AmbassADDOrs for Health Study

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: HIV Infections

Treatments: Behavioral: Comparison drug shops; Behavioral: Loyalty card program at drug shops & supply of HIVST and SRH products

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05357144

R01MH124516 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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;

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups, including a placebo group

Drug shops, also known as Accredited Drug Dispensing Outlets (ADDOs), owners or staff

Experimental group

Description:

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.

Treatment:

Behavioral: Loyalty card program at drug shops & supply of HIVST and SRH products

Shopkeepers in control arm for comparison area

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Comparison drug shops