Life-Steps Counseling + Text Reminders for Medication Adherence

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different methods can help people adhere to their pre-exposure prophylaxis (PrEP) medication routine. It examines whether daily text reminders and counseling sessions (Life-Steps for PrEP) improve adherence compared to standard care. The trial targets men, including trans men, who have sex with men and are either new to PrEP or uncertain about continuing it. Participants should have a cell phone for receiving text messages and face challenges such as depression or heavy alcohol use. As an unphased trial, this study offers participants the chance to contribute to important research that may enhance support for PrEP adherence.

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 prior data suggests that these interventions are safe for improving medication adherence?

Research has shown that Life-Steps for PrEP is generally safe. This program uses cognitive-behavioral therapy (CBT) to help people consistently take their PrEP medication. Most studies have focused on the program's effectiveness in promoting regular medication adherence rather than its safety. However, the methods align with those in other safe therapies.

No specific safety issues have been reported with Life-Steps for PrEP. The program is non-invasive, involving counseling and text reminders without medications or physical procedures.

Prospective trial participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Life-Steps for PrEP approach because it adds a personalized touch to the standard HIV prevention methods. While traditional treatments focus on medication alone, this approach includes daily text message reminders and, for those needing extra support, weekly counseling sessions. This innovative combination aims to boost adherence to medication routines, making it easier for individuals to stay on track and effectively prevent HIV. By integrating digital reminders and personal counseling, researchers hope to enhance the success rates of existing prevention strategies.

What evidence suggests that this trial's interventions could be effective for medication adherence?

In this trial, participants in the Life-Steps for PrEP arm will receive standard care treatment plus daily text message reminders. A subset of these participants, who continue to face adherence challenges, will also receive 4-6 weekly sessions of the Life-Steps for PrEP intervention. Studies have shown that Life-Steps for PrEP, combined with text reminders, can help people take their PrEP medication more consistently. This method uses a type of talking therapy to assist people in remembering and adhering to their medication schedule. Earlier research demonstrated that participants using this approach had high rates of medication adherence. The text reminders provide ongoing support and daily prompts to take the medication. These findings suggest that Life-Steps for PrEP could effectively help people maintain their medication routine, which is crucial for preventing HIV. ^{1 2 4 6 7}

Who Is on the Research Team?

Steven A Safren, Ph.D.

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5381825/

“Life-Steps” for PrEP Adherence: Demonstration of a CBT ... In this paper, we describe a cognitive-behavioral therapy (CBT) PrEP adherence intervention developed for use in high-risk sexual-minority men in the United ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5380582/

Optimizing Pre-Exposure Antiretroviral Prophylaxis Adherence ... Medication adherence was high across a cognitive-behavioral (Life-Steps) and time-matched counseling intervention for PrEP adherence, with some evidence ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03805451

Study Details | NCT03805451 | Life Steps for PrEP for Youth The primary efficacy outcomes will be PrEP adherence-as measured by dried blood spot testing -and retention in PrEP care-as measured by attendance at ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722916300050

“Life-Steps” for PrEP Adherence: Demonstration of a CBT- ... In this paper, we describe a cognitive-behavioral therapy (CBT) PrEP adherence intervention developed for use in high-risk sexual-minority men in the United ...

5. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/optimizing-pre-exposure-antiretroviral-prophylaxis-adherence-in-m

Optimizing Pre-Exposure Antiretroviral Prophylaxis ... Medication adherence was high across a cognitive-behavioral (Life-Steps) and time-matched counseling intervention for PrEP adherence, with some ...

6. withpower.com withpower.com/trial/phase-8-2020-0667c

Life-Steps Counseling + Text Reminders for Medication Adherence The research articles reviewed focus on the effectiveness of text message reminders for medication adherence, but they do not provide specific safety data for ...

7. ajpmonline.org ajpmonline.org/article/S0749-3797(21)00358-5/fulltext

Pre-exposure Prophylaxis Uptake, Adherence, and ... PrEP participants received iNSC at each visit. If they had adherence struggles, they were escalated to targeted iNSC and then the Life-Steps counseling package.