At each of the study locations, individuals testing HIV positive who also have OUD
(n=4x70) will receive concurrent anti-retroviral therapy (ART) and methadone maintenance
treatment (MMT) based on the usual care standards. Their patient level outcomes will be
compared with individuals meeting the same inclusion criteria (n=4x70) and treated under
the proposed improved model (post implementation evaluation). The usual care standard
will consist of provision of ART and medical care for HIV and other medical HIV
co-morbidities provided at the HIV/AIDS treatment center with an expedited and
facilitated referral to a methadone maintenance treatment (MMT). The improved care model
will include the usual care supplemented by continuing education and coaching of medical
staff at HIV/AIDS and MMT clinics and by provision of additional peer-based counseling
intervention focused on behavioral skills and strategies that patients can learn and
master to achieve uninterrupted, long-term ART treatment participation while continuing
OUD recovery through MMT. The primary outcome measure, rates of patients with virologic
suppression (< 20 copies/mL) in the two care models will be assessed at 24 weeks. The
secondary outcomes, also followed for 24 weeks, will include ART adherence measured by
objective measures (tenofovir dried blood spots, clinic records) and self-report;
decreased illicit opioid use measured by rates of opioid negative urine toxicology
results and self-report; and improvements on other health-related and functional status
outcomes.
Aim 1: To evaluate comparative effectiveness of fully implemented seek, test, treat and
retain strategy (FI-STTR) the study will compare clinical, patient level, outcomes
between enhanced usual care (EUC) and FI-STTR across the four study sites.
Hypothesis: The investigators hypothesize a statistically significant effect on the
primary outcome favoring the FI-STTR over EUC. It is also hypothesized that FI-STTR will
be superior over EUC on all secondary outcomes.
Concurrently at each study location, using implementation science mixed methods research
tools and engaging key local stakeholders (treatment providers, patients, their families,
and community activists), and evaluating clinical and healthcare data, the study will
assess existing barriers (organizational, personnel, and community level factors) and
uncover available resources and facilitators for a successful implementation of the
improved care model.
Aim 2: To assess existing barriers; organizational, personnel, community level factors;
and available resources and potentially facilitating factors for successful
implementation of the FI-STTR at HIV/AIDS clinics. There are no hypotheses specified a
priori for Aim 2 of the proposed study.
