AmbassADDOrs for Health Study

NCT05357144 | Completed DMC

• 1 other identifier: R01MH124516
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

HIV self-testing; Human-centred design; Adolescent health; Contraception; Drug shops

Outcome Measures

Primary Outcomes (2)

• Cumulative HIV diagnoses among 15-24 year old females

  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.

  12-15 months

• Antenatal care registrations by 15-24 year old females

  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.

  12-15 months

Secondary Outcomes (7)

• ART initiation among newly diagnosed AGYW

  12-15 months

• Distribution of HIVST to AGYW

  12-15 months

• Distribution contraception to AGYW

  12-15 months

• Program exposure

  12-15 months

• Recent HIV testing

  12-15 months

Study Arms (2)

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

EXPERIMENTAL

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

Shopkeepers in control arm for comparison area

PLACEBO COMPARATOR

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

Interventions

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).

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

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.

Shopkeepers in control arm for comparison area

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

Sponsors & Collaborators

• RTI International: collaborator
• National Institute of Mental Health (NIMH): collaborator
• University of California, San Francisco: lead
• University of California, Berkeley: collaborator
• Health for a Prosperous Nation: collaborator

Study Sites (2)

Mwanza Province

Mwanza, Tanzania

Location

Shinyanga Province

Shinyanga, Tanzania

Location

Related Publications (7)

• 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.

  PMID: 34313728 BACKGROUND

• 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.

  PMID: 27034520 BACKGROUND

• 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.

  PMID: 15452011 BACKGROUND

• 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.

  PMID: 28031299 BACKGROUND

• 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.

  PMID: 26413304 BACKGROUND

• 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.

  PMID: 30028307 BACKGROUND

• Mnyippembe A, Sheira LA, McCoy SI, Njau PF, Packel LJ, Hassan K, Solorzano-Barrera C, Maokola W, Kang Dufour MS, Sabasaba A, Liu J. Supporting young women's health through girl-friendly drug vendors in Lake Zone, Tanzania: protocol for the AmbassADDOrs for Health cluster-randomised controlled trial. BMJ Open. 2024 Jun 8;14(6):e078755. doi: 10.1136/bmjopen-2023-078755.

  PMID: 38851225 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Jenny X Liu, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: No blinding or masking to treatment status throughout the intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: May 2, 2022
• Study Start: July 26, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Everything posted to OSF and Clinical Trials will be made publicly available.

Locations

TA (2)