Evaluation of a Web-based tailored intervention (TAVIE en santé) to support people living with HIV in the adoption of health promoting behaviours: an online randomized controlled trial protocol.

BACKGROUND: Long-term use of antiretroviral therapy, normal aging, and presence of certain risk factors are associated with metabolic disorders that predispose persons living with HIV to diabetes and cardiovascular diseases. The emergence and progression of these disorders can be prevented by adopting healthy behaviours. Based on the theory of planned behaviour, the Web-based tailored intervention TAVIE en santé was developed. The aim of this study is to evaluate the effectiveness of TAVIE en santé in order to support people living with HIV in the adoption of health promoting behaviours. METHODS/DESIGN: An online randomized controlled trial with parallel-groups will be conducted across Canada. To participate in this study, people living with HIV must be: ≥ 18 years, able to read/understand French or English, have access to the Internet. A convenience sample of 750 participants will be randomly assigned either to an experimental group (TAVIE en santé, n = 375) or to a control group (websites, n = 375) (1:1 allocation ratio). The TAVIE en santé intervention is composed of seven interactive computer sessions, lasting between 5 and 10 min. The sessions, hosted by a virtual nurse, aim to develop and strengthen skills required for behaviour change. The control group will receive a validated list of five predetermined conventional health-related Websites. The adoption of health behaviour (smoking cessation or physical activity or healthy eating) is the principal outcome. Cognitions (intention, attitude, perceived behavioral control) are the secondary outcomes. Health indicators will also be assessed. All outcomes will be measured with a self-administered online questionnaire and collected three times: at baseline, 3 and 6 months after. The principal analyses will focus on differences between the two trial groups using Intention-to-Treat analysis. DISCUSSION: This study will yield new results about the efficacy of Web-based tailored health behaviours change interventions in the context of chronic disease. The TAVIE en santé intervention could constitute an accessible complementary service in support of existing specialized services to support people living with HIV adopt health behaviors. TRIAL REGISTRATION: NCT02378766 , assigned on March 3th 2015.

Virtual intervention to support self-management of antiretroviral therapy among people living with HIV.

BACKGROUND: Living with human immunodeficiency virus (HIV) necessitates long-term health care follow-up, particularly with respect to antiretroviral therapy (ART) management. Taking advantage of the enormous possibilities afforded by information and communication technologies (ICT), we developed a virtual nursing intervention (VIH-TAVIE) intended to empower HIV patients to manage their ART and their symptoms optimally. ICT interventions hold great promise across the entire continuum of HIV patient care but further research is needed to properly evaluate their effectiveness. OBJECTIVE: The objective of the study was to compare the effectiveness of two types of follow-up--traditional and virtual--in terms of promoting ART adherence among HIV patients. METHODS: A quasi-experimental study was conducted. Participants were 179 HIV patients on ART for at least 6 months, of which 99 were recruited at a site offering virtual follow-up and 80 at another site offering only traditional follow-up. The primary outcome was medication adherence and the secondary outcomes were the following cognitive and affective variables: self-efficacy, attitude toward medication intake, symptom-related discomfort, stress, and social support. These were evaluated by self-administered questionnaire at baseline (T0), and 3 (T3) and 6 months (T6) later. RESULTS: On average, participants had been living with HIV for 14 years and had been on ART for 11 years. The groups were highly heterogeneous, differing on a number of sociodemographic dimensions: education, income, marital status, employment status, and living arrangements. Adherence at baseline was high, reaching 80% (59/74) in the traditional follow-up group and 84% (81/97) in the virtual follow-up group. A generalized estimating equations (GEE) analysis was run, controlling for sociodemographic characteristics at baseline. A time effect was detected indicating that both groups improved in adherence over time but did not differ in this regard. Improvement at 6 months was significantly greater than at 3 months in both groups. Analysis of variance revealed no significant group-by-time interaction effect on any of the secondary outcomes. A time effect was observed for the two kinds of follow-ups; both groups improved on symptom-related discomfort and social support. CONCLUSIONS: Results showed that both interventions improved adherence to ART. Thus, the two kinds of follow-up can be used to promote treatment adherence among HIV patients on ART.

A nursing virtual intervention: real-time support for managing antiretroviral therapy.

Based on a philosophy of empowerment, we developed the HIV Treatment, Virtual Nursing Assistance and Education intervention to equip persons living with HIV for managing their daily antiretroviral therapies. In this article, we describe the project and the process of developing it, which was carried out in three phases: (1) development of the intervention's clinical content, (2) generation of a multimedia presentation, and (3) implementation of our Web application via computer interface. The HIV Treatment, Virtual Nursing Assistance and Education consists of four interactive sessions at the computer, animated by a virtual nurse that takes the individual through the learning process about the capabilities necessary for taking the treatment. This information and strategies provided by the virtual nurse are specifically adapted to the participant, according to the responses he/she supplies. The virtual intervention approach, still experimental, is intended to be complementary with the actual clinical follow-up and has been developed in the context of reorganizing services and of the scarcity of resources. While we anticipate direct positive outcomes among the HIV clientele, it is also highly probable that this virtual support application will have ramifications among different clienteles who must also contend with the daily challenges of their health conditions.

An Internet-Based Intervention (Condom-Him) to Increase Condom Use Among HIV-Positive Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

BACKGROUND: In the recent years, the Internet has been used as a medium to find sexual partners and engage in risky sexual behavior. This has changed the way in which men having have sex with men (MSM) seek sexual partners and has increased the number of high-risk sexual encounters. Therefore, developers of human immunodeficiency virus (HIV)-prevention interventions have also started using the Internet as a viable medium to promote safe sexual behaviors. However, much of the efforts thus far have been aimed at HIV-negative rather than HIV-positive MSM. HIV-positive individuals continue to engage in risky sexual behaviors and thus constitute an important group in which HIV prevention strategies need to be addressed. Therefore, HIV prevention in HIV-positive MSM is a critical issue. OBJECTIVE: Condom-Him, an Internet-based intervention tailored to increase condom use among HIV-positive MSM, was developed with the aim of improving condom use, self-efficacy, and intentions to use condoms among these individuals. The acceptability and feasibility of this Internet-based intervention will be examined in a pilot study. METHODS: We will perform a randomized controlled parallel-group superiority trial. HIV-positive MSM who currently engage in unprotected anal sex will be recruited for the study. Participants will be randomly assigned using a one-to-one allocation ratio generated by the computer program. The researchers will be blinded to participant's group assignment. Participants will be assigned either to use the Condom-Him intervention (experimental arm) or to view a list of websites containing HIV/AIDS related information (control arm). Self-administered questionnaires will be provided online before randomization (baseline) and two weeks after intervention (post-test). RESULTS: The study will include a total of 60 participants with 30 in each group. The results from this pilot study will provide further evidence for a larger study to examine the effectiveness of this intervention and will provide a cost-effective and widely accessible approach to HIV prevention for HIV-positive MSM. CONCLUSIONS: Internet-based interventions for HIV-positive MSM, a population that has been under-represented in the efforts for positive prevention of HIV within Canada, have the potential to provide a cost-effective strategy, which influences the way in which information is accessed and provided to high-risk individuals. The advantages of an Internet-based intervention include the potential to provide consistency in the delivery of an intervention and the ability to disseminate the intervention to a wider population. Internet-based interventions are perceived as vital tools in combating HIV infection within the realm of social media. Therefore, it is important to determine the feasibility and acceptability of these interventions before implementing them. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01726153; http://clinicaltrials.gov/ct2/show/NCT01726153 (Archived by WebCite at http://www.webcitation.org/6Jljzip8B).

Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial.

BACKGROUND: Living with HIV makes considerable demands on a person in terms of self-management, especially as regards adherence to treatment and coping with adverse side-effects. The online HIV Treatment, Virtual Nursing Assistance and Education (Virus de I'immunodéficience Humaine-Traitement Assistance Virtuelle Infirmière et Enseignement; VIH-TAVIE™) intervention was developed to provide persons living with HIV (PLHIV) with personalized follow-up and real-time support in managing their medication intake on a daily basis. An online randomized controlled trial (RCT) will be conducted to evaluate the efficacy of this intervention primarily in optimizing adherence to combination anti-retroviral therapy (ART) among PLHIV. METHODS/DESIGN: A convenience sample of 232 PLHIV will be split evenly and randomly between an experimental group that will use the web application, and a control group that will be handed a list of websites of interest. Participants must be aged 18 years or older, have been on ART for at least 6 months, and have internet access. The intervention is composed of four interactive computer sessions of 20 to 30 minutes hosted by a virtual nurse who engages the PLHIV in a skills-learning process aimed at improving self-management of medication intake. Adherence constitutes the principal outcome, and is defined as the intake of at least 95% of the prescribed tablets. The following intermediary measures will be assessed: self-efficacy and attitude towards antiretroviral medication, symptom-related discomfort, and emotional support. There will be three measurement times: baseline (T0), after 3 months (T3) and 6 months (T6) of baseline measurement. The principal analyses will focus on comparing the two groups in terms of treatment adherence at the end of follow-up at T6. An intention-to-treat (ITT) analysis will be carried out to evaluate the true value of the intervention in a real context. DISCUSSION: Carrying out this online RCT poses various challenges in terms of recruitment, ethics, and data collection, including participant follow-up over an extended period. Collaboration between researchers from clinical disciplines (nursing, medicine), and experts in behavioral sciences information technology and media will be crucial to the development of innovative solutions to supplying and delivering health services. TRIAL REGISTRATION: CE 11.184 / NCT 01510340.

Acceptability and feasibility of a virtual intervention to help people living with HIV manage their daily therapies.

We conducted a study of the acceptability and feasibility of a web application which was designed to empower people living with HIV to manage their daily antiretroviral therapies. The application (VIH-TAVIE) consists of four interactive computer sessions with a virtual nurse who guides the user through a learning process aimed at enhancing treatment management capacities. The information furnished and the strategies proposed by the nurse are tailored, based on the responses provided by the user. The application was evaluated in a hospital setting as an adjunct to usual care. The participants (n = 71) had a mean age of 47 years (SD = 7.6). There were 59 men and 12 women. They had been diagnosed with HIV some 15 years earlier and had been on antiretroviral medication for a mean duration of 11 years. Data were collected by acceptability questionnaires, field notes and observations. Most participants found the application easy to use. They learned tips for taking their medication, diminishing adverse side-effects and maintaining a positive attitude towards treatment. Many participants deemed their experience with the application highly satisfactory and felt that it met their needs with respect to strategies and proficiencies despite their long experience of medication use. The results of the study support the feasibility and acceptability of the intervention.