NCT02801747

Brief Summary

The present study targets the large population of persons living with HIV/AIDS (PLHA) in the U.S. who are both insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), who are mainly African American/Black and Latino. NIH has emphasized the urgent need for new research approaches to advance intervention science, and the proposed project employs a new, potent, and innovative research methodology, the Multiphase Optimization STrategy (MOST), a framework for developing highly efficacious, efficient, scalable, and cost-effective interventions. The proposed study has the highest public health significance: it addresses a vulnerable population of PLHA, including the critically important subpopulations of men who have sex with men (MSM) and substance users; will develop an efficient and cost effective intervention to increase engagement along the HIV care continuum for these vulnerable groups; and addresses two areas highlighted in the August 2015 notice on research priorities from the NIH Office of AIDS Research (NOT-OD-15-137), namely, engaging PLHA in prevention/treatment services, and reducing HIV/AIDS-related racial/ethnic disparities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
512

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable 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

First Submitted

Initial submission to the registry

June 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

November 3, 2022

Status Verified

July 1, 2022

Enrollment Period

5.3 years

First QC Date

June 8, 2016

Last Update Submit

October 31, 2022

Conditions

HIV

Keywords

HIV care continuumantiretroviral therapyengagement in HIV careMultiphase Optimization Strategy (MOST)

Outcome Measures

Primary Outcomes (1)

  • Change in HIV viral suppression

    Blood will be drawn and viral load will be assessed via laboratory report (Bioreference Lab, HIV-1,RNA,PCR,ULTRA). Participants will not have viral suppression at baseline. Change in viral suppression, that is, whether viral suppression has been achieved, will be coded as present if viral load levels are \< 20 ppml. Viral suppression will be assessed at both FU periods. Participants may achieve this primary endpoint, or not, at one or both FU periods.

    Assessed at 4 month follow up (FU), 12 month FU

Secondary Outcomes (3)

  • Absolute HIV viral load (log10)

    Assessed at baseline, 4 month follow up (FU), 12 month FU

  • Adherence to antiretroviral therapy

    4 month follow up (FU), 8 month FU, 12 month FU

  • Engagement in HIV primary care

    4 month follow up (FU), 12 month FU

Study Arms (16)

Condition 1

EXPERIMENTAL

Receives a core intervention session and the navigation intervention component (long duration; that is, up to 6 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 2

EXPERIMENTAL

Receives a core intervention session, the focused support group component, and the navigation intervention component (short duration, that is, up to 3 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 3

EXPERIMENTAL

Receives a core intervention session, the peer mentorship component, and the navigation intervention component (short duration, that is, up to 3 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 4

EXPERIMENTAL

Receives a core intervention session, the peer mentorship component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 5

EXPERIMENTAL

Receives a core intervention session, the pre-adherence preparation component, and the navigation intervention component (short duration, that is, up to 3 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 6

EXPERIMENTAL

Receives a core intervention session, the pre-adherence preparation component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 7

EXPERIMENTAL

Receives a core intervention session, the pre-adherence preparation component, the peer mentorship component, and the navigation intervention component (long duration, that is, up to 6 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 8

EXPERIMENTAL

Receives a core intervention session, the pre-adherence preparation component, the peer mentorship component, and the navigation intervention component (short duration, that is, up to 3 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 9

EXPERIMENTAL

Receives a core intervention session, the Motivational Interviewing sessions component, and the navigation intervention component (short duration, that is, up to 3 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 10

EXPERIMENTAL

Receives a core intervention session, the Motivational Interviewing sessions component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 11

EXPERIMENTAL

Receives a core intervention session, the Motivational Interviewing sessions component, the peer mentorship component, and the navigation intervention component (long duration, that is, up to 6 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 12

EXPERIMENTAL

Receives a core intervention session, the Motivational Interviewing sessions component, the peer mentorship component, the focused support group component, and the navigation intervention component (short duration, that is, up to 3 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 13

EXPERIMENTAL

Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, and the navigation intervention component (long duration, that is, up to 6 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 14

EXPERIMENTAL

Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, the focused support group component, and the navigation intervention component (short duration, that is, up to 3 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 15

EXPERIMENTAL

Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, the peer mentorship component, and the navigation intervention component (short duration, that is, up to 3 months).

Behavioral: Heart to Heart2 (HTH2)

Condition 16

EXPERIMENTAL

Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, the peer mentorship component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months).

Behavioral: Heart to Heart2 (HTH2)

Interventions

Heart to Heart2 (HTH2)BEHAVIORAL

The present study uses a fractional factorial design to evaluate the efficacy of five distinct culturally appropriate intervention components on the primary outcome, HIV viral suppression.

Condition 1Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9

Eligibility Criteria

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

You may qualify if:

  • African American/Black or Latino/Hispanic race/ethnicity
  • HIV diagnosed for at least 6 months (HIV status confirmed with medical documentation)
  • Has not taken antiretroviral therapy (ART) in the past 6 weeks (the period of time assessed by hair assay, and a reasonable period of time not on ART for the present study)
  • Sub-optimal engagement in HIV care (assessed from the medical record, defined as less than 1 visit in every 4-mo. period in the past year \[two of them at least 90 days apart\], pro-rated for those diagnosed less than a year ago) or \> 2 missed visits (without prior cancellation) in the past year
  • Reside in the New York City (NYC) metropolitan area
  • Not planning to leave the NYC metropolitan area in next year
  • Not actively psychotic based on screening instrument
  • Not a participant in the preliminary pilot HTH R34 study
  • Able to conduct research activities in English or Spanish
  • Willing to provide hair sample (if possible), blood samples (to assess CD4, VL), and Medical Report Form (\[MRF\]; to assess health care attendance) at screening
  • Willing to participate in a Core intervention session and be randomly assigned to 1-5 intervention components.

You may not qualify if:

  • NONE SEE ABOVE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Silver School of Social Work

New York, New York, 10003, United States

Location

Related Publications (2)

  • Strayhorn JC, Cleland CM, Vanness DJ, Wilton L, Gwadz M, Collins LM. Using decision analysis for intervention value efficiency to select optimized interventions in the multiphase optimization strategy. Health Psychol. 2024 Feb;43(2):89-100. doi: 10.1037/hea0001318. Epub 2023 Aug 3.

    PMID: 37535575DERIVED

  • Gwadz MV, Collins LM, Cleland CM, Leonard NR, Wilton L, Gandhi M, Scott Braithwaite R, Perlman DC, Kutnick A, Ritchie AS. Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol. BMC Public Health. 2017 May 4;17(1):383. doi: 10.1186/s12889-017-4279-7.

    PMID: 28472928DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 16, 2016

Study Start

March 20, 2017

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

November 3, 2022

Record last verified: 2022-07

Locations

US(1)