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NCT Number: NCT06820697

Private-sector Access to Testing for Health Sustainability

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mwanza Intervention Trials Unit

Mwanza, Tanzania

Location contact

Happiness Saronga

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low HIVST kit subsidy

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.

High HIVST kit subsidy

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.

Primary outcomes

  1. Number of HIVST kits distributed to AGYW per shop month

    Time frame: 39 months

    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).

Secondary outcomes

  1. Adoption

    Time frame: 39 months

    Proportion of shops continuing to procure HIVST kits throughout the study

  2. Implementation 1

    Time frame: 39 months

    Proportion of shops that offer free HIVST to AGYW mystery client actors

  3. Implementation 2

    Time frame: 39 months

    Proportion of shops continuing to provide free HIVST throughout the study period

  4. Implementation 3

    Time frame: 39 months

    Shopkeeper perspectives on challenges and successes related to providing HIVST kits free to AGYW as measured via surveys and in-depth interviews.

  5. Maintenance

    Time frame: 39 months

    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

  6. Implementation 4

    Time frame: 39 months

    Proportion of shops that sell HIVST to non-AGYW mystery client actors

Study contacts

Contact information is provided by the study sponsor or research team.

Calvin Chiu, PhD

CONTACT

[email protected]

Laura Packel, PhD

CONTACT

[email protected]

4155051741

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: PATHS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 11, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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