The LAIs Are Coming! Implementation Science Considerations for Long-Acting Injectable Antiretroviral Therapy in the United States: A Scoping Review

Kanazawa, John; Saberi, Parya; Sauceda, John A; Dubé, Karine

doi:10.1089/aid.2020.0126

Cited by 37 publications

(24 citation statements)

References 103 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We incorporated perspectives of multiple levels of stakeholders: clinic and external pick-up point providers, medication distribution administrators, and patients who were eligible for ART pickup through CCMDD. PRISM has been applied to study a range of healthcare topics and conditions across countries, including HIV [ 20 – 27 ].…”

Section: Methodsmentioning

confidence: 99%

Implementation of South Africa’s Central Chronic Medicine Dispensing and Distribution Program for HIV Treatment: A Qualitative Evaluation

et al. 2022

View full text Add to dashboard Cite

We used the Practical, Robust Implementation and Sustainability Model to evaluate implementation of South Africa’s Central Chronic Medicine Dispensing and Distribution (CCMDD) program, a differentiated service delivery program which allows clinically stable HIV-positive patients to receive antiretroviral therapy refills at clinic- or community-based pick-up points. Across ten clinics, we conducted 109 semi-structured interviews with stakeholders (pick-up point staff, CCMDD service providers and administrators) and 16 focus groups with 138 patients. Participants had highly favorable attitudes and said CCMDD decreased stigma concerns. Patient-level barriers included inadequate education about CCMDD and inability to get refills on designated dates. Organizational-level barriers included challenges with communication and transportation, errors in medication packaging and tracking, rigid CCMDD rules, and inadequate infrastructure. Recommendations included: (1) provide patient education and improve communication around refills (at the patient level); (2) provide dedicated space and staff, and ongoing training (at the organizational/clinic level); and (3) allow for prescription renewal at pick-up points and less frequent refills, and provide feedback to clinics (at the CCMDD program level).

show abstract

Section: Methodsmentioning

confidence: 99%

Implementation of South Africa’s Central Chronic Medicine Dispensing and Distribution Program for HIV Treatment: A Qualitative Evaluation

et al. 2022

View full text Add to dashboard Cite

show abstract

“…Combination interventions have represented significant scientific advancements in the rapidly evolving landscape in HIV therapeutics for many years, most recently the advent of US Food and Drug Administration (FDA)-approved long-acting intramuscular injectables, as well as other long-term ART in the pipeline, dosed by mouth, via transplantation and sub-cutaneous injection [ 20 ]. However, combining different HIV cure research interventions may increase clinical risks and burdens above standard ART [ 16 , 19 ].…”

Section: Introductionmentioning

confidence: 99%

Considerations for designing and implementing combination HIV cure trials: findings from a qualitative in-depth interview study in the United States

et al. 2021

Self Cite

View full text Add to dashboard Cite

Background An increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered. Methods We used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning. Results We interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research. Conclusion The increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance.

show abstract

“…25 The arrival of efficacious, long-acting injectable PrEP and other emerging methods such as the vaginal ring is likely to further shift this standard of prevention. 25,28 Further, distinctions may need to be made between ethical obligations (basic requirements that must be met) versus ethical aspirations (desirable but not required). 26 Importantly, as highlighted by our informants, determining minimal risk mitigation packages for sexual partners of ATI trial participants will require robust and sustained community and stakeholder engagement to ensure appropriateness, acceptability, and sensitivity to local contexts and cultural issues.…”

Section: Discussionmentioning

confidence: 99%

Ethical and practical considerations for mitigating risks to sexual partners during analytical treatment interruptions in HIV cure-related research

Dubé

Kanazawa

Dee

et al. 2021

HIV Research & Clinical Practice

Self Cite

View full text Add to dashboard Cite

Background: Analytical treatment interruptions (ATIs) in HIV cure-related research can result in trial participants becoming viremic with HIV, placing HIV-negative sexual partners at elevated risk of acquiring HIV. Objective: Our study aimed to generate ethical and practical considerations for designing and implementing appropriate risk mitigation strategies to reduce unintended HIV transmission events during ATIs. Methods: We conducted 21 in-depth interviews with five types of informants: bioethicists, community members, biomedical HIV cure researchers, socio-behavioral scientists/epidemiologists, and HIV care providers. We used conventional content analysis to analyze the data and generate considerations. Results: Key findings include: 1) Ethical permissibility of ATI trials depends on due diligence and informed consent to mitigate risks to participants and their sexual partners; 2) Participants should receive adequate support and/or counseling if they choose to disclose ATI participation to their partners; 3) Measures to protect sexual partners of trial participants from HIV transmission during ATIs should include referral to and/or provision of pre-exposure prophylaxis, as well as other available means of preventing HIV transmission; 4) There is uncertainty regarding the appropriate management of emerging sexually transmitted infections during ATI trials and possible protection measures for multiple and/or anonymous partners of ATI trial participants. Conclusion: While there is no way to completely eliminate the risk of HIV transmission to sexual partners during ATIs, HIV cure trialists and sponsors should consider the ethical concerns related to the sexual partners of ATI participants. Doing so is essential to ensuring the welfare of participants, their partners and the trustworthiness of research.

show abstract

The LAIs Are Coming! Implementation Science Considerations for Long-Acting Injectable Antiretroviral Therapy in the United States: A Scoping Review

Cited by 37 publications

References 103 publications

Implementation of South Africa’s Central Chronic Medicine Dispensing and Distribution Program for HIV Treatment: A Qualitative Evaluation

Implementation of South Africa’s Central Chronic Medicine Dispensing and Distribution Program for HIV Treatment: A Qualitative Evaluation

Considerations for designing and implementing combination HIV cure trials: findings from a qualitative in-depth interview study in the United States

Ethical and practical considerations for mitigating risks to sexual partners during analytical treatment interruptions in HIV cure-related research

Contact Info

Product

Resources

About