HIV, PrEP
Conditions
Keywords
PrEP, young women, pharmacies
Brief summary
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.
Detailed description
This study will evaluate the effectiveness of pharmacy-based PrEP implementation for YW in the Lake Zone, Tanzania. Four models for pharmacy-based PrEP delivery will be evaluated and compared to pharmacies that do not provide any PrEP services for 9 months (phase I of the implementation study). The PrEP implementation models build on one another with each pharmacy-based PrEP model providing progressively expanded access to PrEP in pharmacies for YW. All PrEP implementation models will be implemented alongside a girl-friendly loyalty program (Mwotaji Program) offering free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives. Comparison: Standard facility based PrEP services to YW. After 9 months (phase II), all pharmacies will implement the best performing PrEP model, based on findings from phase I. Moreover, all 50 pharmacies will implement cost-sharing. The investigators will assess acceptability, feasibility, and potential for sustainability of the pharmacy-based PrEP models. Two cost-sharing approaches will be randomized across the CRPS in a 3:2 ratio: 1. Fee-for-service model: PrEP refills provided for 500 Tanzanian Shillings (TZS) each, a standard cash-based transaction for user fees, benchmarked with data from prior studies. 2. Loyalty hybrid model: PrEP refills provided for free with any shop purchase or a fee of 500 TZS without a purchase. The implementation study comprises a cohort study (parent study) conducted among YW and three sub-studies: * Household survey (cross-sectional survey conducted with YW) * Pharmacy surveys (surveys conducted with pharmacy staff) * Stakeholder surveys (surveys conducted with health facility staff and governmental stakeholders)
Interventions
BEHAVIORALPharmacy-based PrEP services
Provision of PrEP services to AGYW in pharmacies.
BEHAVIORALDistribution of HIV self-test kits
Provision of free HIV self-test kits to AGYW in pharmacies.
Sponsors
Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Berkeley
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
(Parent study: YW cohort study): 1. Female sex; 2. Age 18-24 at the baseline visit; 3. Living in one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania with no known plans to move; 4. Interested in starting PrEP; 5. Access to a mobile phone (either own phone or borrowed phone); and 6. Eligible for PrEP based on Tanzania National PrEP Guidelines behavioral screening criteria
Exclusion criteria
Currently taking PrEP (refilled a PrEP prescription within the past 28 days at enrollment). Inclusion Criteria (Sub-study: YW household survey): 1. Female sex; 2. Age 18-24; and 3. Living in one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective use of PrEP | 9 months | 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 | 9 months | 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 | 9 months | Heard of pharmacy-based PrEP services (including screening, referrals, refills, or initiation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of PrEP implementation model | 9 months, 15 months | 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 | 9 months, 15 months | Pharmacy provision of PrEP services (screen, provide referral, refill, or initiate AGYW on PrEP) at least once per month |
| Feasibility of PrEP implementation model | 9 months, 15 months | 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 | 9 months, 15 months | Pharmacy is implementing the PrEP model as assigned. |
Countries
Tanzania
Contacts
CONTACTMackfallen G Anasel, PhD
CONTACTLila A Sheira, PhD MPH
PRINCIPAL_INVESTIGATORMackfallen I Anasel, PhD
Mzumbe University
Outcome results
None listed