Clinical trial NCT05357144: AmbassADDOrs for Health Study
Official title: AmbassADDOrs for Health: Supporting Young Women's Health Through Girl-friendly Drug Vendors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: HIV self-testing
Human-centred design
Adolescent health
Contraception
Drug shops
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
name: Health for a Prosperous Nation
name: RTI International
name: National Institute of Mental Health (NIMH)
First posted: 2022-05-02
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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;

Primary outcomes:
measure: Cumulative HIV diagnoses among 15-24 year old females
timeFrame: 12-15 months
measure: Antenatal care registrations by 15-24 year old females
timeFrame: 12-15 months
Secondary outcomes:
measure: ART initiation among newly diagnosed AGYW
timeFrame: 12-15 months
measure: Distribution of HIVST to AGYW
timeFrame: 12-15 months
measure: Distribution contraception to AGYW
timeFrame: 12-15 months
measure: Program exposure
timeFrame: 12-15 months
measure: Recent HIV testing
timeFrame: 12-15 months
measure: Recent pregnancy testing
timeFrame: 12-15 months
measure: Unmet need for contraception
timeFrame: 12-15 months
Other outcomes:
Locations:
city: Mwanza
country: Tanzania
facility: Mwanza Province
city: Shinyanga
country: Tanzania
facility: Shinyanga Province
Study officials:
affiliation: University of California, San Francisco
name: Jenny X Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.