PEBRA trial - effect of a peer-educator coordinated preference-based ART service delivery model on viral suppression among adolescents and young adults living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho

Thabo Ishmael Lejone, Mathebe Kopo, Nadine Bachmann, Jennifer Anne Brown, Tracy Renée Glass, Josephine Muhairwe, Tebatso Matsela, Ramona Scherrer, Lebohang Chere, Tilo Namane, Niklaus Daniel Labhardt, Alain Amstutz, Thabo Ishmael Lejone, Mathebe Kopo, Nadine Bachmann, Jennifer Anne Brown, Tracy Renée Glass, Josephine Muhairwe, Tebatso Matsela, Ramona Scherrer, Lebohang Chere, Tilo Namane, Niklaus Daniel Labhardt, Alain Amstutz

Abstract

Background: Despite tremendous progress in controlling the HIV epidemic in sub-Saharan Africa, HIV-related mortality continues to increase among adolescents and young people living with HIV (AYPLHIV). Globally, sub-Saharan Africa accounts for 85% of the AYPLHIV. Overall outcomes along the HIV care cascade are worse among AYPLHIV as compared to all other age groups due to various challenges in accessing and adhering to antiretroviral therapy (ART). New, innovative multicomponent packages of differentiated service delivery (DSD) models, are required to address the specific needs of AYPLHIV. This study aims to evaluate the feasibility and effectiveness of a multicomponent DSD model (PEBRA model) designed for AYPLHIV and coordinated by a peer-educator.

Methods: PEBRA (Peer-Educator Based Refill of ART) is a cluster randomized, open-label, superiority trial conducted at 20 health facilities in three districts of Lesotho, Southern Africa. The clusters (health facilities) are randomly assigned to either the PEBRA model or standard of care in a 1:1 ratio, stratified by district. AYPLHIV aged 15-24 years old in care and on ART at one of the clusters are eligible. In the PEBRA model, a peer-educator coordinates the antiretroviral therapy (ART) services - such as medication pick-up, SMS notifications and support options - according to the preferences of the AYPLHIV. The peer-educator delivers this personalized model using a tablet-based application called PEBRApp. The control clusters continue to offer standard of care: ART services coordinated by the nurse. The primary endpoint is viral suppression at 12 months. Secondary endpoints include self-reported adherence to ART, quality of life, satisfaction with care and engagement in care. The target sample size is 300 AYPLHIV. Statistical analyses are conducted and reported in line with CONSORT guidelines for cluster randomized trials.

Discussion: The PEBRA trial will provide evidence on the feasibility and effectiveness of an inclusive, holistic and preference-based DSD model for AYPLHIV that is coordinated by a peer-educator. Many countries in SSA have an existing peer-educator program. If proven effective, the PEBRA model and PEBRApp have the potential to be scaled up to similar settings.

Trial registration: Clinicaltrials.gov, NCT03969030. Registered on 31 May 2019. More information: www.pebra.info.

Keywords: Adolescent; Antiretroviral therapy, differentiated service delivery; HIV; Lesotho, Africa, southern; Peer group; Randomized controlled trial.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
PEBRA intervention versus PEBRA control. Abbreviations: VHW (Village Health Worker), PE (Peer-Educator), CAC (Community Adherence Club), TB (Treatment Buddy), ART (antiretroviral therapy), VL (viral load), FP (Family Planning), VMMC (Voluntary Medical Male Circumcision), GBV (Gender-Based Violence), WORTH (Sentebale Social Asset Building Model). “Pitso” = Village gathering
Fig. 2
Fig. 2
PEBRApp
Fig. 3
Fig. 3
PEBRA trial SPIRIT diagram

References

    1. UNAIDS data 2019 [Internet]. Available from: [cited 2019 25 Nov].
    1. UNICEF HIV and AIDS data 2017 [Internet]. Available from: . [cited 2020 20 Mar].
    1. Davies M-A, Pinto J. Targeting 90–90–90 – don’t leave children and adolescents behind. J Int AIDS Soc. 2015;18(Suppl 6):20745. doi: 10.7448/IAS.18.7.20745.
    1. Slogrove AL, Mahy M, Armstrong A, Davies M-A. Living and dying to be counted: What we know about the epidemiology of the global adolescent HIV epidemic. J Int AIDS Soc. 2017;20 Available from: [cited 2019 25 Feb].
    1. Bekker L-G, Siberry GK, Hirnschall G. Ensuring Children and Adolescents Are Not Left Behind. JAIDS J Acquir Immune Defic Syndr. 2018;78:S1. doi: 10.1097/QAI.0000000000001751.
    1. UNAIDS and UNICEF data 2018 [Internet]. Available from: . [cited 2020 20 Mar].
    1. Auld AF, Agolory SG, Shiraishi RW, Wabwire-Mangen F, Kwesigabo G, Mulenga M, et al. Antiretroviral therapy enrollment characteristics and outcomes among HIV-infected adolescents and young adults compared with older adults--seven African countries, 2004-2013. MMWR Morb Mortal Wkly Rep. 2014;63(47):1097–1103.
    1. Plummer ML, Baltag V, Strong K, Dick B, Ross DA, World Health Organization, et al. Global Accelerated Action for the Health of Adolescents (AA-HA!): guidance to support country implementation [Internet]. 2017 [cited 2019 Feb 25]. Available from: .
    1. Hudelson C, Cluver L. Factors associated with adherence to antiretroviral therapy among adolescents living with HIV/AIDS in low- and middle-income countries: a systematic review. AIDS Care. 2015;27(7):805–816. doi: 10.1080/09540121.2015.1011073.
    1. Govindasamy D, Ford N, Kranzer K. Risk factors, barriers and facilitators for linkage to antiretroviral therapy care: a systematic review. AIDS. 2012;26(16):2059–2067. doi: 10.1097/QAD.0b013e3283578b9b.
    1. Hall BJ, Sou K-L, Beanland R, Lacky M, Tso LS, Ma Q, et al. Barriers and facilitators to interventions improving retention in HIV care: a qualitative evidence meta-synthesis. AIDS Behav. 2017;21(6):1755–1767. doi: 10.1007/s10461-016-1537-0.
    1. McNairy ML, El-Sadr WM. The HIV care continuum: no partial credit given. AIDS Lond Engl. 2012;26(14):1735–1738. doi: 10.1097/QAD.0b013e328355d67b.
    1. Joint United Nations Programme on HIV/AIDS. Miles to go: Closing gaps, breaking barriers, righting injustices. Geneva, Switzerland; UNAIDS; 2018. Available from: [cited 2019 25 Feb].
    1. Kanters S, Park JJH, Chan K, Socias ME, Ford N, Forrest JI, et al. Interventions to improve adherence to antiretroviral therapy: a systematic review and network meta-analysis. Lancet HIV. 4(1):e31–40 Available from: [cited 2017 13 Sep].
    1. International AIDS Society. Differentiated Care for HIV: A Decision Framework for Antiretroviral Therapy. Durban, South Africa: IAS; 2016. Available from: [cited 2019 25 Feb].
    1. WHO/IAS data 2018. Providing differentiated delivery to children and adolescents [Internet]. Available from: . [cited 2020 20 Mar].
    1. Grimsrud A, Bygrave H, Doherty M, Ehrenkranz P, Ellman T, Ferris R, et al. Reimagining HIV service delivery: the role of differentiated care from prevention to suppression. J Int AIDS Soc. 2016;19(1):21484. doi: 10.7448/IAS.19.1.21484.
    1. PATA Technical Brief about Differentiated Service Delivery for Adolescents and Young Adults Living with HIV in South Africa 2019 [Internet]. Available from: . [cited 2020 20 Mar].
    1. A Decision Framework for differentiated antiretroviral therapy delivery for children, adolescents and pregnant and breastfeeding women. International AIDS Society 2017 [Internet]. Available from: . [cited 2020 20 Mar].
    1. WHO data 2019. Adolescent-friendly health services for adolescents living with HIV: from theory to practice [Internet]. Available from: . [cited 2020 20 Mar].
    1. MacKenzie RK, van Lettow M, Gondwe C, et al. Greater retention in care among adolescents on antiretroviral treatment accessing ‘Teen Club’ an adolescent-centred differentiated care model compared with standard of care: a nested case-control study at a tertiary referral hospital in Malawi. J Int AIDS Soc. 2017. p. 20. 10.1002/jia2.25028.
    1. Funck-Brentano I, Dalban C, Veber F, Quartier P, Hefez S, Costagliola D, et al. Evaluation of a peer support group therapy for HIV-infected adolescents. AIDS Lond Engl. 2005;19(14):1501–1508. doi: 10.1097/01.aids.0000183124.86335.0a.
    1. Tsondai PR, Wilkinson LS, Grimsrud A, Mdlalo PT, Ullauri A, Boulle A. High rates of retention and viral suppression in the scale-up of antiretroviral therapy adherence clubs in Cape Town, South Africa. J Int AIDS Soc. 2017;20:21649.
    1. Willis N, Milanzi A, Mawodzeke M, Dziwa C, Armstrong A, Yekeye I, et al. Effectiveness of community adolescent treatment supporters (CATS) interventions in improving linkage and retention in care, adherence to ART and psychosocial well-being: a randomised trial among adolescents living with HIV in rural Zimbabwe. BMC Public Health. 2019;19(1):117. doi: 10.1186/s12889-019-6447-4.
    1. Zvandiri Trial Policy Brief 2019 [Internet]. Available from: . [cited 2020 20 Mar].
    1. UNAIDS. Prevention Gap Report. 2016 [Internet]. Available from: . [cited 2016 10 Apr].
    1. LePHIA report 2016-2017 [Internet]. Available from: . [cited 2020 20 Mar].
    1. Elul B, Lamb MR, Lahuerta M, Abacassamo F, Ahoua L, Kujawski SA, et al. A combination intervention strategy to improve linkage to and retention in HIV care following diagnosis in Mozambique: A cluster-randomized study. PLOS Med. 2017;14(11):e1002433. doi: 10.1371/journal.pmed.1002433.
    1. McNairy ML, Lamb MR, Gachuhi AB, Nuwagaba-Biribonwoha H, Burke S, Mazibuko S, et al. Effectiveness of a combination strategy for linkage and retention in adult HIV care in Swaziland: The Link4Health cluster randomized trial. PLOS Med. 2017;14(11):e1002420. doi: 10.1371/journal.pmed.1002420.

Source: PubMed

3
Prenumerera