- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05357144
AmbassADDOrs for Health Study (ADDO)
AmbassADDOrs for Health: Supporting Young Women's Health Through Girl-friendly Drug Vendors
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jenny X Liu, PhD
- Phone Number: 415-502-5200
- Email: jenny.liu2@ucsf.edu
Study Contact Backup
- Name: Lila A Sheira, MPH
- Email: Lila.sheira@ucsf.edu
Study Locations
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-
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Mwanza, Tanzania
- Recruiting
- Mwanza Province
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Shinyanga, Tanzania
- Not yet recruiting
- Shinyanga Province
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug shops, also known as Accredited Drug Dispensing Outlets (ADDOs), owners or staff
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.
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Consenting drug shops will receive:
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Placebo Comparator: Shopkeepers in control arm for comparison area
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative HIV diagnoses among 15-24 year old females
Time Frame: 24 months
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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.
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24 months
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Antenatal care registrations by 15-24 year old females
Time Frame: 24 months
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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.
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ART initiation among newly diagnosed AGYW
Time Frame: 24 months
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Data on ART initiation abstracted from routinely collected health facility data, disaggregated by sex and age, aggregated to the catchment area level.
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24 months
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Distribution of HIVST to AGYW
Time Frame: 24 months
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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.
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24 months
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Distribution contraception to AGYW
Time Frame: 24 months
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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.
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24 months
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Program exposure
Time Frame: 24 months
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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%.
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24 months
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Recent HIV testing
Time Frame: 24 months
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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%.
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24 months
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Recent pregnancy testing
Time Frame: 24 months
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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%.
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24 months
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Unmet need for contraception
Time Frame: 24 months
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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.
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24 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jenny X Liu, PhD, University of California, San Francisco
Publications and helpful links
General Publications
- Hunter LA, McCoy SI, Rao A, Mnyippembe A, Hassan K, Njau P, Mfaume R, Liu JX. Designing drug shops for young women in Tanzania: applying human-centred design to facilitate access to HIV self-testing and contraception. Health Policy Plan. 2021 Nov 11;36(10):1562-1573. doi: 10.1093/heapol/czab084.
- Liu J, Prach LM, Treleaven E, Hansen M, Anyanti J, Jagha T, Seaman V, Ajumobi O, Isiguzo C. The role of drug vendors in improving basic health-care services in Nigeria. Bull World Health Organ. 2016 Apr 1;94(4):267-75. doi: 10.2471/BLT.15.154666. Epub 2016 Feb 3.
- Peters DH, Mirchandani GG, Hansen PM. Strategies for engaging the private sector in sexual and reproductive health: how effective are they? Health Policy Plan. 2004 Oct;19 Suppl 1:i5-i21. doi: 10.1093/heapol/czh041.
- Corroon M, Kebede E, Spektor G, Speizer I. Key Role of Drug Shops and Pharmacies for Family Planning in Urban Nigeria and Kenya. Glob Health Sci Pract. 2016 Dec 28;4(4):594-609. doi: 10.9745/GHSP-D-16-00197. Print 2016 Dec 23.
- Rutta E, Liana J, Embrey M, Johnson K, Kimatta S, Valimba R, Lieber R, Shekalaghe E, Sillo H. Accrediting retail drug shops to strengthen Tanzania's public health system: an ADDO case study. J Pharm Policy Pract. 2015 Sep 25;8:23. doi: 10.1186/s40545-015-0044-4. eCollection 2015. Erratum In: J Pharm Policy Pract. 2015;8:29.
- Sieverding M, Schatzkin E, Shen J, Liu J. Bias in Contraceptive Provision to Young Women Among Private Health Care Providers in South West Nigeria. Int Perspect Sex Reprod Health. 2018 Mar 1;44(1):19-29. doi: 10.1363/44e5418.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- R01MH124516 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
The SP, SAP, and ICF will be made available on the Open Science Framework (OSF) within 12 months recruitment.
Study results will be posted to OSF and Clinical Trials within 12 months of completion of data collection.
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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