AmbassADDOrs for Health Study

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to evaluate Malkia Klabu (Queen Club) in Tanzania, a loyalty program intervention that creates adolescent girls and young women (AGYW)-friendly drug shops where AGYW can access HIV prevention services and contraception.

Detailed Description
-----------------
The investigators will conduct a cluster-randomized controlled trial of the Malkia Klabu intervention in 40 health facility catchment areas (n=60-70 intervention drug shops;  3-4 drug shops per area) in the Shinyanga and Mwanza regions of Tanzania, plus a mixed-methods, implementation science study to pinpoint supply-side factors influencing effectiveness (e.g., implementation models, intervention fidelity, shop characteristics). Malkia Klabu is a loyalty card program derived from a youth participatory process with human centered design. Young women earn punches on the Malkia Klabu loyalty card when they make drug shop purchases that upon accrual can be used towards prizes of increasing value. When joining, young women receive a free HIV self test kit (HIVST) as an opt out sign-up gift, are invited to interact with a physical display of sexual and reproductive health products, including HIVST, and may elect to view videos on a tablet computer about the program, HIVST, and contraception. The back of the card displays discreet symbols representing sensitive products available at the shop (e.g., HIVST, oral contraception). Club members can ask for or point to the product that they want on the card and receive it for free in a discreet bag. Referrals are provided to youth-friendly services at a nearby catchment area health facility for HIV testing, treatment and care, and/or contraception.

Official Title
-----------------
AmbassADDOrs for Health: Supporting Young Women's Health Through Girl-friendly Drug Vendors

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Loyalty card program at drug shops & supply of HIVST and SRH products
* Behavioral: Comparison drug shops


Participation Criteria
=================
Eligibility Criteria
-----------------
The primary unit of analysis are the wards, and within them, the drug shops who will be enrolled based on the following inclusion criteria: Inclusion Criteria: Wards with no greater than 3 public health facilities; Wards with no less than 4 drug shops; Wards with health facilities that were greater than 20 KM from a primary or secondary road; and Drug shop owners and staff in Shinyanga and Mwanza Regions of Tanzania who are aged 18 or older;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial; Catchment areas will be randomly assigned 1:1 to intervention or comparison arms (n=60-70 intervention drug shops;  3-4 drug shops per area) using a constrained approach to ensure balance in key covariates.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug shops, also known as Accredited Drug Dispensing Outlets (ADDOs), owners or staff<br>All drug shopkeepers in intervention areas (within Shinyanga or Mwanza) will be invited to participate in Malkia Klabu, a loyalty card program. Consenting drug shops in intervention areas should be willing and able to keep records of referrals and sexual and reproductive health (SRH) product distribution given to AGYW through the use of Maisha Meds during the one month run-in period. | Behavioral: Loyalty card program at drug shops & supply of HIVST and SRH products<br>* Consenting drug shops will receive: training on Malkia Klabu implementation; HIVST training (same as comparison drug shops); procedures for referring to youth-friendly HIV/SRH services; a monthly supply of HIVST reserved for free distribution to AGYW, with free price stickers and pre-packaged with referral information; and reimbursement for SRH products given to AGYW (e.g., birth control pills).<br>|
| Placebo Comparator: Shopkeepers in control arm for comparison area<br>Drug shopkeepers, staff and/or owners as part of the control arm will receive standard HIV training, guidance on referring AGYW to proximal HIV care, and HIVST for free distribution to AGYW. | Behavioral: Comparison drug shops<br>* Consenting drug shops in the comparison arm catchment areas will have access to the Maisha Meds inventory management application system for offline digital recording of HIVST, HIVST kits earmarked for free to AGYW, guidance on HIV care referral plan to facilitate linkage to nearby health facilities for AGYW. These control drug shops will not participate in Malkia Klabu (Queen Club) program implementation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative HIV diagnoses among 15-24 year old females | Cumulative HIV-positive tests among 15-24 year old females at 24 months from routinely collected health facility data, disaggregated by sex and age, aggregated to the catchment area level. | 24 months | 
| Antenatal care registrations by 15-24 year old females | Cumulative antenatal care registrations among 15-24 year old females at 24 months from routinely collected health facility data, disaggregated by age, aggregated to the catchment area level. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ART initiation among newly diagnosed AGYW | Data on ART initiation abstracted from routinely collected health facility data, disaggregated by sex and age, aggregated to the catchment area level. | 24 months | 
| Distribution of HIVST to AGYW | Distribution of HIVST to AGYW will be documented in Maisha Meds, a point of sales inventory system to be used by participating drug shops in both arms. This will be a continuous variable with a lower limit of zero and an undefined upper limit and is the simple count of all HIVSTs distributed to AGYW who visit the shops. | 24 months | 
| Distribution contraception to AGYW | Distribution of contraception to AGYW will be documented in Maisha Meds, a point of sales inventory system to be used by participating drug shops in both arms. This will be a continuous variable with a lower limit of zero and an undefined upper limit and is the simple count of the combined total number of oral contraceptive pills, emergency contraception, and condoms sold to AGYW who visit the shops. | 24 months | 
| Program exposure | Self-reported data from AGYW on exposure to Malkia Klabu (if any) will be collected during an endline survey. This will be a proportion defined as the number of AGYW who report ever receiving a Malkia Klabu card (i.e. enrolling) as the numerator over the total number of AGYW interviewed. The values will range from 0-100%. | 24 months | 
| Recent HIV testing | Self-reported data from AGYW on recent HIV testing (if any) will be collected during an endline survey. This will be a proportion defined as the number of AGYW who report testing for HIV in the last 6 months as the numerator over the total number of AGYW interviewed. The values will range from 0-100%. | 24 months | 
| Recent pregnancy testing | Self-reported data from AGYW on recent pregnancy testing (if any) will be collected during an endline survey. This will be a proportion defined as the number of AGYW who report taking a pregnancy test in the last 6 months as the numerator over the total number of AGYW interviewed. The values will range from 0-100%. | 24 months | 
| Unmet need for contraception | Self-reported data from AGYW on contraceptive preferences, desires, and use (if any) will be collected during an endline survey. Unmet need is defined as the number of women who do not want to get pregnant but are not using a method of birth control and are sexually active. We will use the collected data to create a variable where the numerator is the number of women not using a method of birth control and do not desire to get pregnant over the total number of sexually active women. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV self-testing, Human-centred design, Adolescent health, Contraception, Drug shops