Striving Towards EmPowerment and Medication Adherence (STEP-AD)

Study Overview
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Brief Summary
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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
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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

Official Title
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Striving Towards EmPowerment and Medication Adherence (STEP-AD)

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Experimental Intervention (STEP-AD)
* Behavioral: Enhanced Treatment as Usual (E-TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-positive Identify as Black and/or African American Age 18 or older Biologically female English speaking Prescribed ART medication for at least the last two months Low ART adherence (<80%) or detectable viral load within the past six months or History of abuse/trauma (e.g. sexual, physical, and/or emotional abuse, experienced a traumatic event) Capable of completing and fully understanding the informed consent process and the study procedures Exclusion Criteria: Significant mental health diagnosis requiring treatment (e.g., unstable bipolar disorder; any psychotic disorder) Inability (e.g., due to cognitive or psychiatric difficulties) or unwillingness to provide informed consent Recent (past 6 months) behavioral treatment for ART adherence or trauma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEP-AD (10 sessions)<br>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)<br>* 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.<br>* Other names: Striving Towards EmPowerment and Medication Adherence (STEP-AD);|
| Active Comparator: Enhanced Treatment as Usual (E-TAU)<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ART Medication Adherence | Adherence to antiretroviral therapy (ART) as captured by the Wisepill electronic adherence monitor. Change from baseline adherence. | Change from Baseline until study completion (  9 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Change from Baseline until study completion (  9 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Black, African American, Women, Cognitive Behavioral Therapy, Racism, Stigma, Discrimination, Gender related stressors, Resilience, Behavioral Medicine