Private-sector Access to Testing for Health Sustainability
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low HIVST kit subsidy, High HIVST kit subsidy.
- Who it may be relevant to
- Registry conditions: HIV Prevention. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Tanzania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Expanding Access to HIV Self-test Kits: Sustaining Private Sector Channels That Enable Access to Preventive Health Services
Overview
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.
Interventions
- Behavioral 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. - 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.
Primary outcome measures
- Number of HIVST kits distributed to AGYW per shop month [Time frame: 39 months]
Secondary outcome measures (6)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Tanzania · 1 center
- Mwanza Intervention Trials Unit — Mwanza
Identifiers
NCT: NCT06820697 · R01MH136921 · R01MH136921