Private-sector Access to Testing for Health Sustainability

NCT ID: NCT06820697

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-01
• Study Completion Date: 2029-04-30

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.

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.

Conditions

HIV Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

High subsidy

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

Group Type: EXPERIMENTAL

High HIVST kit subsidy

Intervention Type: BEHAVIORAL

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.

Low subsidy

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

Group Type: ACTIVE_COMPARATOR

Low HIVST kit subsidy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jenny Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Mwanza Intervention Trials Unit

Mwanza, , Tanzania

Countries

Tanzania

Central Contacts

Laura Packel, PhD

Role: CONTACT

laura.packel@ucsf.edu

4155051741

Calvin Chiu, PhD

Role: CONTACT

calvin.chiu@ucsf.edu

Facility Contacts

Happiness Saronga

Role: primary

sarongahappiness@yahoo.com

Other Identifiers

R01MH136921

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH136921

Identifier Type: NIH

Identifier Source: org_study_id

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