scholarly journals Connecting Youth and Young Adults to Optimize Antiretroviral Therapy Adherence (YouTHrive): Protocol for a Randomized Controlled Trial

10.2196/11502 ◽  
2019 ◽  
Vol 8 (7) ◽  
pp. e11502 ◽  
Author(s):  
K J Horvath ◽  
R F MacLehose ◽  
A Martinka ◽  
J DeWitt ◽  
L Hightow-Weidman ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Phase 1 ◽  
Art Adherence ◽  
Phase 2 ◽  
Phase 3 ◽  
Randomized Controlled ◽  
Adherence Intervention ◽  
Living With Hiv ◽  
Beta Testing ◽  
Us Cities

Background Despite intensive efforts to engage people living with HIV in the United States, less than half of the youth aged 13 to 24 years achieve viral suppression. There is a clear and continued need for innovative behavioral programs that support optimizing adherence among young persons with HIV. Objective There are 3 phases of this project. Phase 1 involves conducting focus groups to obtain feedback from youth about an existing technology-based antiretroviral therapy (ART) adherence intervention. Phase 2 will be used to conduct beta testing with youth to refine and finalize the YouTHrive (YT) intervention. Phase 3 is a randomized controlled trial (RCT) to test the efficacy of the YT intervention among youth living with HIV (YLWH). Methods In phase 1, we will conduct 6 focus groups with approximately 8 youths (aged 15-19 years) and young adults (aged 20-24 years), each in 3 US cities to obtain (1) feedback from YLWH about the look and feel and content of an existing adult-focused Web-based ART adherence intervention and (2) suggestions for adapting the intervention for YLWH similar to themselves. Phase 2 will involve updating the existing intervention to include features and functionality recommended by YLWH in phase 1; it will conclude with beta testing with 12 participants to gain feedback on the overall design and ensure proper functionality and ease of navigation. For phase 3, we will enroll 300 YLWH in 6 US cities (Atlanta, Chicago, Houston, New York City, Philadelphia, and Tampa) into a 2-arm prospective RCT. Participants will be randomized 1:1 to YT intervention or control group. The randomization sequence will be stratified by city and use random permuted blocks of sizes 2 and 4. Participants randomized to the control condition will view a weekly email newsletter on topics related to HIV, with the exception of ART adherence, for 5 months. Participants randomized to the YT intervention condition will be given access to the YT site for 5 months. Study assessments will occur at enrollment and 5, 8, and 11 months post enrollment. The primary outcome that will be assessed is sustained viral load (VL), defined as the proportion of participants in each study arm who have suppressed VL at both the 5- and 11-month assessment; the secondary outcome that will be assessed is suppressed VL at both the 5- and 11-month assessment between drug-using and nondrug-using participants assigned to the YT intervention arm. Results Participant recruitment began in May 2017 for phase 1 of the study. The data collection for aim 3 is anticipated to end in April 2020. Conclusions The efficacy trial of the YT intervention will help to fill gaps in understanding the efficacy of mobile interventions to improve ART adherence among at-risk populations. Trial Registration ClinicalTrials.gov NCT03149757; https://clinicaltrials.gov/ct2/show/NCT03149757 (Archived by WebCite at http://www.webcitation.org/73pw57Cf1) International Registered Report Identifier (IRRID) DERR1-10.2196/11502

scholarly journals Connecting Youth and Young Adults to Optimize ART Adherence (YouTHrive): Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
K J Horvath Horvath ◽  
R MacLehose ◽  
A Martinka ◽  
J Dewitt ◽  
L Hightow-Weidman ◽  
...  
Keyword(s):  
New York ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Phase 1 ◽  
Art Adherence ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Living With Hiv ◽  
Beta Testing ◽  
Us Cities

BACKGROUND Youth account for a disproportionately high rates of new HIV infections in the United States (US). Despite intensive efforts to engage people living with HIV (PLWH) in the US, less than half of 13-24 years old achieve viral suppression. There is a clear and continued need for innovative behavioral programs that support optimizing adherence among young persons with HIV. OBJECTIVE There are three phases of this project. Phase 1 involves conducting focus groups in three cities (New York City, Chicago, and Houston) to obtain feedback from youth about an existing technology-based antiretroviral therapy (ART) adherence intervention. Phase 2 will be used to conduct beta testing with youth to refine and finalize the YouTHrive (YT) intervention. Phase 3 is a randomized controlled trial (RCT) to test the efficacy of the YouTHrive intervention among youth living with HIV (YLWH) in 6 US cities (Atlanta, New York City, Chicago, Houston, Philadelphia, and Tampa). METHODS In Phase 1, we will conduct six focus groups with approximately 8 youths (15-19 years old) and young adults (20-24 years old) each in three US cities to obtain: 1) feedback from YLWH about the “look and feel” and content of an existing adult-focused web-based ART adherence intervention; and 2) suggestions for adapting the intervention for YLWH similar to themselves. Phase 2 will involve collaboration with our technology development partner to update the existing intervention to include features and functionality recommended by YLWH in Phase 1. Phase 2 will conclude with beta testing with 12 participants to ensure that all features are working properly and function in a way that users can easily navigate. For Phase 3, we will enroll 300 YLWH in 6 US cities into a two-arm prospective randomized controlled trial (RCT). Participants randomized to the control condition will view a weekly newsletter for 20 weeks. The newsletter will be delivered via e-mail and will contain information on topics related to HIV, with the exception of ART adherence. Participants randomized to the YT intervention condition will be given access to the YT site for 20 weeks. Study assessments will occur at enrollment and 5, 8, and 11 months postenrollment. RESULTS Participant recruitment began in May 2017 for Phase 1 of the study. The data collection for Aim 3 is anticipated to end in April 2020. CONCLUSIONS The efficacy trial of the YT intervention will help to fill gaps in understanding about the efficacy of mobile interventions to improve ART adherence among at-risk populations. Other important questions remain to be addressed, including how best to incorporate virtual ART interventions into clinical care and when they are most effectively delivered. CLINICALTRIAL ClinicalTrials.gov (NCT03149757); University of North Carolina at Chapel Hill Institutional Review Board (16-3136).

scholarly journals A Mobile Health App to Improve HIV Medication Adherence: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Susan Ramsey ◽  
Evan Ames ◽  
Julia Uber ◽  
Samia Habib ◽  
Seth Clark
Keyword(s):  
Controlled Trial ◽  
Phase 1 ◽  
Effect Sizes ◽  
Art Adherence ◽  
Phase 2 ◽  
Face To Face ◽  
Mhealth Intervention ◽  
Randomized Controlled ◽  
Persons Living With Hiv ◽  
Living With Hiv

BACKGROUND Adherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence. OBJECTIVE The primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes. METHODS This study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations. RESULTS Phase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020. CONCLUSIONS This study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15356

scholarly journals A Mobile Health App to Improve HIV Medication Adherence: Protocol for a Pilot Randomized Controlled Trial

10.2196/15356 ◽  
2019 ◽  
Vol 8 (11) ◽  
pp. e15356
Author(s):  
Susan Ramsey ◽  
Evan Ames ◽  
Julia Uber ◽  
Samia Habib ◽  
Seth Clark
Keyword(s):  
Controlled Trial ◽  
Phase 1 ◽  
Effect Sizes ◽  
Art Adherence ◽  
Phase 2 ◽  
Face To Face ◽  
Mhealth Intervention ◽  
Randomized Controlled ◽  
Persons Living With Hiv ◽  
Living With Hiv

Background Adherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence. Objective The primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes. Methods This study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations. Results Phase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020. Conclusions This study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus. Trial Registration ClinicalTrials.gov NCT02676128; https://clinicaltrials.gov/ct2/show/NCT02676128 International Registered Report Identifier (IRRID) DERR1-10.2196/15356

scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2019 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

scholarly journals Socio-Ecological Natural Experiment with Randomized Controlled Trial to Promote Active Commuting to Work: Process Evaluation, Behavioral Impacts, and Changes in the Use and Quality of Walking and Cycling Paths

2019 ◽  
Vol 16 (9) ◽  
pp. 1661 ◽  
Author(s):  
Minna Aittasalo ◽  
Johanna Tiilikainen ◽  
Kari Tokola ◽  
Jaana Suni ◽  
Harri Sievänen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Natural Experiment ◽  
Controlled Trial ◽  
Phase 1 ◽  
Active Commuting ◽  
Phase 2 ◽  
Behavioral Strategies ◽  
Beneficial Effects ◽  
Randomized Controlled ◽  
Journey To Work

Active commuting to work (ACW) has beneficial effects on health, traffic, and climate. However, more robust evidence is needed on how to promote ACW. This paper reports the findings of a multilevel natural experiment with a randomized controlled trial in 16 Finnish workplaces. In Phase 1, 11 workplaces (1823 employees) from Area 1 were exposed to environmental improvements in walking and cycling paths. In Phase 2, five more workplaces (826 employees) were recruited from Area 2 and all workplaces were randomized into experimental group (EXP) promoting ACW with social and behavioral strategies and comparison group (COM) participating only in data collection. Process and impact evaluation with questionnaires, travel diaries, accelerometers, traffic calculations, and auditing were conducted. Statistics included Wilcoxon Signed Ranks Test, Mann-Whitney U-test, and after-before differences with 95% confidence intervals (95% CI). After Phase 1, positive change was seen in the self-reported number of days, which the employees intended to cycle part of their journey to work in the following week (p = 0.001). After Phase 2, intervention effect was observed in the proportion of employees, who reported willingness to increase walking (8.7%; 95% CI 1.8 to 15.6) and cycling (5.5%; 2.2 to 8.8) and opportunity to cycle part of their journey to work (5.9%; 2.1 to 9.7). To conclude, the intervention facilitated employees’ motivation for ACW, which is the first step towards behavior change.

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 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 Randomized Controlled Trial of Rise, a Community-Based Culturally Congruent Adherence Intervention for Black Americans Living with HIV

2017 ◽  
Vol 51 (6) ◽  
pp. 868-878 ◽  
Author(s):  
Laura M. Bogart ◽  
Matt G. Mutchler ◽  
Bryce McDavitt ◽  
David J. Klein ◽  
William E. Cunningham ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Black Americans ◽  
Community Based ◽  
Randomized Controlled ◽  
Culturally Congruent ◽  
Adherence Intervention ◽  
Living With Hiv

Systematic Formative Research to Develop HIV Prevention Messages for People Living with HIV

2010 ◽  
Vol 16 (3) ◽  
pp. 23-59 ◽  
Author(s):  
Jennifer Uhrig ◽  
Doğan Eroğlu ◽  
Carla Bann ◽  
Jill L Wasserman ◽  
Carolyn Guenther-Grey
Keyword(s):  
Hiv Prevention ◽  
Phase 1 ◽  
Idea Generation ◽  
Formative Research ◽  
People Living With Hiv ◽  
Phase 2 ◽  
Phase 3 ◽  
Prevention Messages ◽  
Hiv Prevention Strategies ◽  
Living With Hiv

Systematic formative research is vital to the successful development of health communication and marketing messages targeting people living with HIV (PLWH). The purpose of this study was to use a systematic process to develop and pretest HIV prevention messages for PLWH. We conducted our study in three phases with findings from each phase informing the development of the subsequent phase. In Phase 1, we employed idea-generation techniques in group settings with PLWH and HIV prevention experts to elicit a comprehensive list of HIV prevention strategies and persuasive arguments for these strategies. In Phase 2, we conducted focus groups and in-depth interviews with PLWH to evaluate the messages that emerged in Phase 1. In Phase 3, we administered a structured survey instrument to PLWH to quantitatively evaluate audience reactions and receptivity to the 19 most promising messages from Phase 2. By Phase 3, the majority of participants agreed with evaluative statements that expressed favorable attitudes toward the messages. These results support the utility of systematic efforts to generate and screen messages prior to large-scale testing.

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

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