HIVSTEP-ADNCT02764853
Striving Towards EmPowerment and Medication Adherence (STEP-AD)
A study testing Experimental Intervention (STEP-AD) and Enhanced Treatment as Usual (E-TAU) in people with HIV, run by University of Miami at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV
- What is being tested?
- Experimental Intervention (STEP-AD) and Enhanced Treatment as Usual (E-TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2015to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Miami
Miami, Florida, 33136
About this study
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.
Read the 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
- Conditions
- HIV
- Being tested
- Experimental Intervention (STEP-AD), Enhanced Treatment as Usual (E-TAU)
- Keywords
- HIV, Black, African American, Women, Cognitive Behavioral Therapy, Racism, Stigma, Discrimination, Gender related stressors, Resilience, Behavioral Medicine
- Medical subject headings
- Racism, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Intervention (STEP-AD)Behavioural
Also called Striving Towards EmPowerment and Medication Adherence (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.
Enhanced Treatment as Usual (E-TAU)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: 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. Receives: Behavioral: Enhanced Treatment as Usual (E-TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ART Medication Adherence
Adherence to antiretroviral therapy (ART) as captured by the Wisepill electronic adherence monitor. Change from baseline adherence.
Measured: Change from Baseline until study completion (~ 9 months)
Secondary outcomes (2)
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.
Measured: 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).
Measured: Change from Baseline until study completion (~ 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startDec 2015
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sannisha K Dale, University of Miami
- Investigators
- Sannisha K Dale, PhD, EdM, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764853
- Sponsor's protocol ID
- 20170281
- Other IDs
- 1K23MH108439, 2016P001464, 20170281
- Acronym
- STEP-AD
- Status last verified
- Dec 2019
- First submitted
- 3 May 2016
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28604021Dale 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.
PubMed 30147289Boga 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.
PubMed 39580576Reid 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.
PubMed 36997766Boga 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.
PubMed 36040393
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Striving Towards EmPowerment and Medication Adherence (STEP-AD)
- ClinicalTrials.gov ID
- NCT02764853
- Acronym / sponsor ID
- STEP-AD / 20170281
- Conditions
- HIV
- Keywords
- HIV, Black, African American, Women, Cognitive Behavioral Therapy, Racism, Stigma, Discrimination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute of Mental Health (NIMH)
- Study start
- Dec 2015
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEP-AD (10 sessions) | Experimental | Behavioral: Experimental Intervention (STEP-AD)Participants in this arm will receive the manualized 10 session behavioral medicine intervention titled "Striving Towards EmPowerment and Medication Adherence". |
| Enhanced Treatment as Usual (E-TAU) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HIV-positive
- Identify as Black and/or African American
- Age 18 or older
- Biologically female
- English speaking
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Intervention (STEP-AD)Also: Striving Towards EmPowerment and Medication Adherence (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. | Behavioural | STEP-AD (10 sessions) |
| 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 | Behavioural | Enhanced Treatment as Usual (E-TAU) |
Primary outcome
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.
2 secondary outcomes
HIV Viral Load
Time frame: Change from Baseline until study completion (~ 9 months)
Trauma Symptoms
Time frame: Change from Baseline until study completion (~ 9 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Results publication: PubMed 28604021Dale 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.
- Results publication: PubMed 30147289Dale 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.
- Derived from this study: PubMed 39580576Boga 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.
- Derived from this study: PubMed 36997766Reid 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.
- Derived from this study: PubMed 36040393Boga 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sannisha K Dale, PhD, EdM principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Intervention (STEP-AD) and Enhanced Treatment as Usual (E-TAU) in people with HIV, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ART Medication Adherence (time frame: Change from Baseline until study completion (~ 9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02764853, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.