NCT04518241

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

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

August 14, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
1.9 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 1, 2022

Status Verified

July 1, 2022

Enrollment Period

1.9 years

First QC Date

August 14, 2020

Last Update Submit

October 31, 2022

Conditions

Keywords

HIVbehavioral economicsadherenceHIV antiretroviral therapyART non-persistenceHIV non-suppression

Outcome Measures

Primary Outcomes (2)

  • Undetectable HIV viral load

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

    5-months post-baseline

  • Undetectable HIV viral load

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

    8-months post-baseline

Study Arms (8)

Condition 1

EXPERIMENTAL

Core, fixed compensation, TMQQ, MI sessions

Behavioral: MI sessionsBehavioral: TMQQBehavioral: Type of compensation

Condition 2

EXPERIMENTAL

Core, lottery prize, TMQQ, MI sessions

Behavioral: MI sessionsBehavioral: TMQQBehavioral: Type of compensation

Condition 3

EXPERIMENTAL

Core, fixed compensation, MI sessions

Behavioral: MI sessionsBehavioral: Type of compensation

Condition 4

EXPERIMENTAL

Core, lottery prize, MI sessions

Behavioral: MI sessionsBehavioral: Type of compensation

Condition 5

EXPERIMENTAL

Core, fixed compensation, TMQQ

Behavioral: TMQQBehavioral: Type of compensation

Condition 6

EXPERIMENTAL

Core, lottery prize, TMQQ

Behavioral: TMQQBehavioral: Type of compensation

Condition 7

EXPERIMENTAL

Core, fixed compensation

Behavioral: Type of compensation

Condition 8

EXPERIMENTAL

Core, lottery prize

Behavioral: Type of compensation

Interventions

MI sessionsBEHAVIORAL

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

Condition 1Condition 2Condition 3Condition 4
TMQQBEHAVIORAL

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.

Condition 1Condition 2Condition 5Condition 6

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.

Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • None

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 (1)

  • Filippone P, Serrano S, Gwadz M, Cleland CM, Freeman R, Linnemayr S, Cluesman SR, Campos S, Rosmarin-DeStefano C, Amos B, Israel K. A virtual pilot optimization trial for African American/Black and Latino persons with non-suppressed HIV viral load grounded in motivational interviewing and behavioral economics. Front Public Health. 2023 May 10;11:1167104. doi: 10.3389/fpubh.2023.1167104. eCollection 2023.

MeSH Terms

Conditions

HIV SeropositivityMedication Adherence

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Marya Gwadz, PhD

    New York U

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Factorial design with 3 components and 8 conditions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 19, 2020

Study Start

August 14, 2020

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

November 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations