- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01013935
A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish] (CARE+ Spanish)
October 26, 2022 updated by: New York University
The purpose of this study is to see if a computer counseling tool helps Spanish-speaking people living with HIV to have safer sex and to do well on their HIV medicines.
Study Overview
Status
Completed
Conditions
Detailed Description
Latinos are the fastest-growing group with some of the largest health disparities including HIV.
Barriers including language are associated with lower antiretroviral therapy (ART) adherence seen among Latinos.
There are no evidence-based interventions (randomized trials that significantly reduced viral load and HIV transmission risk to sexual partners - 'positive prevention') delivered in Spanish in routine clinical practice.
Our computerized counseling tool (CARE+) in a phase III trial of English-speaking adults increased ART adherence and reduced viral load and condom use errors.
We now propose a longitudinal effectiveness (phase IV) study to evaluate the impact of computerized counseling in audio-narrated Spanish in a busy urban HIV clinic.
This 'CARE+ Spanish' proposal is responsive to 06-OD(OBSSR)-101, for new technologies to improve adherence in clinical practice.
Aim 1: Adapt CARE+ Spanish for use during routine clinical visits by Spanish-speaking HIV clinic attendees using an expert panel to shorten content and add Spanish audio dialects; do usability testing (n≤8).
Aim 2: Establish real-world utility of 'CARE+ Spanish'.
Peer staff will recruit Spanish-speaking adults on ART who will be randomly assigned to intervention (Group A n=250) or risk-assessment control (B, n=250) for 0,3-,6-,9-month sessions; at 12-month session groups will switch to opposite arm (delayed intervention design).
Linear and generalized linear mixed effects models will analyze impact on 30-day ART adherence, clinic visit adherence, HIV-1 viral load and sexual risks, and to assess whether any Group A changes are sustained at month 12, among an expected n=400 retained study participants (120 female, 280 male).
Aim 3: Explore cultural acceptability of tool among clients and clinic providers.
Conduct qualitative exit interviews with patients (n=75) to assess technology uptake factors, cultural/linguistic acceptability, and suggestions for ongoing use among older vs. younger, and US-born vs. foreign-born Latino groups.
Conduct two focus groups with providers (n≤30) to assess perceived technology barriers/facilitators.
Analysis will identify factors affecting acceptability, utilization, and impact.
Technology tools like CARE+ present significant opportunities to bridge the health promotion delivery gap, especially if linguistically adapted for often-neglected groups such as Latinos (15% of the US population).
Study Type
Interventional
Enrollment (Actual)
556
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
-
-
New York
-
New York, New York, United States, 10011
- St. Luke's Roosevelt
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hispanic birth or ancestry
- Speaks Spanish (mono- or multi-lingual)
Exclusion Criteria:
- Lack of fluency in Spanish
- Thought disorder that precludes participation
- Inability to give informed consent due to altered mentation at time of enrollment (e.g., visibly inebriated or high).
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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Full CARE+ Spanish computer-counseling group
|
The computer will ask patients questions about taking HIV medicine.
The computer will also ask patients questions about sexual and substance use activities.
The computer will let patients look at short videos on various HIV medicine and HIV risk reduction topics and will then help patients create a health plan.
Patients will get an anonymous print out at the end of the session and can choose to share with health care provider.
There are questions about depression, suicide, or domestic violence.
If a patient's answers indicate that they may be depressed, suicidal, or currently in an abusive relationship, we will refer them to a health worker at the clinic.
We will repeat the session every 3 months up to 12 months total.
Other Names:
|
Active Comparator: Brief risk assessment study group only (control)
|
The computer will ask patients questions about taking HIV medicine.
The computer will also ask patients questions about sexual and substance use activities.
We will repeat the session every 3 months up to 12 months total.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ART adherence
Time Frame: Every 3 months up to 12 months
|
Every 3 months up to 12 months
|
HIV-1 viral load
Time Frame: Every 3 months up to 12 months
|
Every 3 months up to 12 months
|
Sexual risks
Time Frame: Every 3 months up to 12 months
|
Every 3 months up to 12 months
|
Clinic visit adherence
Time Frame: Every 3 months up to 12 months
|
Every 3 months up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Qualitative exit interviews with patients (n=75) to assess technology uptake factors, cultural/linguistic acceptability, and suggestions for ongoing use among older vs. younger, and US-born vs. foreign-born Latino groups
Time Frame: At end of study
|
At end of study
|
Two focus groups with providers (n≤30) to assess perceived technology barriers/facilitators
Time Frame: End of the study
|
End of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ann Kurth, PhD, NYU
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.
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
June 1, 2010
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
November 13, 2009
First Submitted That Met QC Criteria
November 13, 2009
First Posted (Estimate)
November 16, 2009
Study Record Updates
Last Update Posted (Actual)
October 28, 2022
Last Update Submitted That Met QC Criteria
October 26, 2022
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1RC1MH088307 (U.S. NIH Grant/Contract)
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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