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
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2029
Study Completion
Last participant's last visit for all outcomes
April 30, 2029
April 17, 2026
April 1, 2026
2.8 years
February 5, 2025
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Adoption
39 months
Implementation 1
39 months
Implementation 2
39 months
Implementation 3
39 months
Maintenance
39 months
- +1 more secondary outcomes
Study Arms (2)
High subsidy
EXPERIMENTALThe high subsidy group will start off with a 90% subsidy for purchasing HIV self-test kits to sell in their shops.
Low subsidy
ACTIVE COMPARATORThe low subsidy group will start off with a 50% subsidy for purchasing HIV self-test kits to sell in their shops.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Owners/staff of retail drug shops and pharmacies located in the study regions
- Age 18 and older
You may not qualify if:
- Refusal to install and track sales and distribution of HIVST kits using the Maisha Meds data system provided.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mwanza Intervention Trials Unit
Mwanza, Tanzania
Study Officials
- PRINCIPAL INVESTIGATOR
Jenny Liu, PhD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2025
First Posted
February 11, 2025
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
April 30, 2029
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- 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.
- 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.
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.