NCT03535337 (SMART) is a NA clinical trial of CPS in HIV Infections, sponsored by Florida State University.

Who is sponsoring NCT03535337?

NCT03535337 is sponsored by Florida State University.

What drugs are being tested in NCT03535337?

Interventions in NCT03535337: CPS, SMS.

What condition does NCT03535337 study?

NCT03535337 studies HIV Infections.

Is NCT03535337 still recruiting?

NCT03535337 is currently completed. Last updated 13 December 2024.

Are results published for NCT03535337?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-12-13 · How we verify

NCT03535337: SMART

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 13 December 2024

What this trial tests

NA trial testing CPS in HIV Infections in 83 participants. Completed in 31 May 2022.

Timeline

1 September 2018

Primary endpoint
31 May 2022

31 May 2022

Quick facts

Lead sponsor	Florida State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	supportive care
Enrollment	83
Start date	1 September 2018
Primary completion	31 May 2022
Estimated completion	31 May 2022
Sites	1 location across United States

Drugs / interventions tested

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

Florida State University

Who can join

Adults 15 to 24, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Undetectable Viral Load Primary · baseline, month 3, month 6, month 9, and month 12

Percent of participants that have an undetectable HIV Viral Load.

Baseline

Group	Value	95% CI
Stage 1 Cell Phone Support	58.8
Stage 1 Short Message Service (SMS)	62.9

3 Month

Group	Value	95% CI
Stage 1 Cell Phone Support	89.5
Stage 1 Short Message Service (SMS)	87.5
Stage 2 Cell Phone Support CPS-I	100
Stage 2 Cell Phone Support SMS-I	100
Stage 2 Cell Phone Support CPS-T	100
Stage 2 Cell Phone Support SC	100
Stage 2 Short Message Service SMS-T	90.0
Stage 2 Short Message Service SC	100

6 Month

Group	Value	95% CI
Stage 1 Cell Phone Support	93.8
Stage 1 Short Message Service (SMS)	89.5
Stage 2 Cell Phone Support CPS-I	100
Stage 2 Cell Phone Support CPS-T	85.7
Stage 2 Cell Phone Support SC	100
Stage 2 Short Message Service SMS-T	100
Stage 2 Short Message Service SC	85.7
Stage 2 Short Message Service SMS-I	100

9 Month

Group	Value	95% CI
Stage 1 Cell Phone Support	83.3
Stage 1 Short Message Service (SMS)	83.3
Stage 2 Cell Phone Support CPS-I	100
Stage 2 Cell Phone Support SMS-I	100
Stage 2 Cell Phone Support CPS-T	80.0
Stage 2 Cell Phone Support SC	80.0
Stage 2 Short Message Service SMS-T	100
Stage 2 Short Message Service SC	83
Stage 2 Short Message Service SMS-I	100

12 Month

Group	Value	95% CI
Stage 1 Cell Phone Support	80.0
Stage 1 Short Message Service (SMS)	100.0
Stage 2 Cell Phone Support CPS-T	100
Stage 2 Cell Phone Support SC	50.0
Stage 2 Short Message Service SMS-T	100
Stage 2 Short Message Service SC	100
Stage 2 Short Message Service CPS-I	100

Medication Adherence Rate - 7 Day Primary · 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.

Baseline

Group	Value	95% CI
Stage 1 Cell Phone Support	63.68	± 34.91
Stage 1 Short Message Service (SMS)	74.52	± 29.81

3 month

Group	Value	95% CI
Stage 1 Cell Phone Support	90.69	± 15.57
Stage 1 Short Message Service (SMS)	76.18	± 34.20
Stage 2: Cell Phone Support CPS-I	70.00	± 0.00
Stage 2 Cell Phone Support SMS-I	100	± 0.00
Stage 2 Cell Phone Support CPS-T	94.60	± 8.20
Stage 2 Cell Phone Support SC	88.00	± 19.30
Stage 2 Short Message Service SMS-T	95.40	± 8.80
Stage 2 Short Message Service SC	79.30	± 32.50
Stage 2 Short Message Service CPS-I	15.00	± 21.20
Stage 2 Short Message Service SMS-I	42.00	± 35.60

6 month

Group	Value	95% CI
Stage 1 Cell Phone Support	80.00	± 31.93
Stage 1 Short Message Service (SMS)	84.55	± 20.09
Stage 2: Cell Phone Support CPS-I	100	± 0.00
Stage 2 Cell Phone Support SMS-I	40	± 45.80
Stage 2 Cell Phone Support CPS-T	96.30	± 7.40
Stage 2 Cell Phone Support SC	74.40	± 33.20
Stage 2 Short Message Service SMS-T	94.60	± 8.80
Stage 2 Short Message Service SC	76.70	± 28.10
Stage 2 Short Message Service CPS-I	95.00	± 7.10
Stage 2 Short Message Service SMS-I	70.00	± 24.50

9 month

Group	Value	95% CI
Stage 1 Cell Phone Support	79.17	± 29.18
Stage 1 Short Message Service (SMS)	82.76	± 23.89
Stage 2: Cell Phone Support CPS-I	100	± 0.00
Stage 2 Cell Phone Support SMS-I	76.70	± 40.40
Stage 2 Cell Phone Support CPS-T	85.70	± 21.50
Stage 2 Cell Phone Support SC	72.00	± 35.50
Stage 2 Short Message Service SMS-T	94.60	± 5.20
Stage 2 Short Message Service SC	92.50	± 7.10
Stage 2 Short Message Service CPS-I	56.70	± 40.40
Stage 2 Short Message Service SMS-I	54.00	± 28.80

12 month

Group	Value	95% CI
Stage 1 Cell Phone Support	73.33	± 38.12
Stage 1 Short Message Service (SMS)	79.63	± 30.19
Stage 2 Cell Phone Support SMS-I	33.30	± 57.70
Stage 2 Cell Phone Support CPS-T	98.00	± 4.50
Stage 2 Cell Phone Support SC	79.10	± 29.50
Stage 2 Short Message Service SMS-T	97.00	± 6.70
Stage 2 Short Message Service SC	70.00	± 36.30
Stage 2 Short Message Service CPS-I	66.70	± 25.20
Stage 2 Short Message Service SMS-I	46.70	± 47.30

Medication Adherence - 30 Days Primary · 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.

Baseline

Group	Value	95% CI
Stage 1 Cell Phone Support	68.55	± 27.18
Stage 1 Short Message Service (SMS)	74.33	± 23.60

3 Month

Group	Value	95% CI
Stage 1 Cell Phone Support	87.56	± 20.35
Stage 1 Short Message Service (SMS)	84.87	± 22.73
Stage 2 Cell Phone Support CPS-I	75.00	± 0.00
Stage 2 Cell Phone Support SMS-I	53.00	± 32.50
Stage 2 Cell Phone Support CPS-T	95.10	± 6.00
Stage 2 Cell Phone Support SC	88.00	± 22.00
Stage 2 Short Message Service SMS-T	96.20	± 4.60
Stage 2 Short Message Service SC	83.90	± 24.50
Stage 2 Short Message Service CPS-I	70.00	± 0.00
Stage 2 Short Message Service SMS-I	58.00	± 31.10

6 Month

Group	Value	95% CI
Stage 1 Cell Phone Support	85.48	± 21.14
Stage 1 Short Message Service (SMS)	82.13	± 20.08
Stage 2 Cell Phone Support CPS-I	77.50	± 23.30
Stage 2 Cell Phone Support SMS-I	88.50	± 16.30
Stage 2 Cell Phone Support CPS-T	96.00	± 9.80
Stage 2 Cell Phone Support SC	77.20	± 27.00
Stage 2 Short Message Service SMS-T	94.30	± 8.40
Stage 2 Short Message Service SC	73.50	± 28.30
Stage 2 Short Message Service CPS-I	95.00	± 7.10
Stage 2 Short Message Service SMS-I	55.00	± 35.20

9 Month

Group	Value	95% CI
Stage 1 Cell Phone Support	78.34	± 27.92
Stage 1 Short Message Service (SMS)	83.74	± 21.33
Stage 2 Cell Phone Support CPS-I	93.00	± 1.40
Stage 2 Cell Phone Support SMS-I	90.50	± 13.40
Stage 2 Cell Phone Support CPS-T	87.40	± 21.70
Stage 2 Cell Phone Support SC	67.90	± 35.50
Stage 2 Short Message Service SMS-T	94.60	± 6.00
Stage 2 Short Message Service SC	91.10	± 8.70
Stage 2 Short Message Service CPS-I	56.00	± 39.30
Stage 2 Short Message Service SMS-I	58.00	± 19.60

12 Month

Group	Value	95% CI
Stage 1 Cell Phone Support	83.94	± 22.73
Stage 1 Short Message Service (SMS)	80.60	± 28.73
Stage 2 Cell Phone Support SMS-I	52.00	± 67.90
Stage 2 Cell Phone Support CPS-T	94.00	± 5.50
Stage 2 Cell Phone Support SC	85.60	± 12.80
Stage 2 Short Message Service SMS-T	97.10	± 6.30
Stage 2 Short Message Service SC	75.40	± 29.80
Stage 2 Short Message Service CPS-I	69.00	± 28.60
Stage 2 Short Message Service SMS-I	17.00	± 24.00

Sponsor's own description

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 of the context for wide-scale implementation of cell phone support (CPS) and text messaging support (SMS), with and without incentives.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Accuracy of measures for antiretroviral adherence in people living with HIV.
Smith R, Villanueva G, Probyn K, Sguassero Y, et al · · 2022 · cited 34× · PMID 35871531 · DOI 10.1002/14651858.cd013080.pub2
Antiretroviral adherence for adolescents growing up with HIV: understanding real life, drug delivery and forgiveness.
Foster C, Ayers S, Fidler S. · · 2020 · cited 30× · PMID 32523693 · DOI 10.1177/2049936120920177
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).
Belzer ME, MacDonell KK, Ghosh S, Naar S, et al · · 2018 · cited 27× · PMID 30573448 · DOI 10.2196/11183
An Adaptive Antiretroviral Therapy Adherence Intervention for Youth with HIV Through Text Message and Cell Phone Support with and without Incentives: A Sequential Multiple Assignment Randomized Trial (SMART).
Belzer ME, MacDonell K, Cain D, Ghosh S, et al · · 2025 · cited 5× · PMID 39702557 · DOI 10.1007/s10461-024-04558-x

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03535337 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Florida State University
Last refreshed: 13 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03535337.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03535337: SMART

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for HIV Infections

Other Florida State University trials

Verify against primary sources