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

November 13, 2009
February 20, 2012
June 2010
March 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01013935 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish]
A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish]

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.

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • 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+
  • 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+
  • Active Comparator: Full CARE+ Spanish computer-counseling group
    Intervention: Other: CARE+ Spanish computer counseling session
  • Active Comparator: Brief risk assessment study group only (control)
    Intervention: Other: CARE+ Spanish brief computer risk assessment session
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
586
March 2012
March 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
Yes
Contact: Ann Kurth, PhD 212-998-5316 akurth@nyu.edu
Contact: Nkiru Azikiwe, BA 212-992-7127 na35@nyu.edu
United States
 
NCT01013935
1RC1MH088307
Yes
Ann Kurth, New York University
New York University
St. Luke's-Roosevelt Hospital Center
Principal Investigator: Ann Kurth, PhD NYU
New York University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP