Private-sector Access to Testing for Health Sustainability (PATHS)

University of California San Francisco (UCSF)

Status: Begins enrollment in 2 months

Conditions: HIV Prevention

Treatments: Behavioral: Low HIVST kit subsidy; Behavioral: High HIVST kit subsidy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06820697

R01MH136921 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

High subsidy

Experimental group

Description:

The high subsidy group will start off with a 90% subsidy for purchasing HIV self-test kits to sell in their shops.

Treatment:

Behavioral: High HIVST kit subsidy

Low subsidy

Active Comparator group

Description:

The low subsidy group will start off with a 50% subsidy for purchasing HIV self-test kits to sell in their shops.

Treatment:

Behavioral: Low HIVST kit subsidy