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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by New York University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Ann Kurth, New York University
ClinicalTrials.gov Identifier:
NCT01013935
First received: November 13, 2009
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Other: CARE+ Spanish computer counseling session
Other: CARE+ Spanish brief computer risk assessment session
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish]

Resource links provided by NLM:


Further study details as provided by New York University:

Primary Outcome Measures:
  • ART adherence [ Time Frame: Every 3 months up to 12 months ] [ Designated as safety issue: No ]
  • HIV-1 viral load [ Time Frame: Every 3 months up to 12 months ] [ Designated as safety issue: No ]
  • Sexual risks [ Time Frame: Every 3 months up to 12 months ] [ Designated as safety issue: No ]
  • Clinic visit adherence [ Time Frame: Every 3 months up to 12 months ] [ Designated as safety issue: No ]

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 [ Time Frame: At end of study ] [ Designated as safety issue: No ]
  • Two focus groups with providers (n≤30) to assess perceived technology barriers/facilitators [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 586
Study Start Date: June 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Full CARE+ Spanish computer-counseling group Other: CARE+ Spanish computer counseling session
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 Name: CARE+
Active Comparator: Brief risk assessment study group only (control) Other: CARE+ Spanish brief computer risk assessment session
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 Name: CARE+

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013935

Contacts
Contact: Ann Kurth, PhD 212-998-5316 akurth@nyu.edu
Contact: Nkiru Azikiwe, BA 212-992-7127 na35@nyu.edu

Locations
United States, New York
St. Luke's Roosevelt Recruiting
New York, New York, United States, 10011
Sponsors and Collaborators
New York University
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Ann Kurth, PhD NYU
  More Information

No publications provided

Responsible Party: Ann Kurth, Professor, New York University
ClinicalTrials.gov Identifier: NCT01013935     History of Changes
Other Study ID Numbers: 1RC1MH088307
Study First Received: November 13, 2009
Last Updated: February 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York University:
HIV treatment
ART adherence
Using new technology to improve adherence
CARE+
HIV-1 viral loads

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 21, 2014