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| ID | Type | Description | Link |
|---|---|---|---|
| UG1HD113163 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of California, Berkeley | OTHER |
| University of California, San Francisco | OTHER |
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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. We 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:
The implementation study comprises a cohort study (parent study) conducted among YW and three sub-studies:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model A: PrEP referrals | Experimental | Model A: PrEP Referrals - Pharmacies in CRPS assigned to this implementation model will conduct behavioral screening for PrEP eligibility for young women (see Box 1, Section A). Young women who are determined to be eligible for PrEP based on the behavioral screening will be enrolled and referred to the CTC health facility for clinical screening, PrEP dispensation and required laboratory testing (i.e., HIV and creatinine testing, a component of clinical screening). Pharmacies will also implement the girl-friendly loyalty program, Mwotaji, which provides free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives to AGYW. |
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| Model B: PrEP screening and PrEP refills | Experimental | Model B: PrEP Refills - In addition to PrEP services provided in Model A, pharmacies in CRPS assigned to this implementation model will offer PrEP refills to study participants. Pharmacies will first conduct the behavioral screening for PrEP eligibility for young women. Young women who are determined to be eligible for PrEP based on the behavioral screening will be enrolled and referred to the health facility CTC for PrEP dispensation, further clinical screening and required laboratory testing. Young women will then be able to return to the pharmacy to receive PrEP refills. Refill provision includes rescreening for PrEP eligibility at each visit (Box 1); repeat HIV testing is required at the CTC at Month 1 and then every three months thereafter. Pharmacies will also implement the girl-friendly loyalty program, Mwotaji, which provides free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives to YW. |
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| Model C: PrEP screening, PrEP refills, and PrEP initiation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacy-based PrEP services | Behavioral | Provision of PrEP services to AGYW in pharmacies. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 9 months |
| 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) | 9 months |
| Reach of PrEP implementation model | Heard of pharmacy-based PrEP services (including screening, referrals, refills, or initiation) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 9 months, 15 months |
| Fidelity to PrEP implementation model |
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Inclusion Criteria (Parent study: YW cohort study):
Exclusion Criteria: Currently taking PrEP (refilled a PrEP prescription within the past 28 days at enrollment).
Inclusion Criteria (Sub-study: YW household survey):
Exclusion Criteria (Sub-study: YW household survey): N/A
Inclusion Criteria (Study pharmacies):
Exclusion Criteria (Study pharmacies): N/A
Inclusion Criteria (Sub-study: Pharmacy staff):
Exclusion Criteria (Sub-study: Pharmacy staff): N/A
Inclusion Criteria (Sub-study: Stakeholders):
Exclusion Criteria (Sub-study: Stakeholders): N/A
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mackfallen G Anasel, PhD | Contact | +255784705072 | mganasel@mzumbe.ac.tz | |
| Lila A Sheira, PhD MPH | Contact | Lila.sheira@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mackfallen I Anasel, PhD | Mzumbe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health for a Prosperous Nation | Dar es Salaam | Tanzania |
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Model C: PrEP Initiation - In addition to PrEP services provided in Models A and B, pharmacies in CRPS assigned to this implementation model will offer PrEP initiation services for young women enrolled in the study. Pharmacies in CRPS assigned to this implementation model will first conduct the behavioral and clinical screenings and refer participants to the health facility lab for required laboratory testing. Participants who are HIV negative will return to the pharmacy for dispensation of 30 days of PrEP medication, adherence and side effects counseling, and scheduling a next appointment for a PrEP refill in 30 days. Pharmacies will also implement the girl-friendly loyalty program, Mwotaji, which provides free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives to AGYW. |
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| Model D: PrEP screening, PrEP refills, PrEP initiation, and linkage to a PrEP peer navigator | Experimental | Model D: Peer Navigator - In addition to PrEP services provided in Models A, B, and C, pharmacies in CRPS assigned to this implementation model will offer to link young women utilizing PrEP services to a PrEP peer navigator. Peer navigators are current or former young female PrEP users (age 18 or older, not considered study participants) who are willing to provide periodic advice, guidance, and referrals to the health facility for study participants. The role of the peer navigator is to enhance the pharmacy's protocols for linkage to health facilities for various SRH services, antenatal care, long-acting reversible contraceptives, STI screening, and/or PrEP consultations (e.g., side effects, safely stopping PrEP). There will be a minimum of one and a maximum of three peer navigators assigned to support each pharmacy in this implementation model. Pharmacies will also implement the girl-friendly loyalty program, Mwotaji. |
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| Comparison | Active Comparator | Comparison: No PrEP services will be provided in pharmacies during phase I of the study; young women will receive PrEP from health facilities per the current standard of care. If young women go to a pharmacy and express interest in PrEP, they will be referred to the health facility for more information and PrEP access. In phase II of the study (cost-sharing), pharmacies assigned to the comparison group will provide pharmacy-based PrEP services corresponding to the best performing PrEP model determined at the end of phase I. |
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| Distribution of HIV self-test kits | Behavioral | Provision of free HIV self-test kits to AGYW in pharmacies. |
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Pharmacy provision of PrEP services (screen, provide referral, refill, or initiate AGYW on PrEP) at least once per month |
| 9 months, 15 months |
| 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 | 9 months, 15 months |
| Adoption of PrEP implementation model | Pharmacy is implementing the PrEP model as assigned. | 9 months, 15 months |