A Randomized Controlled Trial of Real-Time Electronic Adherence Monitoring With Text Message Dosing Reminders in People Starting First-Line Antiretroviral Therapy

2015 ◽  
Vol 70 (5) ◽  
pp. 495-502 ◽  
Author(s):  
Catherine Orrell ◽  
Karen Cohen ◽  
Katya Mauff ◽  
David R. Bangsberg ◽  
Gary Maartens ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Real Time ◽  
Controlled Trial ◽  
Text Message ◽  
First Line ◽  
Randomized Controlled ◽  
Adherence Monitoring

scholarly journals Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Paul Drain ◽  
Kenneth Ngure ◽  
Nelly Mugo ◽  
Matthew Spinelli ◽  
Purba Chatterjee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Real Time ◽  
Point Of Care ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Preexposure Prophylaxis ◽  
Adherence Monitoring ◽  
First Time

BACKGROUND The worldwide expansion of preexposure prophylaxis (PrEP) with oral tenofovir-disoproxil-fumarate/emtricitabine will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult, and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to interpreting PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. OBJECTIVE The goal of this study is to examine a point-of-care adherence metric in PrEP to support and increase adherence via a randomized controlled trial. METHODS The paper describes the protocol for a pilot randomized controlled trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine test to provide real-time adherence feedback among women on PrEP. Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling. Acceptability by participants will be assessed by a quantitative survey, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups, 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed, and messages delivered, while in-depth interviews with providers (n=8) will explore the ease of administering the urine test. Tenofovir levels in hair will serve as long-term adherence metrics. A linear mixed-effects model will estimate the effect of the intervention versus standard of care on logarithmically transformed levels of tenofovir in hair. RESULTS This study has been funded by the National Institute of Health, approved by the Kenya Medical Research Institute Institutional Review Board, and will commence in June 2020. CONCLUSIONS A novel urine assay to measure and deliver information on adherence to PrEP in real-time will be tested for the first time in this trial planned among women on PrEP in Kenya. Study findings will inform a larger-scale trial assessing the impact of real-time adherence monitoring/feedback on HIV prevention. Improving adherence to PrEP will have long-term implications for efforts to end the HIV epidemic worldwide. CLINICALTRIAL ClinicalTrials.gov NCT03935464; https://clinicaltrials.gov/ct2/show/NCT03935464 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/15029

scholarly journals Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: An open-label randomized controlled trial in Lesotho

PLoS Medicine ◽  
2020 ◽  
Vol 17 (9) ◽  
pp. e1003325
Author(s):  
Alain Amstutz ◽  
Bienvenu Lengo Nsakala ◽  
Fiona Vanobberghen ◽  
Josephine Muhairwe ◽  
Tracy Renée Glass ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Controlled Trial ◽  
Second Line ◽  
First Line ◽  
Open Label ◽  
Low Level ◽  
Randomized Controlled ◽  
Hiv 1

scholarly journals Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot Randomized Controlled Trial

10.2196/15029 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e15029
Author(s):  
Paul Drain ◽  
Kenneth Ngure ◽  
Nelly Mugo ◽  
Matthew Spinelli ◽  
Purba Chatterjee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Real Time ◽  
Point Of Care ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Preexposure Prophylaxis ◽  
Adherence Monitoring ◽  
First Time

Background The worldwide expansion of preexposure prophylaxis (PrEP) with oral tenofovir-disoproxil-fumarate/emtricitabine will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult, and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to interpreting PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. Objective The goal of this study is to examine a point-of-care adherence metric in PrEP to support and increase adherence via a randomized controlled trial. Methods The paper describes the protocol for a pilot randomized controlled trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine test to provide real-time adherence feedback among women on PrEP. Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling. Acceptability by participants will be assessed by a quantitative survey, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups, 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed, and messages delivered, while in-depth interviews with providers (n=8) will explore the ease of administering the urine test. Tenofovir levels in hair will serve as long-term adherence metrics. A linear mixed-effects model will estimate the effect of the intervention versus standard of care on logarithmically transformed levels of tenofovir in hair. Results This study has been funded by the National Institute of Health, approved by the Kenya Medical Research Institute Institutional Review Board, and will commence in June 2020. Conclusions A novel urine assay to measure and deliver information on adherence to PrEP in real-time will be tested for the first time in this trial planned among women on PrEP in Kenya. Study findings will inform a larger-scale trial assessing the impact of real-time adherence monitoring/feedback on HIV prevention. Improving adherence to PrEP will have long-term implications for efforts to end the HIV epidemic worldwide. Trial Registration ClinicalTrials.gov NCT03935464; https://clinicaltrials.gov/ct2/show/NCT03935464 International Registered Report Identifier (IRRID) PRR1-10.2196/15029

Efficacy and Impact of an mHealth Intervention to promote Mental Wellness for American Indian and Alaska Native Teens and Young Adults: A Randomized Controlled Trial of the BRAVE Study (Preprint)

2020 ◽  
Author(s):  
Stephanie Craig Rushing ◽  
Allyson Kelley ◽  
Sheana Bull ◽  
David Stephens ◽  
Julia Wrobel ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Alaska Native ◽  
Help Seeking ◽  
Culturally Relevant ◽  
Controlled Trial ◽  
Text Message ◽  
Text Messages ◽  
Randomized Controlled ◽  
Mental Wellness

BACKGROUND Culturally-relevant interventions are needed to help American Indian and Alaska Native (AI/AN) teens and young adults navigate common risky situations involving family and friends, including drug and alcohol misuse, dating violence, and suicidality. We R Native – a multimedia health resource for Native teens and young adults – designed an intervention for Native youth, delivered via text message, that includes role model videos, mental wellness strategies, and links to culturally-relevant resources (hotlines, chat-lines, websites, etc.) and social support. OBJECTIVE This study aims to test the efficacy of BRAVE to improve participant’s physical, mental, and spiritual health, their use of mental wellness strategies, their help-seeking skills, and associated factors, including cultural resilience, identity, and cultural pride. METHODS The randomized controlled trial was carried out by the Northwest Portland Area Indian Health Board and the mHealth Impact Lab. The team recruited 2,334 AI/AN teens and young adults nationwide (15-24 years old) via social media channels and text message and enrolled 1,044 to participate. AI/AN teens and young adults enrolled in the study received either: 8 weeks of BRAVE text messages designed to improve mental health, help-seeking skills, and cultural resilience; or 8 weeks of STEM text messages, designed to elevate and re-affirm Native voices in science, technology, engineering, math and medicine (STEM); and then received the other set of messages. Primary and secondary outcomes were tested using linear mixed-effect models and linear regressions. RESULTS A total of 833 AI/AN teens and young adults were included in the analysis. Individuals in the BRAVE and STEM arms showed significant positive trends over the course of the study for all primary outcomes except cultural identity and help seeking behavior. Mean scores were significantly different for health (P<.001), resilience (P<.001), negative coping (P=.027), positive coping (P<.001), self-efficacy (P=.021), and self-esteem (P<.001). Changes in help-seeking self-efficacy were significant for those exhibiting risky behavior at baseline to exit (P=.01). Those who reported positive coping scores at baseline also reported better health on average, but no difference in risky drug and alcohol use (P<.001). The number of participants that used text messages to help themselves increased from 69% at 3-months (427/618) to 75% at 8-months (381/501) (P<.001). Similarly, the number of participants that used text messages to help a friend or family member increased from 22% at 3-months (138/616) to 55% at 8-months (272/498). CONCLUSIONS This is the first nationwide randomized controlled trial for AI/AN teens and young adults to test the efficacy of an mHealth intervention on mental wellness. The findings suggest that culturally-relevant multimedia, mHealth interventions can improve help-seeking behavior. Lessons learned from this study may help other AI/AN-serving organizations, prevention programs, policymakers, researchers, and educators as they support the next generation of AI/AN change-makers.

Educational intervention to adopt selective laser trabeculoplasty as first-line glaucoma treatment: Randomized controlled trial: Educational intervention on selective laser trabeculoplasty

2021 ◽  
pp. 112067212110183
Author(s):  
Evelyn Tran ◽  
Carina Sanvicente ◽  
Lisa A Hark ◽  
Jonathan S Myers ◽  
Qiang Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Selective Laser Trabeculoplasty ◽  
First Line ◽  
Randomized Controlled ◽  
Laser Trabeculoplasty ◽  
Glaucoma Treatment

Purpose: To determine the efficacy of an educational intervention on patient adoption and attitudes toward selective laser trabeculoplasty (SLT) as first-line treatment for glaucoma. Methods: This study is a randomized controlled trial. Subjects include 33 patients within 1-year diagnosis of either primary open-angle glaucoma, ocular hypertension, or pseudoexfoliation syndrome. After informed consent, subjects were randomly assigned to a Usual Care or Educational Intervention group. All subjects completed a pre-intervention questionnaire. The Educational Intervention group was shown a slideshow presentation and a 3-min video and given a post-intervention questionnaire. Follow-up examinations were reviewed for 6 months to determine subject completion of SLT, the primary outcome. Secondary outcomes include assessment of attitude toward SLT before and after intervention. Results: Age, gender, and baseline characteristics between the groups did not differ. The Usual Care group had a higher proportion of African Americans (77% vs 31%, p = 0.04). At 6 months following the intervention, 63% of subjects underwent SLT compared to 35% of Usual Care subjects ( p = 0.12). Older age was associated with decreased SLT uptake (OR 0.90, 95% CI 0.82–0.99, p = 0.03). Prior to the intervention, there were no differences in attitudes of both groups regarding SLT therapy. Nineteen percent of Educational Intervention subjects changed positively toward SLT ( p = 0.08) and 50% scheduled an SLT appointment after intervention ( p = 0.005). Conclusions: A slideshow and video-based educational intervention may positively enhance patient adoption of SLT. Clinical trial registration name, number, URL: Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment, NCT03365778, https://clinicaltrials.gov/ct2/show/NCT03365778

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