Clinical trial NCT02764853: Striving Towards EmPowerment and Medication Adherence (STEP-AD)
Official title: Striving Towards EmPowerment and Medication Adherence (STEP-AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Black
African American
Women
Cognitive Behavioral Therapy
Racism
Stigma
Discrimination
Gender related stressors
Resilience
Behavioral Medicine
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: National Institute of Mental Health (NIMH)
First posted: 2016-05-06
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Actual enrollment at baseline for all the phases are below. Please note that not all participants enrolled at baseline moved on to the relevant phase due the need to meet inclusion criteria.

Formative qualitative phase: 30 Black women living with HIV, 15 community Stakeholders

Open Pilot phase: 20 Black women living with HIV

Pilot RCT: 119 Black women living with HIV

Total: 184

Eligibility criteria: 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

Primary outcomes:
measure: ART Medication Adherence
timeFrame: Change from Baseline until study completion (~ 9 months)
Secondary outcomes:
measure: HIV Viral Load
timeFrame: Change from Baseline until study completion (~ 9 months)
measure: Trauma Symptoms
timeFrame: Change from Baseline until study completion (~ 9 months)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: University of Miami
name: Sannisha K Dale, PhD, EdM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dale SK, Pierre-Louis C, Bogart LM, O'Cleirigh C, Safren SA. Still I rise: The need for self-validation and self-care in the midst of adversities faced by Black women with HIV. Cultur Divers Ethnic Minor Psychol. 2018 Jan;24(1):15-25. doi: 10.1037/cdp0000165. Epub 2017 Jun 12.
citation: Dale SK, Safren SA. Striving Towards Empowerment and Medication Adherence (STEP-AD): A Tailored Cognitive Behavioral Treatment Approach for Black Women Living With HIV. Cogn Behav Pract. 2018 Aug;25(3):361-376. doi: 10.1016/j.cbpra.2017.10.004. Epub 2017 Dec 5.
citation: Boga DJ, Dale SK. Black Women Living with HIV: A Latent Profile Analysis of Intersectional Adversities, Resilience, and Mental Health. AIDS Patient Care STDS. 2022 Sep;36(9):364-374. doi: 10.1089/apc.2022.0053. Epub 2022 Aug 30.