The first year of outpatient HIV medical care is a dynamic, formative and vulnerable time. While adjusting to a life changing diagnosis, patients must simultaneously develop HIV visit adherence and antiretroviral therapy (ART) adherence behavioral skills to achieve plasma viral load (VL) suppression. Moreover, maintaining "HIV adherence" in a broader context is essential to sustaining VL suppression over time, with vital consequences to individual health and profound implications for secondary HIV prevention. It is alarming that no existing evidence-based intervention supports the simultaneous development of patient information, motivation and behavioral skills for both HIV medical visit and ART adherence at this critical time. Accordingly, we will draw content from our existing, pilot-tested interventions that target these separate adherence behaviors to evaluate an integrated intervention approach tailored to the needs of an individual initiating outpatient HIV medical care. The proposed iENGAGE intervention (integrating ENGagement and Adherence Goals upon Entry) has two overarching goals: (1) to facilitate patient adjustment to a new diagnosis of HIV infection, and, (2) to develop the necessary patient information, motivation and skills for optimal HIV visit and ART adherence. The following specific aims are driven by a unified conceptual model, linked with explicit measurement instruments, and a detailed analysis plan.
Aim 1 : Integrate content from our pilot-tested and evidence-based CDC Retention in Care and PACT ART adherence interventions for the comprehensive iENGAGE intervention to promote VL suppression (<50 c/mL) among patients newly initiating outpatient HIV medical care.
Aim 2 : Evaluate the efficacy of the iENGAGE intervention vs. standard of care in achieving 48-week VL suppression (<50 c/mL) among patients newly initiating outpatient HIV medical care.
Aim 3 : Evaluate (a) modifiers and (b) mediators of iENGAGE efficacy, using (a) subgroup analysis to estimate important subgroup effects and (b) marginal structural models to estimate the role of intervention components in the overall effect. Identify (c) baseline and longitudinal predictors of VL outcomes using marginal structural models among patients receiving standard of care. Our investigative team has a strong track record of collaboration and the collective expertise in HIV behavioral, clinical, and epidemiological sciences to successfully complete this innovative scope of work. Considerable emphasis and resources have appropriately focused on expanding HIV testing, and interventions have proven efficacious in linking patients from the community to an HIV clinic. In contrast, a paucity of intervention research has focused on patients newly initiatin outpatient HIV medical care. The iENGAGE intervention aims to convert this vulnerable time to a teachable moment during which patients develop information, motivation and adherence skills to achieve and sustain VL suppression. Study findings will play a pivotal role in addressing the scientific void around this dynamic period - a critical time if we are to maximally realize the individual and population health benefits (i.e., treatment as prevention) of VL suppression.
Following a new HIV diagnosis, patients need to attend frequent health care visits, start HIV medications and take them consistently to control HIV. Consistent with the NIH goals outlined in this RFA, the iENGAGE intervention aims to support patients in the year following initiation of HIV medical care. An iENGAGE counselor will work with patients to help them develop motivation and self-care skills to regularly attend HIV health care visits and take HIV medications in order to control HIV.
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