HIVPhase 1Heart to HeartNCT02086630
Timely Initiation of HIV Antiretroviral Therapy Among Those Who Delay/Decline
A Phase 1 study testing Heart to Heart in people with HIV and Antiretroviral Therapy, run by New York University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Antiretroviral Therapy
- What is being tested?
- Heart to Heart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
- willing to be randomly assigned to an intervention arm
- able to conduct research activities in English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University College of Nursing
New York, New York, 10003
About this study
Official title: Intervention to Increase Timely Initiation of HIV Antiretroviral Therapy (ART) Among Those Who Delay or Decline
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.
Read the detailed description
This application seeks to reduce racial/ethnic disparities in HIV/AIDS treatment. National studies have consistently shown that many persons living with HIV/AIDS (PLHA) in the U.S. (an estimated 10-19% of PLHA), predominantly people of color, delay taking Highly Active Antiretroviral Therapy (HAART) until late in their HIV disease or never initiate HAART when it is medically necessary, even when engaged in care. This population is of critical importance because they experience disproportionately higher morbidity and earlier mortality compared to their peers on HAART, and higher health care costs. Further, they are less likely to achieve virologic suppression, increasing the probability of HIV transmission to others. However, we do not yet have a behavioral intervention to increase the timely initiation and continued use of HAART for PLHA-DD. This proposal seeks to address a serious gap in existing programs by creating a culturally targeted, sustainable, multi-level, and individualized video-based behavioral intervention for the population of PLHA who are medically eligible for HAART but who have delayed or declined HAART (referred to as "PLHA-DD"). This is not an adherence intervention per se, but will serve as a complement to, and primer for, existing adherence interventions, from which PLHA-DD can benefit when they initiate HAART. The proposed study is innovative in that it seeks to broaden the HAART adherence research paradigm to include HAART initiation.
Barriers to HAART initiation for PLHA-DD are multi-faceted. At the individual level, for example, PLHA-DD suffer from negative attitudes toward HAART (particularly medical mistrust and fear), a lack of accurate knowledge about HAART and health, and "competing priorities," including mental health problems and substance use. PLHA-DD also experience powerful social barriers to HAART including negative peer norms regarding medications and stigma. Further, structural barriers such as poor access to necessary resources and supports (e.g., transportation, paperwork) and ancillary services (e.g., mental health care) impede HAART initiation.
We will create a culturally targeted video-based intervention to increase motivation and psychosocial and practical preparedness for HAART among PLHA-DD. The study is guided by two complementary theoretical models: the Theory of Triadic Influence, a social-cognitive theory that integrates individual, social, and structural influences on health behavior and the Anti-racist Stance, which acknowledges the salience of barriers linked to racial/ethnic minority status in the lives of PLHA-DD (associated with exclusion, stress, discrimination, and poor access to institutional structures), without assuming homogeneity among PLHA-DD. The intervention will be flexible and individualized: there will be a 12-week intervention period during which participants will receive three structured sessions (including one with a "support partner" to reduce social barriers, plus patient navigation, an efficacious low-threshold and adaptable approach to reduce individual and structural barriers to initiating and sustaining HAART. The intensity of navigation will depend on need, increasing the intervention's efficiency. The sessions will consist of individualized interactive components and targeted high-quality video components, which will enhance ease-of-use, fidelity, and future sustainability.
The aims of this three-year project are to:
- Explore health care and social service providers' and PLHA-DD's perspectives on barriers to/facilitators of initiation and continuation of HAART for PLHA-DD at the levels of individuals, networks, organizations, and other structures;
- Develop components of an intervention and examine their acceptability, safety, feasibility, and gather preliminary evidence of their efficacy with respect to HAART initiation and continuation among PLHA-DD medically eligible for HAART.
To accomplish these aims, we will conduct a three phase study: (1) an Elicitation Phase to explore barriers to HAART among PLHA-DD (n=16) and health care and social service providers (N=18); (2) a Development Phase to create intervention components using Intervention Mapping, a mechanism for integrating theoretical models, data, and the literature; and (3) an Evaluation Phase to test and revise intervention components (N=30-50 PLHA-DD recruited from two large urban HIV clinics and assigned to an intervention or control arm using permuted blocks random assignment and interviewed at 3 time points).
We will also explore peer recruitment approaches to reaching PLHA-DD. PLHA recruited through peers will be seen at a local field site but will engage in the same procedures as the clinic-recruited cohort.
We will enroll a total of 90-100 PLHA-DD, ideally half from clinics and half through peer recruitment.
The urgent need to address disparities in HAART initiation and continuation and support access to HAART for vulnerable populations has been identified by numerous scientific and community leaders, health care providers, and public health officials. Although PLHA-DD are a modest proportion of the population of PLHA (10-19%), efficacious interventions to reduce morbidity, increase longevity, increase viral load suppression, and reduce health care costs associated with delayed HAART initiation are sorely lacking for this group, and have very high potential public health significance.
- Conditions
- HIV, Antiretroviral Therapy
- Being tested
- Heart to Heart
- Keywords
- disparities, antiretroviral, HIV, barriers, access, delay, decline, discontinue, African American, Black, Latino, Hispanic, care continuum, Heart to Heart Behavioral intervention, Treatment as Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart to HeartBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Heart to Heart |
| Control | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of HAART
Initiation of HAART by self report and Medical Record
Measured: 9 months
Continuation of HAART once initiated
Continuation of HAART once initiated
Measured: 9 months
Secondary outcomes (1)
Adherence to ART once initiated
Adherence to ART once initiated by self report and hair sample
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMay 2012
- Primary completionApr 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center, Beth Israel Medical Center, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086630
- Sponsor's protocol ID
- 11-8455
- Other IDs
- 1R34MH093352
- Acronym
- Heart to Heart
- Status last verified
- Oct 2015
- First submitted
- 11 Mar 2014
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Increase Timely Initiation of HIV Antiretroviral Therapy (ART) Among Those Who Delay or Decline
- ClinicalTrials.gov ID
- NCT02086630
- Acronym / sponsor ID
- Heart to Heart / 11-8455
- Conditions
- HIV, Antiretroviral Therapy
- Keywords
- disparities, antiretroviral, HIV, barriers, access, delay, decline, discontinue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center, Beth Israel Medical Center, National Institute of Mental Health (NIMH)
- Study start
- May 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This application seeks to reduce racial/ethnic disparities in HIV/AIDS treatment. National studies have consistently shown that many persons living with HIV/AIDS (PLHA) in the U.S. (an estimated 10-19% of PLHA), predominantly people of color, delay taking Highly Active Antiretroviral Therapy (HAART) until late in their HIV disease or never initiate HAART when it is medically necessary, even when engaged in care. This population is of critical importance because they experience disproportionately higher morbidity and earlier mortality compared to their peers on HAART, and higher health care costs. Further, they are less likely to achieve virologic suppression, increasing the probability of HIV transmission to others. However, we do not yet have a behavioral intervention to increase the timely initiation and continued use of HAART for PLHA-DD. This proposal seeks to address a serious gap in existing programs by creating a culturally targeted, sustainable, multi-level, and individualized video-based behavioral intervention for the population of PLHA who are medically eligible for HAART but who have delayed or declined HAART (referred to as "PLHA-DD"). This is not an adherence intervention per se, but will serve as a complement to, and primer for, existing adherence interventions, from which PLHA-DD can benefit when they initiate HAART. The proposed study is innovative in that it seeks to broaden the HAART adherence research paradigm to include HAART initiation.
Barriers to HAART initiation for PLHA-DD are multi-faceted. At the individual level, for example, PLHA-DD suffer from negative attitudes toward HAART (particularly medical mistrust and fear), a lack of accurate knowledge about HAART and health, and "competing priorities," including mental health problems and substance use. PLHA-DD also experience powerful social barriers to HAART including negative peer norms regarding medications and stigma. Further, structural barriers such as poor access to necessary resources and supports (e.g., transportation, paperwork) and ancillary services (e.g., mental health care) impede HAART initiation.
We will create a culturally targeted video-based intervention to increase motivation and psychosocial and practical preparedness for HAART among PLHA-DD. The study is guided by two complementary theoretical models: the Theory of Triadic Influence, a social-cognitive theory that integrates individual, social, and structural influences on health behavior and the Anti-racist Stance, which acknowledges the salience of barriers linked to racial/ethnic minority status in the lives of PLHA-DD (associated with exclusion, stress, discrimination, and poor access to institutional structures), without assuming homogeneity among PLHA-DD. The intervention will be flexible and individualized: there will be a 12-week intervention period during which participants will receive three structured sessions (including one with a "support partner" to reduce social barriers, plus patient navigation, an efficacious low-threshold and adaptable approach to reduce individual and structural barriers to initiating and sustaining HAART. The intensity of navigation will depend on need, increasing the intervention's efficiency. The sessions will consist of individualized interactive components and targeted high-quality video components, which will enhance ease-of-use, fidelity, and future sustainability.
The aims of this three-year project are to:
- Explore health care and social service providers' and PLHA-DD's perspectives on barriers to/facilitators of initiation and continuation of HAART for PLHA-DD at the levels of individuals, networks, organizations, and other structures;
- Develop components of an intervention and examine their acceptability, safety, feasibility, and gather preliminary evidence of their efficacy with respect to HAART initiation and continuation among PLHA-DD medically eligible for HAART.
To accomplish these aims, we will conduct a three phase study: (1) an Elicitation Phase to explore barriers to HAART among PLHA-DD (n=16) and health care and social service providers (N=18); (2) a Development Phase to create intervention components using Intervention Mapping, a mechanism for integrating theoretical models, data, and the literature; and (3) an Evaluation Phase to test and revise intervention components (N=30-50 PLHA-DD recruited from two large urban HIV clinics and assigned to an intervention or control arm using permuted blocks random assignment and interviewed at 3 time points).
We will also explore peer recruitment approaches to reaching PLHA-DD. PLHA recruited through peers will be seen at a local field site but will engage in the same procedures as the clinic-recruited cohort.
We will enroll a total of 90-100 PLHA-DD, ideally half from clinics and half through peer recruitment.
The urgent need to address disparities in HAART initiation and continuation and support access to HAART for vulnerable populations has been identified by numerous scientific and community leaders, health care providers, and public health officials. Although PLHA-DD are a modest proportion of the population of PLHA (10-19%), efficacious interventions to reduce morbidity, increase longevity, increase viral load suppression, and reduce health care costs associated with delayed HAART initiation are sorely lacking for this group, and have very high potential public health significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Heart to HeartThe 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. |
| Control | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart to Heart | Behavioural | Intervention |
Primary outcome
Initiation of HAART
Time frame: 9 months
Initiation of HAART by self report and Medical Record
Continuation of HAART once initiated
Time frame: 9 months
Continuation of HAART once initiated
1 secondary outcome
Adherence to ART once initiated
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Heart to Heart in people with HIV and Antiretroviral Therapy, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of HAART (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.