A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish]
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Other: CARE+ Spanish computer counseling session Other: CARE+ Spanish brief computer risk assessment session |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish] |
- 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 ]
- 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 ]
| Enrollment: | 556 |
| Study Start Date: | June 2010 |
| Study Completion Date: | July 2013 |
| Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Full CARE+ Spanish computer-counseling group |
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+
|
| Active Comparator: Brief risk assessment study group only (control) |
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+
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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).
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01013935
| United States, New York | |
| St. Luke's Roosevelt | |
| New York, New York, United States, 10011 | |
| Principal Investigator: | Ann Kurth, PhD | NYU |
More Information
No publications provided
| Responsible Party: | Ann Kurth, Professor, New York University |
| ClinicalTrials.gov Identifier: | NCT01013935 History of Changes |
| Other Study ID Numbers: | 1RC1MH088307 |
| Study First Received: | November 13, 2009 |
| Last Updated: | November 21, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York University:
|
HIV treatment ART adherence Using new technology to improve adherence CARE+ HIV-1 viral loads |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections |
Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases |
ClinicalTrials.gov processed this record on February 26, 2015