About this trial
Implementation study comparing standard pre-exposure prophylaxis (PrEP) services to four models of pharmacy-based PrEP access for young women aged 18-24 (YW) in Tanzania. At 9 months, all sites converge to one pharmacy-based PrEP model and are randomly allocated to one of two cost sharing models to increase the program's potential for sustainability.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female sex;
Age 18-24 at the baseline visit;
Living in one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania with no known plans to move;
Interested in starting PrEP;
Disqualifiers
Female sex;
Age 18-24; and
Living in one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania.
Geographically located within one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania;
Trial design
Parallel
Treatments tested in this trial
Pharmacy-based PrEP services
BehavioralProvision of PrEP services to AGYW in pharmacies.
Distribution of HIV self-test kits
BehavioralProvision of free HIV self-test kits to AGYW in pharmacies.
Treatment groups
Trial outcomes
Primary outcomes
Effective use of PrEP
YW received a PrEP refill for all months during which an YW reports being at risk for HIV and PrEP eligible over the 9-month study period (among PrEP initiates only)
Persistent use of PrEP
YW picked up all scheduled PrEP refills without a delay of \>28 days over the 9- month study period (among PrEP initiates only)
Reach of PrEP implementation model
Heard of pharmacy-based PrEP services (including screening, referrals, refills, or initiation)
Secondary outcomes
Acceptability of PrEP implementation model
YW agrees that PrEP implementation model is acceptable (e.g., satisfactory, high-quality, youth-friendly, discreet, affordable); Pharmacy staff agree that PrEP implementation model is acceptable and/or consistent with AGYW needs
Fidelity to PrEP implementation model
Pharmacy provision of PrEP services (screen, provide referral, refill, or initiate AGYW on PrEP) at least once per month
Feasibility of PrEP implementation model
Agrees that PrEP implementation model at pharmacies is more accessible than seeking PrEP services at health facilities; Agrees that there is sufficient capacity (e.g., space, time, privacy, will) to deliver a particular PrEP implementation model
Adoption of PrEP implementation model
Pharmacy is implementing the PrEP model as assigned.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of California, Berkeley
Collaborator
University of California, San Francisco
Collaborator
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