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

December 16, 2019 updated by: Sannisha K Dale, University of Miami
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute of Mental Health (NIMH)
Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (ESTIMATE)

May 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20170281 (OTHER: UMiami)
  • 1K23MH108439 (NIH)
  • 2016P001464 (OTHER: Mass General)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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