Clinical trial NCT01013935: A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish]
Official title: A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV treatment
ART adherence
Using new technology to improve adherence
CARE+
HIV-1 viral loads
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: St. Luke's-Roosevelt Hospital Center
First posted: 2009-11-16
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).

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).

Primary outcomes:
measure: ART adherence
timeFrame: Every 3 months up to 12 months
measure: HIV-1 viral load
timeFrame: Every 3 months up to 12 months
measure: Sexual risks
timeFrame: Every 3 months up to 12 months
measure: Clinic visit adherence
timeFrame: Every 3 months up to 12 months
Secondary outcomes:
measure: 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
timeFrame: At end of study
measure: Two focus groups with providers (n≤30) to assess perceived technology barriers/facilitators
timeFrame: End of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's Roosevelt
state: New York
Study officials:
affiliation: NYU
name: Ann Kurth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.