HIV PreventionPATHSNCT06820697
Private-sector Access to Testing for Health Sustainability
A study testing Low HIVST kit subsidy and High HIVST kit subsidy in people with HIV Prevention, run by University of California, San Francisco at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Low HIVST kit subsidy and High HIVST kit subsidy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTanzania
- Study dates
- 15 Jan 2027to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Owners/staff of retail drug shops and pharmacies located in the study regions
- Age 18 and older
Who cannot join
- Refusal to install and track sales and distribution of HIVST kits using the Maisha Meds data system provided.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Calvin Chiu, PhD contact
Tanzania1 site
Mwanza Intervention Trials Unit
Mwanza
Happiness Saronga, sarongahappiness@yahoo.com
About this study
Official title: 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.
Read the 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
- Being tested
- Low HIVST kit subsidy, High HIVST kit subsidy
- Keywords
- HIV, Tanzania, Pharmacies, AGYW, HIV self-test kits, adolescent girls and young women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low HIVST kit subsidyBehavioural
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 subsidyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High subsidy | Experimental | The high subsidy group will start off with a 90% subsidy for purchasing HIV self-test kits to sell in their shops. Receives: Behavioral: High HIVST kit subsidy |
| Low subsidy | Active comparator | The low subsidy group will start off with a 50% subsidy for purchasing HIV self-test kits to sell in their shops. Receives: Behavioral: Low HIVST kit subsidy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 39 months
Secondary outcomes (6)
Adoption
Proportion of shops continuing to procure HIVST kits throughout the study
Measured: 39 months
Implementation 1
Proportion of shops that offer free HIVST to AGYW mystery client actors
Measured: 39 months
Implementation 2
Proportion of shops continuing to provide free HIVST throughout the study period
Measured: 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.
Measured: 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
Measured: 39 months
Implementation 4
Proportion of shops that sell HIVST to non-AGYW mystery client actors
Measured: 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start15 Jan 2027 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomization of shops is at the ward level. Wards, and thus shops located in those wards, will be randomized to high or low HIVST kit subsidy groups.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Muhimbili University of Health and Allied Sciences
- Responsible party
- Sponsor
- Investigators
- Jenny Liu, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820697
- Sponsor's protocol ID
- R01MH136921
- Other IDs
- R01MH136921
- Acronym
- PATHS
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Access to HIV Self-test Kits: Sustaining Private Sector Channels That Enable Access to Preventive Health Services
- ClinicalTrials.gov ID
- NCT06820697
- Acronym / sponsor ID
- PATHS / R01MH136921
- Conditions
- HIV Prevention
- Keywords
- HIV, Tanzania, Pharmacies, AGYW, HIV self-test kits, adolescent girls and young women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Muhimbili University of Health and Allied Sciences
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization of shops is at the ward level. Wards, and thus shops located in those wards, will be randomized to high or low HIVST kit subsidy groups.
| Arm | Type | Receives |
|---|---|---|
| High subsidy | Experimental | Behavioral: High HIVST kit subsidyThe high subsidy group will start off with a 90% subsidy for purchasing HIV self-test kits to sell in their shops. |
| Low subsidy | Active comparator | Behavioral: Low HIVST kit subsidyThe low subsidy group will start off with a 50% subsidy for purchasing HIV self-test kits to sell in their shops. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Owners/staff of retail drug shops and pharmacies located in the study regions
- Age 18 and older
Key exclusion criteria (1 listed)
- Refusal to install and track sales and distribution of HIVST kits using the Maisha Meds data system provided.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low HIVST kit subsidyThe 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. | Behavioural | Low subsidy |
| High HIVST kit subsidyThe 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. | Behavioural | High subsidy |
Primary outcome
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).
6 secondary outcomes
Adoption
Time frame: 39 months
Implementation 1
Time frame: 39 months
Implementation 2
Time frame: 39 months
Implementation 3
Time frame: 39 months
Maintenance
Time frame: 39 months
Implementation 4
Time frame: 39 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Calvin Chiu, PhD contact
Jenny Liu, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low HIVST kit subsidy and High HIVST kit subsidy in people with HIV Prevention, run by University of California, San Francisco at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Packel, PhD (4155051741, laura.packel@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of HIVST kits distributed to AGYW per shop month (time frame: 39 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.