scholarly journals Preliminary Effects of a Mobile Interactive Supervised Therapy Intervention on People Living With HIV: Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Yan Pang ◽  
James Steven Molton ◽  
Wei Tsang Ooi ◽  
Nicholas Iain Paton ◽  
Hong-Gu He
Keyword(s):  
Process Evaluation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Routine Care ◽  
Mobile App ◽  
People Living With Hiv ◽  
Art Adherence ◽  
Randomized Controlled ◽  
Living With Hiv ◽  
Pilot Randomized Controlled Trial

BACKGROUND As people living with HIV infection require lifelong treatment, nonadherence to medication will reduce their chance of maintaining viral suppression and increase the risk of developing drug resistance and HIV transmission. OBJECTIVE This study aimed to evaluate the efficacy of a mobile app, Mobile Interactive Supervised Therapy (MIST), for improving adherence to oral HIV medications among HIV-infected adults in Singapore. METHODS We conducted a two-group pilot randomized controlled trial (RCT) with a process evaluation, in which 40 HIV-infected participants with once-daily medication regimes were recruited from a public tertiary hospital in Singapore and randomly assigned equally to either the intervention (receiving MIST and routine care) or control (receiving routine care only) groups. The intervention lasted for 2 months. The outcome of antiretroviral therapy (ART) adherence was measured by a 7-day recall self-report (SR), pill count (PC), an electronic medical device—Medication Event Monitoring System (MEMS)—and a mobile app—MIST (for the intervention group only). In total, 20 participants from the intervention group were interviewed at the end of the intervention to assess the acceptability of MIST. Data were collected at baseline and at 1-month and 2-month postintervention. RESULTS All participants had excellent medication adherence at baseline (median 100, IQR 100-100). The use of MIST did not result in a significant improvement in ART adherence when measured by the SR, PC, and MEMS, as compared with the control group at 1-month (<i>P</i> values &gt;.99, .86, and .74, respectively) and 2-month (<i>P</i> values=.80, .84, and .82, respectively) postintervention. ART adherence also did not improve in each group over the same period. MIST was perceived to be a beneficial tool based on the process evaluation results. CONCLUSIONS Although MIST did not enhance medication adherence to HIV treatments, mainly owing to the ceiling effect, it was perceived to be beneficial among the participants of this study. Our process evaluation provided useful data to further develop MIST for bigger and long-term mobile phone app–assisted intervention RCTs in the future. CLINICALTRIAL ClinicalTrials.gov NCT03794648; https://clinicaltrials.gov/ct2/show/NCT03794648

scholarly journals Preliminary Effects of a Mobile Interactive Supervised Therapy Intervention on People Living With HIV: Pilot Randomized Controlled Trial

10.2196/15702 ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. e15702
Author(s):  
Yan Pang ◽  
James Steven Molton ◽  
Wei Tsang Ooi ◽  
Nicholas Iain Paton ◽  
Hong-Gu He
Keyword(s):  
Process Evaluation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Routine Care ◽  
Mobile App ◽  
People Living With Hiv ◽  
Art Adherence ◽  
Randomized Controlled ◽  
Living With Hiv ◽  
Pilot Randomized Controlled Trial

Background As people living with HIV infection require lifelong treatment, nonadherence to medication will reduce their chance of maintaining viral suppression and increase the risk of developing drug resistance and HIV transmission. Objective This study aimed to evaluate the efficacy of a mobile app, Mobile Interactive Supervised Therapy (MIST), for improving adherence to oral HIV medications among HIV-infected adults in Singapore. Methods We conducted a two-group pilot randomized controlled trial (RCT) with a process evaluation, in which 40 HIV-infected participants with once-daily medication regimes were recruited from a public tertiary hospital in Singapore and randomly assigned equally to either the intervention (receiving MIST and routine care) or control (receiving routine care only) groups. The intervention lasted for 2 months. The outcome of antiretroviral therapy (ART) adherence was measured by a 7-day recall self-report (SR), pill count (PC), an electronic medical device—Medication Event Monitoring System (MEMS)—and a mobile app—MIST (for the intervention group only). In total, 20 participants from the intervention group were interviewed at the end of the intervention to assess the acceptability of MIST. Data were collected at baseline and at 1-month and 2-month postintervention. Results All participants had excellent medication adherence at baseline (median 100, IQR 100-100). The use of MIST did not result in a significant improvement in ART adherence when measured by the SR, PC, and MEMS, as compared with the control group at 1-month (P values >.99, .86, and .74, respectively) and 2-month (P values=.80, .84, and .82, respectively) postintervention. ART adherence also did not improve in each group over the same period. MIST was perceived to be a beneficial tool based on the process evaluation results. Conclusions Although MIST did not enhance medication adherence to HIV treatments, mainly owing to the ceiling effect, it was perceived to be beneficial among the participants of this study. Our process evaluation provided useful data to further develop MIST for bigger and long-term mobile phone app–assisted intervention RCTs in the future. Trial Registration ClinicalTrials.gov NCT03794648; https://clinicaltrials.gov/ct2/show/NCT03794648

scholarly journals A pilot randomized controlled trial of a tailored smoking cessation program for people living with HIV in the Washington, D.C. metropolitan area

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Elexis C. Kierstead ◽  
Emily Harvey ◽  
Denisse Sanchez ◽  
Kimberly Horn ◽  
Lorien C. Abroms ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Self Efficacy ◽  
Text Messaging ◽  
Controlled Trial ◽  
P Value ◽  
People Living With Hiv ◽  
Randomized Controlled ◽  
Living With Hiv ◽  
Pilot Randomized Controlled Trial

Abstract Objective Morbidity and mortality from smoking-related diseases among people living with HIV (PLWH) in the U.S. surpasses that due to HIV itself. Conventional smoking cessation treatments have not demonstrated strong efficacy among PLWH. We conducted a pilot randomized controlled trial (RCT) to evaluate a tailored smoking cessation intervention based on the minority stress model. We compared standard of care counseling (SOC) to a tailored intervention (TI) including one face-to-face counseling session incorporating cognitive behavioral therapy to build resilience, and 30 days of 2-way text messaging. Results The primary outcome was smoking cessation. Secondary outcomes included cigarettes per day (CPD), exhaled carbon monoxide (CO), and cessation self-efficacy. A total of 25 participants were enrolled (TI:11, SOC:14), and 2 were lost to follow-up. There were no significant differences in quit rates between study groups. However, there was a significantly greater decrease in CPD in the TI versus SOC (13.5 vs. 0.0, p-value:0.036). Additionally, self-efficacy increased in both groups (TI p-value:0.012, SOC p-value:0.049) and CO decreased in both groups (TI p-value: < 0.001, SOC p-value:0.049). This intervention shows promise to support smoking cessation among PLWH. A larger study is needed to fully evaluate the efficacy of this approach. Clinical trial: Trial Registration: Retrospectively registered (10/20/2020) NCT04594109.

scholarly journals Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
José Côté ◽  
Geneviève Rouleau ◽  
Maria Pilar Ramirez-Garcia ◽  
Patricia Auger ◽  
Réjean Thomas ◽  
...  
Keyword(s):  
Social Support ◽  
Controlled Trial ◽  
Control Group ◽  
People Living With Hiv ◽  
Art Adherence ◽  
Web Based ◽  
Randomized Controlled ◽  
Living With Hiv ◽  
Experimental Group ◽  
The Web

BACKGROUND Taking antiretroviral therapy (ART) is part of the daily life of people living with HIV. Different electronic health (eHealth) initiatives adjunctive to usual care have been proposed to support optimal medication adherence. A web-based intervention called HIV Treatment, Virtual Nursing Assistance, and Education or VIH-TAVIE (from its French version Virus de l’immunodéficience humaine-Traitement assistance virtuelle infirmière et enseignement) was developed to empower people living with HIV to manage their ART and symptoms optimally. OBJECTIVE We aimed to evaluate the effectiveness of VIH-TAVIE in a web-based randomized controlled trial (RCT). METHODS This RCT was entirely web-based, including recruitment, consent granting, questionnaire completion, and intervention exposure (consultation with VIH-TAVIE [experimental group] or websites [control group]). To be eligible for the study, people living with HIV had to be 18 years or older, be on ART for at least 6 months, have internet access, and have internet literacy. Participants were randomly assigned to either the experimental group (n=45) or control group (n=43). The primary outcome was ART adherence. The secondary outcomes included self-efficacy regarding medication intake, symptom-related discomfort, skills and strategies, and social support. All outcomes were measured with a self-administered web-based questionnaire at the following three time points: baseline and 3 and 6 months later. A generalized linear mixed model was built to assess the evolution of ART adherence over time in both groups. RESULTS The sample included 88 participants, and of these, 73 (83%) were men. The median age of the participants was 42 years. Participants had been diagnosed with HIV a median of 7 years earlier (IQR 3-17) and had been on ART for a median of 5 years (IQR 2-12). The proportion of treatment-adherent participants at baseline was high in both groups (34/41, 83% in the experimental group and 30/39, 77% in the control group). Participants also reported high treatment adherence, high self-efficacy, and high skills; perceived good social support; and experienced low discomfort from symptoms. Analyses revealed no intergroup difference regarding ART adherence (OR 1.9, 95% CI 0.6-6.4). CONCLUSIONS This study highlights the challenges and lessons learned from conducting an entirely web-based RCT among people living with HIV. The challenges were related to the engagement of people living with HIV on the following three levels: starting the web-based study (recruitment), completing the web-based intervention (engagement), and continuing the study (retention). The results contribute to the existing body of knowledge regarding how to conduct web-based evaluation studies of eHealth interventions aimed at developing and strengthening personal skills and abilities. CLINICALTRIAL ClinicalTrials.gov NCT01510340; https://clinicaltrials.gov/ct2/show/NCT01510340

scholarly journals Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial

10.2196/17733 ◽  
2020 ◽  
Vol 6 (2) ◽  
pp. e17733
Author(s):  
José Côté ◽  
Geneviève Rouleau ◽  
Maria Pilar Ramirez-Garcia ◽  
Patricia Auger ◽  
Réjean Thomas ◽  
...  
Keyword(s):  
Social Support ◽  
Controlled Trial ◽  
Control Group ◽  
People Living With Hiv ◽  
Art Adherence ◽  
Web Based ◽  
Randomized Controlled ◽  
Living With Hiv ◽  
Experimental Group ◽  
The Web

Background Taking antiretroviral therapy (ART) is part of the daily life of people living with HIV. Different electronic health (eHealth) initiatives adjunctive to usual care have been proposed to support optimal medication adherence. A web-based intervention called HIV Treatment, Virtual Nursing Assistance, and Education or VIH-TAVIE (from its French version Virus de l’immunodéficience humaine-Traitement assistance virtuelle infirmière et enseignement) was developed to empower people living with HIV to manage their ART and symptoms optimally. Objective We aimed to evaluate the effectiveness of VIH-TAVIE in a web-based randomized controlled trial (RCT). Methods This RCT was entirely web-based, including recruitment, consent granting, questionnaire completion, and intervention exposure (consultation with VIH-TAVIE [experimental group] or websites [control group]). To be eligible for the study, people living with HIV had to be 18 years or older, be on ART for at least 6 months, have internet access, and have internet literacy. Participants were randomly assigned to either the experimental group (n=45) or control group (n=43). The primary outcome was ART adherence. The secondary outcomes included self-efficacy regarding medication intake, symptom-related discomfort, skills and strategies, and social support. All outcomes were measured with a self-administered web-based questionnaire at the following three time points: baseline and 3 and 6 months later. A generalized linear mixed model was built to assess the evolution of ART adherence over time in both groups. Results The sample included 88 participants, and of these, 73 (83%) were men. The median age of the participants was 42 years. Participants had been diagnosed with HIV a median of 7 years earlier (IQR 3-17) and had been on ART for a median of 5 years (IQR 2-12). The proportion of treatment-adherent participants at baseline was high in both groups (34/41, 83% in the experimental group and 30/39, 77% in the control group). Participants also reported high treatment adherence, high self-efficacy, and high skills; perceived good social support; and experienced low discomfort from symptoms. Analyses revealed no intergroup difference regarding ART adherence (OR 1.9, 95% CI 0.6-6.4). Conclusions This study highlights the challenges and lessons learned from conducting an entirely web-based RCT among people living with HIV. The challenges were related to the engagement of people living with HIV on the following three levels: starting the web-based study (recruitment), completing the web-based intervention (engagement), and continuing the study (retention). The results contribute to the existing body of knowledge regarding how to conduct web-based evaluation studies of eHealth interventions aimed at developing and strengthening personal skills and abilities. Trial Registration ClinicalTrials.gov NCT01510340; https://clinicaltrials.gov/ct2/show/NCT01510340

scholarly journals A pilot randomized controlled trial of a tailored smoking cessation program for people living with HIV in the Washington, D.C. metropolitan area

2020 ◽  
Author(s):  
Elexis C. Kierstead ◽  
Emily Harvey ◽  
Denisse Sanchez ◽  
Kimberly Horn ◽  
Lorien C. Abroms ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Study Groups ◽  
P Value ◽  
People Living With Hiv ◽  
Randomized Controlled ◽  
Living With Hiv ◽  
Pilot Randomized Controlled Trial

Abstract ObjectiveMorbidity and mortality from smoking-related diseases among people living with HIV (PLWH) in the U.S. surpasses that due to HIV itself. Conventional smoking cessation treatments have not demonstrated strong efficacy among PLWH. We conducted a pilot randomized controlled trial (RCT) to evaluate a tailored smoking cessation intervention based on the minority stress model. We compared standard of care counseling (SOC) to a tailored intervention (TI) including one face-to-face counseling session incorporating cognitive behavioral therapy to build resilience, and 30 days of 2-way text messaging.ResultsThe primary outcome was smoking cessation. Secondary outcomes included cigarettes per day (CPD), exhaled carbon monoxide (CO), and cessation self-efficacy. A total of 25 participants were enrolled (TI:11, SOC:14), and 2 were lost to follow up. There were no significant differences in quit rates between study groups. However, there was a significantly greater decrease in CPD in the TI versus SOC (13.5 vs. 0.0, p-value:0.036). Additionally, self-efficacy increased in both groups (TI p-value:0.012, SOC p-value:0.049) and CO decreased in both groups (TI p-value:<0.001, SOC p-value:0.0488). This intervention shows promise to support smoking cessation among PLWH. A larger study is needed to fully evaluate the efficacy of this approach.Trial RegistrationRetrospectively registered (10/20/2020) NCT04594109

scholarly journals Effect of a WeChat-Based Intervention (Run4Love) on Depressive Symptoms Among People Living With HIV in China: A Randomized Controlled Trial

10.2196/16715 ◽  
2020 ◽  
Vol 22 (2) ◽  
pp. e16715 ◽  
Author(s):  
Yan Guo ◽  
Y Alicia Hong ◽  
Weiping Cai ◽  
Linghua Li ◽  
Yuantao Hao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
People Living With Hiv ◽  
Mhealth Intervention ◽  
Randomized Controlled ◽  
Hair Samples ◽  
Living With Hiv

Background People living with HIV (PLWH) have high rates of depressive symptoms. However, only a few effective mental health interventions exist for this vulnerable population. Objective The aim of this study was to assess the efficacy of a WeChat-based intervention, Run4Love, with a randomized controlled trial among 300 people living with HIV and depression (PLWHD) in China. Methods We recruited PLWH from the HIV outpatient clinic in South China. Participants were screened based on the Center for Epidemiologic Studies-Depression (CES-D) scale. Those who scored 16 or higher were eligible to participate. A total of 300 eligible patients were enrolled. After obtaining informed consent from the participants, completion of a baseline survey, and collection of participants’ hair samples for measuring cortisol, the participants were randomly assigned to an intervention or a control group in a 1:1 ratio. The intervention group received the Run4Love program, delivered via the popular social media app WeChat. Cognitive behavioral stress management courses and weekly reminders of exercise were delivered in a multimedia format. Participants’ progress was monitored with timely and tailored feedback. The control group received usual care and a brochure on nutrition for PLWH. Data were collected at 3, 6, and 9 months. The primary outcome was depression, which was measured by a validated instrument. Results Participants in the intervention and control groups were comparable at baseline; about 91.3% (139/150), 88.3% (132/150), and 86.7% (130/150) participants completed the 3-, 6-, and 9-month follow-ups, respectively. At the 3-month follow-up, a significant reduction in CES-D score was observed in the intervention group (from 23.9 to 17.7 vs from 24.3 to 23.8; mean difference=−5.77, 95% CI −7.82 to −3.71; P<.001; standard effect size d=0.66). The mean changes in CES-D score from baseline to the 6- and 9-month follow-ups between the two groups remained statistically significant. No adverse events were reported. Conclusions The WeChat-based mobile health (mHealth) intervention Run4Love significantly reduced depressive symptoms among PLWHD, and the effect was sustained. An app-based mHealth intervention could provide a feasible therapeutic option for many PLWHD in resource-limited settings. Further research is needed to assess generalizability and cost-effectiveness of this intervention. Trial Registration Chinese Clinical Trial Registry ChiCTR-IPR-17012606; http://www.chictr.org.cn/showproj.aspx?proj=21019 (Archived by WebCite at https://www.webcitation.org/78Bw2vouF)

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