Striving Towards EmPowerment and Medication Adherence (STEP-AD)
NCT ID: NCT02764853
Last Updated: 2019-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
184 participants
INTERVENTIONAL
2015-12-31
2019-12-01
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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STEP-AD (10 sessions)
Participants in this arm will receive the manualized 10 session behavioral medicine intervention titled "Striving Towards EmPowerment and Medication Adherence".
Experimental Intervention (STEP-AD)
This experimental intervention will consist of 10 sessions- 1 session of Lifesteps (problem solving for medication adherence) and 9 sessions of an intervention specifically tailored for Black women living with HIV to address trauma/abuse, racial discrimination, HIV stigma, and gender roles expectations in order to improve health outcomes (e.g., medication adherence, viral load), increase resiliency, and enhance adaptive coping strategies.
Enhanced Treatment as Usual (E-TAU)
Participants in this arm will receive 1 session of Lifesteps and appropriate services and referrals as needed, followed by bi-weekly check-ins with a study research assistant.
Enhanced Treatment as Usual (E-TAU)
Participants assigned to the E-TAU condition will receive 1 session of Lifesteps (problem solving for medication adherence) and appropriate services and referrals as needed
Interventions
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Experimental Intervention (STEP-AD)
This experimental intervention will consist of 10 sessions- 1 session of Lifesteps (problem solving for medication adherence) and 9 sessions of an intervention specifically tailored for Black women living with HIV to address trauma/abuse, racial discrimination, HIV stigma, and gender roles expectations in order to improve health outcomes (e.g., medication adherence, viral load), increase resiliency, and enhance adaptive coping strategies.
Enhanced Treatment as Usual (E-TAU)
Participants assigned to the E-TAU condition will receive 1 session of Lifesteps (problem solving for medication adherence) and appropriate services and referrals as needed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Massachusetts General Hospital
OTHER
National Institute of Mental Health (NIMH)
NIH
University of Miami
OTHER
Responsible Party
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Sannisha K Dale
Assistant Professor of Psychology
Principal Investigators
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Sannisha K Dale, PhD, EdM
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
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.
Boga DJ, Juste RS, Etienne K, Dale SK. Using network analysis to elucidate the relationships among support systems, trauma and depressive symptoms, self-silencing, and risk of HIV viral non-suppression among black women living with HIV. J Behav Med. 2025 Apr;48(2):268-279. doi: 10.1007/s10865-024-00530-1. Epub 2024 Nov 23.
Reid R, Dale SK. Structural equation modeling of microaggressions, religious and racism-related coping, medication adherence, and viral load among Black women living with HIV. J Behav Med. 2023 Oct;46(5):837-848. doi: 10.1007/s10865-023-00403-z. Epub 2023 Mar 30.
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.
Other Identifiers
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2016P001464
Identifier Type: OTHER
Identifier Source: secondary_id
20170281
Identifier Type: OTHER
Identifier Source: secondary_id
20170281
Identifier Type: -
Identifier Source: org_study_id