HIVMWOTAJINCT07687888
Pharmacy-based Provision of Pre-exposure Prophylaxis (PrEP) for Adolescent Girls and Young Women in Tanzania
A study testing Pharmacy-based PrEP services and Distribution of HIV self-test kits in people with HIV and PrEP, run by Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation at 1 site in Tanzania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- What is being tested?
- Pharmacy-based PrEP services and Distribution of HIV self-test kits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,818 participants
- Where
- 1 siteTanzania
- Study dates
- Sep 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
- Access to a mobile phone (either own phone or borrowed phone); and
- Eligible for PrEP based on Tanzania National PrEP Guidelines behavioral screening criteria
Show all 17Show fewer
- Exclusion Criteria: Currently taking PrEP (refilled a PrEP prescription within the past 28 days at enrollment).
- 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;
- Located within 4 km of at least 1 health facility that provides PrEP services and whose lab conducts creatinine and hepatitis B testing;
- Has no planned extended closures over the next 24 months.
- Pharmacy owners and staff affiliated with study pharmacies; and
- ≥18 years of age.
- 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;
- ≥18 years of age.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lila A Sheira, PhD MPH contact
Tanzania1 site
Health for a Prosperous Nation
Dar es Salaam
Emmanuel Katabaro, MD, +255 765 360 090, manuelkatabaro@gmail.com
About this study
Official title: 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.
Read the 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:
- 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.
- 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)
- Being tested
- Pharmacy-based PrEP services, Distribution of HIV self-test kits
- Keywords
- PrEP, young women, pharmacies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacy-based PrEP servicesBehavioural
Provision of PrEP services to AGYW in pharmacies.
Distribution of HIV self-test kitsBehavioural
Provision of free HIV self-test kits to AGYW in pharmacies.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pharmacy-based PrEP services; Behavioral: Distribution of HIV self-test kits |
| Model B: PrEP screening and PrEP refills | Experimental | 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. Receives: Behavioral: Pharmacy-based PrEP services; Behavioral: Distribution of HIV self-test kits |
| Model C: PrEP screening, PrEP refills, and PrEP initiation | Experimental | 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. Receives: Behavioral: Pharmacy-based PrEP services; Behavioral: Distribution of HIV self-test kits |
| Model D: PrEP screening, PrEP refills, PrEP initiation, and linkage to a PrEP peer navigator | Experimental | 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. Receives: Behavioral: Pharmacy-based PrEP services; Behavioral: Distribution of HIV self-test kits |
| 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. Receives: Behavioral: Distribution of HIV self-test kits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 9 months
Reach of PrEP implementation model
Heard of pharmacy-based PrEP services (including screening, referrals, refills, or initiation)
Measured: 9 months
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 9 months, 15 months
Adoption of PrEP implementation model
Pharmacy is implementing the PrEP model as assigned.
Measured: 9 months, 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,818 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, Berkeley, University of California, San Francisco
- Responsible party
- Principal investigator, Mackfallen Giliadi Anasel, Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation
- Investigators
- Mackfallen I Anasel, PhD, Principal investigator, Mzumbe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687888
- Sponsor's protocol ID
- 1UG1HD113163
- Other IDs
- UG1HD113163
- Acronym
- MWOTAJI
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MWOTAJI: Making Women's Options for HIV Prevention In Tanzania Accessible, and Joining in Implementation Science Capacity Building
- ClinicalTrials.gov ID
- NCT07687888
- Acronym / sponsor ID
- MWOTAJI / 1UG1HD113163
- Keywords
- PrEP, young women, pharmacies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,818 participants (estimated)
- Lead sponsor
- Mzumbe University - Centre of Excellence in Health Monitoring and EvaluationUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, Berkeley, University of California, San Francisco
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Model A: PrEP referrals | Experimental | Behavioral: Pharmacy-based PrEP services, Behavioral: Distribution of HIV self-test kitsModel 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. |
| Model B: PrEP screening and PrEP refills | Experimental | Behavioral: Pharmacy-based PrEP services, Behavioral: Distribution of HIV self-test kitsModel 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. |
| Model C: PrEP screening, PrEP refills, and PrEP initiation | Experimental | Behavioral: Pharmacy-based PrEP services, Behavioral: Distribution of HIV self-test kitsModel 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. |
| Model D: PrEP screening, PrEP refills, PrEP initiation, and linkage to a PrEP peer navigator | Experimental | Behavioral: Pharmacy-based PrEP services, Behavioral: Distribution of HIV self-test kitsModel 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. |
| Comparison | Active comparator | Behavioral: Distribution of HIV self-test kitsComparison: 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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;
- Access to a mobile phone (either own phone or borrowed phone); and
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacy-based PrEP servicesProvision of PrEP services to AGYW in pharmacies. | Behavioural | Model A: PrEP referrals, Model B: PrEP screening and PrEP refills, Model C: PrEP screening, PrEP refills, and PrEP initiation, Model D: PrEP screening, PrEP refills, PrEP initiation, and linkage to a PrEP peer navigator |
| Distribution of HIV self-test kitsProvision of free HIV self-test kits to AGYW in pharmacies. | Behavioural | Comparison, Model A: PrEP referrals, Model B: PrEP screening and PrEP refills, Model C: PrEP screening, PrEP refills, and PrEP initiation, Model D: PrEP screening, PrEP refills, PrEP initiation, and linkage to a PrEP peer navigator |
Primary outcome
Effective use of PrEP
Time frame: 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
Time frame: 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
Time frame: 9 months
Heard of pharmacy-based PrEP services (including screening, referrals, refills, or initiation)
4 secondary outcomes
Acceptability of PrEP implementation model
Time frame: 9 months, 15 months
Fidelity to PrEP implementation model
Time frame: 9 months, 15 months
Feasibility of PrEP implementation model
Time frame: 9 months, 15 months
Adoption of PrEP implementation model
Time frame: 9 months, 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lila A Sheira, PhD MPH contact
Mackfallen I Anasel, PhD principal investigator
Mzumbe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacy-based PrEP services and Distribution of HIV self-test kits in people with HIV and PrEP, run by Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mackfallen G Anasel, PhD (+255784705072, mganasel@mzumbe.ac.tz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective use of PrEP (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.