Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04045912 |
Other study ID # |
5R34MH116804 |
Secondary ID |
R34MH116804 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 22, 2019 |
Est. completion date |
March 11, 2020 |
Study information
Verified date |
January 2023 |
Source |
University of California, San Francisco |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
We will pilot an intervention to deliver sexual and reproductive health services, including
HIV self-testing (HIVST) and contraception, to adolescent girls and young women (AGYW) at
accredited drug dispensing outlets (ADDOs) in Shinyanga, Tanzania. In a 4-month randomized
pilot study, we will compare mediating outcomes (AGYW patronage, product distribution, and
referral) between 10 intervention and 10 comparison ADDOs, using data from time-location
surveys of customers and inventory distribution and referral records.
Description:
Building on our team's formative work using human-centered design methods and behavioral
economics theories, we have designed an intervention (the "Queen Club") to develop
AGYW-friendly drug shops where we will introduce HIVST alongside contraceptives and linkages
to care. In a 4-month randomized pilot study, we will compare mediating outcomes (i.e., AGYW
visits, distribution of HIVST and contraception, referral to SRH services) between 10
intervention and 10 comparison ADDOs, using data from a time-location survey of customers and
records for HIVST and contraception distribution and referrals for sexual and reproductive
health (SRH) services.
ADDOs will be randomly selected from four wards in the Shinyanga municipality. We will use
stratified randomization by ward to assign 20 ADDOs 1:1 into the two study groups. Regardless
of intervention arm, we will conduct the following activities in all ADDOs: in-person
training on HIVST provision, monthly HIVST supply with half of kits explicitly earmarked for
free provision to AGYW customers, an HIV care referral plan, and shop record tracking. The
shop records will collect data on AGYW patronage, HIVST distribution, contraception
distribution, and health facility referrals for SRH services. Monthly reviews of inventory
records by the local team will include review of these records to determine AGYW patronage
(for any service) and the volume and types of contraception and HIVST kits distributed to
AGYW.
ADDOs in the intervention arm will be trained to implement the "Queen Club" intervention. The
Queen Club intervention was developed through a year-long human-centered design process with
AGYW and other stakeholders and is informed by behavioral economic theory and game-design. It
is intended to partially mitigate to the physical, economic, and social constraints faced by
AGYW in Shinyanga, as revealed in the formative research, and motivate them to discreetly
seek HIVST and contraception at local drug shops, while in a context of fun.
In brief, the Queen Club is a loyalty program through which AGYW can earn surprise mystery
gifts through repeated purchases at participating ADDOs. This is intended to build loyalty
and trust with an ADDO shop, and also build the customer base for the ADDO owner. The back of
the Queen Club loyalty card includes symbols, selected by AGYW, that represent oral
contraception, HIVST, emergency contraception, condoms, and pregnancy tests. With the symbol
portion of the card, AGYW can discreetly point to their desired product and receive it for
free without questioning.
In a one-day training, we will review contraceptive methods and counseling techniques with
intervention ADDO owners and staff using training materials adapted from the Ministry of
Health, Community Development, Gender, Elderly, and Children. At every intervention ADDO, we
will provide a countertop display with contraceptive methods and an HIVST kit for
demonstration (if desired by any customer), as well as a tablet computer pre-loaded with
videos about various contraceptive products and the Oraquick HIVST kit instructional video in
Kiswahili.
The primary outcomes are mediators of the intervention's potential effect on preventing HIV
and unintended pregnancy. In this phase, our goal is to measure these mediating, "process"
outcomes and maximize learning for a future effectiveness and sustainability study using
ADDOs as a platform to deliver HIVST and other HIV prevention and SRH services. We will
collect data on the following mediating outcomes from the 10 intervention and 10 comparison
ADDOs:
- AGYW patronage: number and proportion of visits by AGYW.
- Contraceptive distribution: number and types of contraceptives (i.e., condoms, oral
contraception, emergency contraception) distributed to AGYW.
- Health facility referrals: number of referrals for AGYW made for SRH services, including
HIV testing or treatment.
- HIVST kit uptake: number and proportion of kits distributed to AGYW.
We will assess AGYW patronage with a time-location survey of ADDO customers (randomly
selected 3-hour intervals) at baseline (during the month prior to intervention) and during
the final two months of the intervention (12 episodes per ADDO total) in which trained
researchers will discreetly document the number of customers, their sex, and approximate age.
Monthly reviews of inventory and referral records will show the volume and types of SRH
products distributed to customers, including HIVST and contraception distributed to AGYW, and
the number of SRH referrals made, the number and proportion for AGYW, and for which services.
We will compare AGYW patronage, referrals to health facilities, and contraception
transactions between intervention and comparison ADDOs over the 4-month pilot period using:
(1) statistical tests of means (t-tests) and medians (Wilcoxon rank-sum test); (2) a Poisson
regression model (for counts of AGYW visits) to estimate rate ratios and confidence intervals
controlling for baseline levels of AGYW patronage using a "difference-in-differences"
approach; and (3) chi-squared tests for independence to qualitatively assess differences
between groups for all mediating outcomes. Results will be used to understand the potential
effectiveness of AGYW-friendly ADDO environments on AGYW visits and demand generation for HIV
prevention and SRH services, a basis for power calculations to determine the sample size
needed for the future study of effectiveness and sustainability.