Attitudes About Analytic Treatment Interruption (ATI) in HIV Remission Trials with Different Antiretroviral Therapy (ART) Resumption Criteria

Peay, Holly; Rennie, Stuart; Cadigan, R. Jean; Gwaltney, Angela; Jupimai, Thidarat; Phanuphak, Nittaya; Kroon, Eugène; Colby, Donn J.; Ormsby, Nuchanart; Isaacson, Sinéad; Vasan, Sandhya; Sacdalan, Carlo; Prueksakaew, Peeriya; Benjapornpong, Khunthalee; Ananworanich, Jintanat; Henderson, Gail E.

doi:10.1007/s10461-021-03504-5

Cited by 8 publications

(13 citation statements)

References 28 publications

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“…Furthermore, analytic treatment interruption (ATI) is usually designed for HIV cure-related trials to evaluate the efficacy of the experimental agent, which requires well-controlled HIV-1 participants to temporarily stop ART under close monitoring. 17 ATI raises concerns about the potential harms associated with both the experimental agent and ART interruption. 18 There may be different potential factors that affect volunteers' willingness to participate in different types of clinical trials; therefore, it is necessary to conduct relevant surveys to understand the willingness of PLHIV to participate in clinical trials and its influencing factors.…”

Section: Original Articlementioning

confidence: 99%

“…Phase III trials require a large sample size to determine the efficacy and long-term safety of the treatment. Furthermore, analytic treatment interruption (ATI) is usually designed for HIV cure–related trials to evaluate the efficacy of the experimental agent, which requires well-controlled HIV-1 participants to temporarily stop ART under close monitoring 17 . ATI raises concerns about the potential harms associated with both the experimental agent and ART interruption 18 .…”

Section: Introductionmentioning

confidence: 99%

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Acceptance and Factors Associated With Participation in Functional Cure–Related Trials Among People Living With HIV: A Cross-sectional Study in Southern China

Deng,

Shi,

Yuan

et al. 2024

Infect Microb Dis

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HIV remains a global health challenge, and research efforts directed towards a functional cure require people living with HIV (PLHIV) involvement in clinical trials. Our study assessed willingness to participate in HIV functional cure–related clinical trials and associated factors among PLHIV in Guangzhou, China using a questionnaire survey approach. We analyzed responses from 718 questionnaires, finding that 71.2% were willing to participate in Phase III trials, while 51.7% were willing to participate in Phase I trials and 42.9% expressed acceptability for analytic treatment interruption. Multivariate logistic regression demonstrated that male PLHIV, those with awareness of functional cure, and PLHIV who had been on antiretroviral therapy (ART) for less than one year, were more willing to participate in Phase III trials. Those with a Body Mass Index over 24, and those without resistance to ART drug, were more willing to participate in Phase I trials. The major motivations for participation in phase III trials were access to cutting-edge treatments (62.6%) and supporting research (55.3%). Safety was the main concern contributing to hesitancy. Our study revealed a high willingness to participate in HIV functional cure–related trials among PLHIV in Guangzhou, China, and willingness varied across different trial phases and was influenced by multiple factors. This study provides valuable references for future clinical trial recruitment strategies and public health policy formulation.

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Section: Original Articlementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Acceptance and Factors Associated With Participation in Functional Cure–Related Trials Among People Living With HIV: A Cross-sectional Study in Southern China

Deng,

Shi,

Yuan

et al. 2024

Infect Microb Dis

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“…27 Survey questions were developed based on items used previously in formative and impact studies of U=U and treatment as prevention interventions. 12,[28][29][30][31][32][33][34][35][36][37] Surveys were conducted in English or Spanish.…”

Section: Survey Questionnairesmentioning

confidence: 99%

B-OK: A Visual and Tactile Tool for HIV Treatment Adherence Support in a United States Urban Center

Richterman,

Klaiman,

Palma

et al. 2024

Preprint

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Lack of adherence to antiretroviral therapy (ART) and poor retention in care are significant barriers to ending HIV epidemics. Treatment adherence support (TAS) effectiveness may be constrained by limited awareness and understanding of the benefits of ART, particularly the concepts of treatment as prevention and Undetectable=Untransmittable (U=U), for which substantial knowledge gaps persist. We used mixed methods to evaluate a straightforward visual and tactile tool, the B-OK Bottles (“B-OK”), that incorporates human-centered design and behavioral economics principles and is designed to change and strengthen mental models about HIV disease progression and transmission. We enrolled 118 consenting adults living with HIV who were clients of medical case managers at one of four case management agencies in Philadelphia. All participants completed a pre-intervention survey, a B-OK intervention, and a post-intervention survey. A subset (N=52) also completed qualitative interviews before (N=20) or after (N=32) B-OK. Participants had a median age of 55 years (IQR 47-60), about two-thirds were male sex (N=77, 65%), nearly three-quarters identified as non-Hispanic Black (N=85, 72%), and almost all reported receiving ART (N=116, 98%). Exposure to B-OK was associated with improved awareness and understanding of HIV terminology, changes in attitudes about HIV treatment, and increased intention to rely on HIV treatment for transmission prevention. Insights from qualitative interviews aligned with the quantitative findings as respondents expressed a better understanding of U=U and felt that B-OK clearly explained concepts of HIV treatment and prevention. These findings provide a strong rationale to further evaluate the potential for B-OK to improve TAS for PLWH.

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“…From the second survey of 406 RV254 cohort participants, we reported that about 25% of respondents had disclosed their HIV status to no one, and an additional approximately 20% disclosed to only one person. 19 Of those who had disclosed their HIV status to at least one person, more than half had not disclosed it to sexual partner(s). This second survey included this hypothetical scenario and question: "Imagine you had unprotected sex one time today with an HIV-negative partner.…”

Section: Risk-mitigation and Responsibility Approaches In Thai Hiv-re...mentioning

confidence: 99%

“…It included longitudinal interviews of 60 participants in five HIV‐remission trials and two cohort‐wide surveys. From the second survey of 406 RV254 cohort participants, we reported that about 25% of respondents had disclosed their HIV status to no one, and an additional approximately 20% disclosed to only one person 19 . Of those who had disclosed their HIV status to at least one person, more than half had not disclosed it to sexual partner(s).…”

Section: Risk‐mitigation and Responsibility Approaches In Thai Hiv‐re...mentioning

confidence: 99%

The Essential Need for Trust When Transmission Risk Cannot Be Eliminated in HIV‐Remission Trials

Rennie

Henderson

Phanuphak

et al. 2023

Ethics & Human Research

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Analytic treatment interruption (ATI) is scientifically necessary in HIV‐remission (“cure”) studies to test the effects of new interventions. However, stopping antiretroviral treatment poses risks to research participants and their sexual partners. Ethical debate about whether and how to conduct such studies has largely centered on designing risk‐mitigation strategies and identifying the responsibilities of research stakeholders. In this paper, we argue that because the possibility of HIV transmission from research participants to partners during ATI cannot practicably be eliminated—that is, it is ineliminable—the successful conduct of such trials ultimately depends on relationships of trust and trustworthiness. We describe our experiences with conducting and studying HIV‐remission trials with ATI in Thailand to examine the strengths, complexities, and limitations of the risk‐mitigation and responsibility approaches and to explore ways in which the building of trust—and trustworthiness—may help enhance the scientific, practical, and ethical dimensions of these trials.

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Attitudes About Analytic Treatment Interruption (ATI) in HIV Remission Trials with Different Antiretroviral Therapy (ART) Resumption Criteria

Cited by 8 publications

References 28 publications

Acceptance and Factors Associated With Participation in Functional Cure–Related Trials Among People Living With HIV: A Cross-sectional Study in Southern China

Acceptance and Factors Associated With Participation in Functional Cure–Related Trials Among People Living With HIV: A Cross-sectional Study in Southern China

B-OK: A Visual and Tactile Tool for HIV Treatment Adherence Support in a United States Urban Center

The Essential Need for Trust When Transmission Risk Cannot Be Eliminated in HIV‐Remission Trials

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