Pharmacy-based Provision of Pre-exposure Prophylaxis (PrEP) for Adolescent Girls and Young Women in Tanzania

MWOTAJI: Making Women's Options for HIV Prevention In Tanzania Accessible, and Joining in Implementation Science Capacity Building

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.

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)

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.

Exclusion Criteria (Sub-study: YW household survey): N/A

Inclusion Criteria (Study pharmacies):

1. Geographically located within one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania;
2. Located within 4 km of at least 1 health facility that provides PrEP services and whose lab conducts creatinine and hepatitis B testing;
3. Has no planned extended closures over the next 24 months.

Exclusion Criteria (Study pharmacies): N/A

Inclusion Criteria (Sub-study: Pharmacy staff):

1. Pharmacy owners and staff affiliated with study pharmacies; and
2. ≥18 years of age.

Exclusion Criteria (Sub-study: Pharmacy staff): N/A

Inclusion Criteria (Sub-study: Stakeholders):

1. Staff employed at referral health facilities within one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania or local, regional, or national government officials;
2. ≥18 years of age.

Exclusion Criteria (Sub-study: Stakeholders): N/A