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Supporting Health Behavior Among Persons Living With HIV Using Tech, MOST, and Behavioral Economics (SCAP2)

Primary Purpose

HIV Seropositivity, Adherence, Medication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MI sessions
TMQQ
Type of compensation
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Seropositivity focused on measuring HIV, behavioral economics, adherence, HIV antiretroviral therapy, ART non-persistence, HIV non-suppression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65 years
  • Has diagnosis of HIV infection
  • Resides in the New York City or Newark, NJ metropolitan areas
  • Can conduct research activities in English
  • Has a phone that can send and receive text messages
  • Has not participated in a conditional economic incentive program for HIV viral suppression in the past month
  • Has not been enrolled in this research team's two recent studies
  • Has detectable HIV viral load (> 200 pp/mL) by lab report

Exclusion Criteria:

  • None

Sites / Locations

  • New York University Silver School of Social Work

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Condition 1

Condition 2

Condition 3

Condition 4

Condition 5

Condition 6

Condition 7

Condition 8

Arm Description

Core, fixed compensation, TMQQ, MI sessions

Core, lottery prize, TMQQ, MI sessions

Core, fixed compensation, MI sessions

Core, lottery prize, MI sessions

Core, fixed compensation, TMQQ

Core, lottery prize, TMQQ

Core, fixed compensation

Core, lottery prize

Outcomes

Primary Outcome Measures

Undetectable HIV viral load
achievement of undetectable HIV viral load (< 200 pp/mL)
Undetectable HIV viral load
achievement of undetectable HIV viral load (< 200 pp/mL)

Secondary Outcome Measures

Full Information

First Posted
August 14, 2020
Last Updated
October 31, 2022
Sponsor
New York University
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1. Study Identification

Unique Protocol Identification Number
NCT04518241
Brief Title
Supporting Health Behavior Among Persons Living With HIV Using Tech, MOST, and Behavioral Economics
Acronym
SCAP2
Official Title
Supporting Health Behavior Among Persons Living With HIV Using Technology, the Multiphase Optimization Strategy (MOST), and Principles of Behavioral Economics
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study focuses on adult persons living with HIV in the New York City and Newark, New Jersey metropolitan areas who are not highly adherent to HIV medication and who do not evidence undetectable HIV viral load (the ultimate goal of HIV treatment). Those who have not decided whether they wish to take HIV medications are invited to enroll. The study uses technology, is grounded in principles of behavioral economics, and uses the multiphase optimization strategy (MOST) to examine the acceptability, feasibility, and evidence of efficacy of three intervention components. The components are intended to increase rates of HIV viral suppression in the sample. The three components are: prizes for viral suppression (fixed compensation [$275] or lottery prizes [up to $500]), text messages and quiz questions that generate points to earn prizes (to foster engagement), and counseling sessions grounded in the motivational interviewing approach to help participants articulate goals with respect to health and viral suppression, identify and resolve barriers to HIV medication use, and build motivation for viral suppression. Participants are assessed at baseline and then 5- and 8-months later.
Detailed Description
The present study focuses on adult persons living with HIV who are not highly adherent to HIV medication and who do not evidence undetectable HIV viral load (the ultimate goal of HIV treatment). The study uses technology, is grounded in principles of behavioral economics, and uses the multiphase optimization strategy (MOST) to examine the acceptability, feasibility, and evidence of efficacy of three intervention components. The components are intended to increase rates of HIV viral suppression in the sample. All participants receive a core intervention comprised of referrals to care and case management. The three components are: compensation for viral suppression (fixed compensation or lottery-type prizes), weekly text messages and quiz questions (TMQQ) for 21 weeks that generate points to earn compensation (to foster engagement), and three counseling sessions grounded in the motivational interviewing (MI) approach to help participants articulate goals with respect to health and viral suppression, identify and resolve barriers to HIV medication use, and build motivation for viral suppression. We have previously tested variations of these components together as a "packaged" intervention and found high acceptability, feasibility, and evidence of efficacy. We now seek to understand this approach with more precision by testing the effects of individual components using MOST. The components will be tested in a factorial design with 8 intervention conditions. Consistent with the factorial design, each condition will comprise a unique combination of components. Each condition includes at least one component. Participants will be recruited by a proven hybrid strategy that includes peer recruitment, ads placed in a free newspaper, and direct recruitment from an NYU Recruitment Registry managed by Dr. Gwadz. Participants will be screened for eligibility and a total of 80 adult persons living with HIV and with detectable HIV viral load will be enrolled in the study and randomly assigned to an intervention condition. Participants will be assessed at baseline and 5- and 8-months post-baseline with a structured assessment battery. A subset will receive in-depth interviews. The primary outcome is viral suppression. This is a pilot study. It is not powered for efficacy but we will examine evidence of efficacy. All study activities can be carried out in a virtual format, and we can switch to in-person contact for screening, assessment, and some components when appropriate. In-person activities would be conducted at the New York University Silver field site in Manhattan. The study is funded through the Constance and Martin Silver Artificial Intelligence and Social Impact Fund at the New York University Silver School of Social Work.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Seropositivity, Adherence, Medication
Keywords
HIV, behavioral economics, adherence, HIV antiretroviral therapy, ART non-persistence, HIV non-suppression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Factorial design with 3 components and 8 conditions
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Condition 1
Arm Type
Experimental
Arm Description
Core, fixed compensation, TMQQ, MI sessions
Arm Title
Condition 2
Arm Type
Experimental
Arm Description
Core, lottery prize, TMQQ, MI sessions
Arm Title
Condition 3
Arm Type
Experimental
Arm Description
Core, fixed compensation, MI sessions
Arm Title
Condition 4
Arm Type
Experimental
Arm Description
Core, lottery prize, MI sessions
Arm Title
Condition 5
Arm Type
Experimental
Arm Description
Core, fixed compensation, TMQQ
Arm Title
Condition 6
Arm Type
Experimental
Arm Description
Core, lottery prize, TMQQ
Arm Title
Condition 7
Arm Type
Experimental
Arm Description
Core, fixed compensation
Arm Title
Condition 8
Arm Type
Experimental
Arm Description
Core, lottery prize
Intervention Type
Behavioral
Intervention Name(s)
MI sessions
Intervention Description
Three counseling sessions lasting less than 60 minutes each to identify goals, factors that promote or impede goals, and increase "readiness" for ART with high adherence
Intervention Type
Behavioral
Intervention Name(s)
TMQQ
Intervention Description
Weekly text messages with health information as well as motivational messages. Two days later a true/false quiz question is sent. Participants earn 4 points for answering correctly, 2 points for answering incorrectly, and 0 points for not answering. Participants earn $1 for each point. Messages are sent over 21 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Type of compensation
Intervention Description
Participants who achieve HIV viral suppression at 21 weeks will receive either fixed compensation of $275 or be entered into a lottery where they have a 3/10 chance of winning $500, and a 7/10 chance of winning $175. Those who do not achieve HIV viral suppression receive a $50 participant incentive.
Primary Outcome Measure Information:
Title
Undetectable HIV viral load
Description
achievement of undetectable HIV viral load (< 200 pp/mL)
Time Frame
5-months post-baseline
Title
Undetectable HIV viral load
Description
achievement of undetectable HIV viral load (< 200 pp/mL)
Time Frame
8-months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 years Has diagnosis of HIV infection Resides in the New York City or Newark, NJ metropolitan areas Can conduct research activities in English Has a phone that can send and receive text messages Has not participated in a conditional economic incentive program for HIV viral suppression in the past month Has not been enrolled in this research team's two recent studies Has detectable HIV viral load (> 200 pp/mL) by lab report Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marya Gwadz, PhD
Organizational Affiliation
New York U
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Silver School of Social Work
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Supporting Health Behavior Among Persons Living With HIV Using Tech, MOST, and Behavioral Economics

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