TY - JOUR
T1 - The Community PrEP Study
T2 - 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
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
N1 - Funding Information:
This research is funded by the National Institute of Mental Health (NIMH) of the U.S. National Institutes of Health under award number R01MH114648 to AMM and LGB. Complementary funding was provided by The Bill and Melinda Gates Foundation though the South African National HIV Think Tank to AMM and JD. The funders had no role in the study design, data collection and analysis, nor will they have any role in manuscript preparations of publication decisions. As the prime recipient of the NIH grant, the Foundation for Professional Development (FPD) is the study sponsor.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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.govNCT03977181. Registered on 6 June 2019—retrospectively registered.
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.govNCT03977181. Registered on 6 June 2019—retrospectively registered.
KW - Adherence support intervention
KW - Adolescent girls and young women
KW - Community-based delivery platforms
KW - Cost-effectiveness
KW - HIV
KW - HIV prevention
KW - PrEP
KW - Randomized controlled trial
KW - South Africa
UR - http://www.scopus.com/inward/record.url?scp=85111376688&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85111376688&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05402-6
DO - 10.1186/s13063-021-05402-6
M3 - Article
C2 - 34311754
AN - SCOPUS:85111376688
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 489
ER -