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

Официальное название

MWOTAJI: Making Women's Options for HIV Prevention In Tanzania Accessible, and Joining in Implementation Science Capacity Building

Обзор

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.

Подробное описание

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:

1. 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. 2. 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)

Вмешательства

• Поведенческое Pharmacy-based PrEP services
  Provision of PrEP services to AGYW in pharmacies.
• Поведенческое Distribution of HIV self-test kits
  Provision of free HIV self-test kits to AGYW in pharmacies.

Первичные конечные точки

• Effective use of PrEP [Срок оценки: 9 months]
• Persistent use of PrEP [Срок оценки: 9 months]
• Reach of PrEP implementation model [Срок оценки: 9 months]

Вторичные конечные точки (4)

• Acceptability of PrEP implementation model [Срок оценки: 9 months, 15 months]
• Fidelity to PrEP implementation model [Срок оценки: 9 months, 15 months]
• Feasibility of PrEP implementation model [Срок оценки: 9 months, 15 months]
• Adoption of PrEP implementation model [Срок оценки: 9 months, 15 months]

Критерии участия

Inclusion Criteria (Parent study: YW cohort study):

• 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

Exclusion Criteria: Currently taking PrEP (refilled a PrEP prescription within the past 28 days at enrollment).

Inclusion Criteria (Sub-study: YW household survey):

• Female sex;
• Age 18-24; and
• 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):

• 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.

Exclusion Criteria (Study pharmacies): N/A

Inclusion Criteria (Sub-study: Pharmacy staff):

• Pharmacy owners and staff affiliated with study pharmacies; and
• ≥18 years of age.

Exclusion Criteria (Sub-study: Pharmacy staff): N/A

Inclusion Criteria (Sub-study: Stakeholders):

• 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.

Exclusion Criteria (Sub-study: Stakeholders): N/A

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Tanzania · 1 центр

• Health for a Prosperous Nation — Dar es Salaam

Идентификаторы

NCT: NCT07687888 · 1UG1HD113163 · UG1HD113163

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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