Thetha Nami ngithethe nawe (Let’s Talk): a stepped-wedge cluster randomised trial of social mobilisation by peer navigators into community-based sexual health and HIV care, including pre-exposure prophylaxis (PrEP), to reduce sexually transmissible HIV amongst young people in rural KwaZulu-Natal, South Africa

BMC Public Health

Study Protocol

Jacob Busang¹  Theresa Smit¹  Nonhlanhla Okesola¹  Simphiweyenkosi Mdluli¹  Nelisiwe Mtshali¹  Siphesihle Hlongwane¹  Sithembile Msane¹  Kristien Bird¹  Ngundu Behuhuma¹  Ashley Jalazi¹  Dumsani Gumede¹  Samkelisiwe Ngubane¹  Carina Herbst¹  Priscilla Danisa¹  Jaco Dreyer¹  Willem Hanekom²  Thembelihle Zuma³  Natsayi Chimbindi³  Maryam Shahmanesh³  Guy Harling⁴  Limakatso Lebina⁵  Kathy Baisley⁶  Janet Seeley⁷  Lorraine Sherr⁸  Andrew Copas⁸  Jana Jarolimova⁹  Jacqui Miot^1,10  Cheryl Hendrickson^1,11 

[1] Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa;Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa;Institute for Global Health, University College London, London, UK;Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa;Institute for Global Health, University College London, London, UK;University of KwaZulu-Natal, Durban, South Africa;Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa;Institute for Global Health, University College London, London, UK;University of KwaZulu-Natal, Durban, South Africa;University of the Witwatersrand, Johannesburg, South Africa;Harvard T.H. Chan School of Public Health, Boston, USA;Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa;Institute for Global Health, University College London, London, UK;University of the Witwatersrand, Johannesburg, South Africa;Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa;London School of Hygiene & Tropical Medicine, London, UK;Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa;University of KwaZulu-Natal, Durban, South Africa;London School of Hygiene & Tropical Medicine, London, UK;Institute for Global Health, University College London, London, UK;Massachusetts General Hospital, Boston, USA;University of the Witwatersrand, Johannesburg, South Africa;Health Economics and Epidemiology Research Office, Wits Health Consortium, Johannesburg, South Africa;University of the Witwatersrand, Johannesburg, South Africa;Health Economics and Epidemiology Research Office, Wits Health Consortium, Johannesburg, South Africa;Department of Medical Microbiology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands;

关键词: Differentiated HIV prevention;    HIV pre-exposure prophylaxis;    Universal test and treat;    Sexual and reproductive health;    Adolescents and youth;    Implementation trials;    Peer navigators;    Community-based;   

DOI  :  10.1186/s12889-023-16262-x

 received in 2023-04-12, accepted in 2023-07-07,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundAntiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-related mortality and incidence. Effective ART based prevention has not translated into population-level impact in southern Africa due to sub-optimal coverage among youth. We aim to investigate the effectiveness, implementation and cost effectiveness of peer-led social mobilisation into decentralised integrated HIV and sexual reproductive health (SRH) services amongst adolescents and young adults in KwaZulu-Natal (KZN).MethodsWe are conducting a type 1a hybrid effectiveness/implementation study, with a cluster randomized stepped-wedge trial (SWT) to assess effectiveness and a realist process evaluation to assess implementation outcomes. The SWT will be conducted in 40 clusters in rural KZN over 45 months. Clusters will be randomly allocated to receive the intervention in period 1 (early) or period 2 (delayed). 1) Intervention arm: Resident peer navigators in each cluster will approach young men and women aged 15–30 years living in their cluster to conduct health, social and educational needs assessment and tailor psychosocial support and health promotion, peer mentorship, and facilitate referrals into nurse led mobile clinics that visit each cluster regularly to deliver integrated SRH and differentiated HIV prevention (HIV testing, UTT for those positive, and PrEP for those eligible and negative). Standard of Care is UTT and PrEP delivered to 15–30 year olds from control clusters through primary health clinics. There are 3 co-primary outcomes measured amongst cross sectional surveys of 15–30 year olds: 1) effectiveness of the intervention in reducing the prevalence of sexually transmissible HIV; 2) uptake of universal risk informed HIV prevention intervention; 3) cost of transmissible HIV infection averted. We will use a realist process evaluation to interrogate the extent to which the intervention components support demand, uptake, and retention in risk-differentiated biomedical HIV prevention.DiscussionThe findings of this trial will be used by policy makers to optimize delivery of universal differentiated HIV prevention, including HIV pre-exposure prophylaxis through peer-led mobilisation into community-based integrated adolescent and youth friendly HIV and sexual and reproductive health care.Trial registrationClinicalTrials.gov Identifier—NCT05405582. Registered: 6th June 2022.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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