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

Oluwafemi Atanda Adeagbo, Nondumiso Mthiyane, Carina Herbst, Paul Mee, Melissa Neuman, Jaco Dreyer, Natsayi Chimbindi, Theresa Smit, Nonhlanhla Okesola, Cheryl Johnson, Karin Hatzold, Janet Seeley, Frances Cowan, Liz Corbett, Maryam Shahmanesh, Oluwafemi Atanda Adeagbo, Nondumiso Mthiyane, Carina Herbst, Paul Mee, Melissa Neuman, Jaco Dreyer, Natsayi Chimbindi, Theresa Smit, Nonhlanhla Okesola, Cheryl Johnson, Karin Hatzold, Janet Seeley, Frances Cowan, Liz Corbett, Maryam Shahmanesh

Abstract

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.

Keywords: ART; HIV self-testing; HIV/AIDS; PrEP; South Africa; peer delivery model.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Map of study sites in Hlabisa subdistrict in KwaZulu-Natal, South Africa.
Figure 2
Figure 2
Flow diagram of trial enrolment, randomisation and intervention arms. AGYW, adolescent girls and young women; ART, antiretroviral; HIVST, HIV self-testing; PNs, peer navigators; PrEP, pre-exposureprophylaxis.
Figure 3
Figure 3
Peer navigators community outreach workflow. GPS, Global Positioning System; PrEP, pre-exposure prophylaxis; REDCap, Research Electronic Data Capture; VMMC, voluntary medical male circumcision.
Figure 4
Figure 4
Mobile/fixed clinics service workflow. ART, antiretroviral; BSID, Bayley Scales of Infant Development; DoH, Department of Health; PrEP, pre-exposure prophylaxis; REDCap, Research Electronic Data Capture; SA_ID, South Africa national identification number; STI, sexually transmittedinfection.

References

    1. HSRC South African national HIV prevalence, incidence, behaviour and communication survey 2017. Pretoria, South Africa: Human Science Research Council, 2018.
    1. Adeagbo O, Herbst C, Dlamini N, et al. . The ‘Missing Middle’ in HIV Treatment Cascade: Ensuring Men’s and Young People’s access to HIV Care in KwaZulu-Natal, South Africa. Association of Social Science and Humanities in HIV. 2018 International AIDS Society Pre-conference, 2018.
    1. Chimbindi N, Mthiyane N, Birdthistle I, et al. . Persistently high incidence of HIV in adolsescent girls and young women in rural KwaZulu-Natal, South Africa: lessons for determined resilient, Empowered, AIDS free, Mentored and safe (dreams) multilevel HIV prevention scale-up 2017.
    1. World Health Organization Who expands recommendation on oral preexposure prophylaxis of HIV infection (PrEP): policy brief. Geneva: WHO, 2015.
    1. (NDoH) NDoHSA National Policy on HIV Pre Exposure Prophylaxis (PrEP) and test and treat (T&T). Pretoria, South Africa, 2016.
    1. Huerga H, Van Cutsem G, Ben Farhat J, et al. . Progress towards the UNAIDS 90–90-90 goals by age and gender in a rural area of KwaZulu-Natal, South Africa: a household-based community cross-sectional survey. BMC Public Health 2018;18:303 10.1186/s12889-018-5208-0
    1. Carrasco MA, Fleming P, Wagman J, et al. . Toward 90-90-90: identifying those who have never been tested for HIV and differences by sex in Lesotho. AIDS Care 2018;30:284–8. 10.1080/09540121.2017.1372559
    1. Iwuji CC, Orne-Gliemann J, Larmarange J, et al. . Universal test and treat and the HIV epidemic in rural South Africa: a phase 4, open-label, community cluster randomised trial. Lancet HIV 2018;5:e116–25. 10.1016/S2352-3018(17)30205-9
    1. Plazy M, Farouki KE, Iwuji C, et al. . Access to HIV care in the context of universal test and treat: challenges within the ANRS 12249 TASP cluster-randomized trial in rural South Africa. J Int AIDS Soc 2016;19:20913 10.7448/IAS.19.1.20913
    1. Moshabela M, Zuma T, Orne-Gliemann J, et al. . "It is better to die": experiences of traditional health practitioners within the HIV treatment as prevention trial communities in rural South Africa (ANRS 12249 TasP trial). AIDS Care 2016;28:24–32. 10.1080/09540121.2016.1181296
    1. Boyer S, Iwuji C, Gosset A, et al. . Factors associated with antiretroviral treatment initiation amongst HIV-positive individuals linked to care within a universal test and treat programme: early findings of the ANRS 12249 TASP trial in rural South Africa. AIDS Care 2016;28:39–51. 10.1080/09540121.2016.1164808
    1. Spielberg F, Levine RO, Weaver M. Self-testing for HIV: a new option for HIV prevention? Lancet Infect Dis 2004;4:640–6. 10.1016/S1473-3099(04)01150-8
    1. Krause J, Subklew-Sehume F, Kenyon C, et al. . Acceptability of HIV self-testing: a systematic literature review. BMC Public Health 2013;13:735 10.1186/1471-2458-13-735
    1. Choko AT, Desmond N, Webb EL, et al. . The uptake and accuracy of oral kits for HIV self-testing in high HIV prevalence setting: a cross-sectional feasibility study in Blantyre, Malawi. PLoS Med 2011;8:e1001102 10.1371/journal.pmed.1001102
    1. Makusha T, Knight L, Taegtmeyer M, et al. . HIV self-testing could "revolutionize testing in South Africa, but it has got to be done properly": perceptions of key stakeholders. PLoS One 2015;10:e0122783 10.1371/journal.pone.0122783
    1. Knight L, Makusha T, Lim J, et al. . "I think it is right": a qualitative exploration of the acceptability and desired future use of oral swab and finger-prick HIV self-tests by lay users in KwaZulu-Natal, South Africa. BMC Res Notes 2017;10:486 10.1186/s13104-017-2810-7
    1. Spielberg F, Critchlow C, Vittinghoff E, et al. . Home collection for frequent HIV testing: acceptability of oral fluids, dried blood spots and telephone results. Aids 2000;14:1819–28.
    1. Belza MJ, Rosales-Statkus ME, Hoyos J, et al. . Supervised blood-based self-sample collection and rapid test performance: a valuable alternative to the use of saliva by HIV testing programmes with no medical or nursing staff. Sex Transm Infect 2012;88:218–21. 10.1136/sextrans-2011-050131
    1. Harichund C, Karim QA, Kunene P, et al. . Exploring factors that influence the integration of HIVST with HCT using a qualitative comparative cross-over design in KwaZulu-Natal, South Africa. Glob Public Health 2019;14:1275–87. 10.1080/17441692.2019.1587638
    1. Gaydos CA, Hsieh Y-H, Harvey L, et al. . Will patients "opt in" to perform their own rapid HIV test in the emergency department? Ann Emerg Med 2011;58:S74–8. 10.1016/j.annemergmed.2011.03.029
    1. Kalibala S, Tun W, Muraah W, et al. . Knowing myself first’: feasibility of self-testing among health workers in Kenya. Nairobi: Population Council, 2011.
    1. Lee VJ, Tan SC, Earnest A, et al. . User acceptability and feasibility of self-testing with HIV rapid tests. J Acquir Immune Defic Syndr 2007;45:449–53. 10.1097/QAI.0b013e318095a3f3
    1. WHO Guidelines on HIV self-testing and partner notification. Switzerland: WHO, 2016.
    1. Kapaku K, Neuman M, Maluzi K, et al. . Is OraQuick HIV-self-testing valid among intended users? Analysis from a clinical performance study in Lusaka, Zambia. Paris, France: International AIDS Society, 2017.
    1. Cowan FM, Delany-Moretlwe S, Sanders EJ, et al. . Prep implementation research in Africa: what is new? J Int AIDS Soc 2016;19:21101 10.7448/IAS.19.7.21101
    1. Van Damme L, Corneli A, Ahmed K, et al. . Preexposure prophylaxis for HIV infection among African women. N Engl J Med 2012;367:411–22. 10.1056/NEJMoa1202614
    1. Marrazzo JM, Ramjee G, Richardson BA, et al. . Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med 2015;372:509–18. 10.1056/NEJMoa1402269
    1. Yun K, Xu J-J, Zhang J, et al. . Female and younger subjects have lower adherence in PreP trials: a meta-analysis with implications for the uptake of PreP service to prevent HIV. Sex Transm Infect 2018;94:163–8. 10.1136/sextrans-2017-053217
    1. Kim S-H, Gerver SM, Fidler S, et al. . Adherence to antiretroviral therapy in adolescents living with HIV: systematic review and meta-analysis. AIDS 2014;28:1945 10.1097/QAD.0000000000000316
    1. Sharma M, Barnabas RV, Celum C. Community-based strategies to strengthen men’s engagement in the HIV care cascade in sub-Saharan Africa. PLoS medicine 2017;14:e1002262.
    1. van Rooyen H, Barnabas RV, Baeten JM, et al. . High HIV testing uptake and linkage to care in a novel program of home-based HIV counseling and testing with facilitated referral in KwaZulu-Natal, South Africa. J Acquir Immune Defic Syndr 2013;64:e1–8. 10.1097/QAI.0b013e31829b567d
    1. Kanters S, Park JJH, Chan K, et al. . Interventions to improve adherence to antiretroviral therapy: a systematic review and network meta-analysis. Lancet HIV 2017;4:e31–40. 10.1016/S2352-3018(16)30206-5
    1. Pettifor A, Nguyen NL, Celum C, et al. . Tailored combination prevention packages and PreP for young key populations. J Int AIDS Soc 2015;18:19434 10.7448/IAS.18.2.19434
    1. Choko AT, MacPherson P, Webb EL, et al. . One year outcomes following community-based HIV Self-Testing: a prospective study in Malawi. Conference on Retroviruses and Opportunistic Infections, United States, 2014.
    1. Funnell SC, Rogers PJ. Purposeful program theory: effective use of theories of change and logic models. John Wiley & Sons, 2011.
    1. Baral S, Logie CH, Grosso A, et al. . Modified social ecological model: a tool to guide the assessment of the risks and risk contexts of HIV epidemics. BMC Public Health 2013;13:482 10.1186/1471-2458-13-482
    1. Hargreaves JR, Delany-Moretlwe S, Hallett TB, et al. . The HIV prevention cascade: integrating theories of epidemiological, behavioural, and social science into programme design and monitoring. Lancet HIV 2016;3:e318–22. 10.1016/S2352-3018(16)30063-7
    1. Adeagbo O, Carina H, Blandford A, et al. . Building Mobile Phone-connected Diagnostics: A Qualitative Study Exploring People’s ‘Candidacy’ for Mobile Health-Supported HIV Testing and Care Services in Rural KwaZulu-Natal, South Africa. J Med Internet Res 2019;21.
    1. Adeagbo O, Herbst C, Dlamini N, et al. . " If She Tests Negative, It Means I Am Also Negative": Men's Construction of HIV Testing in South Africa. Aids Research And Human Retroviruses 2018;34:85.
    1. Nkosi B, Seeley J, Ngwenya N, et al. . Exploring adolescents and young people's candidacy for utilising health services in a rural district, South Africa. BMC Health Serv Res 2019;19:195 10.1186/s12913-019-3960-1
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. Moore GF, Audrey S, Barker M, et al. . Process evaluation of complex interventions: medical Research Council guidance. BMJ 2015;350 10.1136/bmj.h1258
    1. Jacobs C, Michelo C, Moshabela M. Implementation of a community-based intervention in the most rural and remote districts of Zambia: a process evaluation of safe motherhood action groups. Implementation Science 2018;13 10.1186/s13012-018-0766-1
    1. Hayes RJ, Moulton LH. Cluster randomised trials. Chapman and Hall/CRC, 2017.
    1. Denzin NK, Lincoln YS. The SAGE Handbook of qualitative research. Sage, 2011.
    1. Onyango MA, Adu-Sarkodie Y, Agyarko-Poku T, et al. . "It's all about making a life": poverty, HIV, violence, and other vulnerabilities faced by young female sex workers in Kumasi, Ghana. J Acquir Immune Defic Syndr 2015;68:S131–7. 10.1097/QAI.0000000000000455
    1. Geibel S, King'ola N, Temmerman M, et al. . The impact of peer outreach on HIV knowledge and prevention behaviours of male sex workers in Mombasa, Kenya. Sex Transm Infect 2012;88:357–62. 10.1136/sextrans-2011-050224
    1. Oldenburg CE, Biello KB, Colby D, et al. . Engagement with peer health educators is associated with willingness to use pre-exposure prophylaxis among male sex workers in Ho Chi Minh City, Vietnam. AIDS Patient Care STDS 2014;28:109–12. 10.1089/apc.2013.0372
    1. Ford K, Wirawan DN, Suastina SS, et al. . Evaluation of a peer education programme for female sex workers in Bali, Indonesia. Int J STD AIDS 2000;11:731–3. 10.1258/0956462001915156

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