HivNCT06463886
Striving Towards EmPowerment and Medication Adherence R01
A study testing STEP-AD and Enhanced treatment as usual (E-TAU) in people with Hiv and Mental Health Issue, run by University of Miami at 1 site in United States.
Trial summary
This is a study for Black women living with HIV to test a counseling program for Black women living with HIV. This participant may be a good fit if the participant is a Black woman, living with HIV, has a history of trauma, and is currently taking Antiretroviral Therapy (ART) medicines Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hiv, Mental Health Issue
- What is being tested?
- 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
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Black
- Living with HIV
- Female
- Age 18 or older
- English speaking
- Viral load non-suppression (>200 ml) within the past year OR a detectable HIV viral load (>/= 20 within the past year) OR a lack of HIV viral load measure for 6 consecutive months or more during the past 12 months OR missed HIV care visits greater than 6 months within the past year
- History of trauma/abuse
- Capable of completing and fully understanding the informed consent process and study procedures
Who cannot join
- Unable to completely and fully understand the informed consent process and the study procedures
- Significantly interfering mental health symptoms (e.g., active psychosis that is untreated)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Sannisha Dale, PhD, 3052841991, sdale@med.miami.edu
SHINE Research, 3052436714, shineresearch@miami.edu
About this study
Official title: A Randomized Control Trial of Striving Towards EmPowerment and Medication Adherence (STEP-AD)
This is a study for Black women living with HIV to test a counseling program for Black women living with HIV. This participant may be a good fit if the participant is a Black woman, living with HIV, has a history of trauma, and is currently taking Antiretroviral Therapy (ART) medicines
- Conditions
- Hiv, Mental Health Issue
- Being tested
- STEP-AD, Enhanced treatment as usual (E-TAU)
- Keywords
- HIV, Black women, Trauma, Stigma, Medication adherence
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Wounds and Injuries, Social Stigma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEP-ADBehavioural
This in-person STEP-AD intervention will consist of 10 sessions. Session 1: Life Steps Adherence Session 2: Psychoeducation on the treatment model Session 3: Substance Use and Enhancing Resilience Session 4: Trauma Impact Session 5: Cognitive Restructuring Session 6: Impact of Unique Enacted Stressors and Coping Session 7: HIV Stigma Impact and Coping Session 8: Stressors Women Face and Coping Session 9: Body Image and Healthy Relationships Session 10: Practice, Review, and Relapse Prevention. Each session lasts for about 40 to 60 minutes.
Enhanced treatment as usual (E-TAU)Behavioural
Participants assigned to the E-TAU condition will receive 10 in person sessions to ensure comparable contact time with study staff and identical incentives. The first session will consist of a session on healthy living with HIV (CDC content on HIV 101 [highlights importance of engaging in care, adhering to medication, finding support], nutrition, and physical activity. The remaining 9 sessions will consist of neutral (daily events) writing. Women will be asked to write a description of their plans for the next 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| STEP-AD | Experimental | Participants in this arm will receive the manualized 10 session behavioral medicine intervention titled "Striving Towards EmPowerment and Medication Adherence". Participants will be in this group for a total of up to 1.5 years. Receives: Behavioral: STEP-AD |
| Enhanced treatment as usual | Active comparator | Participants in the comparison condition will also complete 10 in person sessions. The first session will consist of a session on healthy living with HIV. The remaining 9 sessions will consist of neutral (daily events) writing. Participants will be in this group for a total of up to 1.5 years. 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.
Change in viral suppression
HIV viral load <200 copies/ml time averaged. Measured by blood specimen.
Measured: Baseline up to 1.5 years
Secondary outcomes (6)
Change in antiretroviral (ART) adherence
A 3-item self-report instrument that will measure reported adherence to ART. Responses range from 1 to 6. Responses will be averaged (min average of 1, max average of 6) across items with higher scores indicating higher adherence to ART medication.
Measured: Baseline up to 1.5 years
Change in adherence to anti-retroviral medications questionnaire
A list of 12 reasons why individuals may miss taking their ART (e.g., forgot, change in routine) will be used from the AIDS Clinical Trials Group. The minimum score is 0 (no endorsed reasons for missing medication) and maximum score is 36 (endorsing more reasons for missing ART medication).
Measured: Baseline up to 1.5 years
Change in engagement in HIV care
Number of kept versus number of scheduled visits verified by self-report.
Measured: Baseline up to 1.5 years
Change in PTSD as measured by PCL-5
Measured by the Posttraumatic Stress Disorder Checklist (PCL)-5, a 20-item self-report measure of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate higher PTSD severity.
Measured: Baseline up to 1.5 years
Change in Post-traumatic cognitions measured by PTCI
The Posttraumatic Cognitions Inventory (PTCI) is a 36-item, self-report questionnaire, and each item is rated on a 7-point Likert scale that ranges from 1 (totally agree) to 7 (totally disagree).
Measured: Baseline up to 1.5 years
Change in Post-traumatic Stress Disorder Diagnosis
A structured mental health diagnostic interview will be administered to evaluate participants' mental health symptoms and whether they meet criteria for mental health diagnoses (e.g. Post-traumatic Stress Disorder).
Measured: Baseline up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start19 Aug 2024
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sannisha K Dale, University of Miami
- Investigators
- Sannisha Dale, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463886
- Sponsor's protocol ID
- 20230854
- Other IDs
- R01MH135833
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Striving Towards EmPowerment and Medication Adherence (STEP-AD)
- ClinicalTrials.gov ID
- NCT06463886
- Acronym / sponsor ID
- 20230854
- Conditions
- Hiv, Mental Health Issue
- Keywords
- HIV, Black women, Trauma, Stigma, Medication adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 18 Jun 2024 (actual)
- 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.
This is a study for Black women living with HIV to test a counseling program for Black women living with HIV. This participant may be a good fit if the participant is a Black woman, living with HIV, has a history of trauma, and is currently taking Antiretroviral Therapy (ART) medicines
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 | Experimental | Behavioral: STEP-ADParticipants in this arm will receive the manualized 10 session behavioral medicine intervention titled "Striving Towards EmPowerment and Medication Adherence". Participants will be in this group for a total of up to 1.5 years. |
| Enhanced treatment as usual | Active comparator | Behavioral: Enhanced treatment as usual (E-TAU)Participants in the comparison condition will also complete 10 in person sessions. The first session will consist of a session on healthy living with HIV. The remaining 9 sessions will consist of neutral (daily events) writing. Participants will be in this group for a total of up to 1.5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Black
- Living with HIV
- Female
- Age 18 or older
- English speaking
Key exclusion criteria (2 listed)
- Unable to completely and fully understand the informed consent process and the study procedures
- Significantly interfering mental health symptoms (e.g., active psychosis that is untreated)
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 |
|---|---|---|
| STEP-ADThis in-person STEP-AD intervention will consist of 10 sessions. Session 1: Life Steps Adherence Session 2: Psychoeducation on the treatment model Session 3: Substance Use and Enhancing Resilience Session 4: Trauma Impact Session 5: Cognitive Restructuring Session 6: Impact of Unique Enacted Stressors and Coping Session 7: HIV Stigma Impact and Coping Session 8: Stressors Women Face and Coping Session 9: Body Image and Healthy Relationships Session 10: Practice, Review, and Relapse Prevention. Each session lasts for about 40 to 60 minutes. | Behavioural | STEP-AD |
| Enhanced treatment as usual (E-TAU)Participants assigned to the E-TAU condition will receive 10 in person sessions to ensure comparable contact time with study staff and identical incentives. The first session will consist of a session on healthy living with HIV (CDC content on HIV 101 [highlights importance of engaging in care, adhering to medication, finding support], nutrition, and physical activity. The remaining 9 sessions will consist of neutral (daily events) writing. Women will be asked to write a description of their plans for the next 24 hours. | Behavioural | Enhanced treatment as usual |
Primary outcome
Change in viral suppression
Time frame: Baseline up to 1.5 years
HIV viral load <200 copies/ml time averaged. Measured by blood specimen.
6 secondary outcomes
Change in antiretroviral (ART) adherence
Time frame: Baseline up to 1.5 years
Change in adherence to anti-retroviral medications questionnaire
Time frame: Baseline up to 1.5 years
Change in engagement in HIV care
Time frame: Baseline up to 1.5 years
Change in PTSD as measured by PCL-5
Time frame: Baseline up to 1.5 years
Change in Post-traumatic cognitions measured by PTCI
Time frame: Baseline up to 1.5 years
Change in Post-traumatic Stress Disorder Diagnosis
Time frame: Baseline up to 1.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- 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.
Sannisha Dale, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEP-AD and Enhanced treatment as usual (E-TAU) in people with Hiv and Mental Health Issue, run by University of Miami at 1 site 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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sannisha Dale, PhD (3052841991, sdale@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in viral suppression (time frame: Baseline up to 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.