SAVVY Intervention for HIV

(SAVVY Trial)

Overseen By Allison Agwu, MD, SCM

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Antiretrovirals

Disqualifiers: Drug resistance, Pregnancy, Severe illness, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

288 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions 'disallowed medications' as an exclusion criterion. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the SAVVY Intervention treatment for HIV?

Research shows that interventions improving adherence to HIV medication, like the SAVVY Intervention, are most effective when they address various factors such as behavior and social support. Studies have found that comprehensive and personalized approaches can significantly improve adherence and health outcomes for people with HIV. ^{1 2 3 4 5}

What safety data exists for the SAVVY Intervention for HIV?

The safety of antiretroviral drugs, which are used in HIV treatment, has been studied in various settings. These studies highlight the importance of monitoring for unexpected serious adverse reactions and adverse events, especially when these drugs are used in people who do not have HIV. ^{6 7 8 9 10}

How is the SAVVY Intervention treatment for HIV different from other treatments?

The SAVVY Intervention is unique because it focuses on behavioral changes to reduce HIV risk behaviors, rather than relying solely on medication. This approach is particularly important for populations disproportionately affected by HIV, as it emphasizes consistent condom use, sexual self-control, and communication, which are crucial for preventing the spread of HIV. ^{11 12 13 14 15}

What is the purpose of this trial?

Although there have been advances in antiretroviral treatment (ART) for HIV, adolescents and young adults living with HIV (AHIV) continue to have disparate HIV outcomes particularly viral suppression (VS), when compared to other populations likely related to multi-layered challenges (social determinants, cognitive development), system, and biomedical challenges including the reliance on oral ART as the only choice for HIV treatment. Given that approximately 1/3 of AHIV despite being in care fail to attain or sustain VS with resultant individual and public health risk, there is a need to develop real-world implementable interventions that can improve the participants virologic outcomes. The Strategies to AchieVe Viral Suppression for Youth with HIV (SAVVY) Study aims to 1) optimize personal ART choice by using the HIV-ASSIST clinical program to inform CHOICE counseling regarding an AHIV's preferred approach, including the possibility of long-acting injectable ART (LAI-ART); 2) facilitate access to the participants preferred choice through deploying a focused team to navigate barriers to attaining LAI-ART; and 3) decipher and address the patient, provider, and systemic barriers to the uptake and routinization of LAI-ART among AHIV by applying an implementation science framework and assessing cost-effectiveness providing critical data to support comprehensive approaches to optimizing ART and VS for AHIV, a key population identified in the Ending the HIV Epidemic in the United States Initiative.

Research Team

Allison Agwu, MD, SCM

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adolescents and young adults living with HIV who face challenges in achieving viral suppression. It's designed to help those struggling with the standard oral ART treatment by offering personalized options, including long-acting injectable ART.

Inclusion Criteria

Willing to sign informed consent (including communication with one's primary HIV provider)

I am on antiretroviral therapy.

Exclusion Criteria

Pregnancy

Mental health, cognitive, or behavioral dysfunction that in the opinion of the site PI would impair participation

Severe illness/hospitalization at the time of enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo CHOICE counseling to determine ART preferences and may switch to LAI-ART if virally suppressed. Monitoring occurs every 2 weeks for 3 months for those not initially suppressed.

12 months

Baseline, 3, 6, 9, and 12 month assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of viral suppression and quality of life indicators.

12 months

Ongoing assessments

Treatment Details

Interventions

• SAVVY Intervention

Trial Overview The SAVVY study tests a new approach called CHOICE counseling combined with an evidence-based tool, HIV-ASSIST, to optimize personal ART choice. It also aims to facilitate access to long-acting injectable ART and understand barriers in its uptake.

Participant Groups

Group I: Virally suppressed at entry (VL<50 copies/mL) Experimental Treatment 1 Intervention

Participants are on ART and are currently virally suppressed. Participants will undergo CHOICE counseling and determine if the participant prefers to stay on oral ART or switch to LAI-ART. The SAVVY long-acting access team (SLAT) will facilitate prior authorizations and other logistic matters needed to access LAI-ART. The study will not provide drug. Participants will participate in a baseline, 3, 6, 9 and 12 month detailed assessment of viral suppression and quality of life indicators, etc.

Group II: Not virally suppressed at entry (VL >= 50 copies/mL) Experimental Treatment 1 Intervention

Participants are on ART and are currently not virally suppressed. The participants will undergo CHOICE counseling and determine if the participant prefers to stay on oral ART or switch to LAI-ART. As the participant will not be able to switch to LAI-ART given the viremic state, the participant will have q2 week monitoring (for 3 months) of the viral load and if the participant becomes suppressed will then be offered CHOICE counseling again and can select at that point if the participant wants to stay on oral or transition to LAI-ART. The SAVVY long-acting access team will facilitate prior authorizations and other logistic matters needed to access LAI-ART. The study will not provide drug. If the participant has not become suppressed by 3 months the participant would continue to be monitored by standard of care practices. Participants will participate in a baseline, 3, 6, 9 and 12 month detailed assessment of viral suppression and quality of life indicators, etc.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Early entry into and retention in HIV care are crucial for improving patient outcomes, as starting antiretroviral therapy (ART) early and adhering to it can significantly enhance health results.

Implementing evidence-based tools and behavioral interventions in clinical settings can optimize adherence to ART and monitor patient engagement, which is especially important for vulnerable populations like pregnant women and those with mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in human immunodeficiency virus care: linkage, retention, and antiretroviral therapy adherence. Eaton, EF., Saag, MS., Mugavero, M.[2017]

In a pilot study involving 18 marginally housed, substance-using individuals with HIV, the 'DAART+' intervention led to 83% of participants achieving an undetectable viral load, indicating significant effectiveness in managing their HIV.

Participants also reported modest increases in condom usage, suggesting that the intervention may positively influence risk reduction behaviors alongside improving medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary findings of an intervention integrating modified directly observed therapy and risk reduction counseling. Mitchell, CG., Freels, S., Creticos, CM., et al.[2007]

A multidisciplinary approach that included individualized and culturally sensitive interventions significantly improved adherence to an enfuvirtide-based HIV treatment regimen in a patient with a history of poor adherence.

The comprehensive strategies, which involved daily observed therapy and support for symptom management and social relationships, led to notable improvements in the patient's clinical markers and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive clinical adherence interventions to enable antiretroviral therapy: a case report. Nicca, D., Moody, K., Elzi, L., et al.[2007]

An active surveillance pilot program in Namibia successfully monitored adverse events (AEs) in 413 HIV+ adults receiving first-line antiretroviral therapy (ART), with a high recording rate of AEs during follow-up visits.

The study found that 66 patients experienced a total of 119 AEs, with a notable incidence rate of 33 AEs per 100 person-years, highlighting the importance of ongoing monitoring for safety in ART regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel site active surveillance of safety of first-line antiretroviral medicines in Namibia. Mann, M., Mengistu, A., Gaeseb, J., et al.[2018]

HIV treatment failure (HIVTF) is reported more frequently in Africa, with 19.1% of all cases coming from this region, particularly from South Africa, which accounted for 86.8% of the reports.

Children and adolescents are significantly more affected by HIVTF compared to adults, with adjusted odds ratios indicating a higher risk in these younger populations, highlighting the need for improved medical care for them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of HIV treatment failure in Africa using the WHO Pharmacovigilance data. Miantezila Basilua, J., Mesia Kahunu, G., Pochart, P., et al.[2021]

A pilot training program for 70 healthcare providers in South Africa aimed at improving HIV prevention messaging unexpectedly resulted in a decrease in the delivery of prevention messages to HIV positive patients, with the overall message delivery rate dropping from 56% to 50%.

The training did not significantly affect the delivery of prevention messages to HIV negative patients, who maintained a stable message delivery rate of 32%, suggesting that the training's effectiveness may vary based on patient status and that a more focused approach to messaging could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre/post evaluation of a pilot prevention with positives training program for healthcare providers in North West Province, Republic of South Africa. Kemp, CG., de Kadt, J., Pillay, E., et al.[2020]

References

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

Engagement in human immunodeficiency virus care: linkage, retention, and antiretroviral therapy adherence. [2017]

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

Social self-value intervention for empowerment of HIV infected people using antiretroviral treatment: a randomized controlled trial. [2018]

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

Interventions to improve adherence to antiretroviral therapy. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Preliminary findings of an intervention integrating modified directly observed therapy and risk reduction counseling. [2007]

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

Comprehensive clinical adherence interventions to enable antiretroviral therapy: a case report. [2007]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The suspected unexpected and serious adverse events of antiretroviral drugs used as HIV prophylaxis in HIV uninfected persons. [2022]

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

Sentinel site active surveillance of safety of first-line antiretroviral medicines in Namibia. [2018]

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

Overview of HIV treatment failure in Africa using the WHO Pharmacovigilance data. [2021]

9. Uganda pubmed.ncbi.nlm.nih.gov

A pharmacovigilance study of adults on highly active antiretroviral therapy, South Africa: 2007 - 2011. [2022]

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

Pharmacovigilance for antiretroviral drugs in Africa: lessons from a study in Abidjan, Cote d'Ivoire. [2021]

11. South Africa pubmed.ncbi.nlm.nih.gov

SISTA South Africa: the adaptation of an efficacious HIV prevention trial conducted with African-American women for isiXhosa-speaking South African women. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Pre/post evaluation of a pilot prevention with positives training program for healthcare providers in North West Province, Republic of South Africa. [2020]

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

Improving Care Outcomes for PLWH Experiencing Homelessness and Unstable Housing: a Synthetic Review of Clinic-Based Strategies. [2022]

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

Behavioral Interventions to Reduce Sexual Risk Behavior in Adults with HIV/AIDS Receiving HIV Care: A Systematic Review. [2018]

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

Improving HIV/STD prevention in the care of persons living with HIV through a national training program. [2021]