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NCT07687888
Pharmacy-based Provision of Pre-exposure Prophylaxis (PrEP) for Adolescent Girls and Young Women in Tanzania
Conditions: HIV, PrEP
Sex: Female
Ages: 18 Years – 24 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 2818
Sponsor: Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation
Location: Health for a Prosperous Nation Dar es Salaam
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.
Eligibility Criteria
Inclusion Criteria (Parent study: YW cohort study):
1. Female sex;
2. Age 18-24 at the baseline visit;
3. Living in one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania with no known plans to move;
4. Interested in starting PrEP;
5. Access to a mobile phone (either own phone or borrowed phone); and
6. Eligible for PrEP based on Tanzania National PrEP Guidelines behavioral screening criteria
Exclusion Criteria: Currently taking PrEP (refilled a PrEP prescription within the past 28 days at enrollment).
Inclusion Criteria (Sub-study: YW household survey):
1. Female sex;
2. Age 18-24; and
3. Living in one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania.
Exclusion Criteria (Sub-study: YW household survey): N/A
Inclusion Criteria (Study pharmacies):
1. Geographically located within one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania;
2. Located within 4 km of at least 1 health facility that provides PrEP services and whose lab conducts creatinine and hepatitis B testing;
3. Has no planned extended closures over the next 24 months.
Exclusion Criteria (Study pharmacies): N/A
Inclusion Criteria (Sub-study: Pharmacy staff):
1. Pharmacy owners and staff affiliated with study pharmacies; and
2. ≥18 years of age.
Exclusion Criteria (Sub-study: Pharmacy staff): N/A
Inclusion Criteria (Sub-study: Stakeholders):
1. 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;
2. ≥18 years of age.
Exclusion Criteria (Sub-study: Stakeholders): N/A
Source: ClinicalTrials.gov (NCT07687888). StuddyBuddy aggregates publicly available trial information.
