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Clinical Trials/NCT01013935
NCT01013935
Completed
N/A

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

New York University1 site in 1 country556 target enrollmentJune 2010
ConditionsHIV Infections

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV Infections
Sponsor
New York University
Enrollment
556
Locations
1
Primary Endpoint
ART adherence
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
July 2013
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

ART adherence

Time Frame: Every 3 months up to 12 months

HIV-1 viral load

Time Frame: Every 3 months up to 12 months

Clinic visit adherence

Time Frame: Every 3 months up to 12 months

Sexual risks

Time Frame: Every 3 months up to 12 months

Secondary Outcomes

  • 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(At end of study)
  • Two focus groups with providers (n≤30) to assess perceived technology barriers/facilitators(End of the study)

Study Sites (1)

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