 ◽  
Vol 6 (6_suppl3) ◽  
pp. 2325967118S0003
Author(s):  
G Álvarez Rey ◽  
R Balius Matas ◽  
MA Buil Bellver ◽  
C Cano Herrera ◽  
L Varela Sende ◽  
...  

Introduction: Physical therapy and peritendinous hyaluronic acid (HA) injections have both shown promising results in the treatment of shoulder tendinopathies. However, the superiority of treatment combining physical therapy and HA is unclear. Objectives: In this parallel-group, randomized, controlled trial, we investigated the efficacy and safety of peritendinous injection of HA in patients with persistent supraspinatus tendinopathy. To this end, we compared the therapeutic outcome of treatment with HA as an adjuvant to physical therapy with that of physical therapy as sole therapeutic intervention. Methods: 84 Patients with ultrasound-confirmed supraspinatus tendinopathy were randomized to receive either physical therapy + subacromial HA injections or physical therapy only. Treatment efficacy was assessed using a Visual Analog Scale (VAS) for pain and an Activities of Daily Living (ADL) scale. Other measures were the number of rehabilitation sessions and days needed for recovery, the Tampa Scale for Kinesiophobia (TSK), and the physician and patient’s perception of efficacy and tolerability. Patients were followed up for 90 days. Results: Overall, VAS and ADL scores showed a progressive decrease during the follow-up ( P<0.01 at all visits for both groups), without significant differences between groups. The TSK score decreased significantly more in the HA group than in the control group (3.6 vs. 2.4; P<0.001). Patients in the control group needed more rehabilitation sessions (28 vs. 22 in the HA group; P=0.006) and more days for returning to their pre-injury activity (32 vs. 20 in the HA group; P=0.013). Both patients and investigators perceived higher efficacy in the HA group than in the control group ( P=0.034). Both treatments were safe and well tolerated. Conclusion: Subacromial HA injections combined with physical therapy have high efficacy in the treatment of supraspinatus tendinopathy, leading to an earlier return to pre-injury activity and the need for fewer rehabilitation sessions, which may benefit both patients and the healthcare system.


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