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

October 31, 2022 updated by: New York University

Supporting Health Behavior Among Persons Living With HIV Using Technology, the Multiphase Optimization Strategy (MOST), and Principles of Behavioral Economics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York University Silver School of Social Work

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Condition 1
Core, fixed compensation, TMQQ, MI sessions
Behavioral: MI sessions
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
Behavioral: TMQQ
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.
Behavioral: Type of compensation
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.
EXPERIMENTAL: Condition 2
Core, lottery prize, TMQQ, MI sessions
Behavioral: MI sessions
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
Behavioral: TMQQ
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.
Behavioral: Type of compensation
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.
EXPERIMENTAL: Condition 3
Core, fixed compensation, MI sessions
Behavioral: MI sessions
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
Behavioral: Type of compensation
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.
EXPERIMENTAL: Condition 4
Core, lottery prize, MI sessions
Behavioral: MI sessions
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
Behavioral: Type of compensation
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.
EXPERIMENTAL: Condition 5
Core, fixed compensation, TMQQ
Behavioral: TMQQ
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.
Behavioral: Type of compensation
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.
EXPERIMENTAL: Condition 6
Core, lottery prize, TMQQ
Behavioral: TMQQ
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.
Behavioral: Type of compensation
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.
EXPERIMENTAL: Condition 7
Core, fixed compensation
Behavioral: Type of compensation
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.
EXPERIMENTAL: Condition 8
Core, lottery prize
Behavioral: Type of compensation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Undetectable HIV viral load
Time Frame: 5-months post-baseline
achievement of undetectable HIV viral load (< 200 pp/mL)
5-months post-baseline
Undetectable HIV viral load
Time Frame: 8-months post-baseline
achievement of undetectable HIV viral load (< 200 pp/mL)
8-months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marya Gwadz, PhD, New York U

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-FY2020-4630

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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