COAST-AL Intervention for HIV/AIDS

(COAST-AL Trial)

Overseen By Mariel Parman

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Unwillingness, inability to provide consent

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the COAST-AL treatment for HIV/AIDS?

Antiretroviral therapy (ART), which is part of the COAST-AL treatment, has been shown to effectively control HIV infection, reduce the risk of disease progression, and improve life expectancy to near-normal levels for those treated appropriately. Additionally, highly active antiretroviral therapy (HAART) has significantly delayed the progression to AIDS and improved survival rates in patients with HIV-related conditions. ^{1 2 3 4 5}

Is the COAST-AL treatment generally safe for humans?

Antiretroviral therapy (ART), which includes treatments like COAST-AL, is generally safe but can cause side effects. Common side effects include skin issues, mood changes, and stomach problems. Some people may need to change their medication due to these side effects. ^{6 7 8 9 10}

What makes the COAST-AL treatment for HIV/AIDS unique?

The COAST-AL treatment, also known as antiretroviral therapy (ART), is unique because it emphasizes rapid initiation, meaning patients start treatment as soon as possible after diagnosis. This approach helps reduce the spread of HIV and improves health outcomes by lowering the risk of illness and death. ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of this study is to adapt and evaluate a combination intervention that includes: (1) a data-driven approach to directed community-based HIV testing to areas with high need, (2) Project Connect to expedite linkage to care at time of diagnosis, (3) and a Rapid ART (antiretroviral therapy)Start program, all in Mobile County Health Department (MCHD) jurisdictions in Alabama.

Eligibility Criteria

This trial is for adults over 18 involved in HIV care in Alabama's Mobile County Health Department area, including medical and outreach staff. For certain parts of the study, individuals over 13 who were tested for HIV post-implementation are eligible. Those unable to consent cannot participate.

Inclusion Criteria

I am over 18 years old.

AIM 1 & 3: Fit into one of the following categories: MCHD leadership, ADPH leadership, clinic administrators, outreach testing specialists, linkage coordinators and community health workers, physicians, nurses, counselors all working at HIV care facilities in the six MCHD jurisdiction counties

I am over 13 and was tested for HIV in the specified area after COASTAL started.

Exclusion Criteria

Unwillingness or inability to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implementation

Adapt and integrate COAST-AL using a pre-implementation formative assessment guided by the CFIR, including in-depth interviews and clinic observations

3-6 months

Implementation

Evaluate the clinical and implementation effectiveness of COAST-AL in six AL counties, focusing on HIV testing, linkage to care, and Rapid ART Start

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on time to viral suppression and linkage to care

1 year

Treatment Details

Interventions

• COAST-AL

Trial Overview The COAST-AL intervention being tested includes targeted community-based HIV testing, a Project Connect program for quick linkage to care upon diagnosis, and a Rapid ART Start program to begin treatment swiftly in Alabama.

Participant Groups

Group I: COAST-AL Experimental Treatment 1 Intervention

This combination intervention includes three CDC evidence based interventions: (1) a data-driven approach to direct Community-based HIV testing to areas with high need, (2) Project Connect to expedite linkage to care at time of diagnosis, (3) and a Rapid ART Start program, all in MCHD jurisdictions in Alabama

COAST-AL is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Antiretroviral therapy for:

• HIV infection

Approved in United States as Antiretroviral therapy for:

• HIV infection

Approved in Canada as Antiretroviral therapy for:

• HIV infection

Approved in Japan as Antiretroviral therapy for:

• HIV infection

Approved in China as Antiretroviral therapy for:

• HIV infection

Approved in Switzerland as Antiretroviral therapy for:

• HIV infection

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Alabama Department of Public Health

Collaborator

Trials

1

Recruited

130+

Mobile County Health Deparment

Collaborator

Trials

1

Recruited

130+

Findings from Research

In a study of 143 HIV-infected outpatients, pharmacist interventions significantly reduced drug-related problems (DRPs) by 38.43%, highlighting the importance of medication safety in managing HAART.

The intervention group experienced an 84% increase in CD4 counts compared to the control group, suggesting that pharmacist support improves adherence and the effectiveness of antiretroviral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV pharmaceutical care in primary healthcare: Improvement in CD4 count and reduction in drug-related problems. Molino, CGRC., Carnevale, RC., Rodrigues, AT., et al.[2020]

Antiretroviral therapy (ART) is highly effective and can significantly improve the life expectancy of HIV-infected individuals, making it comparable to that of the general population, although some groups may still face challenges.

There are ongoing questions regarding the optimal timing and choice of ART regimens, highlighting the need for further research to enhance treatment strategies and explore new drug classes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiretroviral treatment 2010: progress and controversies. Gulick, RM.[2023]

Over thirty-five anti-HIV-1 therapies have been developed, leading to highly active combination antiretroviral therapies (HAARTs) that significantly delay the progression to AIDS and allow HIV-1-infected individuals in developed countries to potentially live normal life spans.

Despite these advancements, challenges remain, including treatment complexity, drug toxicities, and the emergence of drug-resistant strains, indicating a need for ongoing research to improve efficacy and safety of HIV therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Continuing Evolution of HIV-1 Therapy: Identification and Development of Novel Antiretroviral Agents Targeting Viral and Cellular Targets. Hartman, TL., Buckheit, RW.[2021]

In a study of 178 HIV patients who started anti-retroviral therapy (ART) in 2013 and 2015, early initiation of ART led to a higher percentage of patients achieving an undetectable viral load after one year, with 72% of those starting in 2015 reaching this goal compared to 55% in 2013.

The results indicate that starting ART earlier, regardless of CD4 cell count, significantly improves treatment outcomes, but there is still a need for better strategies to enhance these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Immunological and virological condition of adult patients with HIV infection at the beginning of antiretroviral therapy at Carlos van Buren Hospital. Comparison of 2013 and 2015 periods]. Kral, A., Cortés, J., Wilson, G.[2020]

In a study of 72 patients with acquired immunodeficiency syndrome-related lymphoma (ARL), those in the standard-risk group achieved a high complete remission rate of 79% and had a median survival that was not reached after 47 months, indicating effective treatment with concurrent HAART and CHOP chemotherapy.

The high-risk group had a lower complete remission rate of 29% and a median survival of only 7.2 months, but the study found that administering HAART alongside chemotherapy did not compromise immune parameters, suggesting it can be safely used as a first-line treatment for ARL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acquired immunodeficiency syndrome-related lymphoma: simultaneous treatment with combined cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy and highly active antiretroviral therapy is safe and improves survival--results of the German Multicenter Trial. Weiss, R., Mitrou, P., Arasteh, K., et al.[2015]

In a 6-month study of 92 HIV-infected children in Mali, 14.1% experienced at least one adverse drug reaction (ADR) during antiretroviral treatment, with the most common side effects being skin rash, nausea, vomiting, and diarrhea.

Most side effects were mild (grade 1), but there were instances of more severe reactions, leading to treatment changes in 15.2% of cases, highlighting the need for improved monitoring and management of ADRs in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to antiretroviral therapy: prospective study in children in sikasso (mali). Oumar, AA., Diallo, K., Dembélé, JP., et al.[2022]

In a study of 844 adult HIV patients in Mali, 42.3% experienced adverse drug reactions (ADRs) after starting antiretroviral therapy, with neurological issues being the most common (45.9%).

Zidovudine (AZT) and stavudine (d4T) were identified as significant risk factors for anemia and peripheral neuropathy, emphasizing the need for careful monitoring and potential changes in ART regimens to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiretroviral-induced adverse drug reactions in HIV-infected patients in Mali: a resource-limited setting experience. Oumar, AA., Dakouo, M., Tchibozo, A., et al.[2022]

In a study of 2650 patients on antiretroviral therapy in Nigeria, the incidence of adverse drug reactions (ADRs) was found to be 4.6 per 100 person-years, with the majority of ADRs occurring in the first six months of treatment, highlighting the need for close monitoring during this period.

Most ADRs were mild (grade 1), with pain and skin rash being the most common types reported, and patients on tenofovir (TDF) experienced fewer ADRs compared to those on zidovudine (AZT) or stavudine (d4T), suggesting that TDF may be a safer option in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. Eluwa, GI., Badru, T., Agu, KA., et al.[2022]

In a study of people living with HIV/AIDS in Brazil, 25.7% of patients modified their antiretroviral therapy (ART) within the first year due to adverse events, with the median time to modification being 70.5 days after starting treatment.

The most common adverse events leading to ART modification were dermatological, neuropsychiatric, and gastrointestinal issues, with patients on a specific combination of zidovudine, lamivudine, and efavirenz being twice as likely to switch therapies compared to those on tenofovir with lamivudine and efavirenz.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. Azevedo, LN., Ximenes, RAA., Monteiro, P., et al.[2022]

In a study of 602 patients on antiretroviral treatment (ART) over five years, the rate of major adverse drug reactions (ADRs) was found to be 4.3 per 100 patient-years, indicating a significant risk associated with ART.

Factors such as lower educational status, occupation in NGOs, advanced clinical stages of HIV, and lack of opportunistic infection (OI) prophylaxis were identified as strong predictors of ADRs, highlighting the need for targeted counseling and monitoring for at-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time to development of adverse drug reactions and associated factors among adult HIV positive patients on antiretroviral treatment in Bahir Dar City, Northwest Ethiopia. Kindie, E., Alamrew Anteneh, Z., Worku, E.[2018]

The study found good agreement between two certified readers using the Chest Radiographic Reading and Reporting System (CRRS) to identify TB-related abnormalities in chest X-rays of 203 patients with advanced HIV, indicating reliable reporting methods (kappa = 0.63).

Despite the good inter-observer agreement, the sensitivity (68%) and specificity (53%) of radiology for detecting culture-confirmed pulmonary TB were low, suggesting that while CRRS is reliable for reporting, its effectiveness as a routine screening tool in this patient population is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chest radiograph reading and recording system: evaluation for tuberculosis screening in patients with advanced HIV. Dawson, R., Masuka, P., Edwards, DJ., et al.[2021]

A study comparing electronic medical records (EMR) and paper registers in Malawi found that up to 24% of case registrations were missing from paper records at one hospital, indicating significant inaccuracies in data transcription.

There were also major discrepancies in recorded deaths between EMR and paper registers at two of the five facilities, highlighting the unreliability of paper systems as a backup for EMR failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is transcription of data on antiretroviral treatment from electronic to paper-based registers reliable in Malawi? Gadabu, OJ., Munthali, CV., Zachariah, R., et al.[2020]

A study involving 412 patients from four ARV clinics in South Africa identified six key recommendations to improve the patient experience in the ART program, emphasizing the need for better waiting areas, more convenient pharmacy hours, and less frequent file returns for stable patients.

Implementing these patient-centered recommendations could enhance adherence to antiretroviral therapy, highlighting the importance of involving patients in assessing and improving healthcare services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' recommendations for a patient-centred public antiretroviral therapy programme in eThekwini, KwaZulu-Natal. Mulqueeny, DM., Taylor, M.[2022]

In a study of 400 HIV-positive adults in Ethiopia, 39% experienced delayed initiation of antiretroviral therapy (ART), highlighting a significant barrier to effective HIV treatment.

Factors such as being male, having opportunistic infections, chronic diseases, substance abuse, and lacking HIV-positive family members were identified as key predictors of delayed ART initiation, indicating the need for targeted interventions for these high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed ART initiation in "Test and Treat era" and its associated factors among adults receiving antiretroviral therapy at public health institutions in Northwest Ethiopia: A multicenter cross-sectional study. Bantie, B., Kassaw Yirga, G., Abate, MW., et al.[2022]

Rapid initiation of antiretroviral therapy (ART) at the time of HIV diagnosis significantly improves rates of viral suppression compared to standard care, as shown in three randomized controlled trials and other studies.

Starting ART earlier not only leads to faster viral suppression but also enhances retention in care, which is crucial for reducing HIV transmission and achieving the goals set by the Getting to Zero initiative by 2030.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence Regarding Rapid Initiation of Antiretroviral Therapy in Patients Living with HIV. Michienzi, SM., Barrios, M., Badowski, ME.[2022]

References

1. Saudi Arabia pubmed.ncbi.nlm.nih.gov

HIV pharmaceutical care in primary healthcare: Improvement in CD4 count and reduction in drug-related problems. [2020]

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

Antiretroviral treatment 2010: progress and controversies. [2023]

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

The Continuing Evolution of HIV-1 Therapy: Identification and Development of Novel Antiretroviral Agents Targeting Viral and Cellular Targets. [2021]

4. Chile pubmed.ncbi.nlm.nih.gov

[Immunological and virological condition of adult patients with HIV infection at the beginning of antiretroviral therapy at Carlos van Buren Hospital. Comparison of 2013 and 2015 periods]. [2020]

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

Acquired immunodeficiency syndrome-related lymphoma: simultaneous treatment with combined cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy and highly active antiretroviral therapy is safe and improves survival--results of the German Multicenter Trial. [2015]

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

Adverse drug reactions to antiretroviral therapy: prospective study in children in sikasso (mali). [2022]

7. India pubmed.ncbi.nlm.nih.gov

Antiretroviral-induced adverse drug reactions in HIV-infected patients in Mali: a resource-limited setting experience. [2022]

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

Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. [2022]

9. Brazil pubmed.ncbi.nlm.nih.gov

Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. [2022]

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

Time to development of adverse drug reactions and associated factors among adult HIV positive patients on antiretroviral treatment in Bahir Dar City, Northwest Ethiopia. [2018]

11. France pubmed.ncbi.nlm.nih.gov

Chest radiograph reading and recording system: evaluation for tuberculosis screening in patients with advanced HIV. [2021]

12. France pubmed.ncbi.nlm.nih.gov

Is transcription of data on antiretroviral treatment from electronic to paper-based registers reliable in Malawi? [2020]

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

Patients' recommendations for a patient-centred public antiretroviral therapy programme in eThekwini, KwaZulu-Natal. [2022]

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

Delayed ART initiation in "Test and Treat era" and its associated factors among adults receiving antiretroviral therapy at public health institutions in Northwest Ethiopia: A multicenter cross-sectional study. [2022]

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

Evidence Regarding Rapid Initiation of Antiretroviral Therapy in Patients Living with HIV. [2022]