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

NCT07687888 | Not Yet Recruiting DMC

• 2 other identifiers: 1UG1HD113163UG1HD113163
• Study Type: interventional
• Target: 2,818
• Locations: 1 country
• Sites: 1

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.

Conditions

PrEP; HIV

Keywords

PrEP; young women; pharmacies

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Acceptability of PrEP implementation model

  9 months, 15 months

• Fidelity to PrEP implementation model

  9 months, 15 months

• Feasibility of PrEP implementation model

  9 months, 15 months

• Adoption of PrEP implementation model

  9 months, 15 months

Study Arms (5)

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.

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.

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.

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.

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.

Behavioral: Distribution of HIV self-test kits

Interventions

Pharmacy-based PrEP services BEHAVIORAL

Provision of PrEP services to AGYW in pharmacies.

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 kits BEHAVIORAL

Provision of free HIV self-test kits to AGYW in pharmacies.

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

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Berkeley: collaborator
• Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Health for a Prosperous Nation

Dar es Salaam, Tanzania

Location

Study Officials

• Mackfallen I Anasel, PhD

  Mzumbe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mackfallen G Anasel, PhD

CONTACT

+255784705072; mganasel@mzumbe.ac.tz

Lila A Sheira, PhD MPH

CONTACT

Lila.sheira@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Health Systems Management and Centre of Excellence in Health Monitoring and Evaluation, Mzumbe University

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)