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Isisekelo Sempilo study protocol for the effectiveness of HIV prevention embedded in sexual health with or without peer navigator support (Thetha Nami) to reduce prevalence of transmissible HIV amongst adolescents and young adults in rural KwaZulu-Natal: a 2 x 2 factorial randomised controlled trial

Isisekelo Sempilo study protocol for the effectiveness of HIV prevention embedded in sexual health with or without peer navigator support (Thetha Nami) to reduce prevalence of transmissible HIV amongst adolescents and young adults in rural KwaZulu-Natal: a 2 x 2 factorial randomised controlled trial
Isisekelo Sempilo study protocol for the effectiveness of HIV prevention embedded in sexual health with or without peer navigator support (Thetha Nami) to reduce prevalence of transmissible HIV amongst adolescents and young adults in rural KwaZulu-Natal: a 2 x 2 factorial randomised controlled trial
Background: Antiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-related mortality, morbidity and incidence. Effective individual-level prevention modalities have not translated into population-level impact in southern Africa due to sub-optimal coverage among adolescents and youth who are hard to engage. We aim to investigate the feasibility, acceptability, and preliminary population level effectiveness of HIV prevention services with or without peer support to reduce prevalence of transmissible HIV amongst adolescents and young adults in KwaZulu-Natal.

Methods: We are conducting a 2 × 2 factorial trial among young men and women aged 16–29 years, randomly selected from the Africa Health Research Institute demographic surveillance area. Participants are randomly allocated to one of four intervention combinations: 1) Standard of Care (SOC): nurse-led services for HIV testing plus ART if positive or PrEP for those eligible and negative; 2) Sexual and Reproductive Health (SRH): Baseline self-collected vaginal and urine samples with study-organized clinic appointments for results, treatment and delivery of HIV testing, ART and PrEP integrated with SRH services; 3) Peer-support: Study referral of participants to a peer navigator to assess their health, social and educational needs and provide risk-informed HIV prevention, including facilitating clinic attendance; or 4) SRH + peer-support. The primary outcomes for effectiveness are: (1) the proportion of individuals with infectious HIV at 12 months and (2) uptake of risk-informed comprehensive HIV prevention services within 60 days of enrolment. At 12 months, all participants will be contacted at home and the study team will collect a dried blood spot for HIV ELISA and HIV viral load testing.

Discussion: This trial will enable us to understand the relative importance of SRH and peer support in creating demand for effective and risk informed biomedical HIV prevention and preliminary data on their effectiveness on reducing the prevalence of transmissible HIV amongst all adolescents and youth.

Trial registration: Trial Registry: clincialtrials.gov. ClinicalTrials.gov Identifier NCT04532307. Registered: March 2020.
Community-based care, Contraception, HIV prevention, Peer navigator, Pre-Exposure prophylaxis
1471-2458
Chidumwa, Glory
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Chimbindi, Natsayi
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Herbst, Carina
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Okeselo, Nonhlanhla
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Dreyer, Jaco
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Zuma, Thembelihle
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Smith, Theresa
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Molina, Jean Michel
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Khoza, Thandeka
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McGrath, Nuala
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Seeley, Janet
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Pillay, Deenan
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Tanser, Frank
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Harling, Guy
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Sherr, Lorraine
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Copas, Andrew
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Baisley, Kathy
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Shahmanesh, Maryam
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Chidumwa, Glory
bda0a64d-e8f6-4fad-bed5-2fd9c86f857f
Chimbindi, Natsayi
c518d13f-6c0b-4eb2-92f5-89d260eeba87
Herbst, Carina
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Okeselo, Nonhlanhla
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Dreyer, Jaco
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Zuma, Thembelihle
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Smith, Theresa
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Molina, Jean Michel
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Khoza, Thandeka
fc1df6ed-f574-4728-9569-3ad8ea710ba2
McGrath, Nuala
b75c0232-24ec-443f-93a9-69e9e12dc961
Seeley, Janet
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Pillay, Deenan
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Tanser, Frank
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Harling, Guy
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Sherr, Lorraine
dcc07842-49e3-44fc-bf87-d56dd0f15323
Copas, Andrew
10c9d680-f510-4969-ab9a-9e2a61568cb8
Baisley, Kathy
5fe8c276-d9d2-4bb6-91a3-8acd38a5151f
Shahmanesh, Maryam
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Chidumwa, Glory, Chimbindi, Natsayi, Herbst, Carina, Okeselo, Nonhlanhla, Dreyer, Jaco, Zuma, Thembelihle, Smith, Theresa, Molina, Jean Michel, Khoza, Thandeka, McGrath, Nuala, Seeley, Janet, Pillay, Deenan, Tanser, Frank, Harling, Guy, Sherr, Lorraine, Copas, Andrew, Baisley, Kathy and Shahmanesh, Maryam (2022) Isisekelo Sempilo study protocol for the effectiveness of HIV prevention embedded in sexual health with or without peer navigator support (Thetha Nami) to reduce prevalence of transmissible HIV amongst adolescents and young adults in rural KwaZulu-Natal: a 2 x 2 factorial randomised controlled trial. BMC Public Health, 22 (1), [454]. (doi:10.1186/s12889-022-12796-8).

Record type: Article

Abstract

Background: Antiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-related mortality, morbidity and incidence. Effective individual-level prevention modalities have not translated into population-level impact in southern Africa due to sub-optimal coverage among adolescents and youth who are hard to engage. We aim to investigate the feasibility, acceptability, and preliminary population level effectiveness of HIV prevention services with or without peer support to reduce prevalence of transmissible HIV amongst adolescents and young adults in KwaZulu-Natal.

Methods: We are conducting a 2 × 2 factorial trial among young men and women aged 16–29 years, randomly selected from the Africa Health Research Institute demographic surveillance area. Participants are randomly allocated to one of four intervention combinations: 1) Standard of Care (SOC): nurse-led services for HIV testing plus ART if positive or PrEP for those eligible and negative; 2) Sexual and Reproductive Health (SRH): Baseline self-collected vaginal and urine samples with study-organized clinic appointments for results, treatment and delivery of HIV testing, ART and PrEP integrated with SRH services; 3) Peer-support: Study referral of participants to a peer navigator to assess their health, social and educational needs and provide risk-informed HIV prevention, including facilitating clinic attendance; or 4) SRH + peer-support. The primary outcomes for effectiveness are: (1) the proportion of individuals with infectious HIV at 12 months and (2) uptake of risk-informed comprehensive HIV prevention services within 60 days of enrolment. At 12 months, all participants will be contacted at home and the study team will collect a dried blood spot for HIV ELISA and HIV viral load testing.

Discussion: This trial will enable us to understand the relative importance of SRH and peer support in creating demand for effective and risk informed biomedical HIV prevention and preliminary data on their effectiveness on reducing the prevalence of transmissible HIV amongst all adolescents and youth.

Trial registration: Trial Registry: clincialtrials.gov. ClinicalTrials.gov Identifier NCT04532307. Registered: March 2020.

Text
s12889-022-12796-8 - Version of Record
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Accepted/In Press date: 17 February 2022
Published date: 7 March 2022
Additional Information: Funding Information: This randomised controlled trial is funded by US National Institute of Health (NIH) R01 (award no: 5R01MH114560-03) and 3ie international initiative for impact evaluation. Africa Health Research Institute is supported by core funding from the Wellcome Trust (Core grant number (082384/Z/07/Z). N. McGrath is a recipient of an NIHR Research Professorship award (Ref: RP-2017–08-ST2-008). G.H. is supported by a fellowship from the Wellcome Trust and Royal Society [grant number 210479/Z/18/Z]. This research was in part, by the Wellcome Trust [Grant numbers 201433/Z/16/Z and 210479/Z/18/Z]. 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 have played no role in the study design, writing of the manuscript and in the decision to submit the manuscript for publication.
Keywords: Community-based care, Contraception, HIV prevention, Peer navigator, Pre-Exposure prophylaxis

Identifiers

Local EPrints ID: 456677
URI: http://eprints.soton.ac.uk/id/eprint/456677
ISSN: 1471-2458
PURE UUID: d0627f8d-43ad-4071-976f-33e1ef7fd53c
ORCID for Nuala McGrath: ORCID iD orcid.org/0000-0002-1039-0159

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Date deposited: 06 May 2022 16:35
Last modified: 11 Nov 2022 02:43

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Contributors

Author: Glory Chidumwa
Author: Natsayi Chimbindi
Author: Carina Herbst
Author: Nonhlanhla Okeselo
Author: Jaco Dreyer
Author: Thembelihle Zuma
Author: Theresa Smith
Author: Jean Michel Molina
Author: Thandeka Khoza
Author: Nuala McGrath ORCID iD
Author: Janet Seeley
Author: Deenan Pillay
Author: Frank Tanser
Author: Guy Harling
Author: Lorraine Sherr
Author: Andrew Copas
Author: Kathy Baisley
Author: Maryam Shahmanesh

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