scholarly journals A Trial Protocol for the Effectiveness of Digital Interventions for Preventing Depression in Adolescents: The Future Proofing Study

2019 ◽  
Author(s):  
Aliza Werner-Seidler ◽  
Kit Huckvale ◽  
Mark E. Larsen ◽  
Alison L. Calear ◽  
Kate Maston ◽  
...  
Keyword(s):  
Large Scale ◽  
Controlled Trial ◽  
Control Group ◽  
School Students ◽  
Mixed Effect ◽  
School Based ◽  
Cognitive Behaviour ◽  
The Future ◽  
To Receive

Abstract Background Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programs. However, barriers to implementing and accessing these programs remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programs. The Future Proofing Study is a large-scale school-based trial investigating whether Cognitive Behaviour Therapies (CBT) delivered by smartphone application can prevent depression.Methods A randomized controlled trial targeting up to 20,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomized at the cluster level to receive either the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level RCT (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur at post-intervention (both trial stages), and at 6, 12, 24, 36, 48- and 60-months post-baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed effect models.Discussion This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programs should be deployed in school-based settings in Australia and beyond.

scholarly journals A Trial Protocol for the Effectiveness of Digital Interventions for Preventing Depression in Adolescents: The Future Proofing Study

2019 ◽  
Author(s):  
Aliza Werner-Seidler ◽  
Kit Huckvale ◽  
Mark E. Larsen ◽  
Alison L. Calear ◽  
Kate Maston ◽  
...  
Keyword(s):  
Large Scale ◽  
Controlled Trial ◽  
Control Group ◽  
School Students ◽  
Mixed Effect ◽  
School Based ◽  
Cognitive Behaviour ◽  
The Future ◽  
To Receive

Abstract Background Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programs. However, barriers to implementing and accessing these programs remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programs. The Future Proofing Study is a large-scale school-based trial investigating whether Cognitive Behaviour Therapies (CBT) delivered by smartphone application can prevent depression.Methods A randomized controlled trial targeting up to 20,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomized at the cluster level to receive either the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level RCT (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur at post-intervention (both trial stages), and at 6, 12, 24, 36, 48- and 60-months post-baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed effect models.Discussion This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programs should be deployed in school-based settings in Australia and beyond.

scholarly journals A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Aliza Werner-Seidler ◽  
Kit Huckvale ◽  
Mark E. Larsen ◽  
Alison L. Calear ◽  
Kate Maston ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Trial Registration ◽  
Control Group ◽  
School Students ◽  
School Based ◽  
Randomised Controlled ◽  
To Receive

Abstract Background Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programmes. However, barriers to implementing and accessing these programmes remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programmes. The Future Proofing Study is a large-scale school-based trial investigating whether cognitive behaviour therapies (CBT) delivered by smartphone application can prevent depression. Methods A randomised controlled trial targeting up to 10,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomised at the cluster level either to receive the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression, and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level randomised controlled trial (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur post intervention (both trial stages) and at 6, 12, 24, 36, 48 and 60 months post baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed-effect models. Discussion This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much-needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programmes should be deployed in school-based settings in Australia and beyond. Trial registration Australian and New Zealand Clinical Trial Registry, ACTRN12619000855123. Registered on 31 May 2019. Clinical Trial Notification Scheme (CTN), CT-2019-CTN-02110-1-v1. Registered on 30 June 2019.

Manganese and Lipoflavonoid Plus® to Treat Tinnitus: A Randomized Controlled Trial

2016 ◽  
Vol 27 (08) ◽  
pp. 661-668 ◽  
Author(s):  
Eveling Rojas-Roncancio ◽  
Richard Tyler ◽  
Hyung-Jin Jun ◽  
Tang-Chuan Wang ◽  
Haihong Ji ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Data Collection And Analysis ◽  
Loudness Match ◽  
Minimal Masking Level ◽  
Lost To Follow Up ◽  
To Receive

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.

scholarly journals Effectiveness of Platelet Rich Plasma for the Management of Knee Osteoarthritis

2021 ◽  
Vol 15 (7) ◽  
pp. 1553-1556
Author(s):  
Adnan Qamar ◽  
Saima Naz Mohsin ◽  
Uzma Nasim Siddiqui ◽  
Sana Naz ◽  
Sana Danish
Keyword(s):  
Knee Osteoarthritis ◽  
Normal Saline ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Saline Group ◽  
Control Group ◽  
Plasma Therapy ◽  
Vas Score ◽  
To Receive

Aim: To determine impact of platelet rich plasma therapy for the management of knee osteoarthritis. Study design: Prospective double-blinded, add –on randomized, placebo-controlled trial Place and duration of study: Department of Orthopedics, Shaikh Zayed Hospital Lahore from 1st January 2019 to 30th June 2019 Methodology: Fifty volunteer participants fulfilling inclusion criteria were enrolled. One hundred knees of patients were randomly allocated into two groups. Knees were assigned either of the two groups. Platelet rich plasma group which was assigned to receive 5ml of platelet rich plasma and normal saline (NS) group which was assigned to receive 5ml of NS labeled as control group. All patients given 3 successive intra-articular injections of 5 mL of autologous platelet rich plasma or 5ml of normal saline was given at weekly intervals. Patients were blinded and subjected to a standardized injection protocol and the intensity of pain was assessed on visual analog scale (VAS) for pain. Results: The VAS scores decreased from 50.9±14.7 at baseline assessment to 43.6±16.2 at 1-month follow-up after completion of therapy for PRP group (p<0.0203). The improvement was maintained from the end of the therapy to 3 and 6 months’ follow-up, as measure of VAS score as 30.54±11.8 and 20.2±8.6 respectively (p<0.0001). In normal saline group, there was very slight decrease in VAS score from baseline i.e. 49.8±19.5 to 48±22.7, 44±16.6, and 42±21.7 at 1, 3 and 6 months interval. Conclusion: Platelet rich plasma therapy can provide effective pain control up to 6 months post injection in knee osteoarthritis. Key words: Platelet rich plasma (PRP), Knee osteoarthritis (OA), Pain score

scholarly journals Classroom-based cognitive behavioural therapy: a large-scale non-randomised controlled trial of the ‘Journey of the Brave’

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Yuko Urao ◽  
Ikuyo Ohira ◽  
Takako Koshiba ◽  
Shin-ichi Ishikawa ◽  
Yasunori Sato ◽  
...  
Keyword(s):  
Cognitive Behavioural Therapy ◽  
Large Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioural Therapy ◽  
Anxiety Score ◽  
Small Scale ◽  
Control Group ◽  
Cognitive Behavioural

Abstract Background In Japan, ‘Journey of the Brave’, a cognitive behavioural therapy (CBT)-based anxiety preventive education programme, was previously developed and its effectiveness examined in two small-scale controlled trials. These studies had some limitations, including a small number of participants and not having regular classroom teachers as programme facilitators. Therefore, we conducted a large-scale controlled trial, with teachers as programme implementers. Methods Twenty-seven elementary schools participated: 1622 and 1123 children were allocated to the intervention and control groups, respectively. The intervention group received a programme comprising ten 45-min sessions, while the control group underwent the regular school curriculum. Anxiety symptoms among participants were assessed using the Spence Children’s Anxiety Scale (SCAS) at three stages (pre-intervention, post-intervention, and follow-up). Results Following primary analysis, estimated mean changes in SCAS from baseline to follow-up were − 4.91 (95% CI − 5.91, − 3.90) in the intervention group and − 2.53 (95% CI − 3.52, − 1.54) in the control group; the group difference was 2.37 (95% CI 1.42, 3.33, p < 0.0001). Children in the intervention group showed significant reduction in their anxiety score versus children in the control group. Conclusions The results showed a statistically significant anxiety score reduction in the intervention group, thus verifying the programme’s effectiveness. Trial registration The University Hospital Medical Information Network (UMIN): UMIN000032517. Registered 10 May 2018—Retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037083

scholarly journals Efficacy of Text Messaging and Personal Consultation by Pharmacy Students Among Adults With Hypertension: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Panpan Zhai ◽  
Khezar Hayat ◽  
Wenjing Ji ◽  
Qian Li ◽  
Li Shi ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Text Messaging ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Messages ◽  
Chinese Patients ◽  
Control Group ◽  
To Receive ◽  
Sms Text Messaging

BACKGROUND Hypertension is one of the leading risk factors for ischemic heart diseases, and high rates of hypertension prevalence have either remained the same or increased in developing countries in recent years. Unfortunately, about 20% to 50% of patients with chronic diseases have been nonadherent to their drug therapy. SMS text messaging and pharmacy student–led consultations have the potential to help patients manage their blood pressure (BP). OBJECTIVE The aim of this study was to assess the effectiveness, feasibility, and acceptability of SMS text messaging and consultation to manage the BP of Chinese patients with hypertension. METHODS We conducted a two-arm cluster randomized controlled trial among patients with hypertension in Xi’an City, Shaanxi Province, China, and recruited 384 patients from 8 community health care centers. Patients were randomized into an intervention group to receive SMS text messages and consultations or into a control group to receive usual care for 3 months. We sent SMS text messages at 3-day intervals and collected data at baseline (including demographics, clinical outcomes, medication complexity, side effects, patient behavior, knowledge about hypertension, BP, and medication adherence) and the 3-month follow-up (including BP, medication adherence, and knowledge about hypertension). RESULTS We assessed 445 patients with hypertension and excluded 61 patients who were not eligible or who had not filled out their questionnaires. The mean age of the patients was 68.5 (SD 7.9) years in the intervention group and 69.4 (SD 9.7) years in the control group, and the sample was primarily female (265/384, 69.0%). Patients in the intervention group showed significant improvements in systolic BP (SBP; mean 134.5 mm Hg, SD 15.5 mm Hg vs mean 140.7 mm Hg, SD 15.2 mm Hg; <i>P</i>=.001), medication adherence (mean 7.4, SD 1.2 vs mean 7.0, SD 1.3; <i>P</i>=.04), and knowledge about hypertension (mean 6.3, SD 0.9 vs mean 5.9, SD 1.2; <i>P</i>=.004) compared with those in the control group. In measures of diastolic BP (DBP), the two arms showed nonsignificant improvements (mean 78.2 mm Hg, SD 9.0 mm Hg vs mean 77.2 mm Hg, SD 10.3 mm Hg; <i>P</i>=.06). In total, 176 patients had controlled BP at the 3-month follow-up (98 patients in the intervention group vs 78 patients in the control group), but it was nonsignificant (<i>P</i>=.08). CONCLUSIONS The use of SMS text messaging and consultation to manage SBP and improve medication adherence is effective, feasible, and acceptable among Chinese patients with hypertension, although a significant difference was not observed with regard to DBP. It is important to maximize the potential of SMS text messaging and consultation by increasing the feasibility and acceptance of mobile interventions and conduct a cost-effectiveness analysis on this method. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR1900026862; http://www.chictr.org.cn/showproj.aspx?proj=42717.

Prevention of Fungal Peritonitis with Nystatin Prophylaxis in Patients Receiving CAPD

2007 ◽  
Vol 27 (5) ◽  
pp. 531-536 ◽  
Author(s):  
Ping-Nam Wong ◽  
Kin-Yee Lo ◽  
Gensy M.W. Tong ◽  
Shuk-Fan Chan ◽  
Man-Wai Lo ◽  
...  
Keyword(s):  
Antibiotic Therapy ◽  
Large Scale ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Control Group ◽  
Fungal Peritonitis ◽  
Kaplan Meier ◽  
Prospective Randomized Controlled Trial ◽  
And Control

Objective Fungal peritonitis (FP) is a serious complication of continuous ambulatory peritoneal dialysis (CAPD), being associated with significant morbidity and mortality. The role of nystatin prophylaxis during antibiotic therapy in the prevention of FP remains controversial, especially in programs with a modest or low baseline FP rate. The aim of the present study was to evaluate the effect of nystatin prophylaxis on the occurrence of FP in programs with a relatively modest baseline FP rate. Patients and Methods Incident and prevalent patients receiving CAPD between April 1995 and April 2005 at our center were included and divided into 2 groups. The control group included 320 patients (total follow-up 8875 patient-months) being treated without nystatin before October 1999; the nystatin group included 481 patients (total follow-up 13725 patient-months) being treated after October 1999. Nystatin tablets (500000 units, 4 times per day) were given orally during whatever use of antibiotics to cover the whole course of antibiotic therapy. Occurrence of FP and antibiotic-related FP (AR-FP) in patients with and without nystatin prophylaxis was compared. Results The two groups were of similar age but the nystatin group had a significantly higher percentage of diabetics. In addition, the nystatin group had a higher proportion of patients using disconnecting twin-bag exchange systems and had a significantly lower peritonitis rate compared with the control. There were 13 and 14 episodes of FP in the nystatin and control groups respectively. The fungal peritonitis rate of the nystatin group was slightly lower than that of the control group (0.011 vs 0.019 per patient-year) but it did not reach statistical significance. There was, however, a significant decrease in the incidence and proportion of AR-FP in the nystatin group compared with the control group, which persisted even after adjustment for the peritonitis rate. Kaplan–Meier analysis further demonstrated significantly better AR-FP-free survival in the nystatin group compared with the control group. No significant side effects were observed for nystatin. Subgroup analyses in patients of the 2 different connecting systems revealed a similar but nonsignificant trend toward reduction of AR-FP in patients given nystatin prophylaxis. Conclusion Oral nystatin prophylaxis might prevent the occurrence of AR-FP in CAPD patients, resulting in a trend toward reduction in the incidence of FP even in programs with a modest baseline FP rate. A large scale, prospective, randomized controlled trial is needed to further examine this issue.

scholarly journals SAFE PACE 2: Syncope and Falls in the Elderly — Pacing and Carotid Sinus Evaluation

EP Europace ◽  
1999 ◽  
Vol 1 (1) ◽  
pp. 69-72 ◽  
Author(s):  
R. A. Kenny
Keyword(s):  
Carotid Sinus ◽  
Controlled Trial ◽  
The Elderly ◽  
Primary Outcome Measure ◽  
Inhibitory Response ◽  
Control Group ◽  
Loop Recorder ◽  
Number Of Patients ◽  
To Receive

Abstract SAFE PACE is a multicentre randomized controlled trial to assess the efficacy of dual-chamber pacing in older patients with carotid sinus hypersensitivity and recurrent un-explained falls. Patients are eligible if they have had two or more unexplained falls (± up to one syncope) and if they have a cardio-inhibitory response (>3 s asystole) to carotid sinus massage. Patients will be randomized to receive either a Medtronic Kappa 700(Europe)/Kappa 400(North America) pacemaker or an implantable loop recorder (ILR)(control group). Patients will be required to complete weekly fall diaries. The primary outcome measure is the number of patients who fall in the 24-month follow-up period. Recruitment began in October 1998 and continues for 12 months; the follow-up is for 24 months.

scholarly journals School-based, two-arm, parallel, controlled trial of a culturally adapted resilience intervention to improve adolescent mental health in Vietnam: study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e039343
Author(s):  
Thach Tran ◽  
Huong Thanh Nguyen ◽  
Ian Shochet ◽  
Astrid Wurfl ◽  
Jayne Orr ◽  
...  
Keyword(s):  
Logistic Regression ◽  
School Connectedness ◽  
Coping Skills ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Mixed Effect ◽  
School Based ◽  
Secondary Outcomes ◽  
Resilience Intervention

IntroductionThe Resourceful Adolescent Program (RAP) is an evidence-based resilience intervention for adolescents. Operating in a strength-focused paradigm, the programme uses an integration of cognitive behavioural therapy and interpersonal psychotherapy to improve coping skills and build resilience. This study aims to establish whether a culturally and linguistically adapted intervention informed by RAP principles is effective in increasing resilience, enhancing coping skills and preventing symptoms of depression and anxiety.Methods and analysisWe will translate, back-translate and culturally adapt the RAP for adolescents and training materials for facilitators, and the adapted intervention will be called Happy House. A two-arm parallel controlled trial will be conducted in eight high schools in the north of Vietnam. In each of the selected schools, all students from four randomly selected grade 10 classes (an estimation of about 1204 students) will be invited to participate. The control group will receive the usual curriculum. The intervention group will receive six weekly 90 min school-based group sessions of Happy House in addition to the usual curriculum. The primary outcome, depressive symptoms, will be measured using a locally validated version of the Centre for Epidemiologic Studies Depression Scale Revised. Secondary outcomes are mental well-being, coping self-efficacy, school connectedness, anger management and health risk behaviours. Data will be collected at recruitment, and at two weeks and six months post intervention. Mixed-effect logistic regression for the main outcome and mixed-effect linear and logistic regression models for the secondary outcomes will be conducted to estimate the effects of the intervention on the outcomes.Ethics and disseminationThis trial has been approved by Monash University Human Research Ethics Committee (No. 21455) and the Institutional Review Board of the Hanoi School of Public Health (488/2019/YTCC-HD3). Dissemination of findings will include peer-reviewed publications, international and national conferences, seminar and media presentations, national policy briefings in Vietnam, local language reports and lay language summaries for participants.Trial registration numbersRegistered with the Australian New Zealand Clinical Trials Registry, registration number: ACTRN12620000088943 (3/2/2020).WHO Universal Trial Number: U1111-1246-4079.

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

2020 ◽  
Author(s):  
Lilian Maureen Nyatichi Kebaya ◽  
Dalton Wamalwa ◽  
Nyambura Kariuki ◽  
Bashir Admani ◽  
Philip Ayieko ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Retention In Care ◽  
Control Group ◽  
Hiv Exposed Infants ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Hiv Exposed ◽  
To Receive

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

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