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Reaching Adolescent Girls and Young Women Through Girl-Friendly Drug Vendors

Reaching Adolescent Girls and Young Women Through Girl-Friendly Drug Vendors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04045912
Enrollment
20
Registered
2019-08-06
Start date
2019-07-22
Completion date
2020-03-11
Last updated
2023-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, HIV

Keywords

HIV self-testing, Accredited drug dispensing outlets, Adolescent girls and young women

Brief 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.

Detailed 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.

Interventions

OTHERAGYW-Friendly Services

Drug shops will offer a loyalty program (the Queen Club) through which AGYW can earn mystery prizes and discreetly request free SRH products. Drug shops will also have an SRH product display and a tablet with SRH videos for interested customers, and drug shop employees will receive training on contraceptive counseling for AGYW.

OTHERHIVST

Drug shops will provide HIVST kits to AGYW for free. Employees will receive training on HIVST and will institute an HIV care referral plan for customers who require linkage to confirmatory testing or treatment.

Sponsors

University of California, Berkeley
CollaboratorOTHER
Health for a Prosperous Nation
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Ministry of Health, Community Development, Gender, Elderly and Children, Tanzania
CollaboratorUNKNOWN
RTI International
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* At least 18 years of age; * Owns an accredited drug dispensing outlet (ADDO); * Willing to offer HIVST and AGYW-friendly services at drug shop; * Provides written informed consent for the study.

Exclusion criteria

* Less than 18 years of age; * Owns a drug shop that is not accredited; * Unwilling to offer HIVST and/or AGYW-friendly services at drug shop; * Does not provide informed consent.

Design outcomes

Primary

MeasureTime frameDescription
AGYW Patronage (Count)Baseline (pre-randomization) through Month 4Number of visits by adolescent girls and young women (AGYW) during drug shop observations at baseline (before randomization), midline (after 2-3 months), and endline (after 3-4 months).
AGYW Patronage (Proportion)Baseline (pre-randomization) through Month 4Proportion of visits by AGYW during drug shop observations at baseline (before randomization), midline (after 2-3 months), and endline (after 3-4 months); calculated as the number of AGYW customers divided by the total number of customers per observation.
HIVST Kit UptakeMonth 1 (post-randomization) through Month 4Number of HIV self-test (HIVST) kits distributed to AGYW over four months of post-randomization study arm implementation. Drug shopkeepers maintained standardized records of the number of HIVST kits distributed to AGYW customers in participating drug shops throughout the implementation period.
Contraceptive DistributionMonth 1 (post-randomization) through Month 4Number of contraceptives distributed to AGYW, including condoms, oral contraception, and emergency contraception, over four months of post-randomization study arm implementation. Drug shopkeepers maintained standardized records of the number and types of contraceptives distributed to AGYW customers in participating drug shops throughout the implementation period.
Health Facility ReferralsMonth 1 (post-randomization) through Month 4Number of health facility referrals provided to AGYW for sexual and reproductive health (SRH) services, including HIV testing/treatment, family planning, and pregnancy services, over four months of post-randomization study arm implementation. Drug shopkeepers maintained standardized records of the number and types of SRH health facility referrals provided to AGYW customers in participating drug shops throughout the implementation period.

Secondary

MeasureTime frameDescription
Pregnancy Test DistributionMonth 1 (post-randomization) through Month 4Number of urine pregnancy tests distributed to AGYW over four months of post-randomization study arm implementation. Drug shopkeepers maintained standardized records of the number of pregnancy tests distributed to AGYW customers in participating drug shops throughout the implementation period.

Countries

Tanzania

Participant flow

Recruitment details

We randomly selected 41 drug shops from a registry of Accredited Drug Dispensing Outlets that included contact information for the shops' primary shopkeepers. Of the 41 shopkeepers, 14 were ineligible and 6 could not be contacted. Of the 21 shopkeepers that were eligible and could be contacted, 20 consented to participate (corresponding to 20 participating drug shops). Adolescent girls and young women (AGYW) customers were not enrolled as participants in this trial.

Pre-assignment details

Enrollment and pre-randomization baseline data collection began July 22, 2019 and ended August 17, 2019. All participating drug shopkeepers were randomized into study arms on August 19, 2019.

Participants by arm

ArmCount
HIVST + AGYW-Friendly Services
Drug shops in Arm 1 will implement AGYW-friendly services, including a sexual and reproductive health (SRH) product display, a tablet with SRH videos, and a loyalty program (the Queen Club) through which AGYW can earn mystery prizes and discreetly request free SRH products. They will also provide HIV self-test (HIVST) kits to AGYW customers for free. AGYW-Friendly Services: Drug shops will offer a loyalty program (the Queen Club) through which AGYW can earn mystery prizes and discreetly request free SRH products. Drug shops will also have an SRH product display and a tablet with SRH videos for interested customers, and drug shop employees will receive training on contraceptive counseling for AGYW. HIVST: Drug shops will provide HIVST kits to AGYW for free. Employees will receive training on HIVST and will institute an HIV care referral plan for customers who require linkage to confirmatory testing or treatment.
10
HIVST + AGYW-Friendly Services
Drug shops in Arm 1 will implement AGYW-friendly services, including a sexual and reproductive health (SRH) product display, a tablet with SRH videos, and a loyalty program (the Queen Club) through which AGYW can earn mystery prizes and discreetly request free SRH products. They will also provide HIV self-test (HIVST) kits to AGYW customers for free. AGYW-Friendly Services: Drug shops will offer a loyalty program (the Queen Club) through which AGYW can earn mystery prizes and discreetly request free SRH products. Drug shops will also have an SRH product display and a tablet with SRH videos for interested customers, and drug shop employees will receive training on contraceptive counseling for AGYW. HIVST: Drug shops will provide HIVST kits to AGYW for free. Employees will receive training on HIVST and will institute an HIV care referral plan for customers who require linkage to confirmatory testing or treatment.
10
HIVST Only
Drug shops in Arm 2 will provide HIVST kits to AGYW customers for free. HIVST: Drug shops will provide HIVST kits to AGYW for free. Employees will receive training on HIVST and will institute an HIV care referral plan for customers who require linkage to confirmatory testing or treatment.
10
HIVST Only
Drug shops in Arm 2 will provide HIVST kits to AGYW customers for free. HIVST: Drug shops will provide HIVST kits to AGYW for free. Employees will receive training on HIVST and will institute an HIV care referral plan for customers who require linkage to confirmatory testing or treatment.
10
Total40

Baseline characteristics

CharacteristicHIVST + AGYW-Friendly ServicesTotalHIVST Only
Age, Continuous48.5 Years
STANDARD_DEVIATION 15.3
43.6 Years
STANDARD_DEVIATION 15.9
38.7 Years
STANDARD_DEVIATION 15.7
Location of drug shop
Ward 1
3 drug shops6 drug shops3 drug shops
Location of drug shop
Ward 2
3 drug shops6 drug shops3 drug shops
Location of drug shop
Ward 3
2 drug shops4 drug shops2 drug shops
Location of drug shop
Ward 4
2 drug shops4 drug shops2 drug shops
Number of people who work in drug shop
1 person
7 drug shops17 drug shops10 drug shops
Number of people who work in drug shop
2 people
2 drug shops2 drug shops0 drug shops
Number of people who work in drug shop
3 people
1 drug shops1 drug shops0 drug shops
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants20 Participants10 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Tanzania
10 Participants20 Participants10 Participants
Sex: Female, Male
Female
7 Participants15 Participants8 Participants
Sex: Female, Male
Male
3 Participants5 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 10
other
Total, other adverse events
0 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 10

Outcome results

Primary

AGYW Patronage (Count)

Number of visits by adolescent girls and young women (AGYW) during drug shop observations at baseline (before randomization), midline (after 2-3 months), and endline (after 3-4 months).

Time frame: Baseline (pre-randomization) through Month 4

Population: We randomly sampled five 3-hour observation day/time blocks per shop per time point, corresponding to up to 15 observations per shop across the study period.

ArmMeasureGroupValue (MEAN)Dispersion
HIVST + AGYW-Friendly ServicesAGYW Patronage (Count)Baseline (pre-randomization)1.0 AGYW customers per observationStandard Deviation 1.2
HIVST + AGYW-Friendly ServicesAGYW Patronage (Count)Endline4.0 AGYW customers per observationStandard Deviation 5.2
HIVST + AGYW-Friendly ServicesAGYW Patronage (Count)Midline1.7 AGYW customers per observationStandard Deviation 2.9
HIVST + AGYW-Friendly ServicesAGYW Patronage (Count)Midline/endline combined2.9 AGYW customers per observationStandard Deviation 4.4
HIVST OnlyAGYW Patronage (Count)Midline1.0 AGYW customers per observationStandard Deviation 1.3
HIVST OnlyAGYW Patronage (Count)Baseline (pre-randomization)1.0 AGYW customers per observationStandard Deviation 1.1
HIVST OnlyAGYW Patronage (Count)Midline/endline combined0.9 AGYW customers per observationStandard Deviation 1.2
HIVST OnlyAGYW Patronage (Count)Endline0.8 AGYW customers per observationStandard Deviation 1.2
Primary

AGYW Patronage (Proportion)

Proportion of visits by AGYW during drug shop observations at baseline (before randomization), midline (after 2-3 months), and endline (after 3-4 months); calculated as the number of AGYW customers divided by the total number of customers per observation.

Time frame: Baseline (pre-randomization) through Month 4

Population: We randomly sampled five 3-hour observation day/time blocks per shop per time point, corresponding to up to 15 observations per shop across the study period. Unlike the first AGYW patronage outcome, this outcome excludes observations during which zero customers were observed.

ArmMeasureGroupValue (MEAN)Dispersion
HIVST + AGYW-Friendly ServicesAGYW Patronage (Proportion)Baseline (pre-randomization)0.17 Proportion of AGYW customersStandard Deviation 0.19
HIVST + AGYW-Friendly ServicesAGYW Patronage (Proportion)Midline0.22 Proportion of AGYW customersStandard Deviation 0.28
HIVST + AGYW-Friendly ServicesAGYW Patronage (Proportion)Endline0.39 Proportion of AGYW customersStandard Deviation 0.31
HIVST + AGYW-Friendly ServicesAGYW Patronage (Proportion)Midline/endline combined0.31 Proportion of AGYW customersStandard Deviation 0.31
HIVST OnlyAGYW Patronage (Proportion)Midline/endline combined0.12 Proportion of AGYW customersStandard Deviation 0.17
HIVST OnlyAGYW Patronage (Proportion)Baseline (pre-randomization)0.12 Proportion of AGYW customersStandard Deviation 0.13
HIVST OnlyAGYW Patronage (Proportion)Endline0.11 Proportion of AGYW customersStandard Deviation 0.21
HIVST OnlyAGYW Patronage (Proportion)Midline0.12 Proportion of AGYW customersStandard Deviation 0.12
Primary

Contraceptive Distribution

Number of contraceptives distributed to AGYW, including condoms, oral contraception, and emergency contraception, over four months of post-randomization study arm implementation. Drug shopkeepers maintained standardized records of the number and types of contraceptives distributed to AGYW customers in participating drug shops throughout the implementation period.

Time frame: Month 1 (post-randomization) through Month 4

ArmMeasureGroupValue (MEAN)Dispersion
HIVST + AGYW-Friendly ServicesContraceptive DistributionContraceptives (all)664.9 Contraceptives provided per shopStandard Deviation 1073.5
HIVST + AGYW-Friendly ServicesContraceptive DistributionCondoms128.9 Contraceptives provided per shopStandard Deviation 142.7
HIVST + AGYW-Friendly ServicesContraceptive DistributionDaily oral contraception77.3 Contraceptives provided per shopStandard Deviation 60.5
HIVST + AGYW-Friendly ServicesContraceptive DistributionEmergency contraception458.7 Contraceptives provided per shopStandard Deviation 904.4
HIVST OnlyContraceptive DistributionEmergency contraception4.0 Contraceptives provided per shopStandard Deviation 4.9
HIVST OnlyContraceptive DistributionContraceptives (all)19.9 Contraceptives provided per shopStandard Deviation 27.4
HIVST OnlyContraceptive DistributionDaily oral contraception3.6 Contraceptives provided per shopStandard Deviation 5.3
HIVST OnlyContraceptive DistributionCondoms12.3 Contraceptives provided per shopStandard Deviation 25.8
Primary

Health Facility Referrals

Number of health facility referrals provided to AGYW for sexual and reproductive health (SRH) services, including HIV testing/treatment, family planning, and pregnancy services, over four months of post-randomization study arm implementation. Drug shopkeepers maintained standardized records of the number and types of SRH health facility referrals provided to AGYW customers in participating drug shops throughout the implementation period.

Time frame: Month 1 (post-randomization) through Month 4

ArmMeasureGroupValue (MEAN)Dispersion
HIVST + AGYW-Friendly ServicesHealth Facility ReferralsSRH referrals (all)66.1 Referrals provided per shopStandard Deviation 157.5
HIVST + AGYW-Friendly ServicesHealth Facility ReferralsHIV referrals8.2 Referrals provided per shopStandard Deviation 20
HIVST + AGYW-Friendly ServicesHealth Facility ReferralsFamily planning referrals49.5 Referrals provided per shopStandard Deviation 120
HIVST + AGYW-Friendly ServicesHealth Facility ReferralsPregnancy referrals8.4 Referrals provided per shopStandard Deviation 17.8
HIVST OnlyHealth Facility ReferralsPregnancy referrals1.6 Referrals provided per shopStandard Deviation 4
HIVST OnlyHealth Facility ReferralsSRH referrals (all)6.7 Referrals provided per shopStandard Deviation 19.1
HIVST OnlyHealth Facility ReferralsFamily planning referrals4.9 Referrals provided per shopStandard Deviation 15.1
HIVST OnlyHealth Facility ReferralsHIV referrals0.2 Referrals provided per shopStandard Deviation 0.4
Primary

HIVST Kit Uptake

Number of HIV self-test (HIVST) kits distributed to AGYW over four months of post-randomization study arm implementation. Drug shopkeepers maintained standardized records of the number of HIVST kits distributed to AGYW customers in participating drug shops throughout the implementation period.

Time frame: Month 1 (post-randomization) through Month 4

ArmMeasureValue (MEAN)Dispersion
HIVST + AGYW-Friendly ServicesHIVST Kit Uptake145.6 HIVST kits distributed per shopStandard Deviation 107.6
HIVST OnlyHIVST Kit Uptake59.6 HIVST kits distributed per shopStandard Deviation 30.4
Secondary

Pregnancy Test Distribution

Number of urine pregnancy tests distributed to AGYW over four months of post-randomization study arm implementation. Drug shopkeepers maintained standardized records of the number of pregnancy tests distributed to AGYW customers in participating drug shops throughout the implementation period.

Time frame: Month 1 (post-randomization) through Month 4

ArmMeasureValue (MEAN)Dispersion
HIVST + AGYW-Friendly ServicesPregnancy Test Distribution182.2 Pregnancy tests provided per shopStandard Deviation 236
HIVST OnlyPregnancy Test Distribution28.1 Pregnancy tests provided per shopStandard Deviation 29

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026