HIV SeropositivitySCAP2NCT04518241
Supporting Health Behavior Among Persons Living With HIV Using Tech, MOST, and Behavioral Economics
A study testing MI sessions, TMQQ and Type of compensation in people with HIV Seropositivity and Adherence, Medication, run by New York University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Seropositivity, Adherence, Medication
- What is being tested?
- MI sessions, TMQQ and Type of compensation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2020to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Silver School of Social Work
New York, New York, 10003
About this study
Official title: 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.
Read the 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
- HIV Seropositivity, Adherence, Medication
- Being tested
- MI sessions, TMQQ, Type of compensation
- Keywords
- HIV, behavioral economics, adherence, HIV antiretroviral therapy, ART non-persistence, HIV non-suppression
- Medical subject headings
- HIV Seropositivity, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI sessionsBehavioural
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
TMQQBehavioural
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 compensationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Core, fixed compensation, TMQQ, MI sessions Receives: Behavioral: MI sessions; Behavioral: TMQQ; Behavioral: Type of compensation |
| Condition 2 | Experimental | Core, lottery prize, TMQQ, MI sessions Receives: Behavioral: MI sessions; Behavioral: TMQQ; Behavioral: Type of compensation |
| Condition 3 | Experimental | Core, fixed compensation, MI sessions Receives: Behavioral: MI sessions; Behavioral: Type of compensation |
| Condition 4 | Experimental | Core, lottery prize, MI sessions Receives: Behavioral: MI sessions; Behavioral: Type of compensation |
| Condition 5 | Experimental | Core, fixed compensation, TMQQ Receives: Behavioral: TMQQ; Behavioral: Type of compensation |
| Condition 6 | Experimental | Core, lottery prize, TMQQ Receives: Behavioral: TMQQ; Behavioral: Type of compensation |
| Condition 7 | Experimental | Core, fixed compensation Receives: Behavioral: Type of compensation |
| Condition 8 | Experimental | Core, lottery prize Receives: Behavioral: Type of compensation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable HIV viral load
achievement of undetectable HIV viral load (< 200 pp/mL)
Measured: 5-months post-baseline
Undetectable HIV viral load
achievement of undetectable HIV viral load (< 200 pp/mL)
Measured: 8-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start14 Aug 2020
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Factorial design with 3 components and 8 conditions
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marya Gwadz, PhD, Principal investigator, New York U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518241
- Sponsor's protocol ID
- IRB-FY2020-4630
- Acronym
- SCAP2
- Status last verified
- Jul 2022
- First submitted
- 14 Aug 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37234760
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Health Behavior Among Persons Living With HIV Using Technology, the Multiphase Optimization Strategy (MOST), and Principles of Behavioral Economics
- ClinicalTrials.gov ID
- NCT04518241
- Acronym / sponsor ID
- SCAP2 / IRB-FY2020-4630
- Conditions
- HIV Seropositivity, Adherence, Medication
- Keywords
- HIV, behavioral economics, adherence, HIV antiretroviral therapy, ART non-persistence, HIV non-suppression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Factorial design with 3 components and 8 conditions
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: MI sessions, Behavioral: TMQQ, Behavioral: Type of compensationCore, fixed compensation, TMQQ, MI sessions |
| Condition 2 | Experimental | Behavioral: MI sessions, Behavioral: TMQQ, Behavioral: Type of compensationCore, lottery prize, TMQQ, MI sessions |
| Condition 3 | Experimental | Behavioral: MI sessions, Behavioral: Type of compensationCore, fixed compensation, MI sessions |
| Condition 4 | Experimental | Behavioral: MI sessions, Behavioral: Type of compensationCore, lottery prize, MI sessions |
| Condition 5 | Experimental | Behavioral: TMQQ, Behavioral: Type of compensationCore, fixed compensation, TMQQ |
| Condition 6 | Experimental | Behavioral: TMQQ, Behavioral: Type of compensationCore, lottery prize, TMQQ |
| Condition 7 | Experimental | Behavioral: Type of compensationCore, fixed compensation |
| Condition 8 | Experimental | Behavioral: Type of compensationCore, lottery prize |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI sessionsThree 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 | Behavioural | Condition 1, Condition 2, Condition 3, Condition 4 |
| TMQQWeekly 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. | Behavioural | Condition 1, Condition 2, Condition 5, Condition 6 |
| Type of compensationParticipants 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. | Behavioural | Condition 1, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8 |
Primary outcome
Undetectable HIV viral load
Time frame: 5-months post-baseline
achievement of undetectable HIV viral load (< 200 pp/mL)
Undetectable HIV viral load
Time frame: 8-months post-baseline
achievement of undetectable HIV viral load (< 200 pp/mL)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 37234760Filippone 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marya Gwadz, PhD principal investigator
New York U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI sessions, TMQQ and Type of compensation in people with HIV Seropositivity and Adherence, Medication, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undetectable HIV viral load (time frame: 5-months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04518241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.