Timely Initiation of HIV Antiretroviral Therapy Among Those Who Delay/Decline

This application seeks to reduce racial/ethnic disparities in HIV/AIDS treatment. National
studies have consistently shown that many persons living with HIV/AIDS (PLHA) in the U.S.
(an estimated 10-19% of PLHA), predominantly people of color, delay taking Highly Active
Antiretroviral Therapy (HAART) until late in their HIV disease or never initiate HAART when
it is medically necessary, even when engaged in care. This population is of critical
importance because they experience disproportionately higher morbidity and earlier mortality
compared to their peers on HAART, and higher health care costs. Further, they are less
likely to achieve virologic suppression, increasing the probability of HIV transmission to
others. However, we do not yet have a behavioral intervention to increase the timely
initiation and continued use of HAART for PLHA-DD. This proposal seeks to address a serious
gap in existing programs by creating a culturally targeted, sustainable, multi-level, and
individualized video-based behavioral intervention for the population of PLHA who are
medically eligible for HAART but who have delayed or declined HAART (referred to as
"PLHA-DD"). This is not an adherence intervention per se, but will serve as a complement to,
and primer for, existing adherence interventions, from which PLHA-DD can benefit when they
initiate HAART. The proposed study is innovative in that it seeks to broaden the HAART
adherence research paradigm to include HAART initiation.

Barriers to HAART initiation for PLHA-DD are multi-faceted. At the individual level, for
example, PLHA-DD suffer from negative attitudes toward HAART (particularly medical mistrust
and fear), a lack of accurate knowledge about HAART and health, and "competing priorities,"
including mental health problems and substance use. PLHA-DD also experience powerful social
barriers to HAART including negative peer norms regarding medications and stigma. Further,
structural barriers such as poor access to necessary resources and supports (e.g.,
transportation, paperwork) and ancillary services (e.g., mental health care) impede HAART
initiation.

We will create a culturally targeted video-based intervention to increase motivation and
psychosocial and practical preparedness for HAART among PLHA-DD. The study is guided by two
complementary theoretical models: the Theory of Triadic Influence, a social-cognitive theory
that integrates individual, social, and structural influences on health behavior and the
Anti-racist Stance, which acknowledges the salience of barriers linked to racial/ethnic
minority status in the lives of PLHA-DD (associated with exclusion, stress, discrimination,
and poor access to institutional structures), without assuming homogeneity among PLHA-DD.
The intervention will be flexible and individualized: there will be a 12-week intervention
period during which participants will receive three structured sessions (including one with
a "support partner" to reduce social barriers, plus patient navigation, an efficacious
low-threshold and adaptable approach to reduce individual and structural barriers to
initiating and sustaining HAART. The intensity of navigation will depend on need, increasing
the intervention's efficiency. The sessions will consist of individualized interactive
components and targeted high-quality video components, which will enhance ease-of-use,
fidelity, and future sustainability.

The aims of this three-year project are to:

1. Explore health care and social service providers' and PLHA-DD's perspectives on
barriers to/facilitators of initiation and continuation of HAART for PLHA-DD at the
levels of individuals, networks, organizations, and other structures;

2. Develop components of an intervention and examine their acceptability, safety,
feasibility, and gather preliminary evidence of their efficacy with respect to HAART
initiation and continuation among PLHA-DD medically eligible for HAART.

To accomplish these aims, we will conduct a three phase study: (1) an Elicitation Phase to
explore barriers to HAART among PLHA-DD (n=16) and health care and social service providers
(N=18); (2) a Development Phase to create intervention components using Intervention
Mapping, a mechanism for integrating theoretical models, data, and the literature; and (3)
an Evaluation Phase to test and revise intervention components (N=30-50 PLHA-DD recruited
from two large urban HIV clinics and assigned to an intervention or control arm using
permuted blocks random assignment and interviewed at 3 time points).

We will also explore peer recruitment approaches to reaching PLHA-DD. PLHA recruited through
peers will be seen at a local field site but will engage in the same procedures as the
clinic-recruited cohort.

We will enroll a total of 90-100 PLHA-DD, ideally half from clinics and half through peer
recruitment.

The urgent need to address disparities in HAART initiation and continuation and support
access to HAART for vulnerable populations has been identified by numerous scientific and
community leaders, health care providers, and public health officials. Although PLHA-DD are
a modest proportion of the population of PLHA (10-19%), efficacious interventions to reduce
morbidity, increase longevity, increase viral load suppression, and reduce health care costs
associated with delayed HAART initiation are sorely lacking for this group, and have very
high potential public health significance.

Inclusion Criteria clinic cohort:

1. HIV-infected for at least six months by medical chart review

2. age 18 years or older

3. African-American or Latino/Hispanic race/ethnicity

4. CD4 < 500

5. enrolled as a patient at PKC/CCC (that is, has been seen a provider at least once in
the clinic in the past year)

6. medically eligible for HAART by DHHS criteria for at least three months by provider
report

7. does not have any condition that in the opinion of the primary care provider would
interfere with provision of informed consent or make it unsafe to participate in this
study

8. has never taken HAART in his/her life OR has taken HAART in the past but on fewer
than 60 days in the past 6 months and not at all in the past 30 days

9. willing to be randomly assigned to an intervention arm

10. able to conduct research activities in English

Inclusion criteria for peer-recruited cohort

1. HIV-infected for at least six months - with medical confirmation

2. age 18 years or older

3. African-American or Latino/Hispanic race/ethnicity

4. CD4 < 500 by self report or medical chart review if possible

5. has never taken HAART in his/her life OR has taken HAART in the past but on fewer
than 60 days in the past 6 months and not at all in the past 30 days by self report

6. willing to be randomly assigned to an intervention arm

7. able to conduct research activities in English