History of Changes for Study: NCT04518241

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

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	August 17, 2020	None (earliest Version on record)
2	June 27, 2021	Recruitment Status, Study Status, Contacts/Locations and Study Design
3	July 15, 2022	Recruitment Status and Study Status
4	October 31, 2022	Sponsor/Collaborators and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	IRB-FY2020-4630
Brief Title:	Supporting Health Behavior Among Persons Living With HIV Using Tech, MOST, and Behavioral Economics (SCAP2)
Official Title:	Supporting Health Behavior Among Persons Living With HIV Using Technology, the Multiphase Optimization Strategy (MOST), and Principles of Behavioral Economics
Secondary IDs:

Study Status


Record Verification:	August 2020
Overall Status:	Recruiting
Study Start:	August 14, 2020
Primary Completion:	August 31, 2021 [Anticipated]
Study Completion:	August 31, 2021 [Anticipated]

First Submitted:	August 14, 2020
First Submitted that Met QC Criteria:	August 17, 2020
First Posted:	August 19, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	August 17, 2020
Last Update Posted:	August 19, 2020 [Actual]

Sponsor/Collaborators


Sponsor:	New York University
Responsible Party:	Principal Investigator Investigator: Marya Gwadz Official Title: Professor Affiliation: New York University
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

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.

Conditions


Conditions:	HIV Seropositivity Adherence, Medication
Keywords:	HIV behavioral economics adherence HIV antiretroviral therapy ART non-persistence HIV non-suppression

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Factorial Assignment
	Factorial design with 3 components and 8 conditions
Number of Arms:	8
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	80 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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.

Outcome Measures


Primary Outcome Measures:
1.	Undetectable HIV viral load [ Time Frame: 5-months post-baseline ] achievement of undetectable HIV viral load (< 200 pp/mL)
2.	Undetectable HIV viral load [ Time Frame: 8-months post-baseline ] achievement of undetectable HIV viral load (< 200 pp/mL)

Eligibility


Minimum Age:	18 Years
Maximum Age:	65 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Central Contact Person:	Samantha Serrano, BA Telephone: (862) 256-3339 Email: scap-research-study@nyu.edu
Central Contact Backup:	Marya Gwadz, PhD Telephone: 212-998-5965 Email: mg2890@nyu.edu
Study Officials:	Marya Gwadz, PhD Principal Investigator New York U
Locations:	United States, New York
	New York University Silver School of Social Work [Recruiting] New York, New York, United States, 10003 Contact:Contact: Marya Gwadz, PhD 212-998-5965 marya.gwadz@nyu.edu

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: