A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish] (CARE+ Spanish)
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ClinicalTrials.gov Identifier: NCT01013935 |
Recruitment Status :
Completed
First Posted : November 16, 2009
Last Update Posted : October 28, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Other: CARE+ Spanish computer counseling session Other: CARE+ Spanish brief computer risk assessment session | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 556 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish] |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
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+ |
- ART adherence [ Time Frame: Every 3 months up to 12 months ]
- HIV-1 viral load [ Time Frame: Every 3 months up to 12 months ]
- Sexual risks [ Time Frame: Every 3 months up to 12 months ]
- Clinic visit adherence [ Time Frame: Every 3 months up to 12 months ]
- 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 ]
- Two focus groups with providers (n≤30) to assess perceived technology barriers/facilitators [ Time Frame: End of the study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01013935
United States, New York | |
St. Luke's Roosevelt | |
New York, New York, United States, 10011 |
Principal Investigator: | Ann Kurth, PhD | NYU |
Responsible Party: | New York University |
ClinicalTrials.gov Identifier: | NCT01013935 |
Other Study ID Numbers: |
1RC1MH088307 ( U.S. NIH Grant/Contract ) |
First Posted: | November 16, 2009 Key Record Dates |
Last Update Posted: | October 28, 2022 |
Last Verified: | September 2018 |
HIV treatment ART adherence Using new technology to improve adherence CARE+ HIV-1 viral loads |
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |