The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocol

dc.contributor.authorMedina-Marino, Andrew
dc.contributor.authorBezuidenhout, Dana
dc.contributor.authorHosek, Sybil
dc.contributor.authorBarnabas, Ruanne V.
dc.contributor.authorAtujuna, Millicent
dc.contributor.authorBezuidenhout, Charl
dc.contributor.authorNgwepe, Phuti
dc.contributor.authorPeters, Remco P H
dc.contributor.authorLittle, Francesca
dc.contributor.authorCelum, Connie L
dc.contributor.authorDaniels, Joseph
dc.contributor.authorBekker, Linda-Gail
dc.date.accessioned2021-10-08T15:04:37Z
dc.date.available2021-10-08T15:04:37Z
dc.date.issued2021-07-26
dc.date.updated2021-08-01T03:14:57Z
dc.description.abstractBackground HIV incidence among South African adolescent girls and young women (AGYW) remains high, but could be reduced by highly effective pre-exposure prophylaxis (PrEP). Unfortunately, AGYW report significant barriers to clinic-based sexual and reproductive health services. Even when AGYW access PrEP as an HIV prevention method, poor prevention-effective use was a serious barrier to achieving its optimal HIV prevention benefits. Determining the acceptability and feasibility of community-based platforms to increase AGYW’s access to PrEP, and evaluating behavioural interventions to improve prevention-effective use of PrEP are needed. Methods We propose a mixed-methods study among AGYW aged 16–25 years in Eastern Cape Province, South Africa. In the first component, a cross-sectional study will assess the acceptability and feasibility of leveraging community-based HIV counselling and testing (CBCT) platforms to refer HIV-negative, at-risk AGYW to non-clinic-based, same-day PrEP initiation services. In the second component, we will enrol 480 AGYW initiating PrEP via our CBCT platforms into a three-armed (1:1:1) randomized control trial (RCT) that will evaluate the effectiveness of adherence support interventions to improve the prevention-effective use of PrEP. Adherence will be measured over 24 months via tenofovir-diphosphate blood concentration levels. Qualitative investigations will explore participant, staff, and community experiences associated with community-based PrEP services, adherence support activities, study implementation, and community awareness. Costs and scalability of service platforms and interventions will be evaluated. Discussion This will be the first study to assess the acceptability and feasibility of leveraging CBCT platforms to identify and refer at-risk AGYW to community-based, same-day PrEP initiation services. It will also provide quantitative and qualitative results to inform adherence support activities and services that promote the prevention-effective use of PrEP among AGYW. By applying principles of implementation science, behavioural science, and health economics research, we aim to inform strategies to improve access to and prevention-effective use of PrEP by AGYW. Trial registration ClinicalTrials.gov NCT03977181 . Registered on 6 June 2019—retrospectively registered.en_US
dc.identifier.apacitationMedina-Marino, A., Bezuidenhout, D., Hosek, S., Barnabas, Ruanne V., Atujuna, M., Bezuidenhout, C., ... Bekker, L. (2021). The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocol. <i>Trials</i>, :22(1), 489. http://hdl.handle.net/11427/35138en_ZA
dc.identifier.chicagocitationMedina-Marino, Andrew, Dana Bezuidenhout, Sybil Hosek, Ruanne V. Barnabas, Millicent Atujuna, Charl Bezuidenhout, Phuti Ngwepe, et al "The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocol." <i>Trials</i> :22, 1. (2021): 489. http://hdl.handle.net/11427/35138en_ZA
dc.identifier.citationMedina-Marino, A., Bezuidenhout, D., Hosek, S., Barnabas, Ruanne V., Atujuna, M., Bezuidenhout, C., Ngwepe, P. & Peters, R.P.H. et al. 2021. The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocol. <i>Trials.</i> :22(1):489. http://hdl.handle.net/11427/35138en_ZA
dc.identifier.ris TY - Journal Article AU - Medina-Marino, Andrew AU - Bezuidenhout, Dana AU - Hosek, Sybil AU - Barnabas, Ruanne V. AU - Atujuna, Millicent AU - Bezuidenhout, Charl AU - Ngwepe, Phuti AU - Peters, Remco P H AU - Little, Francesca AU - Celum, Connie L AU - Daniels, Joseph AU - Bekker, Linda-Gail AB - Background HIV incidence among South African adolescent girls and young women (AGYW) remains high, but could be reduced by highly effective pre-exposure prophylaxis (PrEP). Unfortunately, AGYW report significant barriers to clinic-based sexual and reproductive health services. Even when AGYW access PrEP as an HIV prevention method, poor prevention-effective use was a serious barrier to achieving its optimal HIV prevention benefits. Determining the acceptability and feasibility of community-based platforms to increase AGYW’s access to PrEP, and evaluating behavioural interventions to improve prevention-effective use of PrEP are needed. Methods We propose a mixed-methods study among AGYW aged 16–25 years in Eastern Cape Province, South Africa. In the first component, a cross-sectional study will assess the acceptability and feasibility of leveraging community-based HIV counselling and testing (CBCT) platforms to refer HIV-negative, at-risk AGYW to non-clinic-based, same-day PrEP initiation services. In the second component, we will enrol 480 AGYW initiating PrEP via our CBCT platforms into a three-armed (1:1:1) randomized control trial (RCT) that will evaluate the effectiveness of adherence support interventions to improve the prevention-effective use of PrEP. Adherence will be measured over 24 months via tenofovir-diphosphate blood concentration levels. Qualitative investigations will explore participant, staff, and community experiences associated with community-based PrEP services, adherence support activities, study implementation, and community awareness. Costs and scalability of service platforms and interventions will be evaluated. Discussion This will be the first study to assess the acceptability and feasibility of leveraging CBCT platforms to identify and refer at-risk AGYW to community-based, same-day PrEP initiation services. It will also provide quantitative and qualitative results to inform adherence support activities and services that promote the prevention-effective use of PrEP among AGYW. By applying principles of implementation science, behavioural science, and health economics research, we aim to inform strategies to improve access to and prevention-effective use of PrEP by AGYW. Trial registration ClinicalTrials.gov NCT03977181 . Registered on 6 June 2019—retrospectively registered. DA - 2021-07-26 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - Trials KW - HIV KW - HIV prevention KW - PrEP KW - Randomized controlled trial KW - Adolescent girls and young women KW - Community-based delivery platforms KW - Adherence support intervention KW - Cost-effectiveness KW - South Africa LK - https://open.uct.ac.za PY - 2021 T1 - The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocol TI - The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocol UR - http://hdl.handle.net/11427/35138 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s13063-021-05402-6
dc.identifier.urihttp://hdl.handle.net/11427/35138
dc.identifier.vancouvercitationMedina-Marino A, Bezuidenhout D, Hosek S, Barnabas Ruanne V, Atujuna M, Bezuidenhout C, et al. The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocol. Trials. 2021;:22(1):489. http://hdl.handle.net/11427/35138.en_ZA
dc.language.isoenen_US
dc.language.rfc3066en
dc.publisher.departmentDivision of Infectious Disease and HIV Meden_US
dc.publisher.facultyFaculty of Health Sciencesen_US
dc.rights.holderThe Author(s)
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.sourceTrialsen_US
dc.source.journalissue1en_US
dc.source.journalvolume:22en_US
dc.source.pagination489en_US
dc.source.urihttps://trialsjournal.biomedcentral.com/
dc.subjectHIVen_US
dc.subjectHIV preventionen_US
dc.subjectPrEPen_US
dc.subjectRandomized controlled trialen_US
dc.subjectAdolescent girls and young womenen_US
dc.subjectCommunity-based delivery platformsen_US
dc.subjectAdherence support interventionen_US
dc.subjectCost-effectivenessen_US
dc.subjectSouth Africaen_US
dc.titleThe Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocolen_US
dc.typeJournal Articleen_US
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