NCT02086630

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P75+ for phase_1 hiv

Timeline
Completed

Started May 2012

Longer than P75 for phase_1 hiv

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

Study Start

First participant enrolled

May 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2015

Enrollment Period

1.9 years

First QC Date

March 11, 2014

Last Update Submit

October 31, 2022

Conditions

HIVAntiretroviral Therapy

Keywords

disparitiesantiretroviralHIVbarriersaccessdelaydeclinediscontinueAfrican AmericanBlackLatinoHispaniccare continuumHeart to Heart Behavioral interventionTreatment as Usual

Outcome Measures

Primary Outcomes (2)

  • Initiation of HAART

    Initiation of HAART by self report and Medical Record

    9 months

  • Continuation of HAART once initiated

    Continuation of HAART once initiated

    9 months

Secondary Outcomes (1)

  • Adherence to ART once initiated

    9 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Treatment as usual

Interventions

Heart to HeartBEHAVIORAL
Intervention

Eligibility Criteria

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

You may qualify if:

  • HIV-infected for at least six months by medical chart review
  • age 18 years or older
  • African-American or Latino/Hispanic race/ethnicity
  • CD4 \< 500
  • enrolled as a patient at PKC/CCC (that is, has been seen a provider at least once in the clinic in the past year)
  • medically eligible for HAART by DHHS criteria for at least three months by provider report
  • 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
  • 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
  • willing to be randomly assigned to an intervention arm
  • able to conduct research activities in English
  • HIV-infected for at least six months - with medical confirmation
  • age 18 years or older
  • African-American or Latino/Hispanic race/ethnicity
  • CD4 \< 500 by self report or medical chart review if possible
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University College of Nursing

New York, New York, 10003, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 13, 2014

Study Start

May 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2015

Last Updated

November 3, 2022

Record last verified: 2015-10

Locations

US(1)