Qualitative study of the BREATHER trial (Short Cycle antiretroviral therapy): is it acceptable to young people living with HIV?

Bernays, Sarah; Paparini, Sara; Seeley, Janet; Kihika, Stella Namukwaya; Gibb, Diana; Rhodes, Tim

doi:10.1136/bmjopen-2016-012934

Cited by 14 publications

(21 citation statements)

References 20 publications

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“…It was the first HIV/AIDS treatment center in Uganda to provide ART and is currently the country’s only reference center for third-line therapy. The study was embedded within a clinical trial ( 36 ) (BREATHER) which was testing the efficacy of a treatment interruption intervention, Short Cycle Therapy on efavirenz-based regimens (5 days on, 2 days off treatment) for young people (8–24 years) living with HIV ( 37 ).…”

Section: Methodsmentioning

confidence: 99%

“How Do We Start? And How Will They React?” Disclosing to Young People with Perinatally Acquired HIV in Uganda

Namukwaya

Paparini

Seeley

et al. 2017

Front. Public Health

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Despite great advances in pediatric HIV care, rates and the extent of full disclosure of HIV status to infected children remain low especially in resource-constrained setting. The World Health Organisation recommends that, by the age of 10–12 years old, children should be made fully aware of their HIV-positive status. However, this awareness is often delayed until much later in their adolescence. Few studies have been conducted to investigate what influences caregivers’ decision-making process in this regard in low-income settings. In this article, we present an analysis of care dyads of caregivers and HIV-positive young people in Kampala, Uganda, as part of the findings of a longitudinal qualitative study about young people’s adherence to antiretroviral therapy embedded in an international clinical trial (BREATHER). Repeat in-depth interviews were conducted with 26 young people living with HIV throughout the course of the trial, and once-off interviews with 16 of their caregivers were also carried out toward the end of the trial. In this article, we examine why and how caregivers decide to disclose a young person’s HIV status to them and explore their feelings and dilemmas toward disclosure, as well as how young people reacted and the influence it had on their relationships with and attitudes toward their caregivers. Caregivers feared the consequences of disclosing the young person’s positive status to them and disclosure commonly occurred hurriedly in response to a crisis, rather than as part of an anticipated and planned process. A key impediment to disclosure was that caregivers feared that disclosing would damage their relationships with the young people and commonly used this as a reason to continue to postpone disclosure. However, young people did not report prolonged feelings of blame or anger toward their caregivers about their own infection, but they did express frustration at the delay and obfuscation surrounding the disclosure process. Our findings can inform the ways in which mainstream HIV services support caregivers through the disclosure process. This includes providing positive encouragement to disclose fully and to be more confident in initiating and sustaining the timely process of disclosure.

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Section: Methodsmentioning

confidence: 99%

“How Do We Start? And How Will They React?” Disclosing to Young People with Perinatally Acquired HIV in Uganda

Namukwaya

Paparini

Seeley

et al. 2017

Front. Public Health

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“…This model has been used in a few new trials (e.g. D3, BREATHER-plus, LATA) in children, adolescents and young people led by Penta and/or the Clinical Trials Unit at the University College of London [33].…”

Section: Designing Specific Clinical Trial Materials For Adolescentsmentioning

confidence: 99%

The HIV drug optimization agenda: promoting standards for earlier investigation and approvals of antiretroviral drugs for use in adolescents living with HIV

Rojo¹,

Carpenter

Venter

et al. 2020

J Intern AIDS Soc

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Introduction Most clinical trials for new antiretroviral (ARV) agents are conducted among narrowly defined adult populations. Only after safety and efficacy have been clearly demonstrated among adults living with HIV are trials including adolescents, children and infants conducted. This approach contributes to significant delays in the availability of optimal new ARV regimens for infants, children and adolescents. This commentary discusses issues related to the inclusion of adolescents aged 12 to 18 years in initial HIV clinical phase 3 trials of novel antiretrovirals (ARVs) or conducting parallel phase 3 clinical trials among adolescents. Discussion The absorption, metabolic and excretion or elimination pathways for drugs do not significantly differ between adolescents and adults. In fact, dosing recommendations for ARVs are the same for adults and adolescents who meet the age and weight criteria. Although conducting clinical trials among adolescents present special challenges (e.g. consenting minors and concerns about trial completion and contraception), these challenges can be addressed to obtain high‐quality trial results. Importantly, new agents and optimized combinations have more favourable dosing schedules and side‐effect profiles and are more effective ARV agents with higher HIV drug resistance thresholds, which would be extremely beneficial to improve outcomes among HIV‐positive adolescents. Conclusions Adolescents may not present with significantly different pharmacokinetic characteristics from those in adults. Including HIV‐positive adolescents in phase 3 ARV clinical trials, either with adults or in specific adolescent studies conducted in parallel, would allow adolescents to access promising, more effective treatment for HIV years earlier than with the current stepwise approach.

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“…The qualitative study consisted of repeat in-depth interviews with a sample of participants from both arms of the trial, and discussion groups at the end to discuss emerging trial results. The qualitative data showed that while there was a strong preference for the option of short-cycle therapy, to allow weekends off from treatment, young people from both arms reported frequent medication side effects and occasional missed doses that they had rarely shared with clinical staff [34]. The final discussion group allowed participants to voice concerns about the risks of short-cycle therapy for young people who struggled to adhere to treatment [35].…”

Section: A Multi-country Trial To Develop a Treatment Intervention mentioning

confidence: 99%

“…It should be noted that while some of the qualitative study findings were integrated into the "main" trial paper the paper [17] detailing the qualitative findings (which was submitted at the same time as the main trial findings paper) was not accepted for publication. The qualitative findings paper was published later in a different journal [34].…”

Section: A Multi-country Trial To Develop a Treatment Intervention mentioning

confidence: 99%

Qualitative research on community experiences in large HIV research trials: what have we learned?

Camlin

Seeley

2018

J Intern AIDS Soc

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IntroductionVery few pragmatic and community‐level effectiveness trials integrate the use of qualitative research over all stages of the trial, to inform trial design, implementation optimization, results interpretation and post‐trial policy recommendations. This is despite the growing demand for mixed methods research from funding agencies and awareness of the vital importance of qualitative and mixed methods research for understanding trial successes and challenges.DiscussionWe offer examples from work we have been involved in to illustrate how qualitative research conducted within trials can reveal vital contextual factors that influence implementation and outcomes, can enable an informed adaptation of trials as they are being conducted and can lead to the formulation of theory regarding the social and behavioural pathways of intervention, while also enabling community engagement in trial design and implementation. These examples are based on published findings from qualitative studies embedded within two ongoing large‐scale studies demonstrating the population‐level impacts of universal HIV testing and treatment strategies in southern and eastern Africa, and a qualitative study conducted alongside a clinical trial testing the adaptation, acceptability and experience of short‐cycle therapy in children and adolescents living with HIV.ConclusionsWe advocate for the integration of qualitative with clinical and survey research methods in pragmatic clinical and community‐level trials and implementation studies, and for increasing visibility of qualitative and mixed methods research in medical journals. Qualitative research from trials ideally should be published along with clinical outcome data, either integrated into the “main” trial papers or published concurrently in the same journal issue. Integration of qualitative research within trials can help not only to understand the why behind success or failure of interventions in different contexts, but also inform the adaptation of interventions that can facilitate their success, and lead to new alternative strategies and to policy changes that may be vital for achieving public health goals, including the end of AIDS.

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Qualitative study of the BREATHER trial (Short Cycle antiretroviral therapy): is it acceptable to young people living with HIV?

Cited by 14 publications

References 20 publications

“How Do We Start? And How Will They React?” Disclosing to Young People with Perinatally Acquired HIV in Uganda

“How Do We Start? And How Will They React?” Disclosing to Young People with Perinatally Acquired HIV in Uganda

The HIV drug optimization agenda: promoting standards for earlier investigation and approvals of antiretroviral drugs for use in adolescents living with HIV

Qualitative research on community experiences in large HIV research trials: what have we learned?

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