Timely Initiation of HIV Antiretroviral Therapy Among Those Who Delay/Decline (Heart to Heart)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. Luke's-Roosevelt Hospital Center
Beth Israel Medical Center
Information provided by (Responsible Party):
Marya Gwadz, New York University
ClinicalTrials.gov Identifier:
NCT02086630
First received: March 11, 2014
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

This study addresses racial/ethnic disparities in HIV/AIDS treatment. Many persons living with HIV/AIDS (PLHA) in the U.S. (10-19% of PLHA), predominantly African-Americans and Latinos, delay taking Highly Active Antiretroviral Therapy (HAART) until late in the course of their HIV disease or never initiate HAART when it is medically indicated. However, there are no behavioral interventions to increase HAART initiation among PLHA who delay or decline HAART ("PLHA-DD"). The overarching aim of the proposed study is to develop a flexible, targeted, and sustainable behavioral intervention to increase HAART initiation among PLHA-DD, which, if efficacious, will lead to reductions in morbidity, early mortality, and health care costs, as well as increased viral load suppression (reducing transmission to others). Further, the study complements and primes participants for existing adherence interventions, from which PLHA-DD can benefit when they initiate HAART.


Condition Intervention Phase
HIV
Antiretroviral Therapy
Behavioral: Heart to Heart
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intervention to Increase Timely Initiation of HIV Antiretroviral Therapy (ART) Among Those Who Delay or Decline

Resource links provided by NLM:


Further study details as provided by New York University:

Primary Outcome Measures:
  • Initiation of HAART [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Initiation of HAART by self report and Medical Record

  • Continuation of HAART once initiated [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Continuation of HAART once initiated


Secondary Outcome Measures:
  • Adherence to ART once initiated [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Adherence to ART once initiated by self report and hair sample


Enrollment: 95
Study Start Date: May 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
The Heart to Heart (HTH) intervention was a flexible and individualized intervention with the following components: 3 intervention sessions with video-components; patient navigation lasting up to 24 weeks; treatment initiation support groups (up to 5); and inclusion of a Support Partner. This is a behavioral intervention. The intervention uses Motivational Interviewing.
Behavioral: Heart to Heart
No Intervention: Control
Treatment as usual

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria clinic cohort:

  1. HIV-infected for at least six months by medical chart review
  2. age 18 years or older
  3. African-American or Latino/Hispanic race/ethnicity
  4. CD4 < 500
  5. enrolled as a patient at PKC/CCC (that is, has been seen a provider at least once in the clinic in the past year)
  6. medically eligible for HAART by DHHS criteria for at least three months by provider report
  7. does not have any condition that in the opinion of the primary care provider would interfere with provision of informed consent or make it unsafe to participate in this study
  8. has never taken HAART in his/her life OR has taken HAART in the past but on fewer than 60 days in the past 6 months and not at all in the past 30 days
  9. willing to be randomly assigned to an intervention arm
  10. able to conduct research activities in English

Inclusion criteria for peer-recruited cohort

  1. HIV-infected for at least six months - with medical confirmation
  2. age 18 years or older
  3. African-American or Latino/Hispanic race/ethnicity
  4. CD4 < 500 by self report or medical chart review if possible
  5. has never taken HAART in his/her life OR has taken HAART in the past but on fewer than 60 days in the past 6 months and not at all in the past 30 days by self report
  6. willing to be randomly assigned to an intervention arm
  7. able to conduct research activities in English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02086630

Locations
United States, New York
New York University College of Nursing
New York, New York, United States, 10003
Sponsors and Collaborators
New York University
St. Luke's-Roosevelt Hospital Center
Beth Israel Medical Center
  More Information

No publications provided

Responsible Party: Marya Gwadz, Senior Research Scientist, New York University
ClinicalTrials.gov Identifier: NCT02086630     History of Changes
Other Study ID Numbers: 11-8455, 1R34MH093352
Study First Received: March 11, 2014
Last Updated: March 12, 2014
Health Authority: United States: New York University

Keywords provided by New York University:
disparities
antiretroviral
HIV
barriers
access
delay
decline
discontinue
African American
Black
Latino
Hispanic
care continuum
Heart to Heart Behavioral intervention
Treatment as Usual

ClinicalTrials.gov processed this record on July 23, 2014