Personalized Coaching for HIV Infection

Overseen By Kathrine A Meyers, DrPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: HIV-positive, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on people who have already stopped taking cab-LA injections.

What data supports the effectiveness of the treatment TAIL-PrEP for HIV infection?

The research suggests that health coaching and behavioral interventions can help improve medication adherence and viral suppression in people living with HIV. Although the specific TAIL-PrEP treatment was not directly evaluated, similar interventions like health coaching and motivational interviewing have shown potential benefits in improving health outcomes for HIV patients. ^{1 2 3 4 5}

Is personalized coaching for HIV infection safe for humans?

The studies reviewed focus on adherence to HIV treatment and prevention, and they generally report positive experiences with coaching and feedback interventions. Participants found these interventions acceptable and feasible, with no significant negative reactions or safety concerns reported. ^{4 6 7 8 9}

What makes the TAIL-PrEP treatment unique for HIV prevention?

TAIL-PrEP is unique because it combines personalized coaching with pre-exposure prophylaxis (PrEP) to enhance adherence and effectiveness. This approach includes individualized risk assessments and behavioral interventions, which are not typically part of standard PrEP treatments. ^{6 10 11 12 13}

What is the purpose of this trial?

The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) while maximizing the public health impact of biomedical HIV prevention interventions. In Aim 1, the study will pilot test and assess the acceptability and feasibility of the TAIL-PrEP intervention, which will use cabotegravir drug level monitoring to provide personalized HIV prevention coaching to patients discontinuing long-acting cab-LA. In Aim 2, the study will refine the TAIL-PrEP intervention and implementation strategy based on findings from the pilot study.

Research Team

Kathrine A Meyers, DrPH

Principal Investigator

Columbia University

Eligibility Criteria

The TAIL-PrEP Study is for individuals who are currently using injectable long-acting cabotegravir (cab-LA) for HIV prevention and are considering stopping it. Participants should be interested in receiving personalized coaching based on their cabotegravir drug levels to maintain effective HIV prevention during the discontinuation process.

Inclusion Criteria

Able to receive and send monthly packages

Have access to an internet-connected device capable of running the Zoom video conferencing platform

Have a private location at which to take Zoom calls

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TAIL-PrEP intervention, which includes cabotegravir drug level monitoring and personalized HIV prevention coaching

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TAIL-PrEP

Trial Overview This study tests the TAIL-PrEP intervention, which includes monitoring of cabotegravir drug levels and providing personalized HIV prevention coaching to those discontinuing cab-LA. The aim is to ensure safe cessation while maintaining public health benefits of HIV preventive measures.

Participant Groups

Group I: TAIL-PrEP Experimental Treatment 1 Intervention

Patients receiving the TAIL-PrEP intervention

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

The mHealth intervention using the Fitbit Plus app for health coaching showed high feasibility and acceptability among 53 participants living with HIV, with 76.5% regularly using the app after 12 months.

While not statistically significant, there was a consistent trend indicating better ART adherence in the Fitbit Plus group compared to the standard care group, suggesting potential benefits of the intervention for improving medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Test of an mHealth Facilitated Health Coaching Intervention to Improve Medication Adherence among Persons Living with HIV. Ramsey, SE., Ames, EG., Uber, J., et al.[2022]

In a study involving 1456 participants across 14 sites in Sub-Saharan Africa, monitoring the fidelity of counseling for the dapivirine vaginal ring was feasible and effective, with 54.1% of expected counseling sessions being audio-recorded.

The majority of reviewed sessions (83.9%) were rated as 'good' or 'fair', indicating that consistent and high-quality counseling can be maintained, which is crucial for supporting adherence to PrEP interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a fidelity monitoring process to assess delivery of an evidence-based adherence counseling intervention in a multi-site biomedical HIV prevention study. Balán, IC., Lentz, C., Giguere, R., et al.[2021]

Antiretroviral pre-exposure prophylaxis (PrEP) can help prevent HIV transmission, but its effectiveness is enhanced when combined with comprehensive support services, including risk-reduction counseling and regular HIV testing.

The authors propose a five-component framework for optimizing PrEP delivery, which includes drug provision, safety screening, behavioral interventions, long-term engagement strategies, and population-level monitoring to ensure successful implementation in clinical and community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Packaging PrEP to Prevent HIV: An Integrated Framework to Plan for Pre-Exposure Prophylaxis Implementation in Clinical Practice. Underhill, K., Operario, D., Skeer, M., et al.[2022]

References

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

Effects of Behavioral Intervention Components for African American/Black and Latino Persons Living with HIV with Non-suppressed Viral Load Levels: Results of an Optimization Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of a computer-based and counseling support intervention to improve HIV patients' viral loads. [2021]

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

Clinical decision tools are needed to identify HIV-positive patients at high risk for poor outcomes after initiation of antiretroviral therapy. [2018]

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

A Preliminary Test of an mHealth Facilitated Health Coaching Intervention to Improve Medication Adherence among Persons Living with HIV. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

[Frequent dialogues may help in patients who are HIV-positive and have massive adherence problems and treatment failure]. [2013]

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

Pilot controlled trial of the adherence readiness program: an intervention to assess and sustain HIV antiretroviral adherence readiness. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Implementation of a fidelity monitoring process to assess delivery of an evidence-based adherence counseling intervention in a multi-site biomedical HIV prevention study. [2021]

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

Using Real-Time Adherence Feedback to Enhance Communication About Adherence to Antiretroviral Therapy: Patient and Clinician Perspectives. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Acceptability of drug detection monitoring among participants in an open-label pre-exposure prophylaxis study. [2022]

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

Provider-delivered, theory-based, individualized prevention interventions for HIV positive adults receiving HIV comprehensive care. [2007]

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

A Review of Telehealth Innovations for HIV Pre-Exposure Prophylaxis (PrEP). [2020]

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

Packaging PrEP to Prevent HIV: An Integrated Framework to Plan for Pre-Exposure Prophylaxis Implementation in Clinical Practice. [2022]

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

On-Demand Oral Pre-exposure Prophylaxis with Tenofovir/Emtricitabine: What Every Clinician Needs to Know. [2021]