A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish]
- Conditions
- HIV Infections
- Interventions
- Other: CARE+ Spanish brief computer risk assessment sessionOther: CARE+ Spanish computer counseling session
- Registration Number
- NCT01013935
- Lead Sponsor
- New York University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 556
- Hispanic birth or ancestry
- Speaks Spanish (mono- or multi-lingual)
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Brief risk assessment study group only (control) CARE+ Spanish brief computer risk assessment session - Full CARE+ Spanish computer-counseling group CARE+ Spanish computer counseling session -
- Primary Outcome Measures
Name Time Method ART adherence Every 3 months up to 12 months HIV-1 viral load Every 3 months up to 12 months Clinic visit adherence Every 3 months up to 12 months Sexual risks Every 3 months up to 12 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
St. Luke's Roosevelt
🇺🇸New York, New York, United States