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

ConditionsHIVPrEP
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-24
SponsorMzumbe University - Centre of Excellence in Health Monitoring and Evaluation

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pharmacy-based PrEP services

    Behavioral

    Provision of PrEP services to AGYW in pharmacies.

  • Distribution of HIV self-test kits

    Behavioral

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

Treatment groups

2,818 Participants
are divided into 5 treatment groups
Group A: Model A: PrEP referralsExperimental treatment 2 interventions
Group B: Model B: PrEP screening and PrEP refillsExperimental treatment 2 interventions
Group C: Model C: PrEP screening, PrEP refills, and PrEP initiationExperimental treatment 2 interventions
Group D: Model D: PrEP screening, PrEP refills, PrEP initiation, and linkage to a PrEP peer navigatorExperimental treatment 2 interventions
Group E: ComparisonActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

Reach of PrEP implementation model

Heard of pharmacy-based PrEP services (including screening, referrals, refills, or initiation)

Time frame
9 months

Secondary outcomes

1

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
2

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
3

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
4

Adoption of PrEP implementation model

Pharmacy is implementing the PrEP model as assigned.

Time frame
9 months, 15 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

University of California, Berkeley

Collaborator

University of California, San Francisco

Collaborator

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