Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 18, 2018
Date Accepted: Dec 18, 2018
(closed for review but you can still tweet)
Adherence Connection for Counseling, Education, and Support (ACCESS): Research Protocol for a Proof of Concept Study
ABSTRACT
Background:
The highest rates of new human immunodeficiency virus (HIV)-infections are observed in African Americans/Blacks and Hispanics (AABH) adolescents and young adults (AYA). Initiation and maintenance of optimal antiretroviral treatment (ART) adherence is the single most important criterion to prevent HIV related morbidity, mortality, and secondary transmission. HIV-infected AABH AYA are less likely to initiate and maintain adherence to ART and medical care, as compared to adult counterparts. To date, there is a pressing need for effective and novel adherence interventions targeting HIV-infected AABH AYA.
Objective:
The current protocol, Adherence Connection for Counseling, Education, and Support (ACCESS), was developed to test the concept of implementing a peer-led, mHealth cognitive behavioral intervention (CBI), delivered via remote videoconferencing using smartphones, and its potential to influence ART adherence in HIV-infected AABH AYA. Our secondary aim is to obtain initial estimates of the biobehavioral impact of ACCESS on HIV virologic outcomes and self-reported ART adherence, beliefs and knowledge about ART treatment, adherence self-efficacy and healthcare utilization (retention in HIV care).
Methods:
An exploratory sequential, mixed methods study design will be used with conceptual determinants of adherence behavior informed by the Information - Motivation - Behavioral (IMB) Skills model. A convenience sample will be recruited, HIV-infected AABH AYA aged 16-29 years with detectable HIV serum viral load of > 200 copies/ml (N=25). Qualitative pre-testing including semi-structured, in-depth, individual interviews with a convenience sample of HIV-infected AABH AYA meeting study inclusion criteria will be conducted. HIV-infected AABH AYA participants will be asked to provide feedback regarding the ACCESS intervention, barriers and facilitators of ART adherence, and potential impact on ART adherence and retention in care. Preliminary analysis of qualitative data will be used to inform and tailor the ACCESS pilot intervention. Testing and implementation will include a one group, pre/posttest pilot, delivered by a trained “successful†peer-health coach who lives with HIV, and is well engaged in HIV care and taking ART. A total of five peer-led, remote videoconferencing sessions will be delivered using study funded smartphones targeting determinants of adherence behavior, namely adherence information (HIV-knowledge), motivation (beliefs and perceptions), and behavioral skills (self-efficacy). Participant satisfaction will be assessed with post-study focus groups and quantitative survey methodology. Bivariate analyses will be computed to assess the potential impact of ACCESS on viral suppression. Changes in self-reported ART adherence, beliefs and knowledge about ART, adherence self-efficacy, and healthcare utilization (retention in care) will be compared pre and post the ACCESS intervention.
Results:
The major outcomes of this pilot study will include intervention feasibility, acceptability, and preliminary evidence of impact with respect to biobehavioral outcomes; namely, serum HIV RNA quantitative viral load (primary adherence outcome variable). Self-reported ART adherence and healthcare utilization (retention in HIV care) will be assessed as secondary outcomes.
Conclusions:
Should the ACCESS intervention prove feasible and acceptable in this proof of concept study, a shift in technology-enabled behavioral interventions for improved HIV self-management is possible, lending to application for other chronic diseases among vulnerable populations. Clinical Trial: NCT02753049
Citation