Life-Steps Counseling + Text Reminders for Medication Adherence

Recruiting at 1 trial location

Overseen By Marc Puccinelli, Ph.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Must be taking: PrEP

Disqualifiers: Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 18 months

250 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on adherence to PrEP medication, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment Life-Steps Counseling + Text Reminders for Medication Adherence?

Research shows that text message reminders can help people remember to take their medication, as seen in patients with heart disease. Additionally, counseling has been shown to improve medication adherence in various conditions, suggesting that combining these approaches could be effective. ^{1 2 3 4 5}

Is Life-Steps Counseling + Text Reminders for Medication Adherence safe for humans?

The research articles reviewed focus on the effectiveness of text message reminders for medication adherence, but they do not provide specific safety data for this treatment. Generally, text message reminders are considered safe as they are a form of electronic communication. ^{1 2 6 7 8}

What makes the Life-Steps Counseling + Text Reminders treatment unique for medication adherence?

This treatment is unique because it combines personalized counseling with text message reminders to help people remember to take their medication, which is different from other treatments that might only use one of these methods. ^{1 2 9 10 11}

Research Team

Steven A Safren, Ph.D.

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for adults who were assigned male at birth or are trans men, indicated for PrEP by CDC guidelines, and have issues like depression, substance use, or trauma. They must own a smartphone with texting/internet and be new to PrEP or unsure about sticking to it. People can't join if they're unable to consent due to severe illness/cognitive impairment, have kidney issues preventing PrEP use, or active suicidal thoughts/untreated major mental illness.

Inclusion Criteria

I have never taken PrEP or am unsure if I will continue taking it.

I am a man or a trans man.

I identify as a man who has sex with men.

Exclusion Criteria

Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of enrollment (these patients will be referred immediately for treatment, but may join the study when this is resolved)

Laboratory or clinical findings that would preclude PrEP initiation (e.g. decreased creatinine clearance)

Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care treatment with optional Life-Steps intervention and daily text message reminders

18 months

Regular visits at 3, 6, 9, 12, 15, and 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Daily text message reminders
• Lifesteps for PrEP

Trial Overview The study is testing how daily text message reminders and LifeSteps counseling might help people take their PrEP medication more consistently. Participants will receive interventions aimed at improving adherence and engagement in their preventive care routine.

Participant Groups

Group I: Life-Steps for PreP Experimental Treatment 2 Interventions

Participants in this group will receive standard of care treatment plus daily text message reminders. A subset of participants who demonstrate continued adherence challenges will also receive 4-6 weekly sessions of the Lifesteps for PrEP intervention.

Group II: Standard of Care Active Control 1 Intervention

Participants in this group will not receive an intervention outside the standard of care.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Text message reminders (TMR) significantly improved medication adherence among 1678 patients with coronary heart disease, showing a 2.85 times greater adherence rate compared to the control group.

TMR also led to notable reductions in systolic blood pressure and cholesterol levels, contributing to better clinical outcomes, although it did not affect mortality or diastolic blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of text message reminders on medication adherence among patients with coronary heart disease: A systematic review and meta-analysis. Zhao, YY., Dang, FP., Zhai, TT., et al.[2022]

Counseling during a simulated medication adherence activity significantly reduced the incidence of simulated food-drug interactions, with 22% in the counseling group compared to 30% in the group without counseling.

The majority of students (70%) found the activity valuable, and 89% felt it improved their understanding of medication adherence challenges, highlighting the importance of counseling in enhancing adherence education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Potential Impact of Pharmacist Counseling on Medication Adherence Using a Simulation Activity. Volino, LR., Das, RP., Mansukhani, RP., et al.[2023]

The use of Talking Pill Bottles, which provide audio-assisted medication instructions, significantly improved blood pressure control among hypertensive patients with low health literacy, indicating a positive impact on health outcomes.

Patients showed high acceptance of the Talking Pill Bottle technology, suggesting it is a viable tool for enhancing medication adherence and understanding, although further research is needed to explore its effectiveness in newly diagnosed patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing low health literacy with "Talking Pill Bottles": A pilot study in a community pharmacy setting. Lam, AY., Nguyen, JK., Parks, JJ., et al.[2018]

A cluster randomized controlled trial involving 160 chronic patients across six hospitals showed that a Tailored Multimedia Intervention, which combined technology and personalized counseling, improved patient satisfaction with nurses' communication and enhanced self-efficacy regarding medication adherence.

The positive effects on self-efficacy were sustained even after six months, indicating that this approach can effectively support patients in managing their medication regimens over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating a synergy effect: A cluster randomized controlled trial testing the effect of a tailored multimedia intervention on patient outcomes. Linn, AJ., van Dijk, L., van Weert, JCM., et al.[2019]

In a study involving 1,677 children with uncomplicated malaria, SMS reminders significantly improved the likelihood of returning to the health facility for follow-up visits on day 3 and day 28, but did not significantly affect adherence to the medication regimen of artemether-lumefantrine (AL), which was already high in both groups.

The results suggest that while SMS reminders can enhance post-treatment attendance, they may not be necessary for improving medication adherence, indicating a need for further research in real-world settings to explore their full potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of text-message reminders on paediatric malaria treatment adherence and their post-treatment return to health facilities in Kenya: a randomized controlled trial. Talisuna, AO., Oburu, A., Githinji, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of text message reminders on medication adherence among patients with coronary heart disease: A systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Potential Impact of Pharmacist Counseling on Medication Adherence Using a Simulation Activity. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the effectiveness of education on medication adherence for patients with hypertension, hyperlipidaemia and diabetes. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Telephone counseling and home telehealth monitoring to improve medication adherence: results of a pilot trial among individuals with multiple sclerosis. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Development and piloting of a highly tailored digital intervention to support adherence to antihypertensive medications as an adjunct to primary care consultations. [2021]

6. Estonia pubmed.ncbi.nlm.nih.gov

The Effectiveness of Mobile Phone Text Messaging in Improving Medication Adherence for Patients with Chronic Diseases: A Systematic Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Addressing low health literacy with "Talking Pill Bottles": A pilot study in a community pharmacy setting. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Assessment of medication adherence and the costs associated with a calendar blister pack intervention among hypertensive patients in Malaysia: A randomized controlled trial. [2020]

9. Ireland pubmed.ncbi.nlm.nih.gov

Creating a synergy effect: A cluster randomized controlled trial testing the effect of a tailored multimedia intervention on patient outcomes. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Use of pictorial aids in medication instructions: a review of the literature. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Efficacy of text-message reminders on paediatric malaria treatment adherence and their post-treatment return to health facilities in Kenya: a randomized controlled trial. [2022]