An interventional study of Pharmacy-based PrEP services and Distribution of HIV self-test kits in HIV and PrEP, sponsored by Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation. Not yet recruiting at 1 site in Tanzania. Open to female participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation · Not applicable, Interventional, and Prevention
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:
The implementation study comprises a cohort study (parent study) conducted among YW and three sub-studies:
This is the only study on the registry with Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Pharmacy-based PrEP services · Behavioral: Distribution of HIV self-test kits
Model B: PrEP Refills - In addition to behavioral screening for PrEP eligibility for young women, 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.
Behavioral: Pharmacy-based PrEP services · Behavioral: Distribution of HIV self-test kits
Model C: PrEP Initiation - 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.
Behavioral: Pharmacy-based PrEP services · Behavioral: Distribution of HIV self-test kits
Model D: Peer Navigator - Pharmacies in CRPS assigned to this implementation model will offer to link young women utilizing PrEP services to a PrEP peer navigator. This is in addition to PrEP screening, PrEP initiation, and refill services for young women. 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.
Behavioral: Pharmacy-based PrEP services · Behavioral: Distribution of HIV self-test kits
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.
Behavioral: Distribution of HIV self-test kits
Provision of PrEP services to AGYW in pharmacies.
Provision of free HIV self-test kits to AGYW in pharmacies.
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)
Time frame: 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)
Time frame: 9 months
Reach of PrEP implementation model
Heard of pharmacy-based PrEP services (including screening, referrals, refills, or initiation)
Time frame: 9 months
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
Time frame: 9 months, 15 months
Fidelity to PrEP implementation model
Pharmacy provision of PrEP services (screen, provide referral, refill, or initiate AGYW on PrEP) at least once per month
Time frame: 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
Time frame: 9 months, 15 months
Adoption of PrEP implementation model
Pharmacy is implementing the PrEP model as assigned.
Time frame: 9 months, 15 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2028, 17 months later.
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