Effectiveness of Platelet Rich Plasma for the Management of Knee Osteoarthritis

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

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

Journal of the American Academy of Audiology ◽

10.3766/jaaa.15106 ◽

2016 ◽

Vol 27 (08) ◽

pp. 661-668 ◽

Cited By ~ 2

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.

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Leucocyte-Rich Platelet-Rich Plasma Treatment of Gluteus Medius and Minimus Tendinopathy: A Double-Blind Randomized Controlled Trial With 2-Year Follow-up

The American Journal of Sports Medicine ◽

10.1177/0363546519826969 ◽

2019 ◽

Vol 47 (5) ◽

pp. 1130-1137 ◽

Cited By ~ 17

Author(s):

Jane Fitzpatrick ◽

Max K. Bulsara ◽

John O’Donnell ◽

Ming Hao Zheng

Keyword(s):

Randomized Controlled Trial ◽

Ultrasound Guidance ◽

Platelet Rich Plasma ◽

Corticosteroid Injection ◽

Controlled Trial ◽

Harris Hip Score ◽

Randomized Controlled ◽

Gluteal Tendinopathy ◽

To Receive

Background: A previously published trial showed that patients with chronic gluteal tendinopathy achieved greater clinical improvement at 12 weeks when treated with a single platelet-rich plasma (PRP) injection than those treated with a single corticosteroid injection (CSI). Purpose: This follow-up study was conducted to determine whether there would be a sustained long-term difference in the modified Harris Hip Score (mHHS) at 2 years for a leucocyte-rich PRP (LR-PRP) injection in the treatment of chronic gluteal tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This trial included 80 patients randomized 1:1 to receive LR-PRP or CSI intratendinously under ultrasound guidance. Patients had a mean age of 60 years, a 9:1 ratio of women to men, a mean body mass index of 27, and a mean length of symptoms >15 months. No patients had full-thickness tears of the gluteal tendons. An open-labeled extension allowed patients to receive crossover treatment after 3 months. The main outcome measure was the mHHS. Results: The mean mHHS improved significantly at 12 weeks in the PRP group (74.05; SD, 13.92) as compared with the CSI group (67.13; SD, 16.04) ( P = .048). At 24 weeks, the LR-PRP group (77.60; SD, 11.88) improved further than the CSI group (65.72; SD, 15.28; P = .0003). Twenty-seven patients were deemed to have failed the CSI treatment at 16 to 24 weeks, with an exit score of 59.22 (SD, 11.54), and then had treatment with LR-PRP. The crossover group improved with the LR-PRP: from 59.22 (SD, 11.22) at baseline to 75.55 (SD, 16.05) at 12 weeks, 77.69 (SD, 15.30) at 24 weeks, and 77.53 (SD, 14.54) at 104 weeks. The LR-PRP group retained 38 of 39 patients to 52 weeks and continued to improve. Their baseline scores of 53.77 (SD, 12.08) improved to 82.59 (SD, 9.71) at 104 weeks ( P < .0001). Conclusion: Among patients with chronic gluteal tendinopathy and a length of symptoms >15 months, a single intratendinous LR-PRP injection performed under ultrasound guidance results in greater improvement in pain and function than a single CSI. The improvement after LR-PRP injection is sustained at 2 years, whereas the improvement from a CSI is maximal at 6 weeks and not maintained beyond 24 weeks. Registration: ACTRN12613000677707 (Australian New Zealand Clinical Trials identifier).

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

10.21203/rs.2.14135/v1 ◽

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.

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

10.2196/preprints.16019 ◽

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; P=.001), medication adherence (mean 7.4, SD 1.2 vs mean 7.0, SD 1.3; P=.04), and knowledge about hypertension (mean 6.3, SD 0.9 vs mean 5.9, SD 1.2; P=.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; P=.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 (P=.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.

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Application of Iced Normal Saline Combined with Cocktail Perfusion in Total Knee Arthroplasty:Randomized Controlled Trialrandomized Controlled Trial

10.21203/rs.3.rs-750958/v1 ◽

2021 ◽

Author(s):

Laijian Sui ◽

Aihua Jiang ◽

Pengzhou Gai ◽

Xiaojun Qi ◽

Jinwei Wang ◽

...

Keyword(s):

Normal Saline ◽

Controlled Trial ◽

Postoperative Recovery ◽

Control Group ◽

Double Blind ◽

Vas Score ◽

Postoperative Drainage ◽

Group A ◽

Total Knee ◽

Group B

Abstract Background: The present study was designed to investigate the safety and effectiveness of iced normal saline combined with cocktail perfusion during total knee arthroplasty (TKA).Method: Sixty patients undergoing TKA were divided into three groups, then three different intro-operative articular cavity perfusion treatment was given according to the randomized, double-blind and controlled rule. One way ANOVA analysis on visual analogue scale (VAS) score, functional recovery, drainage, and edema of the affected limb were performed to assess the efficiency of the treatment in the following three days after the operation.Results: Postoperative drainage in group A and B reduced significantly (P<0.05). The IHC scores of the surgical limbs were markedly lower comparing with the control group (P<0.05). No differential postoperative edema was observed and the patient acquired better rehabilitation in group A and B than control group. Compared with group A, no differential postoperative drainage and edema was seen in group B (P>0.05). The VAS score of group B was significantly lower than in group A(P<0.05). Postoperative recovery of the surgical limb function in group B was better than in group A (P<0.05), and PGE2 in the postoperative drainage volume of group B was significantly decreased (P<0.05).Conclusions: Intra-operation articular cavity perfusion therapy with iced normal saline combined with cocktail perfusion therapy can greatly reduce the early inflammation, contributing to the better rehabilitation of TKA.

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Positive Effect of Platelet-Rich Plasma on Pain in Plantar Fasciitis: A Double-Blind Multicenter Randomized Controlled Trial

The American Journal of Sports Medicine ◽

10.1177/0363546519877181 ◽

2019 ◽

Vol 47 (13) ◽

pp. 3238-3246 ◽

Cited By ~ 6

Author(s):

Joost C. Peerbooms ◽

Paul Lodder ◽

Brenda L. den Oudsten ◽

Kamiel Doorgeest ◽

Hans M. Schuller ◽

...

Keyword(s):

Quality Of Life ◽

Plantar Fasciitis ◽

Platelet Rich Plasma ◽

Corticosteroid Injection ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Pain Scores

Background: When nonoperative treatment for chronic plantar fasciitis fails, often a corticosteroid injection is given. Corticosteroid injection gives temporary pain reduction but no healing. Platelet-rich plasma (PRP) has proven to be a safe therapeutic option in the treatment of tendon, muscle, bone, and cartilage injuries. Purpose: To determine the effectiveness of PRP as compared with corticosteroid injections for chronic plantar fasciitis. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients with chronic plantar fasciitis were allocated to have steroid injection or PRP. The primary outcome measure was the Foot Function Index (FFI) Pain score. Secondary outcome measures were function, as scored by the FFI Activity, FFI Disability, and American Orthopaedic Foot & Ankle Society, and quality of life, as scored with the short version of the World Health Organization Quality of Life (WHOQOL-BREF). All outcomes were measured at baseline and at 4, 12, and 26 weeks and 1 year after the procedure. Results: Of the 115 patients, 63 were allocated to the PRP group, of which 46 (73%) completed the study, and 52 were allocated to the control group (corticosteroid injection), of which 36 (69%) completed the study. In the control group, FFI Pain scores decreased quickly and then remained stable during follow-up. In the PRP group, FFI Pain reduction was more modest but reached a lower point after 12 months than the control group. After adjusting for baseline differences, the PRP group showed significantly lower pain scores at the 1-year follow-up than the control group (mean difference, 14.4; 95% CI, 3.2-25.6). The number of patients with at least 25% improvement (FFI Pain score) between baseline and 12-month follow-up differed significantly between the groups. Of the 46 patients in the PRP group, 39 (84.4%) improved at least 25%, while only 20 (55.6%) of the 36 in the control group showed such an improvement ( P = .003). The PRP group showed significantly lower FFI Disability scores than the control group (mean difference, 12.0; 95% CI, 2.3-21.6). Conclusion: Treatment of patients with chronic plantar fasciitis with PRP seems to reduce pain and increase function more as compared with the effect of corticosteroid injection. Registration: NCT00758641 (ClinicalTrials.gov identifier).

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

EP Europace ◽

10.1053/eupc.1998.0016 ◽

1999 ◽

Vol 1 (1) ◽

pp. 69-72 ◽

Cited By ~ 16

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.

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Comparing efficacy of intraarticular single crosslinked Hyaluronan (HYAJOINT Plus) and platelet-rich plasma (PRP) versus PRP alone for treating knee osteoarthritis

Scientific Reports ◽

10.1038/s41598-020-80333-x ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Shu-Fen Sun ◽

Guan-Chyun Lin ◽

Chien-Wei Hsu ◽

Huey-Shyan Lin ◽

I.-H.siu Liou ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Platelet Rich Plasma ◽

Controlled Trial ◽

Pain Reduction ◽

Womac Pain ◽

Knee Oa ◽

Lequesne Index ◽

Injection Group ◽

The One

AbstractIntraarticular hyaluronan or platelet-rich plasma (PRP) is widely used in the treatment of knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP remained inconclusive. This study aimed to investigate the efficacy of combined a single crosslinked hyaluronan (HYAJOINT Plus) and a single PRP versus a single PRP in patients with knee OA. In a prospective randomized-controlled trial, 85 patients with knee OA (Kellgren-Lawrence 2) were randomized to receive a single intraarticular injection of HYAJOINT Plus (3 ml, 20 mg/ml) followed by 3 ml PRP (the combined-injection group, N = 43) or a single injection of 3 ml PRP (the one-injection group, N = 42). The primary outcome was the change from baseline in the visual analog scale (VAS) pain (0–00 mm) at 6 months. Secondary outcomes included The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale), Lequesne index, single leg stance test (SLS), use of rescue analgesics and patient satisfaction at 1, 3 and 6 months. Seventy-eight patients were available for the intention-to-treat analysis at 6 months. Both groups improved significantly in VAS pain, WOMAC, Lequesne index and SLS at each follow-up visit (p < 0.001). Patients receiving a single PRP experienced significantly greater improvements in VAS pain than patients receiving combined injections at 1-month follow-up (adjusted mean difference: − 5.6; p = 0.017). There were no significant between-group differences in several of the second outcomes at each follow-up visit, except the WOMAC-pain and WOMAC-stiffness scores favoring the one-injection group at 1 month (p = 0.025 and p = 0.011). However, at 6-month follow-up, the combined-injection group achieved significantly better VAS pain reduction (p = 0.020). No serious adverse events occurred following injections. In conclusion, either combined injections of HYAJOINT Plus and PRP or a single PRP alone was safe and effective for 6 months in patients with Kellgren-Lawrence 2 knee OA. Combined injections of HYAJOINT Plus and PRP achieved better VAS pain reduction than a single PRP at 6 months. The results indicating a long term benefit effect of a combination of HYAJOINT Plus and PRP in a particular subset of patients with moderate knee OA need to be replicated in larger trials.ClinicalTrials.gov number NCT04315103.

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A Randomized Placebo-Controlled Trial of Efficacy and Safety: Drug-Free Gel Containing Ultra-Deformable Phospholipid Vesicles (TDT 064) in Osteoarthritic Knees

Clinical Medicine Insights Arthritis and Musculoskeletal Disorders ◽

10.1177/11795441211031338 ◽

2021 ◽

Vol 14 ◽

pp. 117954412110313

Author(s):

Varah Yuenyongviwat ◽

Khanin Iamthanaporn ◽

Pakjai Tuntarattanapong ◽

Theerawit Hongnaparak ◽

Boonsin Tangtrakulwanich

Keyword(s):

Knee Osteoarthritis ◽

Rescue Medication ◽

Rating Scale ◽

Numerical Rating Scale ◽

Controlled Trial ◽

Topical Therapy ◽

Phospholipid Vesicles ◽

Control Group ◽

Drug Free

Background: There are a number of topical agents that are used for treatment of knee osteoarthritis. Drug-free gels, containing ultra-deformable phospholipid vesicles (TDT 064) are one such topical therapy, which have been stated to act as a bio lubricant. However, the evidence of TDT 064 in treatment of knee osteoarthritis is limited. Hence, the aim of this study was to evaluate the efficacy of pain control as a primary outcome and safety of TDT 064 compared with a topical placebo. Methods: Sixty-four patients with primary osteoarthritis, with radiographic showing Kellgren and Lawrence classification grade II to III, were randomized into 2 groups. In the first group of 32 patients TDT 064 was used as topical agent, whilst in the second group of 32 patients a placebo identical in appearance was used instead. The verbal numerical rating scale (VNRS) was used for recording pain levels, Self-reported Knee Injury and Osteoarthritis Outcome Scores (KOOS) as well as amounts of rescue medication were also recorded. The data were recorded at the start of the study, and then at follow-up appointments of 14 days, 6 weeks, and 3 months. Results: The mean VNRS for pain in both groups were significantly improved, when compared to the start of treatment ( P < .0001); however, there were no differences between groups at any follow up visit. KOOS in all subscales were not significantly different between both groups at baseline and at the end of treatment. However, the average amount of NSAIDs in the TDT 064 group was 26.39 ± 22.11 tabs, which was significantly lower than the control group; which used an average 37.03 ± 19.22 tabs in 3 months ( P = .047). Conclusions: There were no differences in the VNRS for pain and KOOS scores between the active and placebo groups. Although, TDT 064 could decrease usage of rescue medication the difference with use of a placebo was minimal. Further, larger trials would also be beneficial to demonstrate any differences between TDT 064 and a placebo. Trial Registration: TCTR, TCTR 20190302001. Registered 1 March, 2019: http://www.clinicaltrials.in.th

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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

10.21203/rs.3.rs-47935/v1 ◽

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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