Cluster randomised controlled trial to determine the effect of peer delivery HIV self-testing to support linkage to HIV prevention among young women in rural KwaZulu-Natal, South Africa: a study protocol
IntroductionA cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years)...
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Published in | BMJ open Vol. 9; no. 12; p. e033435 |
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Main Authors | , , , , , , , , , , , , , , |
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23.12.2019
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Abstract | IntroductionA cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.Methods and analysisA three-arm cRCT started mid-March 2019, in 24 areas in rural KwaZulu-Natal. Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months were randomised to: (1) incentivised-peer-networks: peer-navigators recruited participants ‘seeds’ to distribute up to five HIVST packs and HIV prevention information to peers within their social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution: peer-navigators distribute HIVST packs and information directly to young people; (3) standard of care: peer-navigators distribute referral slips and information. All arms promote sexual health information and provide barcoded clinic referral slips to facilitate linkage to HIV testing, prevention and care services. The primary outcome is the difference in linkage rate between arms, defined as the number of women (18 to 24 years) per peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status, within 90 days of receiving the clinic referral slip.Ethics and disseminationThis study was approved by the Institutional Review Boards at the WHO, Switzerland (Protocol ID: STAR CRT, South Africa), London School of Hygiene and Tropical Medicine, UK (Reference: 15 990–1), University of KwaZulu-Natal (BFC311/18) and the KwaZulu-Natal Department of Health (Reference: KZ_201901_012), South Africa. The findings of this trial will be disseminated at local, regional and international meetings and through peer-reviewed publications.Trial registration number NCT03751826; Pre-results. |
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AbstractList | A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.
A three-arm cRCT started mid-March 2019, in 24 areas in rural KwaZulu-Natal. Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months were randomised to: (1)
peer-navigators recruited participants 'seeds' to distribute up to five HIVST packs and HIV prevention information to peers within their social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2)
peer-navigators distribute HIVST packs and information directly to young people; (3)
peer-navigators distribute referral slips and information. All arms promote sexual health information and provide barcoded clinic referral slips to facilitate linkage to HIV testing, prevention and care services. The primary outcome is the difference in linkage rate between arms, defined as the number of women (18 to 24 years) per peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status, within 90 days of receiving the clinic referral slip.
This study was approved by the Institutional Review Boards at the WHO, Switzerland (Protocol ID: STAR CRT, South Africa), London School of Hygiene and Tropical Medicine, UK (Reference: 15 990-1), University of KwaZulu-Natal (BFC311/18) and the KwaZulu-Natal Department of Health (Reference: KZ_201901_012), South Africa. The findings of this trial will be disseminated at local, regional and international meetings and through peer-reviewed publications.
NCT03751826; Pre-results. IntroductionA cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.Methods and analysisA three-arm cRCT started mid-March 2019, in 24 areas in rural KwaZulu-Natal. Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months were randomised to: (1) incentivised-peer-networks: peer-navigators recruited participants ‘seeds’ to distribute up to five HIVST packs and HIV prevention information to peers within their social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution: peer-navigators distribute HIVST packs and information directly to young people; (3) standard of care: peer-navigators distribute referral slips and information. All arms promote sexual health information and provide barcoded clinic referral slips to facilitate linkage to HIV testing, prevention and care services. The primary outcome is the difference in linkage rate between arms, defined as the number of women (18 to 24 years) per peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status, within 90 days of receiving the clinic referral slip.Ethics and disseminationThis study was approved by the Institutional Review Boards at the WHO, Switzerland (Protocol ID: STAR CRT, South Africa), London School of Hygiene and Tropical Medicine, UK (Reference: 15 990–1), University of KwaZulu-Natal (BFC311/18) and the KwaZulu-Natal Department of Health (Reference: KZ_201901_012), South Africa. The findings of this trial will be disseminated at local, regional and international meetings and through peer-reviewed publications.Trial registration number NCT03751826; Pre-results. IntroductionA cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.Methods and analysisA three-arm cRCT started mid-March 2019, in 24 areas in rural KwaZulu-Natal. Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months were randomised to: (1) incentivised-peer-networks: peer-navigators recruited participants ‘seeds’ to distribute up to five HIVST packs and HIV prevention information to peers within their social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution: peer-navigators distribute HIVST packs and information directly to young people; (3) standard of care: peer-navigators distribute referral slips and information. All arms promote sexual health information and provide barcoded clinic referral slips to facilitate linkage to HIV testing, prevention and care services. The primary outcome is the difference in linkage rate between arms, defined as the number of women (18 to 24 years) per peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status, within 90 days of receiving the clinic referral slip.Ethics and disseminationThis study was approved by the Institutional Review Boards at the WHO, Switzerland (Protocol ID: STAR CRT, South Africa), London School of Hygiene and Tropical Medicine, UK (Reference: 15 990–1), University of KwaZulu-Natal (BFC311/18) and the KwaZulu-Natal Department of Health (Reference: KZ_201901_012), South Africa. The findings of this trial will be disseminated at local, regional and international meetings and through peer-reviewed publications.Trial registration numberNCT03751826; Pre-results. Introduction A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.Methods and analysis A three-arm cRCT started mid-March 2019, in 24 areas in rural KwaZulu-Natal. Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months were randomised to: (1) incentivised-peer-networks: peer-navigators recruited participants ‘seeds’ to distribute up to five HIVST packs and HIV prevention information to peers within their social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution: peer-navigators distribute HIVST packs and information directly to young people; (3) standard of care: peer-navigators distribute referral slips and information. All arms promote sexual health information and provide barcoded clinic referral slips to facilitate linkage to HIV testing, prevention and care services. The primary outcome is the difference in linkage rate between arms, defined as the number of women (18 to 24 years) per peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status, within 90 days of receiving the clinic referral slip.Ethics and dissemination This study was approved by the Institutional Review Boards at the WHO, Switzerland (Protocol ID: STAR CRT, South Africa), London School of Hygiene and Tropical Medicine, UK (Reference: 15 990–1), University of KwaZulu-Natal (BFC311/18) and the KwaZulu-Natal Department of Health (Reference: KZ_201901_012), South Africa. The findings of this trial will be disseminated at local, regional and international meetings and through peer-reviewed publications.Trial registration number NCT03751826; Pre-results. |
Author | Neuman, Melissa Adeagbo, Oluwafemi Atanda Chimbindi, Natsayi Shahmanesh, Maryam Seeley, Janet Corbett, Liz Hatzold, Karin Okesola, Nonhlanhla Mee, Paul Dreyer, Jaco Cowan, Frances Smit, Theresa Mthiyane, Nondumiso Johnson, Cheryl Herbst, Carina |
AuthorAffiliation | 3 Epidemiology and Public Health, London School of Hygiene and Tropical Medicine , London , UK 5 Population Services International , Harare , Zimbabwe 4 Department of HIV/AIDS , World Health Organization , Geneva , Switzerland 9 Infectious and Tropical Diseases , London School of Hygiene and Tropical Medicine , London , UK 10 Institute for Global Health , University College London , London , UK 6 Public Health and Policy , London School of Hygiene and Tropical Medicine , London , United Kingdom 2 Sociology , University of Johannesburg , Auckland Park , Gauteng , South Africa 1 Africa Health Research Institute , Mtubatuba , KwaZulu-Natal , South Africa 7 International Public Health , Liverpool School of Tropical Medicine , Liverpool , UK 8 CeSHHAR Zimbabwe , Harare , Zimbabwe |
AuthorAffiliation_xml | – name: 2 Sociology , University of Johannesburg , Auckland Park , Gauteng , South Africa – name: 10 Institute for Global Health , University College London , London , UK – name: 7 International Public Health , Liverpool School of Tropical Medicine , Liverpool , UK – name: 1 Africa Health Research Institute , Mtubatuba , KwaZulu-Natal , South Africa – name: 5 Population Services International , Harare , Zimbabwe – name: 9 Infectious and Tropical Diseases , London School of Hygiene and Tropical Medicine , London , UK – name: 8 CeSHHAR Zimbabwe , Harare , Zimbabwe – name: 4 Department of HIV/AIDS , World Health Organization , Geneva , Switzerland – name: 3 Epidemiology and Public Health, London School of Hygiene and Tropical Medicine , London , UK – name: 6 Public Health and Policy , London School of Hygiene and Tropical Medicine , London , United Kingdom |
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CitedBy_id | crossref_primary_10_1080_09540121_2021_1981217 crossref_primary_10_1136_bmjgh_2020_004574 crossref_primary_10_3390_ijerph18073709 crossref_primary_10_1186_s12889_021_11399_z crossref_primary_10_1186_s12889_023_16081_0 crossref_primary_10_1093_ije_dyaa264 crossref_primary_10_1186_s12889_023_16262_x crossref_primary_10_1136_bmjopen_2021_048780 |
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Snippet | IntroductionA cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through... A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised... INTRODUCTIONA cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through... Introduction A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through... |
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SubjectTerms | Adult AIDS Serodiagnosis - methods Antiretroviral drugs Cluster Analysis Disease prevention Female Girls HIV HIV Infections - diagnosis HIV Infections - prevention & control HIV/AIDS Human immunodeficiency virus Humans Intervention Medical tests Peer Group Randomized Controlled Trials as Topic Rural Population South Africa Surveillance Womens health Young Adult Young adults |
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Title | Cluster randomised controlled trial to determine the effect of peer delivery HIV self-testing to support linkage to HIV prevention among young women in rural KwaZulu-Natal, South Africa: a study protocol |
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