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



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:9/30/2018
Start Date:June 2010
End Date:July 2013

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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).

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).
We found this trial at
1
site
New York, New York 10019
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mi
from
New York, NY
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