HIV Trials


Dec, 2017

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


Authors: Namukwaya S, Paparini S, Seeley J, Bernays S.

Published in: Front Public Health. 2017;5:343

Abstract: 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.



Jul, 2017

“Not Taking it Will Just be Like a Sin”: Young People Living with HIV and the Stigmatization of Less-Than-Perfect Adherence to Antiretroviral Therapy.


Authors: Bernays S, Paparini S, Seeley J, Rhodes T.

Published inMed Anthropol. 2017;36(5):485-499.

Abstract: Global health priorities are being set to address questions on adherence to HIV antiretroviral therapy in adolescence. Few studies have explored young people’s perspectives on the complex host of social and relational challenges they face in dealing with their treatment in secret and their condition in silence. In redressing this, we present findings from a longitudinal qualitative study with young people living with HIV in the UK, Ireland, US, and Uganda, embedded within the BREATHER international clinical trial. Drawing from Goffman’s notion of stigma, we analyze relational dynamics in HIV clinics, as rare spaces where HIV is “known,” and how young people’s relationships may be threatened by non-adherence to treatment. Young people’s reflections on and strategies for maintaining their reputation as patients raise questions about particular forms of medicalization of HIV and the moralization of treatment adherence that affect them, and how these may restrict opportunities for care across the epidemic.



Dec, 2016

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


Authors: Bernays S, Paparini S, Seeley J, Namukwaya Kihika S, Gibb D, Rhodes T.

Published inBMJ Open. 2017;7(2):e012934

Abstract: A qualitative study of the BREATHER (PENTA 16) randomised clinical trial, which compared virological control of Short Cycle Therapy (SCT) (5 days on: 2 days off ) with continuous efavirenz (EFV)-based antiretroviral therapy (CT) in children and young people (aged 8–24) living with HIV with viral load <50 c/mL to examine adaptation, acceptability and experience of SCT to inform intervention development



Jun, 2016

BREATHER (PENTA 16) short-cycle therapy (SCT) (5 days on/2 days off) in young people with chronic human immunodeficiency virus infection: an open, randomised, parallel-group Phase II/III trial


Author: Butler K, Inshaw J, Ford D, et al.

Published in:  Health Technol Assess2016;20(49):1-108.

Abstract: The trial showed that short-cycle antiretroviral therapy was not inferior to continuous therapy in suppressing human immunodeficiency viral load in young people taking efavirenz-based first-line therapy and a viral load of < 50 copies/ml, with similar resistance, safety and inflammatory marker profiles.



Jun, 2016

Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial


Author: The BREATHER (PENTA 16) Trial Group

Published inLancet HIV. 2016;3(9):e421-430

Abstract: For HIV-1-infected young people facing lifelong antiretroviral therapy (ART), short cycle therapy with long-acting drugs offers potential for drug-free weekends, less toxicity, and better quality-of-life. We aimed to compare short cycle therapy (5 days on, 2 days off ART) versus continuous therapy (continuous ART).



Apr, 2016

Neurocognition and quality of life after reinitiating antiretroviral therapy in children randomized to planned treatment interruption” has been accepted for publication in AIDS


Authors: Ananworanich J, Melvin D, Ramos Amador JT, Childs T, Medin G, Boscolo V, Compagnucci A, Kanjanavanit S, Montero S, Gibb DM, on behalf of the PENTA 11 study group.

Published in: AIDS: 24 April 2016 – Volume 30 – Issue 7 – p 1075–1081



Jan, 2016

Response to Planned Treatment Interruptions in HIV-infection varies across Childhood in the PENTA 11 Trial


Published in: Aids. 2010;24(2):231-241.



Dec, 2015

When information does not suffice: young people living with HIV and communication about ART adherence in the clinic.


Despite mounting evidence recommending disclosure of human immunodeficiency virus (HIV) status to young people with perinatally acquired HIV as a central motivating factor for adherence to antiretroviral therapy, many young people continue to experience disclosure as a partial event, rather than a process. Drawing from two longitudinal, interview-based qualitative studies with young people living with HIV (aged 10–24) in five different countries in low and high income settings, we present data regarding disclosure and information about HIV in the clinic. The article highlights the limits of discussions framing disclosure and patient literacy, and young people’s reluctance to voice their adherence difficulties in the context of their relationships with clinical care teams. We suggest that a clinician-initiated, explicit acknowledgment of the social and practical hurdles of daily adherence for young people would aid a more transparent conversation and encourage young people to disclose missed doses and other problems they may be facing with their treatment. This may help to reduce health harms and poor adherence in the longer-term.

Authors: Bernays, S. Paparini, D. Gibb & J. Seeley

Published in: Vulnerable Children and Youth Studies: An International Interdisciplinary Journal for Research, Policy and Care. E-pub Dec 2015



Sep, 2015

HIV-1 Drug Resistance and Second-line Treatment in Children Randomized to Switch at Low versus Higher RNA Thresholds


Authors: Harrison L., Melvin A., Fiscus S., Saidi Y., Nastouli E., Harper L., Compagnucci A., Babiker A., McKinney R., Gibb D., Tudor-Williams G.

Published in: JAIDS 2015 Sep 1;70(1):42-53.



Sep, 2015

I was like, oh my God, what happens if it doesn’t work’?: young people living with HIV, clinical trial participation, and the truth economy accepted for presentation at BSA Medical Sociology Conference


Authors: Bernays S, Seeley J, Paparini S, Rhodes T

Published: BSA Medical Sociology Conference, York, 9-11 September 2015 (Paper ID No: W0012148)