NCT01013935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 28, 2022

Status Verified

September 1, 2018

Enrollment Period

3.1 years

First QC Date

November 13, 2009

Last Update Submit

October 26, 2022

Conditions

HIV Infections

Keywords

HIV treatmentART adherenceUsing new technology to improve adherenceCARE+HIV-1 viral loads

Outcome Measures

Primary Outcomes (4)

  • ART adherence

    Every 3 months up to 12 months

  • HIV-1 viral load

    Every 3 months up to 12 months

  • Sexual risks

    Every 3 months up to 12 months

  • Clinic visit adherence

    Every 3 months up to 12 months

Secondary Outcomes (2)

  • 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

Study Arms (2)

Full CARE+ Spanish computer-counseling group

ACTIVE COMPARATOR
Other: CARE+ Spanish computer counseling session

Brief risk assessment study group only (control)

ACTIVE COMPARATOR
Other: CARE+ Spanish brief computer risk assessment session

Interventions

CARE+ Spanish computer counseling sessionOTHER

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.

Also known as: CARE+
Full CARE+ Spanish computer-counseling group
CARE+ Spanish brief computer risk assessment sessionOTHER

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.

Also known as: CARE+
Brief risk assessment study group only (control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hispanic birth or ancestry
  • Speaks Spanish (mono- or multi-lingual)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's Roosevelt

New York, New York, 10011, United States

Location

Related Publications (1)

  • 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.

    PMID: 27417531DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Ann Kurth, PhD

    NYU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2009

First Posted

November 16, 2009

Study Start

June 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 28, 2022

Record last verified: 2018-09

Locations

US(1)