Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART)

A study testing CPS and SMS in people with HIV Infections, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to test an adaptive adherence intervention, which utilizes two mobile health (mHealth) intervention designs, in an effort to promote adherence to antiretroviral therapy (ART) and achieve and maintain viral load (VL) suppression in youth living with HIV (YLH) while increasing understanding… Read more about this study

Who is it for?: Ages 15 to 24 years
Conditions the study is for: HIV Infections
What is being tested?: CPS and SMS
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2018to 31 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 15 to 24 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

HIV diagnosis
Viral load ≥ 200 copies/mL within 3 months prior to enrollment or self-reported adherence ≤ 80%
ART medication regimen prescribed minimum of 3 months prior to eligibility VL or self-reported adherence
Sole owner of device capable of sending/receiving calls and text messages
Willingness to permit research team to communicate with their HIV care provider team

Who cannot join

Mental, physical, or emotional capacity prevents completion of protocol as written
Inability to understand written/spoken English
Concurrent participant in any adherence behavioral research intervention

Trial locations and contacts

1 site in 1 country.

United States1 site

The City University of New York
New York, New York, 10018

Other trials in United States

About this study

Official title: Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living With HIV Through Text Messaging and Cell Phone Support Embedded Within the Sequential Multiple Assignment Randomized Trial (SMART) Design

Read the detailed description

The study will consist of two points of randomization. The first step involves randomization of participants to receive either CPS or SMS using a 1:1 allocation ratio. Both intervention conditions will receive 3 months of intervention (i.e., 12 weeks of CPS or SMS).

The second step involves a stratified randomization in blocks with 8 possible intervention trajectories. Within each condition, participants are categorized into two groups - responders with VL<200 (Rsp) and non-responders with VL ≥200 (NRsp). Responders in the CPS condition will be randomly assigned to receive either 3 months of CPS tapered (CPS-T) intervention followed by standard care (SC) or only SC. Similarly, responders in the SMScondition will be randomly assigned to receive either 3 months of SMS tapered (SMS-T) intervention followed by SC or only SC. Non-responders in both CPS and SMS conditions will be randomly assigned to receive either 3 months of incentivized CPS (CPS-I) followed by 3 months of CPS-T and 3 months of SC or 3 months of incentivized SMS (SMS-I) followed by 3 months of SMS-T and 3 months of SC.

Conditions: HIV Infections
Being tested: CPS, SMS
Keywords: Interventions, youth living with HIV, mHealth, ART adherence, adaptive intervention, cell phone, text messaging
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CPSBehavioural
Assessment of participant's medication adherence and barrier problem solving via phone conversation
SMSBehavioural
Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.

Study groups in NCT03535337
Study group	Role	What they receive
CPS-Rsp-T	Active comparator	After 3 months of intervention, this group of CPS Rsp will receive 3 months of CPS-T intervention followed by SC. Receives: Behavioral: CPS
CPS-Rsp-SC	Active comparator	After 3 months of intervention, this group of CPS Rsp's intervention will discontinue and they'll receive SC only Receives: Behavioral: CPS
CPS-NRsp-I	Active comparator	After 3 months of intervention, this group of CPS NRsp will receive 3 months of CPS-I followed by 3 months of CPS-T and 3 months of SC. Receives: Behavioral: CPS
CPS-NRsp-SMS-I	Active comparator	After 3 months of intervention, this group of CPS NRsp will receive 3 months of SMS-I followed by 3 months of SMS-T and 3 months of SC Receives: Behavioral: CPS
SMS-Rsp-T	Active comparator	After 3 months of intervention, this group of SMS Rsp will receive 3 months of SMS tapered (SMS-T) intervention followed by SC. Receives: Behavioral: SMS
SMS-Rsp-SC	Active comparator	After 3 months of intervention, this group of SMS Rsp, intervention will discontinue and they'll receive SC only Receives: Behavioral: SMS
SMS-NRsp-CPS-I	Active comparator	After 3 months of intervention, this group of SMS NRsp will receive 3 months of CPS-I followed by 3 months CPS-T and 3 months SC Receives: Behavioral: SMS
SMS-NRsp-I	Active comparator	After 3 months of intervention, this group of SMS NRsp will receive 3 months of SMS-I followed by 3 months of SMS-T and 3 months of SC Receives: Behavioral: SMS

What is being measured

The primary outcome is the main question the study is designed to answer.

Undetectable Viral Load
Percent of participants that have an undetectable HIV Viral Load.
Measured: baseline, month 3, month 6, month 9, and month 12
Medication Adherence Rate - 7 Day
Self reported percentage of medication taken in the past 7 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups.
Measured: baseline, month 3, month 6, month 9, and month 12
Medication Adherence - 30 Days
Self reported percentage of medication taken in the past 30 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups.
Measured: baseline, month 3, month 6, month 9, and month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201831 May 2022

First posted24 May 2018
Study start1 Sep 2018
Primary completion31 May 2022
Study completion31 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Florida State UniversityThe sponsor's other registered studies.
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: Supportive care
Allocation: Randomised
Intervention model: Sequential
Model description: Multiple Assignment Randomized Trial
Masking: None (open label)
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03535337
Sponsor's protocol ID: ATN 144
Acronym: SMART
Status last verified: Dec 2024
First submitted: 12 Apr 2018
Last updated: 13 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Belzer ME, MacDonell KK, Ghosh S, Naar S, McAvoy-Banerjea J, Gurung S, Cain D, Fan CA, Parsons JT. Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living With HIV Through Text Message and Cell Phone Support With and Without Incentives: Protocol for a Sequential Multiple Assignment Randomized Trial (SMART). JMIR Res Protoc. 2018 Dec 20;7(12):e11183. doi: 10.2196/11183.
PubMed 30573448

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living With HIV Through Text Messaging and Cell Phone Support Embedded Within the Sequential Multiple Assignment Randomized Trial (SMART) Design
ClinicalTrials.gov ID: NCT03535337
Acronym / sponsor ID: SMART / ATN 144
Conditions: HIV Infections
Keywords: Interventions, youth living with HIV, mHealth, ART adherence, adaptive intervention, cell phone, text messaging
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Florida State UniversityUniversity, hospital or other
Collaborators: Children's Hospital Los Angeles, Hunter College of City University of New York, Wayne State University
Study start: 1 Sep 2018 (actual)
Primary completion: 31 May 2022 (actual)
Study completion: 31 May 2022 (actual)
First posted: 24 May 2018 (actual)
Results: Posted 13 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 8
Model description: Multiple Assignment Randomized Trial

Arm	Type	Receives
CPS-Rsp-T	Active comparator	Behavioral: CPSAfter 3 months of intervention, this group of CPS Rsp will receive 3 months of CPS-T intervention followed by SC.
CPS-Rsp-SC	Active comparator	Behavioral: CPSAfter 3 months of intervention, this group of CPS Rsp's intervention will discontinue and they'll receive SC only
CPS-NRsp-I	Active comparator	Behavioral: CPSAfter 3 months of intervention, this group of CPS NRsp will receive 3 months of CPS-I followed by 3 months of CPS-T and 3 months of SC.
CPS-NRsp-SMS-I	Active comparator	Behavioral: CPSAfter 3 months of intervention, this group of CPS NRsp will receive 3 months of SMS-I followed by 3 months of SMS-T and 3 months of SC
SMS-Rsp-T	Active comparator	Behavioral: SMSAfter 3 months of intervention, this group of SMS Rsp will receive 3 months of SMS tapered (SMS-T) intervention followed by SC.
SMS-Rsp-SC	Active comparator	Behavioral: SMSAfter 3 months of intervention, this group of SMS Rsp, intervention will discontinue and they'll receive SC only
SMS-NRsp-CPS-I	Active comparator	Behavioral: SMSAfter 3 months of intervention, this group of SMS NRsp will receive 3 months of CPS-I followed by 3 months CPS-T and 3 months SC
SMS-NRsp-I	Active comparator	Behavioral: SMSAfter 3 months of intervention, this group of SMS NRsp will receive 3 months of SMS-I followed by 3 months of SMS-T and 3 months of SC

Who may qualify

Ages: 15 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

HIV diagnosis
Viral load ≥ 200 copies/mL within 3 months prior to enrollment or self-reported adherence ≤ 80%
ART medication regimen prescribed minimum of 3 months prior to eligibility VL or self-reported adherence
Sole owner of device capable of sending/receiving calls and text messages
Willingness to permit research team to communicate with their HIV care provider team

Key exclusion criteria (3 listed)

Mental, physical, or emotional capacity prevents completion of protocol as written
Inability to understand written/spoken English
Concurrent participant in any adherence behavioral research intervention

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
CPSAssessment of participant's medication adherence and barrier problem solving via phone conversation	Behavioural	CPS-NRsp-I, CPS-NRsp-SMS-I, CPS-Rsp-SC, CPS-Rsp-T
SMSParticipants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.	Behavioural	SMS-NRsp-CPS-I, SMS-NRsp-I, SMS-Rsp-SC, SMS-Rsp-T

Primary outcome

Undetectable Viral Load
Time frame: baseline, month 3, month 6, month 9, and month 12
Percent of participants that have an undetectable HIV Viral Load.
Medication Adherence Rate - 7 Day
Time frame: baseline, month 3, month 6, month 9, and month 12
Self reported percentage of medication taken in the past 7 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups.
Medication Adherence - 30 Days
Time frame: baseline, month 3, month 6, month 9, and month 12
Self reported percentage of medication taken in the past 30 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups.

Results and safety

Results posted to the registry on 13 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1 Cell Phone Support	40	40
Stage 1 Short Message Service (SMS)	43	43
Stage 2 Cell Phone Support CPS-I	0	0
Stage 2 Cell Phone Support SMS-I	0	0
Stage 2 Cell Phone Support CPS-T	0	0
Stage 2 Cell Phone Support SC	0	0
Stage 2 Short Message Service SMS-T	0	0
Stage 2 Short Message Service SC	0	0
Stage 2 Short Message Service CPS-I	0	0
Stage 2 Short Message Service SMS-I	0	0

Primary outcome: Undetectable Viral Load

Time frame: baseline, month 3, month 6, month 9, and month 12. Number. Unit: percentage of participants

Measure	Stage 1 Cell Phone Support n = 34	Stage 1 Short Message Service (SMS) n = 35	Stage 2 Cell Phone Support CPS-I n = 1	Stage 2 Cell Phone Support SMS-I n = 1	Stage 2 Cell Phone Support CPS-T n = 7	Stage 2 Cell Phone Support SC n = 8	Stage 2 Short Message Service SMS-T n = 9	Stage 2 Short Message Service SC n = 12	Stage 2 Short Message Service CPS-I n = 1	Stage 2 Short Message Service SMS-I n = 2
Baseline	58.8	62.9	–	–	–	–	–	–	–	–
3 Month	89.5	87.5	100	100	100	100	90.0	100	–	–
6 Month	93.8	89.5	100	–	85.7	100	100	85.7	–	100
9 Month	83.3	83.3	100	100	80.0	80.0	100	83	–	100
12 Month	80.0	100.0	–	–	100	50.0	100	100	100	–

Population analysed: Significant attrition at follow-ups for viral load testing. Therefore the overall model would not converge.

Primary outcome: Medication Adherence Rate - 7 Day

Time frame: baseline, month 3, month 6, month 9, and month 12. Mean (Standard Deviation). Unit: percentage of medication adherence

Measure	Stage 1 Cell Phone Support n = 40	Stage 1 Short Message Service (SMS) n = 43	Stage 2: Cell Phone Support CPS-I n = 2	Stage 2 Cell Phone Support SMS-I n = 4	Stage 2 Cell Phone Support CPS-T n = 11	Stage 2 Cell Phone Support SC n = 15	Stage 2 Short Message Service SMS-T n = 14	Stage 2 Short Message Service SC n = 14	Stage 2 Short Message Service CPS-I n = 3	Stage 2 Short Message Service SMS-I n = 5
Baseline	63.68 (34.91)	74.52 (29.81)	–	–	–	–	–	–	–	–
3 month	90.69 (15.57)	76.18 (34.20)	70.00 (0.00)	100 (0.00)	94.60 (8.20)	88.00 (19.30)	95.40 (8.80)	79.30 (32.50)	15.00 (21.20)	42.00 (35.60)
6 month	80.00 (31.93)	84.55 (20.09)	100 (0.00)	40 (45.80)	96.30 (7.40)	74.40 (33.20)	94.60 (8.80)	76.70 (28.10)	95.00 (7.10)	70.00 (24.50)
9 month	79.17 (29.18)	82.76 (23.89)	100 (0.00)	76.70 (40.40)	85.70 (21.50)	72.00 (35.50)	94.60 (5.20)	92.50 (7.10)	56.70 (40.40)	54.00 (28.80)
12 month	73.33 (38.12)	79.63 (30.19)	–	33.30 (57.70)	98.00 (4.50)	79.10 (29.50)	97.00 (6.70)	70.00 (36.30)	66.70 (25.20)	46.70 (47.30)

Stage 1 Cell Phone Support vs Stage 1 Short Message Service (SMS): Slope: 2.44 (95% CI 0.28 to 4.59), p = 0.03, Mixed Models Analysis

Primary outcome: Medication Adherence - 30 Days

Time frame: baseline, month 3, month 6, month 9, and month 12. Mean (Standard Deviation). Unit: percentage of medication adherence

Measure	Stage 1 Cell Phone Support n = 31	Stage 1 Short Message Service (SMS) n = 36	Stage 2 Cell Phone Support CPS-I n = 2	Stage 2 Cell Phone Support SMS-I n = 2	Stage 2 Cell Phone Support CPS-T n = 10	Stage 2 Cell Phone Support SC n = 14	Stage 2 Short Message Service SMS-T n = 13	Stage 2 Short Message Service SC n = 13	Stage 2 Short Message Service CPS-I n = 3	Stage 2 Short Message Service SMS-I n = 4
Baseline	68.55 (27.18)	74.33 (23.60)	–	–	–	–	–	–	–	–
3 Month	87.56 (20.35)	84.87 (22.73)	75.00 (0.00)	53.00 (32.50)	95.10 (6.00)	88.00 (22.00)	96.20 (4.60)	83.90 (24.50)	70.00 (0.00)	58.00 (31.10)
6 Month	85.48 (21.14)	82.13 (20.08)	77.50 (23.30)	88.50 (16.30)	96.00 (9.80)	77.20 (27.00)	94.30 (8.40)	73.50 (28.30)	95.00 (7.10)	55.00 (35.20)
9 Month	78.34 (27.92)	83.74 (21.33)	93.00 (1.40)	90.50 (13.40)	87.40 (21.70)	67.90 (35.50)	94.60 (6.00)	91.10 (8.70)	56.00 (39.30)	58.00 (19.60)
12 Month	83.94 (22.73)	80.60 (28.73)	–	52.00 (67.90)	94.00 (5.50)	85.60 (12.80)	97.10 (6.30)	75.40 (29.80)	69.00 (28.60)	17.00 (24.00)

Stage 1 Cell Phone Support vs Stage 1 Short Message Service (SMS): Slope: 0.17 (95% CI -1.32 to 1.66), p = 0.82, Mixed Models Analysis

Adverse events

Time frame: Every 1 Year, for up to 3 years and 9 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1 Cell Phone Support	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Stage 1 Short Message Service (SMS)	0 of 43 (0%)	0 of 43 (0%)	0 of 43
Stage 2 Cell Phone Support CPS-I	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Stage 2 Cell Phone Support SMS-I	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Stage 2 Cell Phone Support CPS-T	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Stage 2 Cell Phone Support SC	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Stage 2 Short Message Service SMS-T	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Stage 2 Short Message Service SC	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Stage 2 Short Message Service CPS-I	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Stage 2 Short Message Service SMS-I	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30573448Belzer ME, MacDonell KK, Ghosh S, Naar S, McAvoy-Banerjea J, Gurung S, Cain D, Fan CA, Parsons JT. Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living With HIV Through Text Message and Cell Phone Support With and Without Incentives: Protocol for a Sequential Multiple Assignment Randomized Trial (SMART). JMIR Res Protoc. 2018 Dec 20;7(12):e11183. doi: 10.2196/11183.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CPS and SMS in people with HIV Infections, run by Florida State 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 5 inclusion and 3 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 13 Dec 2024. 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?

Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Viral Load (time frame: baseline, month 3, month 6, month 9, and month 12). The study lists 3 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 NCT03535337, 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 13 Dec 2024.