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

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ClinicalTrials.gov Identifier: NCT02764853
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sannisha K Dale, University of Miami

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Experimental Intervention (STEP-AD) Behavioral: Enhanced Treatment as Usual (E-TAU) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Striving Towards EmPowerment and Medication Adherence (STEP-AD)
Study Start Date : December 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: STEP-AD (10 sessions)
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)
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.
Other Name: Striving Towards EmPowerment and Medication Adherence (STEP-AD)

Active Comparator: 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.
Behavioral: 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




Primary Outcome Measures :
  1. ART Medication Adherence [ Time Frame: Change from Baseline until study completion (~ 9 months) ]
    Adherence to antiretroviral therapy (ART) as captured by the Wisepill electronic adherence monitor. Change from baseline adherence.


Secondary Outcome Measures :
  1. HIV Viral Load [ Time Frame: Change from Baseline until study completion (~ 9 months) ]
    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.

  2. Trauma Symptoms [ Time Frame: Change from Baseline until study completion (~ 9 months) ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764853


Contacts
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Contact: Sannisha K Dale, PhD, EdM 305-243-3288 sdale@med.miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Sannisha Dale, PhD    305-243-6714    sdale@med.miami.edu   
Contact: Sherene Saunders, MPH    305-243-6714    shineresearch@miami.edu   
Principal Investigator: Sannisha K Dale, PhD, EdM         
United States, Massachusetts
Massachusetts General Hospital Completed
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
University of Miami
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Sannisha K Dale, PhD, EdM University of Miami

Publications of Results:
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Responsible Party: Sannisha K Dale, Assistant Professor of Psychology, University of Miami
ClinicalTrials.gov Identifier: NCT02764853     History of Changes
Other Study ID Numbers: 20170281
1K23MH108439 ( U.S. NIH Grant/Contract )
2016P001464 ( Other Identifier: Mass General )
20170281 ( Other Identifier: UMiami )
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sannisha K Dale, University of Miami:
HIV
Black
African American
Women
Cognitive Behavioral Therapy
Racism
Stigma
Discrimination
Gender related stressors
Resilience
Behavioral Medicine