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A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish] (CARE+ Spanish)

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CARE+ Spanish computer counseling session
CARE+ Spanish brief computer risk assessment session
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV treatment, ART adherence, Using new technology to improve adherence, CARE+, HIV-1 viral loads

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • St. Luke's Roosevelt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Full CARE+ Spanish computer-counseling group

Brief risk assessment study group only (control)

Arm Description

Outcomes

Primary Outcome Measures

ART adherence
HIV-1 viral load
Sexual risks
Clinic visit adherence

Secondary Outcome Measures

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
Two focus groups with providers (n≤30) to assess perceived technology barriers/facilitators

Full Information

First Posted
November 13, 2009
Last Updated
October 26, 2022
Sponsor
New York University
Collaborators
St. Luke's-Roosevelt Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT01013935
Brief Title
A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish]
Acronym
CARE+ Spanish
Official Title
A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish]
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
St. Luke's-Roosevelt Hospital Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV treatment, ART adherence, Using new technology to improve adherence, CARE+, HIV-1 viral loads

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
556 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full CARE+ Spanish computer-counseling group
Arm Type
Active Comparator
Arm Title
Brief risk assessment study group only (control)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
CARE+ Spanish computer counseling session
Other Intervention Name(s)
CARE+
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CARE+ Spanish brief computer risk assessment session
Other Intervention Name(s)
CARE+
Intervention Description
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.
Primary Outcome Measure Information:
Title
ART adherence
Time Frame
Every 3 months up to 12 months
Title
HIV-1 viral load
Time Frame
Every 3 months up to 12 months
Title
Sexual risks
Time Frame
Every 3 months up to 12 months
Title
Clinic visit adherence
Time Frame
Every 3 months up to 12 months
Secondary Outcome Measure Information:
Title
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
Title
Two focus groups with providers (n≤30) to assess perceived technology barriers/facilitators
Time Frame
End of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Kurth, PhD
Organizational Affiliation
NYU
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Roosevelt
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27417531
Citation
Kurth AE, Chhun N, Cleland CM, Crespo-Fierro M, Pares-Avila JA, Lizcano JA, Norman RG, Shedlin MG, Johnston BE, Sharp VL. Linguistic and Cultural Adaptation of a Computer-Based Counseling Program (CARE+ Spanish) to Support HIV Treatment Adherence and Risk Reduction for People Living With HIV/AIDS: A Randomized Controlled Trial. J Med Internet Res. 2016 Jul 13;18(7):e195. doi: 10.2196/jmir.5830.
Results Reference
derived

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A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish]

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