Trial Outcomes & Findings for Reaching Adolescent Girls and Young Women Through Girl-Friendly Drug Vendors (NCT NCT04045912)
NCT ID: NCT04045912
Last Updated: 2023-02-03
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline (pre-randomization) through Month 4
Results posted on
2023-02-03
Participant Flow
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.
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.
Unit of analysis: drug shops
Participant milestones
| Measure |
HIVST + AGYW-Friendly Services
Drug shops in Arm 1 will implement adolescent girl and young women (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.
|
HIVST Only
Drug shops in Arm 2 will provide HIV self-test (HIVST) kits to adolescent girl and young women (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.
|
|---|---|---|
|
Overall Study
STARTED
|
10 10
|
10 10
|
|
Overall Study
COMPLETED
|
10 10
|
10 10
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reaching Adolescent Girls and Young Women Through Girl-Friendly Drug Vendors
Baseline characteristics by cohort
| Measure |
HIVST + AGYW-Friendly Services
n=10 drug shops
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.
|
HIVST Only
n=10 drug shops
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.
|
Total
n=20 drug shops
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.5 Years
STANDARD_DEVIATION 15.3 • n=93 Participants
|
38.7 Years
STANDARD_DEVIATION 15.7 • n=4 Participants
|
43.6 Years
STANDARD_DEVIATION 15.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Tanzania
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Location of drug shop
Ward 1
|
3 drug shops
n=10 drug shops
|
3 drug shops
n=10 drug shops
|
6 drug shops
n=20 drug shops
|
|
Location of drug shop
Ward 2
|
3 drug shops
n=10 drug shops
|
3 drug shops
n=10 drug shops
|
6 drug shops
n=20 drug shops
|
|
Location of drug shop
Ward 3
|
2 drug shops
n=10 drug shops
|
2 drug shops
n=10 drug shops
|
4 drug shops
n=20 drug shops
|
|
Location of drug shop
Ward 4
|
2 drug shops
n=10 drug shops
|
2 drug shops
n=10 drug shops
|
4 drug shops
n=20 drug shops
|
|
Number of people who work in drug shop
1 person
|
7 drug shops
n=10 drug shops
|
10 drug shops
n=10 drug shops
|
17 drug shops
n=20 drug shops
|
|
Number of people who work in drug shop
2 people
|
2 drug shops
n=10 drug shops
|
0 drug shops
n=10 drug shops
|
2 drug shops
n=20 drug shops
|
|
Number of people who work in drug shop
3 people
|
1 drug shops
n=10 drug shops
|
0 drug shops
n=10 drug shops
|
1 drug shops
n=20 drug shops
|
PRIMARY outcome
Timeframe: Baseline (pre-randomization) through Month 4Population: 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.
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).
Outcome measures
| Measure |
HIVST + AGYW-Friendly Services
n=141 drug shop observations
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.
|
HIVST Only
n=132 drug shop observations
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.
|
|---|---|---|
|
AGYW Patronage (Count)
Baseline (pre-randomization)
|
1.0 AGYW customers per observation
Standard Deviation 1.2
|
1.0 AGYW customers per observation
Standard Deviation 1.1
|
|
AGYW Patronage (Count)
Midline
|
1.7 AGYW customers per observation
Standard Deviation 2.9
|
1.0 AGYW customers per observation
Standard Deviation 1.3
|
|
AGYW Patronage (Count)
Endline
|
4.0 AGYW customers per observation
Standard Deviation 5.2
|
0.8 AGYW customers per observation
Standard Deviation 1.2
|
|
AGYW Patronage (Count)
Midline/endline combined
|
2.9 AGYW customers per observation
Standard Deviation 4.4
|
0.9 AGYW customers per observation
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Baseline (pre-randomization) through Month 4Population: 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.
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.
Outcome measures
| Measure |
HIVST + AGYW-Friendly Services
n=134 drug shop observations
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.
|
HIVST Only
n=127 drug shop observations
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.
|
|---|---|---|
|
AGYW Patronage (Proportion)
Baseline (pre-randomization)
|
0.17 Proportion of AGYW customers
Standard Deviation 0.19
|
0.12 Proportion of AGYW customers
Standard Deviation 0.13
|
|
AGYW Patronage (Proportion)
Midline
|
0.22 Proportion of AGYW customers
Standard Deviation 0.28
|
0.12 Proportion of AGYW customers
Standard Deviation 0.12
|
|
AGYW Patronage (Proportion)
Endline
|
0.39 Proportion of AGYW customers
Standard Deviation 0.31
|
0.11 Proportion of AGYW customers
Standard Deviation 0.21
|
|
AGYW Patronage (Proportion)
Midline/endline combined
|
0.31 Proportion of AGYW customers
Standard Deviation 0.31
|
0.12 Proportion of AGYW customers
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: Month 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.
Outcome measures
| Measure |
HIVST + AGYW-Friendly Services
n=10 drug shops
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.
|
HIVST Only
n=10 drug shops
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.
|
|---|---|---|
|
HIVST Kit Uptake
|
145.6 HIVST kits distributed per shop
Standard Deviation 107.6
|
59.6 HIVST kits distributed per shop
Standard Deviation 30.4
|
PRIMARY outcome
Timeframe: Month 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.
Outcome measures
| Measure |
HIVST + AGYW-Friendly Services
n=10 drug shops
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.
|
HIVST Only
n=10 drug shops
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.
|
|---|---|---|
|
Contraceptive Distribution
Daily oral contraception
|
77.3 Contraceptives provided per shop
Standard Deviation 60.5
|
3.6 Contraceptives provided per shop
Standard Deviation 5.3
|
|
Contraceptive Distribution
Contraceptives (all)
|
664.9 Contraceptives provided per shop
Standard Deviation 1073.5
|
19.9 Contraceptives provided per shop
Standard Deviation 27.4
|
|
Contraceptive Distribution
Condoms
|
128.9 Contraceptives provided per shop
Standard Deviation 142.7
|
12.3 Contraceptives provided per shop
Standard Deviation 25.8
|
|
Contraceptive Distribution
Emergency contraception
|
458.7 Contraceptives provided per shop
Standard Deviation 904.4
|
4.0 Contraceptives provided per shop
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: Month 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.
Outcome measures
| Measure |
HIVST + AGYW-Friendly Services
n=10 drug shops
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.
|
HIVST Only
n=10 drug shops
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.
|
|---|---|---|
|
Health Facility Referrals
SRH referrals (all)
|
66.1 Referrals provided per shop
Standard Deviation 157.5
|
6.7 Referrals provided per shop
Standard Deviation 19.1
|
|
Health Facility Referrals
HIV referrals
|
8.2 Referrals provided per shop
Standard Deviation 20.0
|
0.2 Referrals provided per shop
Standard Deviation 0.4
|
|
Health Facility Referrals
Family planning referrals
|
49.5 Referrals provided per shop
Standard Deviation 120.0
|
4.9 Referrals provided per shop
Standard Deviation 15.1
|
|
Health Facility Referrals
Pregnancy referrals
|
8.4 Referrals provided per shop
Standard Deviation 17.8
|
1.6 Referrals provided per shop
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Month 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.
Outcome measures
| Measure |
HIVST + AGYW-Friendly Services
n=10 drug shops
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.
|
HIVST Only
n=10 drug shops
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.
|
|---|---|---|
|
Pregnancy Test Distribution
|
182.2 Pregnancy tests provided per shop
Standard Deviation 236.0
|
28.1 Pregnancy tests provided per shop
Standard Deviation 29.0
|
Adverse Events
HIVST + AGYW-Friendly Services
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIVST Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jenny Liu
University of California, San Francisco
Phone: 1-415-502-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place