Group Clinical Visit Adherence Intervention for HIV+ Women of Color



Status:Terminated
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:6/10/2018
Start Date:May 17, 2017
End Date:December 7, 2017

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Development and Testing of a Group Clinical Visit Adherence Intervention for HIV+ Women of Color

The investigators will conduct a pilot randomized controlled trial (RCT) of Sisters-GPS with
HIV-positive women of color with suboptimal ARV adherence and detectable HIV viral loads
(VL). Participants will be randomized to Sisters-GPS (intervention involving weekly group
clinical visits for seven weeks plus social media website) or appointment with an adherence
counselor (a minimum of 3 visits) (control condition). Data sources will include interviews,
medical and pharmacy records, and blood samples. The primary outcome will be ARV adherence at
the completion of the intervention assessed via pill count. The secondary outcome will be HIV
VL suppression.

African American and Latina women comprise about 80% of the approximately 300,000
HIV-positive women in the United States. HIV/AIDS is one of the leading causes of death among
African American and Latina women age 20 to 55 years. HIV-positive women of color are
disproportionately impacted by poverty and other factors such as substance abuse and mental
illness which increase vulnerability to HIV and risk of poor health outcomes (e.g.,
progression to AIDS and death).

The stages of HIV treatment cascade include linkage to and retention in HIV care,
antiretroviral (ARV) utilization, and viral suppression. While all of these stages are
important, what has ultimately lengthened life expectancy among HIV-positive persons has been
achieving long-term viral suppression by optimizing ARV adherence. Suboptimal ARV adherence
is associated with increased risk of progression to AIDS, mortality, and the development of
ARV resistance. Recent studies indicate that significant racial and ethnic disparities in ARV
adherence persist, with African Americans and Latinos having lower levels of adherence than
whites. This disparity is also reflected among HIV+ women, with women of color, and in
particular African American women, having significantly lower rates of ARV adherence than
white women.

Peer-based health interventions have been shown to affect behavior and improve patient
outcomes. For HIV-positive persons, receiving care within a group of peers is associated with
decreased levels of shame, HIV-related stigma, and risk behaviors, and increased levels of
perceived social support. A group-based approach to care involving peers may be especially
important for HIV-positive women of color as HIV-positive women of color may lack positive
social support. Consequently, the peer-group dynamic may help not only to normalize living
with HIV and provide social support but also to motivate healthy behaviors such as ARV
adherence.

Group clinical visits, in which the same group of patients who share a common medical
condition receives care simultaneously from a health care provider over time, is a model of
care that seeks to take advantage of the peer-group dynamic. This model often includes a
clinical assessment, education, and self-management skills development, all in the group
setting. It has been utilized in the care of patients with chronic conditions such as
diabetes mellitus and Hepatitis C infection and improves health outcomes. Therefore, guided
by an enhanced version of the Social Learning Theory, which posits that people learn not only
from their own experiences but from the experiences and actions of others, the investigators
will tailor the group clinical visit model to a model of group HIV treatment focused on
optimizing ARV adherence.

Use of social media, whereby people interact by creating, sharing, and exchanging content
using internet-based technologies, transcends race/ethnicity and socioeconomic status. Within
the arena of health care, its use is becoming increasingly popular. For example, social media
is used by persons who may have a common medical condition, such as HIV, to communicate about
coping with the disease or taking medications. Among HIV-positive persons, social media may
be used to enhance communication and social support; hence, the investigators have
incorporated social media as a component of Sisters-GPS.

To begin to address disparities in ARV adherence and the limitations of current
interventions, the investigators will test Sisters-GPS, an intervention for HIV-positive
women of color with suboptimal ARV adherence that the investigators have developed.
Sisters-GPS is an intervention adapted from the group clinical visit and which incorporated
social media. If proven effective, this intervention has the potential to be a model of
health care delivery for HIV care and treatment, more generally, and can be disseminated to
diverse clinical settings.

Inclusion criteria:

1. HIV-positive

2. Cis gender women (assigned female sex at birth and current identifies as female)

3. ≥ 18 years old

4. English proficiency

5. At least one visit to community health center where received HIV primary care within
the last 12 months

6. Self-reported ARV adherence <100% in the previous 30 days

7. Most recent HIV viral load in last 12 months detectable

8. Prescribed HIV medications for at least 16 weeks prior to detectable HIV viral load

9. Currently prescribed HIV medications (i.e., current active HIV medication prescription
in electronic medical record or pharmacy)

10. Able to attend most/all group visits

Exclusion Criteria:

1. Untreated severe mental illness including major depressive disorder, bipolar disorder,
schizophrenia, psychosis, or current suicidal ideation.

2. Acute intoxication
We found this trial at
1
site
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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from
Bronx, NY
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