HIV Infections
Conditions
Keywords
HIV self-testing, Human-centred design, Adolescent health, Contraception, Drug shops
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.
Interventions
BEHAVIORALLoyalty 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).
BEHAVIORALComparison 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.
Sponsors
University of California, San Francisco
University of California, Berkeley
Health for a Prosperous Nation
RTI International
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Masking description
No blinding or masking to treatment status throughout the intervention.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative HIV Diagnoses Among 15-24 Year Old Females | 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. |
| Antenatal Care Registrations by 15-24 Year Old Females | 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
| Measure | Time frame | Description |
|---|---|---|
| ART Initiation Among Newly Diagnosed AGYW | 12-15 months | Data on antiretroviral therapy (ART) initiation abstracted from routinely collected health facility data, disaggregated by sex and age, aggregated to the catchment area level. |
| Distribution of HIV Self-test Kits to Adolescent Girls and Young Women | 12-15 months | Distribution of HIV self-test kits (HIVST) to adolescent girls and young women (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. |
| Distribution Contraception to Adolescent Girls and Young Women | 12-15 months | Distribution of contraception to adolescent girls and young women (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. |
| Program Exposure | 12-15 months | Self-reported data from adolescent girls and young women (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%. |
| Recent HIV Testing | 12-15 months | Self-reported data from adolescent girls and young women (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%. |
| Recent Pregnancy Testing | 12-15 months | Self-reported data from adolescent girls and young women (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%. |
| Unmet Need for Contraception | 12-15 months | Self-reported data from adolescent girls and young women (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. |
Countries
Tanzania
Contacts
PRINCIPAL_INVESTIGATORJenny X Liu, PhD
University of California, San Francisco
Participant flow
Recruitment details
The research team recruited registered and licensed small drug shops, referred to as DLDMs (duka la dawa muhimu), operating in the Mwanza and Shinyanga regions of Tanzania in the Lake Victoria Zone. The results include data collected from August 2022 through December 2023 from 41 wards and 157 DLDMs. Adolescent girls and young women (AGYW) were not enrolled as study participants. AGYW were only recipients of services provided through participating drug shops.
Pre-assignment details
The research team randomized 152 DLDMs in 41 wards. To account for loss to follow-up, the research team added additional shops, resulting in a final analysis sample of 157 DLDMs. For the baseline characteristics, the research team interviewed one pharmacist per facility.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30 Age |
| Education of respondent Certificate or diploma | 80 Participants |
| Education of respondent Primary or less | 9 Participants |
| Education of respondent Secondary or less | 30 Participants |
| Education of respondent Some or completed university | 9 Participants |
| N of years in business (Median) | 4.3 Years |
| N Shopkeepers One | 60 Participants |
| N Shopkeepers Three | 3 Participants |
| N Shopkeepers Two | 20 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 78 |
| other Total, other adverse events | 1 / 79 | 0 / 78 |
| serious Total, serious adverse events | 0 / 79 | 0 / 78 |
Outcome results
None listed