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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how to safely discontinue the use of an injectable HIV prevention medicine called cabotegravir while maintaining protection against HIV. It tests a program that provides personalized HIV prevention coaching through drug level monitoring and video calls. The trial seeks HIV-negative individuals who have stopped cabotegravir injections in the past three months and can access Zoom. Participants must send in blood samples and attend monthly coaching sessions. As an unphased trial, this study offers a unique opportunity to contribute to innovative HIV prevention strategies.

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 prior data suggests that the TAIL-PrEP intervention is safe?

Research has shown that cabotegravir (cab-LA), the injectable drug used in the TAIL-PrEP study, is safe and effective for preventing HIV in various groups, including cisgender men, women, and transgender women. The researchers are still gathering information about its safety in transgender men and non-binary people.

Although there isn't enough safety data for pregnant women, cab-LA has generally been well-tolerated by others. Prospective participants should discuss any concerns with the study team to understand how this information might relate to them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TAIL-PrEP because it offers a personalized coaching approach for HIV prevention, setting it apart from standard PrEP (pre-exposure prophylaxis) treatments. Unlike traditional methods that rely solely on medication, TAIL-PrEP integrates tailored support and guidance to enhance adherence and effectiveness. This innovative method could potentially improve outcomes for individuals by addressing personal barriers and encouraging consistent use, which is essential for preventing HIV infection.

What evidence suggests that the TAIL-PrEP intervention could be effective for HIV prevention?

Research has shown that long-acting cabotegravir (cab-LA) is highly effective in preventing HIV infection. Studies have found it reduces the risk of HIV by 89% compared to some other treatments. Specifically, cab-LA was 100% effective for women and 96% effective for a mostly male group in preventing HIV. This indicates that cab-LA is highly effective at stopping HIV before it starts. The TAIL-PrEP program is being studied in this trial to help people safely discontinue cab-LA while remaining protected against HIV. Overall, PrEP (pre-exposure prophylaxis) methods like this are known to be effective and practical. ^{2 6 7 8 9}

Who Is on the Research Team?

Kathrine A Meyers, DrPH

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7435a1.htm

Clinical Recommendation for the Use of Injectable ... The two trials reported LEN efficacy at reducing HIV infection as 100% among females and 96% among a primarily male trial population, compared ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10687690/

Efficacy and Safety of Pre-Exposure Prophylaxis to Control ... The findings indicated that PrEP is a highly effective and feasible strategy against HIV infection in terms of prophylactic response, retention, and compliance.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06868641

Study Details | NCT06868641 | The TAIL-PrEP Study The goal of the TAIL-PrEP study is to pilot test and assess the acceptability and feasibility of the TAIL-PrEP intervention, which will use cabotegravir drug ...

4. who.int who.int/news/item/09-11-2020-trial-results-reveal-that-long-acting-injectable-cabotegravir-as-prep-is-highly-effective-in-preventing-hiv-acquisition-in-women

Trial results reveal that long-acting injectable cabotegravir ... While both methods were highly effective at preventing HIV acquisition, long-acting cabotegravir was 89% (95% CI 68-96%) more effective than FTC ...

5. hivguidelines.org hivguidelines.org/guideline/hiv-prep/

PrEP to Prevent HIV and Promote Sexual Health Deep sequencing with unique molecular identifiers for evaluation of HIV-1 drug resistance in the DISCOVER pre-exposure prophylaxis trial.

6. cdc.gov cdc.gov/hivnexus/hcp/prep/index.html

Clinical Guidance for PrEP | HIV Nexus PrEP is a safe method for HIV prevention​​ F/TAF has not yet been studied for HIV prevention for receptive vaginal sex. Because F/TDF and F/TAF are eliminated by ...

7. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/guidelines/perinatal/pre-exposure-prophylaxis-prep-prevent-hiv

Pre-exposure Prophylaxis (PrEP) to Prevent HIV During ... When taken as prescribed, TDF/FTC provides greater than 90% protection against HIV acquisition. Of the FDA-approved PrEP agents for receptive ...

8. hivprep.uw.edu hivprep.uw.edu/go/hiv-prep-fundamentals/hiv-prep-medication-options/core-concept/all

Core Concepts - HIV PrEP Medications and Dosing Options For women who are pregnant, CAB-LA is not recommended due to insufficient safety data. For people who inject drugs, TDF-FTC and LEN-SQ are the ...

9. prepwatch.org prepwatch.org/products/injectable-cab-for-prep/

Injectable Cabotegravir for PrEP Found to be safe and effective for cisgender men and women and transgender women; additional data collection is ongoing in transgender men and non-binary ...