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

Adherence, Medication Clinical Trial

— SCAP2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518241
• Other study ID #: IRB-FY2020-4630
• Status: Completed
• Phase: N/A
• Start date: August 14, 2020
• Est. completion date: July 15, 2022

Study information

• Verified date: July 2022
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• HIV Seropositivity

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
United States	New York University Silver School of Social Work	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Undetectable HIV viral load	achievement of undetectable HIV viral load (< 200 pp/mL)	5-months post-baseline
Primary	Undetectable HIV viral load	achievement of undetectable HIV viral load (< 200 pp/mL)	8-months post-baseline