AmbassADDOrs for Health Study

Not Applicable

Recruiting

• Conditions: HIV Infections
• Interventions: Behavioral: Comparison drug shops; Behavioral: Loyalty card program at drug shops & supply of HIVST and SRH products

• Registration Number: NCT05357144
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-05-02
• Study Start: 2022-07-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-14
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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;

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shopkeepers in control arm for comparison area	Comparison drug shops	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.
Drug shops, also known as Accredited Drug Dispensing Outlets (ADDOs), owners or staff	Loyalty card program at drug shops & supply of HIVST and SRH products	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.

Primary Outcome Measures

Name	Time	Method
Cumulative HIV diagnoses among 15-24 year old females	12-15 months	Cumulative HIV-positive tests among 15-24 year old females at 12-15 months from routinely collected health facility data, disaggregated by sex and age, aggregated to the catchment area level.
Antenatal care registrations by 15-24 year old females	12-15 months	Cumulative antenatal care registrations among 15-24 year old females at 12-15 months from routinely collected health facility data, disaggregated by age, aggregated to the catchment area level.

Secondary Outcome Measures

Name	Time	Method
ART initiation among newly diagnosed AGYW	12-15 months	Data on ART initiation abstracted from routinely collected health facility data, disaggregated by sex and age, aggregated to the catchment area level.
Distribution of HIVST to AGYW	12-15 months	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.
Distribution contraception to AGYW	12-15 months	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.
Program exposure	12-15 months	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%.
Recent HIV testing	12-15 months	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%.
Recent pregnancy testing	12-15 months	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%.
Unmet need for contraception	12-15 months	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.

Trial Locations

Locations (2)

Mwanza Province; 🇹🇿 Mwanza, Tanzania

Shinyanga Province; 🇹🇿 Shinyanga, Tanzania