An interventional study of Experimental Intervention (STEP-AD) and Enhanced Treatment as Usual (E-TAU) in HIV, sponsored by University of Miami. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
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
25 studies on the registry are indexed under Racism; 6 are open to participants now.
This study's enrollment of 184 is above the median of 150 across 21 interventional studies indexed under Racism.
Browse Racism studies →University of Miami is the lead sponsor of 838 studies on the registry; 164 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 96 (84%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in this arm will receive the manualized 10 session behavioral medicine intervention titled "Striving Towards EmPowerment and Medication Adherence".
Behavioral: Experimental Intervention (STEP-AD)
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.
Behavioral: Enhanced Treatment as Usual (E-TAU)
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.
Also known as: Striving Towards EmPowerment and Medication Adherence (STEP-AD)
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
ART Medication Adherence
Adherence to antiretroviral therapy (ART) as captured by the Wisepill electronic adherence monitor. Change from baseline adherence.
Time frame: Change from Baseline until study completion (~ 9 months)
HIV Viral Load
A decrease in participants' HIV viral load ( and/or a change from detectable to undetectable) since the study's start as captured via medical records or blood specimen if recent medical records are unavailable.
Time frame: Change from Baseline until study completion (~ 9 months)
Trauma Symptoms
A decrease in participants' trauma symptoms since the study's start as captured by the Davidson Trauma Scale (DTS), a 17-item self-rating scale used to assess symptoms of Post-Traumatic Stress Disorder (PTSD).
Time frame: Change from Baseline until study completion (~ 9 months)
Plan to share: No
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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