Clinic Remodeling for HIV

Overseen By Sarah Lofgren, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Unable to consent, Language barrier

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the feasibility and acceptability of implementing clinic system changes and physical structures in Uganda to improve aesthetics, welcome, and privacy to reduce HIV stigma, improve retention-in-care, and improve the patient experience. To evaluate pilot/implementation outcomes, the outcomes of fidelity, feasibility, and acceptability will be assessed prior to intervention. After the changes are done to two HIV interventions clinics, the outcome surveys will assess if the changes were disruptive or impeded the workings of the clinics.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Clinics remodeling for HIV?

The systematic review on the organization of care for persons with HIV suggests that interventions like case management and outreach programs, which can be part of clinic remodeling, are associated with improved medical and economic outcomes, such as better antiretroviral prescribing and healthcare utilization. ^{1 2 3 4 5}

What safety data exists for Clinic Remodeling for HIV treatment?

The available research highlights that safety reporting in clinical trials is often inadequate, which can lead to misunderstandings about the safety of treatments. While specific safety data for Clinic Remodeling for HIV is not provided, general findings suggest that adverse events are often underreported, and systems for reporting these events vary in effectiveness. ^{6 7 8 9 10}

How is the Clinic Remodeling treatment for HIV different from other treatments?

Clinic Remodeling for HIV is unique because it focuses on restructuring the way clinics provide care, rather than introducing a new medication. This approach aims to improve the delivery of existing treatments by enhancing clinic operations and care practices, potentially leading to better patient outcomes and access to care. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for adults over 18 who are enrolled in specific HIV clinics in Uganda and can consent to interviews, surveys, or focus groups. It's not specified who cannot join the trial.

Inclusion Criteria

Enrolled in the HIV clinics where we are working

I can make my own decisions about participating in research.

Exclusion Criteria

I am unable to give my consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention Assessment

Assessment of fidelity, feasibility, and acceptability prior to intervention

Baseline

Intervention

Implementation of clinic system changes and physical structure modifications

6 months

Post-Intervention Follow-up

Outcome surveys to assess if changes were disruptive or impeded clinic workings

6 months post intervention

Treatment Details

Interventions

• Clinics remodeling

Trial Overview The study is testing how changing clinic systems and architectural design can reduce HIV stigma and improve patient care. Two clinics will be remodeled to enhance aesthetics, welcome, and privacy.

Participant Groups

Group I: Interventions clinics to be remodeled Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

Community-based clinics caring for advanced HIV patients offered longer hours and better access to unscheduled care compared to hospital-based general medicine clinics, which may enhance patient accessibility and timely treatment.

HIV specialty clinics provided more comprehensive HIV-specific care features, such as dedicated directors and multidisciplinary conferences, compared to general medicine clinics, indicating a potential gap in specialized care for patients in those settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinic services for persons with AIDS. Experience in a high-prevalence state. Markson, LE., Turner, BJ., Cocroft, J., et al.[2019]

In a study of 124 HIV-positive patients in rural Limpopo, South Africa, 84% achieved viral suppression within 6 months of starting antiretroviral treatment (ART), and CD4 counts significantly increased from 128 to 470 cells/mm3 by 24 months, indicating effective treatment outcomes.

Despite initial success, there was a notable viral rebound after 6 months, particularly among younger patients and pregnant women, emphasizing the need for improved adherence support to prevent mother-to-child transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment outcomes in a rural HIV clinic in South Africa: Implications for health care. Omole, OB., Semenya, MML.[2022]

A survey of 131 physicians revealed that they believe the most important treatment characteristics for AIDS/HIV patients include minimal impact on appearance, the ability for self-administration, and low incidence of side effects like nausea and diarrhea.

The study found that emotional quality of life significantly influences patient treatment preferences, highlighting the need for treatment options that prioritize both emotional and physical well-being to enhance patient adherence and compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the concordance of physician judgments and patient preferences on AIDS/HIV therapy - a Discrete Choice Experiment. Mühlbacher, AC., Stoll, M., Mahlich, J., et al.[2023]

Case management interventions were most consistently linked to improvements in immunological outcomes for people living with HIV/AIDS, although they did not show clear benefits for other health measures.

Outreach interventions demonstrated significant improvements in mortality rates, access to antiretroviral medications, and overall healthcare utilization, suggesting they are effective strategies for enhancing care for HIV/AIDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organization of care for persons with HIV-infection: a systematic review. Handford, CD., Tynan, AM., Agha, A., et al.[2019]

The study surveyed 15 adult HIV clinics to assess the organization of outpatient care, revealing significant variability in key parameters such as patient volume, appointment wait times, and follow-up rates.

Findings showed that the median annual patient panel size was 1300, with a 28% no-show rate and an average wait time of 5 days for new appointments, indicating areas for potential improvement in chronic care management for HIV patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structures of care in the clinics of the HIV Research Network. Yehia, BR., Gebo, KA., Hicks, PB., et al.[2021]

In a study of 193 pediatric patients with severe traumatic brain injury (sTBI), 53% experienced at least one adverse event (AE), highlighting the high risk of complications in this vulnerable population.

The most common AE was decubitus ulcers, and patients with AEs had longer hospital stays and higher costs, indicating that identifying and preventing AEs can improve patient safety and reduce healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of adverse events in pediatric severe traumatic brain injury patients to target evidence-based prevention for increased performance improvement and patient safety. Charyk Stewart, T., Luong, K., Alharfi, I., et al.[2021]

In a review of 133 randomized controlled trials published in high-impact medical journals, 88.7% reported adverse events, but significant gaps in safety reporting were found, with 27.1% lacking information on severe adverse events and 47.4% not reporting patient withdrawals due to adverse events.

The study highlighted that 32.3% of articles had restricted reporting on harm-related data, focusing only on certain types of adverse events, which can lead to misinterpretation of the safety and efficacy of medical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of safety results in published reports of randomized controlled trials. Pitrou, I., Boutron, I., Ahmad, N., et al.[2022]

Current incident reporting systems in Denmark are inadequate, primarily focusing on litigation and failing to capture a comprehensive range of adverse events, as evidenced by U.S. studies showing only 2.7% of qualifying events are reported.

Anonymous and confidential reporting systems yield higher coverage than open ones, and providing fast feedback to informants can enhance both the quantity and quality of reports, suggesting that improvements in reporting mechanisms could lead to better patient safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Reporting of incidents. Experiences with medical registration systems]. Lipczak, H., Schiøler, T.[2006]

In the UK, a robust system for reporting and analyzing serious adverse events related to ocular tissue transplantation has been established, ensuring safety and quality in accordance with EU regulations.

The most significant adverse reactions identified in this system are endophthalmitis (0.58%) and primary graft failure (0.3%), highlighting the importance of ongoing monitoring and analysis to improve transplantation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A UK scheme for reporting serious adverse events and reactions associated with ocular tissue transplantation. Kaye, S., Baddon, A., Jones, M., et al.[2016]

Out of 279 systematic reviews analyzed, only 70.61% considered the impact of interventions/controls on adverse events, while other important effect modifiers like treatment duration (21.15%) and dosage (24.73%) were rarely investigated.

The study highlights a significant gap in current systematic reviews regarding the assessment of effect modifiers on harmful effects, suggesting that methodological guidelines should include these factors to improve the evaluation of safety in healthcare interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation. Zhou, X., Yang, X., Cai, F., et al.[2023]

In a study of 1,594 patients (110 adolescents and 1,484 adults) receiving antiretroviral therapy (ART), younger adults (ages 20-29) showed significantly higher attrition rates compared to older adults (ages 30 and above), indicating a need for targeted support for this age group.

No significant differences in ART retention were found between younger (ages 10-14) and older adolescents (ages 15-19), suggesting that both age groups may face similar challenges in maintaining treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of antiretroviral therapy among younger versus older adolescents and adults in an urban clinic, Zimbabwe. Matyanga, CM., Takarinda, KC., Owiti, P., et al.[2020]

Multidisciplinary HIV care in ambulatory settings is essential as more individuals with HIV are living longer, but there is significant variability in care practices across different clinics, which can affect patient health and access to care.

The review aims to identify optimal care practices and barriers in HIV-ambulatory clinics to help establish standardized care protocols that can be widely implemented, improving overall treatment for people living with HIV/AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nature of multidisciplinary HIV care in the ambulatory setting: a synthesis of the literature. Van Manen, L., Laschinger, SJ., Stevenson, T., et al.[2006]

In a study of 150 HIV-infected patients with newly diagnosed pulmonary tuberculosis (PTB), specific radiographic patterns were linked to CD4+ T-lymphocyte counts, indicating the stage of HIV disease progression.

Upper zone infiltrates were associated with early HIV infection (mean CD4+ count of 389), while more severe radiographic patterns like lower/midzone infiltrates and normal radiographs indicated advanced HIV disease (mean CD4+ count of 105), demonstrating that chest X-rays can help assess the severity of HIV in patients with PTB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary tuberculosis in HIV infection: radiographic appearance is related to CD4+ T-lymphocyte count. Post, FA., Wood, R., Pillay, GP.[2019]

In a study of 2393 HIV-infected patients in New York City, the incidence of tuberculosis (TB) was found to be low at 0.53 cases per 100 person-years, indicating that TB prevention efforts were somewhat effective, but most cases occurred before patients visited the clinic.

Preventive therapy with isoniazid (INH) showed a trend towards reduced TB incidence, particularly in patients who received 12 months of treatment, but overall benefits were limited, suggesting a need for improved strategies to identify and treat TB in HIV patients earlier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TB prevention in HIV clinics in New York City. Sackoff, JE., Torian, LV., Frieden, TR.[2013]

The establishment of a primary care HIV/AIDS clinic at a university teaching hospital successfully expanded its patient base from 36 in 1986 to 500 by 1990, demonstrating a significant increase in demand for specialized care.

The success of the clinic was largely due to collaborative planning and decision-making among a multidisciplinary team of health professionals, which ensured that the needs of the growing HIV/AIDS population were effectively met.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory care for patients with HIV/AIDS: creating a specialty clinic. Satterwhite, BE., Settle, JT., Cushnie, PB., et al.[2018]

References

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

Clinic services for persons with AIDS. Experience in a high-prevalence state. [2019]

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

Treatment outcomes in a rural HIV clinic in South Africa: Implications for health care. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Evaluating the concordance of physician judgments and patient preferences on AIDS/HIV therapy - a Discrete Choice Experiment. [2023]

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

Organization of care for persons with HIV-infection: a systematic review. [2019]

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

Structures of care in the clinics of the HIV Research Network. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Identification of adverse events in pediatric severe traumatic brain injury patients to target evidence-based prevention for increased performance improvement and patient safety. [2021]

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

Reporting of safety results in published reports of randomized controlled trials. [2022]

8. Denmark pubmed.ncbi.nlm.nih.gov

[Reporting of incidents. Experiences with medical registration systems]. [2006]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A UK scheme for reporting serious adverse events and reactions associated with ocular tissue transplantation. [2016]

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

Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation. [2023]

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

Outcomes of antiretroviral therapy among younger versus older adolescents and adults in an urban clinic, Zimbabwe. [2020]

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

The nature of multidisciplinary HIV care in the ambulatory setting: a synthesis of the literature. [2006]

13. Scotland pubmed.ncbi.nlm.nih.gov

Pulmonary tuberculosis in HIV infection: radiographic appearance is related to CD4+ T-lymphocyte count. [2019]

14. France pubmed.ncbi.nlm.nih.gov

TB prevention in HIV clinics in New York City. [2013]

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

Ambulatory care for patients with HIV/AIDS: creating a specialty clinic. [2018]