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Completed

NCT Number: NCT05357144

AmbassADDOrs for Health Study

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mwanza Province, Mwanza, Tanzania

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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

Behavioral

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).

Comparison drug shops

Behavioral

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.

Primary outcomes

  1. Cumulative HIV diagnoses among 15-24 year old females

    Time frame: 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.

  2. Antenatal care registrations by 15-24 year old females

    Time frame: 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 outcomes

  1. ART initiation among newly diagnosed AGYW

    Time frame: 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.

  2. Distribution of HIVST to AGYW

    Time frame: 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.

  3. Distribution contraception to AGYW

    Time frame: 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.

  4. Program exposure

    Time frame: 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%.

  5. Recent HIV testing

    Time frame: 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%.

  6. Recent pregnancy testing

    Time frame: 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%.

  7. Unmet need for contraception

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Health for a Prosperous Nation
  • National Institute of Mental Health (NIMH)
  • RTI International
  • University of California, Berkeley

Registry information

Official study title

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

Acronym: ADDO

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 2, 2022
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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