HIV/AIDSNCT03584282
Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users
A study testing Text Messaging and Peer Navigation in people with HIV/AIDS and Adherence, Medication, run by University of Washington at 2 sites in United States.
Trial summary
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Adherence, Medication, Drug Use
- What is being tested?
- Text Messaging and Peer Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jul 2018to 30 Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets the clinic's eligibility criteria for PrEP
- 18 years of age or older
- HIV-negative
- Cisgender man or individual on the trans gender variant spectrum who has sex with men
- Ability to understand, read, and speak English
- Reports meth use in the past 3 months
- Has a cell phone able to send and receive text messages
Who cannot join
- PrEP use in the prior month,
- Discomfort or anxiety with regards to text messaging.
- Has any circumstances that, based on the study staff's opinion, would preclude provision of informed consent, make participation unsafe, or make it unlikely the participant would be able to participate for 6 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kelley-Ross One-Step PrEP
Seattle, Washington, 98104
Gay City
Seattle, Washington, 98122
About this study
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable.
Read the detailed description
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Despite apparent high levels of PrEP knowledge and exceptional insurance and medication coverage, few meth-users in Western WA have enrolled in local PrEP programs. The investigators' preliminary work with meth-using MSM/TG has identified both traditional barriers to PrEP and barriers specific for meth users, including competing priorities (e.g., getting high); lack of regularity in daily schedules leading to difficulties complying with appointments and medication adherence; and concomitant wellness and social concerns, notably depression and meth-related stigma. Additional work is needed to develop new strategies to increase PrEP uptake and support persistence and adherence among meth-using MSM/TG. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable. The first, peer navigation, has been studied in ARV treatment and has been proposed for PrEP. The second, text messaging, has been shown to increase ARV and PrEP adherence.
- Conditions
- HIV/AIDS, Adherence, Medication, Drug Use
- Being tested
- Text Messaging, Peer Navigation
- Keywords
- Pre-Exposure Prophylaxis (PrEP), Methamphetamine
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessagingBehavioural
The text messaging intervention will send three text messages per day from a library. One will be a reminder to take PrEP, one will include PrEP information, and the third will have the content of the participant's choosing from categories of harm reduction messages and health information. Participants will also select the time period to receive these texts.
Peer NavigationBehavioural
The peer navigation intervention will provide support from a peer that is responsive to a participant's individualized needs. Peer support may include phone call reminders, help refilling PrEP prescriptions, transit assistance, or other referrals.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants in this group will receive the standard of care for PrEP follow-up and no additional research interventions. |
| Text Messaging | Active comparator | Participants in this group will receive the text messaging intervention. Receives: Behavioral: Text Messaging |
| Peer Navigation | Active comparator | Participants in this group will receive the peer navigator intervention. Receives: Behavioral: Peer Navigation |
| Text Messaging and Peer Navigation | Active comparator | Participants in this group will receive both the text messaging and peer navigation interventions. Receives: Behavioral: Text Messaging; Behavioral: Peer Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Text Messaging
Self-reported likelihood to recommend the text messaging intervention, via survey response, among those who received the text messaging intervention (may have been in the Standard of care group or the Peer Navigation group). Only participants who received the text messaging intervention are included in the analysis group.
Measured: 6 months
Acceptability of Peer Navigation
Self-reported likelihood to recommend the peer navigation intervention, via survey response, among those who were assigned to the peer navigation group. Only participants who received the peer navigation intervention are included in the analysis group.
Measured: 6 months
Secondary outcomes (2)
PrEP Persistence
Persistence on PrEP comparing standard of care or text messaging vs peer navigation, as measured by whether the participant had returned to the clinic at 6 months follow up their DBS card collection.
Measured: 6 months
PrEP Adherence
PrEP adherence measured in dried blood spots comparing standard of care/text messaging vs peer navigation, as measured by the detection of tenofovir-diphosphate (TFV-DP) in DBS collected 6 months after study enrollment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start11 Jul 2018
- Primary completion31 Dec 2021
- Study completion30 Jun 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 (15)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The investigators will randomly assign 10 participants to each arm: 1) standard of care, 2) text messaging only, 3) peer navigation only, and 4) text messaging and peer navigation.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Joanne Stekler, MD MPH, University of Washington
- Investigators
- Joanne Stekler, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584282
- Sponsor's protocol ID
- STUDY00004760
- Other IDs
- 1R34DA045620-01
- Status last verified
- May 2024
- First submitted
- 19 Jun 2018
- Last updated
- 5 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mera R, McCallister S, Palmer B, Mayer G, Magnuson D, Rawlings K. Truvada (TVD) for HIV pre-exposure prophylaxis (PrEP) utilization in the United States (2013-2015). 21st International AIDS Conference; Durban, South Africa; July 18-22, 2016 [abstract TUAX0105LB]. In.
Hood JE, Buskin SE, Dombrowski JC, Kern DA, Barash EA, Katz DA, Golden MR. Dramatic increase in preexposure prophylaxis use among MSM in Washington state. AIDS. 2016 Jan 28;30(3):515-9. doi: 10.1097/QAD.0000000000000937.
PubMed 26562845Beyrer C, Baral SD, van Griensven F, Goodreau SM, Chariyalertsak S, Wirtz AL, Brookmeyer R. Global epidemiology of HIV infection in men who have sex with men. Lancet. 2012 Jul 28;380(9839):367-77. doi: 10.1016/S0140-6736(12)60821-6. Epub 2012 Jul 20.
PubMed 22819660Pitasi M, Llata E, Stenger M, Kerani R, Kohn R, Murphy R, et al. HIV prevalence among transgender women and men: results from the STD Surveillance Network, 2010-2013. 2015 National HIV Prevention Conference; Atlanta, GA; December 6-9, 2015 [abstract #1193]. In.
Habarta N, Wang G, Mulatu MS, Larish N. HIV Testing by Transgender Status at Centers for Disease Control and Prevention-Funded Sites in the United States, Puerto Rico, and US Virgin Islands, 2009-2011. Am J Public Health. 2015 Sep;105(9):1917-25. doi: 10.2105/AJPH.2015.302659. Epub 2015 Jul 16.
PubMed 26180964Buskin S, Hood J, Katz DA. Estimating the population-level impact of methamphetamine use on HIV acquisition among men who have sex with men using population attributable risk percent - a powerful and underused planning tool. International AIDS Society Conference 2015. July 19-22, 2015. Vancouver. Abstract MOPEC491. In.
McMahan V, Martin A, Garske L, Baeten JM, Banta-Green C, Stekler J. Knowledge about PrEP among MSM and Trans* Methamphetamine Users in Seattle. 24th Conference on Retroviruses and Opportunistic Infections; Seattle, WA; February 13-16, 2017 [#2063]. In.
Simoni JM, Huh D, Frick PA, Pearson CR, Andrasik MP, Dunbar PJ, Hooton TM. Peer support and pager messaging to promote antiretroviral modifying therapy in Seattle: a randomized controlled trial. J Acquir Immune Defic Syndr. 2009 Dec 1;52(4):465-473. doi: 10.1097/qai.0b013e3181b9300c.
PubMed 19911481Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W, Habyarimana J, Sadatsafavi M, Najafzadeh M, Marra CA, Estambale B, Ngugi E, Ball TB, Thabane L, Gelmon LJ, Kimani J, Ackers M, Plummer FA. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010 Nov 27;376(9755):1838-45. doi: 10.1016/S0140-6736(10)61997-6. Epub 2010 Nov 9.
PubMed 21071074Dowshen N, Kuhns LM, Johnson A, Holoyda BJ, Garofalo R. Improving adherence to antiretroviral therapy for youth living with HIV/AIDS: a pilot study using personalized, interactive, daily text message reminders. J Med Internet Res. 2012 Apr 5;14(2):e51. doi: 10.2196/jmir.2015.
PubMed 22481246Finitsis DJ, Pellowski JA, Johnson BT. Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials. PLoS One. 2014 Feb 5;9(2):e88166. doi: 10.1371/journal.pone.0088166. eCollection 2014.
PubMed 24505411Liu A, Stojanovski K, Lester R. Developing and Implementing a Mobile Health (mHealth) Adherence Support System for HIV- Uninfected Men who have Sex with Men (MSM) Taking Pre-Exposure Prophylaxis (PrEP): The iText Study. 8th International Conference on HIV Treatment and Prevention Adherence; Miami, FL; June 2-4, 2013 [Abstract #165]. In.
McMahan VM, Atkins DL, Buckler S, Violette LR, Niemann L, Frank N, Kimiam Waters, Herrera Perales LE, Viquez L, Tung E, Stekler JD. Challenges recruiting and retaining people at risk for HIV who use methamphetamine in a randomized PrEP adherence trial in Seattle, WA. Int J STD AIDS. 2024 Jul;35(8):635-643. doi: 10.1177/09564624241244835. Epub 2024 Apr 17.
PubMed 38630433Frank N, McMahan VM, Violette LR, Martin A, Glick SN, Stekler JD. Efficient Expansion of a Behavioral Survey to Assess Sex, Gender, and Behavioral Risk Among Transgender and Nonbinary Individuals: HMU! (HIV Prevention for Methamphetamine Users). Transgend Health. 2023 Oct 4;8(5):472-476. doi: 10.1089/trgh.2021.0082. eCollection 2023 Oct.
PubMed 37810934McMahan VM, Frank N, Buckler S, Violette LR, Baeten JM, Banta-Green CJ, Barnabas RV, Simoni J, Stekler JD. Protocol Development for HMU! (HIV Prevention for Methamphetamine Users), a Study of Peer Navigation and Text Messaging to Promote Pre-Exposure Prophylaxis Adherence and Persistence Among People Who Use Methamphetamine: Qualitative Focus Group and Interview Study. JMIR Form Res. 2020 Sep 14;4(9):e18118. doi: 10.2196/18118.
PubMed 32924952
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users
- ClinicalTrials.gov ID
- NCT03584282
- Acronym / sponsor ID
- STUDY00004760
- Conditions
- HIV/AIDS, Adherence, Medication, Drug Use
- Keywords
- Pre-Exposure Prophylaxis (PrEP), Methamphetamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Posted 5 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable.
Detailed description
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Despite apparent high levels of PrEP knowledge and exceptional insurance and medication coverage, few meth-users in Western WA have enrolled in local PrEP programs. The investigators' preliminary work with meth-using MSM/TG has identified both traditional barriers to PrEP and barriers specific for meth users, including competing priorities (e.g., getting high); lack of regularity in daily schedules leading to difficulties complying with appointments and medication adherence; and concomitant wellness and social concerns, notably depression and meth-related stigma. Additional work is needed to develop new strategies to increase PrEP uptake and support persistence and adherence among meth-using MSM/TG. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable. The first, peer navigation, has been studied in ARV treatment and has been proposed for PrEP. The second, text messaging, has been shown to increase ARV and PrEP adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The investigators will randomly assign 10 participants to each arm: 1) standard of care, 2) text messaging only, 3) peer navigation only, and 4) text messaging and peer navigation.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants in this group will receive the standard of care for PrEP follow-up and no additional research interventions. |
| Text Messaging | Active comparator | Behavioral: Text MessagingParticipants in this group will receive the text messaging intervention. |
| Peer Navigation | Active comparator | Behavioral: Peer NavigationParticipants in this group will receive the peer navigator intervention. |
| Text Messaging and Peer Navigation | Active comparator | Behavioral: Text Messaging, Behavioral: Peer NavigationParticipants in this group will receive both the text messaging and peer navigation interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meets the clinic's eligibility criteria for PrEP
- 18 years of age or older
- HIV-negative
- Cisgender man or individual on the trans gender variant spectrum who has sex with men
- Ability to understand, read, and speak English
Key exclusion criteria (3 listed)
- PrEP use in the prior month,
- Discomfort or anxiety with regards to text messaging.
- Has any circumstances that, based on the study staff's opinion, would preclude provision of informed consent, make participation unsafe, or make it unlikely the participant would be able to participate for 6 months.
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 |
|---|---|---|
| Text MessagingThe text messaging intervention will send three text messages per day from a library. One will be a reminder to take PrEP, one will include PrEP information, and the third will have the content of the participant's choosing from categories of harm reduction messages and health information. Participants will also select the time period to receive these texts. | Behavioural | Text Messaging, Text Messaging and Peer Navigation |
| Peer NavigationThe peer navigation intervention will provide support from a peer that is responsive to a participant's individualized needs. Peer support may include phone call reminders, help refilling PrEP prescriptions, transit assistance, or other referrals. | Behavioural | Peer Navigation, Text Messaging and Peer Navigation |
Primary outcome
Acceptability of Text Messaging
Time frame: 6 months
Self-reported likelihood to recommend the text messaging intervention, via survey response, among those who received the text messaging intervention (may have been in the Standard of care group or the Peer Navigation group). Only participants who received the text messaging intervention are included in the analysis group.
Acceptability of Peer Navigation
Time frame: 6 months
Self-reported likelihood to recommend the peer navigation intervention, via survey response, among those who were assigned to the peer navigation group. Only participants who received the peer navigation intervention are included in the analysis group.
2 secondary outcomes
PrEP Persistence
Time frame: 6 months
PrEP Adherence
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundMera R, McCallister S, Palmer B, Mayer G, Magnuson D, Rawlings K. Truvada (TVD) for HIV pre-exposure prophylaxis (PrEP) utilization in the United States (2013-2015). 21st International AIDS Conference; Durban, South Africa; July 18-22, 2016 [abstract TUAX0105LB]. In.
- Background: PubMed 26562845Hood JE, Buskin SE, Dombrowski JC, Kern DA, Barash EA, Katz DA, Golden MR. Dramatic increase in preexposure prophylaxis use among MSM in Washington state. AIDS. 2016 Jan 28;30(3):515-9. doi: 10.1097/QAD.0000000000000937.
- Background: PubMed 22819660Beyrer C, Baral SD, van Griensven F, Goodreau SM, Chariyalertsak S, Wirtz AL, Brookmeyer R. Global epidemiology of HIV infection in men who have sex with men. Lancet. 2012 Jul 28;380(9839):367-77. doi: 10.1016/S0140-6736(12)60821-6. Epub 2012 Jul 20.
- BackgroundPitasi M, Llata E, Stenger M, Kerani R, Kohn R, Murphy R, et al. HIV prevalence among transgender women and men: results from the STD Surveillance Network, 2010-2013. 2015 National HIV Prevention Conference; Atlanta, GA; December 6-9, 2015 [abstract #1193]. In.
- Background: PubMed 26180964Habarta N, Wang G, Mulatu MS, Larish N. HIV Testing by Transgender Status at Centers for Disease Control and Prevention-Funded Sites in the United States, Puerto Rico, and US Virgin Islands, 2009-2011. Am J Public Health. 2015 Sep;105(9):1917-25. doi: 10.2105/AJPH.2015.302659. Epub 2015 Jul 16.
- BackgroundBuskin S, Hood J, Katz DA. Estimating the population-level impact of methamphetamine use on HIV acquisition among men who have sex with men using population attributable risk percent - a powerful and underused planning tool. International AIDS Society Conference 2015. July 19-22, 2015. Vancouver. Abstract MOPEC491. In.
- BackgroundMcMahan V, Martin A, Garske L, Baeten JM, Banta-Green C, Stekler J. Knowledge about PrEP among MSM and Trans* Methamphetamine Users in Seattle. 24th Conference on Retroviruses and Opportunistic Infections; Seattle, WA; February 13-16, 2017 [#2063]. In.
- Background: PubMed 19911481Simoni JM, Huh D, Frick PA, Pearson CR, Andrasik MP, Dunbar PJ, Hooton TM. Peer support and pager messaging to promote antiretroviral modifying therapy in Seattle: a randomized controlled trial. J Acquir Immune Defic Syndr. 2009 Dec 1;52(4):465-473. doi: 10.1097/qai.0b013e3181b9300c.
- Background: PubMed 21071074Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W, Habyarimana J, Sadatsafavi M, Najafzadeh M, Marra CA, Estambale B, Ngugi E, Ball TB, Thabane L, Gelmon LJ, Kimani J, Ackers M, Plummer FA. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010 Nov 27;376(9755):1838-45. doi: 10.1016/S0140-6736(10)61997-6. Epub 2010 Nov 9.
- Background: PubMed 22481246Dowshen N, Kuhns LM, Johnson A, Holoyda BJ, Garofalo R. Improving adherence to antiretroviral therapy for youth living with HIV/AIDS: a pilot study using personalized, interactive, daily text message reminders. J Med Internet Res. 2012 Apr 5;14(2):e51. doi: 10.2196/jmir.2015.
- Background: PubMed 24505411Finitsis DJ, Pellowski JA, Johnson BT. Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials. PLoS One. 2014 Feb 5;9(2):e88166. doi: 10.1371/journal.pone.0088166. eCollection 2014.
- BackgroundLiu A, Stojanovski K, Lester R. Developing and Implementing a Mobile Health (mHealth) Adherence Support System for HIV- Uninfected Men who have Sex with Men (MSM) Taking Pre-Exposure Prophylaxis (PrEP): The iText Study. 8th International Conference on HIV Treatment and Prevention Adherence; Miami, FL; June 2-4, 2013 [Abstract #165]. In.
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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.
Joanne Stekler, MD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging and Peer Navigation in people with HIV/AIDS and Adherence, Medication, run by University of Washington at 2 sites 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 7 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 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 5 Jun 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?
Acceptability of Text Messaging (time frame: 6 months). 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 NCT03584282, which also lists 15 linked publications.
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 5 Jun 2024; AzTrials last refreshed its copy on 28 Oct 2026.