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Completed

NCT Number: NCT01013935

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CARE+ Spanish computer counseling session

Other

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 names: CARE+

CARE+ Spanish brief computer risk assessment session

Other

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 names: CARE+

Primary outcomes

  1. ART adherence

    Time frame: Every 3 months up to 12 months

  2. HIV-1 viral load

    Time frame: Every 3 months up to 12 months

  3. Sexual risks

    Time frame: Every 3 months up to 12 months

  4. Clinic visit adherence

    Time frame: Every 3 months up to 12 months

Secondary outcomes

  1. 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

  2. Two focus groups with providers (n≤30) to assess perceived technology barriers/facilitators

    Time frame: End of the study

Sponsors and collaborators

Lead sponsor

New York University

Other

Collaborators

  • St. Luke's-Roosevelt Hospital Center

Registry information

Acronym: CARE+ Spanish

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 16, 2009
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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