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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: High HIVST kit subsidy; Behavioral: Low HIVST kit subsidy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Packel, PhD; Phone Number: 4155051741; Email: laura.packel@ucsf.edu
• Study Contact Backup: Name: Calvin Chiu, PhD; Email: calvin.chiu@ucsf.edu

Study Locations

• Tanzania
  • Mwanza, Tanzania
    • Mwanza Intervention Trials Unit
    • Contact: Happiness Saronga; Email: sarongahappiness@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High subsidy; The high subsidy group will start off with a 90% subsidy for purchasing HIV self-test kits to sell in their shops.	Behavioral: 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.
Active Comparator: Low subsidy; The low subsidy group will start off with a 50% subsidy for purchasing HIV self-test kits to sell in their shops.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of HIVST kits distributed to AGYW per shop month	HIVST kit distribution per shop per month will be tracked via Maisha Meds sales and inventory management system. The data from Maisha Meds will include a tag that identifies the kit recipient as an AGYW and will include the price paid for the HIVST kit ($0 for AGYW).	39 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption	Proportion of shops continuing to procure HIVST kits throughout the study	39 months
Maintenance	Proportion of shopkeepers who intend to continue to purchase and sell HIVST kits; Shopkeeper and stakeholder perspectives on subsidies, reimbursements, and sustainability; Reasons for discontinuing the sale of HIVST kits; Proportion of shops continuing to purchase and sell HIVST kits after subsidies end	39 months
Implementation 1	Proportion of shops that offer free HIVST to AGYW mystery client actors	39 months
Implementation 2	Proportion of shops continuing to provide free HIVST throughout the study period	39 months
Implementation 3	Shopkeeper perspectives on challenges and successes related to providing HIVST kits free to AGYW as measured via surveys and in-depth interviews.	39 months
Implementation 4	Proportion of shops that sell HIVST to non-AGYW mystery client actors	39 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Mental Health (NIMH); Muhimbili University of Health and Allied Sciences
• Investigators: Principal Investigator: Jenny Liu, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Tanzania; Pharmacies; AGYW; HIV self-test kits; adolescent girls and young women
• Other Study ID Numbers: R01MH136921 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This project will produce survey data, in-depth interview transcripts, and product sales and distribution data. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier (GUID) for the NIMH Data Archive (NDA) will be collected for each subject if possible. This information includes First Name, Middle Name, Last Name, Sex, Date of Birth, City/Municipality of Birth. Because investigators are collecting data from participants in Tanzania, some of this information may be unavailable or may not meet the requirements for the GUID. In that case, pseudoGUIDs will be utilized.
• IPD Sharing Time Frame: The research community will have access to data when the award ends. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid in findability. Investigators will include that DOI in relevant publications. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
• IPD Sharing Access Criteria: To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No