NCT02764853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

4 years

First QC Date

May 3, 2016

Last Update Submit

December 16, 2019

Conditions

HIV

Keywords

HIVBlackAfrican AmericanWomenCognitive Behavioral TherapyRacismStigmaDiscriminationGender related stressorsResilienceBehavioral Medicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • HIV Viral Load

    Change from Baseline until study completion (~ 9 months)

  • Trauma Symptoms

    Change from Baseline until study completion (~ 9 months)

Study Arms (2)

STEP-AD (10 sessions)

EXPERIMENTAL

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)

Enhanced Treatment as Usual (E-TAU)

ACTIVE COMPARATOR

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)

Interventions

Experimental Intervention (STEP-AD)BEHAVIORAL

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)
STEP-AD (10 sessions)
Enhanced Treatment as Usual (E-TAU)BEHAVIORAL

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

Enhanced Treatment as Usual (E-TAU)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (5)

  • 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.

    PMID: 28604021RESULT

  • 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.

    PMID: 30147289RESULT

  • 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.

    PMID: 39580576DERIVED

  • 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.

    PMID: 36997766DERIVED

  • 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.

    PMID: 36040393DERIVED

MeSH Terms

Conditions

RacismSocial Stigma

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial Discrimination

Study Officials

  • Sannisha K Dale, PhD, EdM

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 6, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 18, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)