Adherence Connection for Counseling, Education, and Support: Research Protocol for a Proof-of-Concept Study

Background: The highest rates of new HIV infections are observed in African Americans and Hispanics/Latinos (ethnic minority) adolescents and young adults (youth). HIV-infected ethnic minority youth are less likely to initiate and maintain adherence to antiretroviral treatment (ART) and medical care, as compared with their adult counterparts.

Objective: The objective of this research protocol was to describe our proposed methods for testing a peer-led mobile health cognitive behavioral intervention, delivered via remote videoconferencing and smartphones with HIV-infected ethnic minority youth, Adherence Connection for Counseling, Education, and Support (ACCESS). Our secondary aim was 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 health care utilization (retention in care).

Methods: An exploratory, sequential mixed-methods study design will be used with conceptual determinants of adherence behavior informed by the information-motivation-behavioral skills model. HIV-infected ethnic minority youth aged 16 to 29 years with a detectable HIV serum viral load of more than 200 copies/ml (N=25) will be recruited. Qualitative pretesting will be conducted, including semistructured, in-depth, individual interviews with a convenience sample meeting the study inclusion criteria. Preliminary analysis of qualitative data will be used to inform and tailor the ACCESS 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 5 peer-led remote videoconferencing sessions will be delivered using study-funded smartphones and targeting adherence information (HIV knowledge), motivation (beliefs and perceptions), and behavioral skills (self-efficacy). Participant satisfaction will be assessed with poststudy focus groups and quantitative survey methodology. Bivariate analyses will be computed to compare pre- and postintervention changes in HIV biomarkers, self-reported ART adherence, beliefs and knowledge about ART, adherence self-efficacy, and retention in care.

Results: As of December 2018, we are in the data analysis phase of this pilot and anticipate completion with dissemination of final study findings by spring/summer 2019. The major outcomes will include intervention feasibility, acceptability, and preliminary evidence of impact on serum HIV RNA quantitative viral load (primary adherence outcome variable). Self-reported ART adherence and retention in care will be assessed as secondary outcomes. Findings from the qualitative pretesting will contribute to an improved understanding of adherence behavior.

Conclusions: Should the ACCESS intervention prove feasible and acceptable, this research protocol will contribute to a shift in existent HIV research paradigms by offering a blueprint for technology-enabled peer-led interventions and models.

International Registered Report Identifier (irrid): DERR1-10.2196/12543.