Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART) (SMART)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03535337 |
Recruitment Status :
Completed
First Posted : May 24, 2018
Last Update Posted : July 7, 2022
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | April 12, 2018 | ||||
First Posted Date ICMJE | May 24, 2018 | ||||
Last Update Posted Date | July 7, 2022 | ||||
Actual Study Start Date ICMJE | September 1, 2018 | ||||
Actual Primary Completion Date | May 31, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Viral Load Comparison [ Time Frame: 3 months ] Viral Load (VL) suppression rate will be compared between the CPS and SMS groups using an X2 test. Also the drop in VL will be compared between the two groups.
|
||||
Original Primary Outcome Measures ICMJE |
Viral Load Comparison [ Time Frame: 12 months ] Viral Load (VL) suppression rate will be compared between the CPS and SMS groups using an X2 test. Also the drop in VL will be compared between the two groups.
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Medication Adherence Rate [ Time Frame: 3 months ] Medication adherence rates will be compared between CPS and SMS groups, focusing on non-responders.
|
||||
Original Secondary Outcome Measures ICMJE |
Medication Adherence Rate [ Time Frame: 12 months ] Medication adherence rates will be compared between CPS and SMS groups, focusing on non-responders.
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART) | ||||
Official Title ICMJE | 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 | ||||
Brief 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 of the context for wide-scale implementation of cell phone support (CPS) and text messaging support (SMS), with and without incentives. | ||||
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. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Intervention Model Description: Multiple Assignment Randomized Trial Masking: None (Open Label)Primary Purpose: Supportive Care |
||||
Condition ICMJE | HIV Infections | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
83 | ||||
Original Estimated Enrollment ICMJE |
190 | ||||
Actual Study Completion Date ICMJE | May 31, 2022 | ||||
Actual Primary Completion Date | May 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 15 Years to 24 Years (Child, Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03535337 | ||||
Other Study ID Numbers ICMJE | ATN 144 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Sylvie Naar, Florida State University | ||||
Original Responsible Party | Florida State University | ||||
Current Study Sponsor ICMJE | Florida State University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
|
||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Florida State University | ||||
Verification Date | July 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |