Clinical trial NCT06820697: Private-sector Access to Testing for Health Sustainability
Official title: Expanding Access to HIV Self-test Kits: Sustaining Private Sector Channels That Enable Access to Preventive Health Services
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Prevention
Keywords: HIV
Tanzania
Pharmacies
AGYW
HIV self-test kits
adolescent girls and young women
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Muhimbili University of Health and Allied Sciences
First posted: 2025-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of HIVST kits distributed to AGYW per shop month
timeFrame: 39 months
Secondary outcomes:
measure: Adoption
timeFrame: 39 months
measure: Implementation 1
timeFrame: 39 months
measure: Implementation 2
timeFrame: 39 months
measure: Implementation 3
timeFrame: 39 months
measure: Maintenance
timeFrame: 39 months
measure: Implementation 4
timeFrame: 39 months
Other outcomes:
Locations:
city: Mwanza
country: Tanzania
facility: Mwanza Intervention Trials Unit
Study officials:
affiliation: University of California, San Francisco
name: Jenny Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: