Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV

The Centers for Disease Control's Retention In Care (CDC RIC) and the Participating and
Communicating Together (PACT) antiretroviral therapy (ART) adherence interventions have shown
success in the literature, and they are well suited to target the two essential HIV adherence
behaviors needed to achieve better overall health: HIV medical visit adherence and ART
adherence. While these original interventions target each of these behaviors separately, the
comprehensive iENGAGE intervention combines these two approaches to address the experience of
an individual who is initiating HIV care. Upon entry to care, knowledge, motivation, and
skills for adherence to HIV medical visits and ART must be learned rapidly. Jointly targeting
these behaviors offers a distinct advantage over addressing them separately.

iENGAGE integrates CDC RIC and PACT through their common intervention targets with the
assistance of trained interventionists, who will maintain contact with the new patient to
educate and assist with reinforcing the importance of adherence to care. While the actions
required to attend HIV medical care appointments and take medications properly are distinct,
each is influenced by an individual's personal motivation and skills for self-management of
HIV infection and overall health; these principles are the focus of the intervention sessions
for this protocol .

During this intervention, our team will make every effort to protect all participants'
confidential and private information in order to minimize possible study-associated risks. In
addition, the follow up measurement plan for this study is unique, as it aims to utilize the
X060831001: Unsolicited R24 for the Centers for AIDS Research (CFAR) Network of Integrated
Clinical Sciences, (CNICS), PI Michael Saag) secure electronic data infrastructure, which has
existing defined protocols for the protection of human subjects data, including a data
management core that is housed at the collaborating site at the University of Washington.

Stigma Supplement (Michael J. Mugavero, Janet M. Turan, Bulent Turan)

As part of this supplement, the research team has incorporated multi-item questionnaire
measures of stigma into baseline and final data collection for the iENGAGE trial. The goal of
Aim 1 is to examine the longitudinal associations and potential causal mechanisms in the
relationships between dimensions of HIV-related stigma and HIV visit adherence,
antiretroviral therapy (ART) adherence, and viral load suppression, among control
participants in the study. In addition, in Aim 2, we will examine the effects of the iENGAGE
intervention on dimensions of stigma, by comparing changes in stigma in the two arms of the
Randomized Controlled Trial (RCT).

For Aim 3, after participants have completed the 48-week iENGAGE intervention, we will
conduct up to 40 individual in-depth face-to-face qualitative interviews with selected
participants using a separate informed consent process. Topics to be explored in these
interviews include qualitative exploration of how HIV-related stigma and other intersectional
stigmas affect engagement in HIV care, as wells as exploring how participation in the iENGAGE
intervention may have influenced the participant's experiences of anticipated, internalized,
and experienced stigma; as well as disclosure concerns and actual disclosure behavior.

Inclusion Criteria:

- Documented HIV infection

- Newly establishing HIV care at study site

- Age 18 years or older

- English speaking

Exclusion Criteria:

- Not willing or able to provide informed consent

- Received prior outpatient HIV care

- Completed >1 primary care visits