Striving Towards EmPowerment and Medication Adherence (STEP-AD)

Among Black women with HIV in the U.S, generally low rates of adherence to ART are likely due
to relevant psychosocial and contextual factors facing Black women with HIV, such as having a
history of physical, sexual, and emotional abuse, post traumatic stress, racial
discrimination, and contextual variables related to traditional gender roles; each of which
are associated with worse HIV outcomes.

Despite the need, there is currently no evidenced-based psychosocial intervention for Black
women with HIV that addresses these contextual factors to improve adherence to HIV self-care.
A psychosocial intervention including content on reducing the effects of trauma and
discrimination and increasing resilient coping strategies and gender empowerment may be most
culturally appropriate, and therefore effective, in improving quality of life and increasing
treatment adherence in Black women living with HIV/AIDS.

Striving Towards Empowerment and Medication Adherence (STEP-AD) is a research study aimed at
developing an intervention for Black women living with HIV to address psychosocial factors
(i.e. abuse/trauma histories, racial discrimination, HIV stigma/discrimination, and
prescribed traditional gender roles) that have been associated with medication nonadherence
or poor HIV outcomes (e.g. viral load, CD4), but are unaddressed in existing interventions.

Individual, in-depth qualitative interviews (n=30) were conducted with Black women with HIV
and community stakeholders to gather information on the perceived acceptability and to inform
the development of a manualized intervention of an integrated treatment to improve ART
adherence by addressing trauma symptoms, racial discrimination, HIV discrimination, and
gender related stressors experienced by Black women with HIV. This information was used to
develop the resulting intervention.

An open pilot trial (n=5) of the resulting intervention was conducted (December 2015 through
August 2016) in order to initially assess the feasibility of all study procedures and
intervention delivery, acceptability, and a potential clinically significant improvement on
ART adherence and hypothesized psychosocial mediators.

A pilot randomized control trial (RCT) comparing the newly developed intervention (N=25) to
an enhanced treatment as usual control (N=25) on ART adherence (primary outcome) and viral
load (secondary outcome) over 6 months (baseline, 10 weekly treatment visits [approximately 3
months], and a 6 month follow-up) begun enrolling participants as of August 2016.

Inclusion Criteria:

1. HIV-positive

2. Identify as Black and/or African American

3. Age 18 or older

4. Biologically female

5. English speaking

6. Prescribed ART medication for at least the last two months

7. Low ART adherence (<80%) or detectable viral load within the past six months or

8. History of abuse/trauma (e.g. sexual, physical, and/or emotional abuse, experienced a
traumatic event)

9. Capable of completing and fully understanding the informed consent process and the
study procedures

Exclusion Criteria:

1. Significant mental health diagnosis requiring treatment (e.g., unstable bipolar
disorder; any psychotic disorder)

2. Inability (e.g., due to cognitive or psychiatric difficulties) or unwillingness to
provide informed consent

3. Recent (past 6 months) behavioral treatment for ART adherence or trauma