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Counseling Program for Black Women with HIV

N/A
Recruiting
Led By Sannisha Dale, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older
Cis-gender female
Must not have
Significantly interfering mental health symptoms (e.g., active psychosis that is untreated)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1.5 years
Awards & highlights

Summary

This trial is for Black women living with HIV to test a counseling program specifically designed for them. If you are a Black woman with HIV, have a history of trauma, and are currently taking Antire

Who is the study for?
This trial is specifically for Black women who are living with HIV, have experienced trauma, and are currently on Antiretroviral Therapy (ART). It aims to help them manage their health condition better.
What is being tested?
The study is testing a counseling program called STEP-AD against an enhanced usual treatment (E-TAU) to see which one helps participants stick to their medication regimen more effectively.
What are the potential side effects?
Since the interventions involve counseling programs rather than medications, there may not be direct side effects like those seen with drugs. However, discussing traumatic experiences could potentially cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am a cisgender female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have untreated severe mental health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in viral suppression
Secondary study objectives
Change in PTSD as measured by PCL-5
Change in Post-traumatic Stress Disorder Diagnosis
Change in Post-traumatic cognitions measured by PTCI
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: STEP-ADExperimental Treatment1 Intervention
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.
Group II: Enhanced treatment as usualActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,286 Total Patients Enrolled
University of MiamiLead Sponsor
935 Previous Clinical Trials
421,967 Total Patients Enrolled
Sannisha Dale, PhDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
20,400 Total Patients Enrolled
~167 spots leftby Jun 2029
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