HIV Prevention
Conditions
Keywords
HIV, Tanzania, Pharmacies, AGYW, HIV self-test kits, adolescent girls and young women
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.
Interventions
BEHAVIORALLow 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.
BEHAVIORALHigh 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.
Sponsors
University of California, San Francisco
National Institute of Mental Health (NIMH)
Muhimbili University of Health and Allied Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of HIVST kits distributed to AGYW per shop month | 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
| Measure | Time frame | Description |
|---|---|---|
| Adoption | 39 months | Proportion of shops continuing to procure HIVST kits throughout the study |
| Implementation 1 | 39 months | Proportion of shops that offer free HIVST to AGYW mystery client actors |
| Implementation 2 | 39 months | Proportion of shops continuing to provide free HIVST throughout the study period |
| Implementation 3 | 39 months | Shopkeeper perspectives on challenges and successes related to providing HIVST kits free to AGYW as measured via surveys and in-depth interviews. |
| Maintenance | 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 |
| Implementation 4 | 39 months | Proportion of shops that sell HIVST to non-AGYW mystery client actors |
Countries
Tanzania
Contacts
CONTACTLaura Packel, PhD
CONTACTCalvin Chiu, PhD
PRINCIPAL_INVESTIGATORJenny Liu, PhD
University of California, San Francisco
Outcome results
None listed