TY - JOUR
T1 - Thetha Nami ngithethe nawe (Let’s Talk)
T2 - 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
AU - Busang, Jacob
AU - Zuma, Thembelihle
AU - Herbst, Carina
AU - Okesola, Nonhlanhla
AU - Chimbindi, Natsayi
AU - Dreyer, Jaco
AU - Mtshali, Nelisiwe
AU - Smit, Theresa
AU - Ngubane, Samkelisiwe
AU - Hlongwane, Siphesihle
AU - Gumede, Dumsani
AU - Jalazi, Ashley
AU - Mdluli, Simphiweyenkosi
AU - Bird, Kristien
AU - Msane, Sithembile
AU - Danisa, Priscilla
AU - Hanekom, Willem
AU - Lebina, Limakatso
AU - Behuhuma, Ngundu
AU - Hendrickson, Cheryl
AU - Miot, Jacqui
AU - Seeley, Janet
AU - Harling, Guy
AU - Jarolimova, Jana
AU - Sherr, Lorraine
AU - Copas, Andrew
AU - Baisley, Kathy
AU - Shahmanesh, Maryam
N1 - Funding Information: This trial was made possible through funding from Bill and Melinda Gates Foundation (INV-033650); US National Institute of Health (NIH) R01 (5R01MH114560-03); Africa Health Research Institute is the trial sponsor and is supported by core funding from the Wellcome Trust (Core grant number (082384/Z/07/Z). MS is an NIHR Research Professor (NIHR 301634). GH. is supported by a fellowship from the Wellcome Trust and Royal Society [grant number 210479/Z/18/Z]. NC is supported by a Wellcome Trust Early career fellowship (grant number 224309/Z/21/Z). The open access publication was made possible via the Bill and Melinda Gates Foundation (OPP1136774 and OPP1171600). For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. The funders and sponsor have played no role in the study design, writing of the manuscript and in the decision to submit the manuscript for publication. Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.
PY - 2023/12/1
Y1 - 2023/12/1
N2 - Background: Antiretroviral 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). Methods: We 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. Discussion: The 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 registration: ClinicalTrials.gov Identifier—NCT05405582. Registered: 6th June 2022.
AB - Background: Antiretroviral 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). Methods: We 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. Discussion: The 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 registration: ClinicalTrials.gov Identifier—NCT05405582. Registered: 6th June 2022.
KW - Adolescents and youth
KW - Community-based
KW - Differentiated HIV prevention
KW - HIV pre-exposure prophylaxis
KW - Implementation trials
KW - Peer navigators
KW - Sexual and reproductive health
KW - Universal test and treat
UR - http://www.scopus.com/inward/record.url?scp=85168261494&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12889-023-16262-x
DO - https://doi.org/10.1186/s12889-023-16262-x
M3 - Article
C2 - 37582746
SN - 1471-2458
VL - 23
JO - BMC public health
JF - BMC public health
IS - 1
M1 - 1553
ER -