Private-sector Access to Testing for Health Sustainability

Официальное название

Expanding Access to HIV Self-test Kits: Sustaining Private Sector Channels That Enable Access to Preventive Health Services

Обзор

New and innovative strategies are urgently needed to increase the uptake of HIV prevention and sexual and reproductive health services among adolescent girls and young women (AGYW) in sub-Saharan Africa. To ensure the real-world sustainability of free distribution of HIV self-test kits to AGYW by private drug shops and pharmacies, investigators will rigorously test supply-side subsidy structures for shopkeepers' provision of HIV-self test kits to AGYW combined with prosocial motivational supports. The combination of non-monetary and monetary support structures aims to emulate real-world health financing models for public-private partnerships and ultimately aims to improve equity in access to critical prevention services for AGYW at scale.

Подробное описание

This is an implementation-effectiveness trial that tests program adoption, implementation, and maintenance of free HIV self-test kit (HIVST) distribution to adolescent girls and young women (AGYW) financed by profits from HIVST kit sales to non-AGYW customers. To initiate adoption, the study will offer pharmacy and drug shopkeepers the opportunity to procure subsidized HIVST to simultaneously distribute to AGYW for free (reimbursed by the study mimicking government-supported provision) and sell to non-AGYW customers for profit, gradually phasing out procurement subsidies over 36 months to test maintenance of the segmented pricing model for real-world sustainability (Aim 1). Investigators will implement non-monetary motivation boosters to sustain shopkeeper engagement over the study period and use mixed-methods to understand shopkeepers' experiences and necessary conditions for program maintenance and provider behavior change (Aim 2), which will inform the co-design of a progressive scale-up plan to achieve national coverage with Tanzanian AGYW, public, and private partnership stakeholders (Aim 3). At the study's conclusion, investigators will have a comprehensive understanding of the support structures shops need to sustain HIVST kit provision for AGYW. Importantly, the study will contribute to generalizable learning about the structures required for commercially sustainable public-private partnerships for high-impact public health interventions.

Вмешательства

• Поведенческое Low HIVST kit subsidy
  The two study groups are the "high" and "low" subsidy groups. The high subsidy group will start off with a 90% subsidy while the low subsidy group will start off with a 50% subsidy. Both study groups will experience decreasing subsidies at each phase of the study.
• Поведенческое High HIVST kit subsidy
  The two study groups are the "high" and "low" subsidy groups. The high subsidy group will start off with a 90% subsidy while the low subsidy group will start off with a 50% subsidy. Both study groups will experience decreasing subsidies at each phase of the study.

Первичные конечные точки

• Number of HIVST kits distributed to AGYW per shop month [Срок оценки: 39 months]

Вторичные конечные точки (6)

• Adoption [Срок оценки: 39 months]
• Implementation 1 [Срок оценки: 39 months]
• Implementation 2 [Срок оценки: 39 months]
• Implementation 3 [Срок оценки: 39 months]
• Maintenance [Срок оценки: 39 months]
• Implementation 4 [Срок оценки: 39 months]

Критерии участия

Критерии включения

• Owners/staff of retail drug shops and pharmacies located in the study regions
• Age 18 and older

Критерии исключения

• Refusal to install and track sales and distribution of HIVST kits using the Maisha Meds data system provided.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Tanzania · 1 центр

• Mwanza Intervention Trials Unit — Mwanza

Идентификаторы

NCT: NCT06820697 · R01MH136921 · R01MH136921

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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