AmbassADDOrs for Health Study

HIV Infections Clinical Trial

— ADDO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357144
• Other study ID #: R01MH124516
• Secondary ID: R01MH124516
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: Jenny X Liu, PhD
• Phone: 415-502-5200
• Email: jenny.liu2[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Tanzania	Mwanza Province	Mwanza
Tanzania	Shinyanga Province	Shinyanga

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Health for a Prosperous Nation, National Institute of Mental Health (NIMH), RTI International, University of California, Berkeley

Country where clinical trial is conducted

Tanzania, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. Erratum In: J Pharm Policy Pract. 2015;8:29. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative HIV diagnoses among 15-24 year old females	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.	24 months
Primary	Antenatal care registrations by 15-24 year old females	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.	24 months
Secondary	ART initiation among newly diagnosed AGYW	Data on ART initiation abstracted from routinely collected health facility data, disaggregated by sex and age, aggregated to the catchment area level.	24 months
Secondary	Distribution of HIVST to AGYW	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.	24 months
Secondary	Distribution contraception to AGYW	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.	24 months
Secondary	Program exposure	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%.	24 months
Secondary	Recent HIV testing	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%.	24 months
Secondary	Recent pregnancy testing	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%.	24 months
Secondary	Unmet need for contraception	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.	24 months