Trial Outcomes & Findings for AmbassADDOrs for Health Study (NCT NCT05357144)
NCT ID: NCT05357144
Last Updated: 2026-08-20
Results Overview
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.
TERMINATED
NA
157 participants
12-15 months
2026-08-20
Participant Flow
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.
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.
Unit of analysis: Shops
Participant milestones
| Measure |
Intervention
DLDMs in wards randomized to the intervention received the following intervention components:
1. Training on the Maisha Meds point-of-sale electronic inventory system to be used to record sales as well as continuous customer service support;
2. Training on how to use HIVST kits and training on how to provide "girl-friendly" care, including contraceptive counseling;
3. Linkage with 1-2 peer navigators and 1 study-affiliated health facility nurse or caregiver to provide Malkia Klabu members with referrals for care outside the breadth of DLDM care (i.e., injectable contraceptives, STI testing, PrEP);
4. All study-related commodities, including HIVST kits affixed with information for the local study-affiliated public health facility for confirmatory testing or PrEP in addition to the referral contacts; two sequin bags for the prizes; club membership cards; prizes for the prize bags; two tablets (one for inventory, one for young women engagement); and product displays. Shops were required to procure the other study-related products of interest (contraceptives, UPTs) per business-as-usual; and
5. Biweekly reimbursement for sales of products to Malkia Klabu members recorded in Maisha Meds at a set wholesale price.
|
Standard of Care
DLDMs in wards randomized to the control arm received the same training on Maisha Meds and HIVST kits as well as a monthly supply of HIVST kits for distribution to young women only, with a "Free for young women" sticker affixed and referral information for the local public health facility affixed for confirmatory testing. Other sexual health products were sold as per normal business operations and no reimbursements were provided for sales to young women. Restocking of HIVST kits was contingent upon recorded HIVST kit distribution to young women.
|
|---|---|---|
|
Overall Study
STARTED
|
79 79
|
78 78
|
|
Overall Study
COMPLETED
|
79 79
|
78 78
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention
n=79 Participants
DLDMs in wards randomized to the intervention received the following intervention components:
1. Training on the Maisha Meds point-of-sale electronic inventory system to be used to record sales as well as continuous customer service support;
2. Training on how to use HIVST kits and training on how to provide "girl-friendly" care, including contraceptive counseling;
3. Linkage with 1-2 peer navigators and 1 study-affiliated health facility nurse or caregiver to provide Malkia Klabu members with referrals for care outside the breadth of DLDM care (i.e., injectable contraceptives, STI testing, PrEP);
4. All study-related commodities, including HIVST kits affixed with information for the local study-affiliated public health facility for confirmatory testing or PrEP in addition to the referral contacts; two sequin bags for the prizes; club membership cards; prizes for the prize bags; two tablets (one for inventory, one for young women engagement); and product displays. Shops were required to procure the other study-related products of interest (contraceptives, UPTs) per business-as-usual; and
5. Biweekly reimbursement for sales of products to Malkia Klabu members recorded in Maisha Meds at a set wholesale price.
|
Control
n=78 Participants
DLDMs in wards randomized to the control arm received the same training on Maisha Meds and HIVST kits as well as a monthly supply of HIVST kits for distribution to young women only, with a "Free for young women" sticker affixed and referral information for the local public health facility affixed for confirmatory testing. Other sexual health products were sold as per normal business operations and no reimbursements were provided for sales to young women. Restocking of HIVST kits was contingent upon recorded HIVST kit distribution to young women.
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 Age
n=79 Participants
|
30 Age
n=78 Participants
|
30 Age
n=157 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=79 Participants
|
54 Participants
n=78 Participants
|
102 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=79 Participants
|
24 Participants
n=78 Participants
|
55 Participants
n=157 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Education of respondent
Primary or less
|
2 Participants
n=78 Participants • There are 2 missings from the dataset for eduction--this question was not answered by 2 shopkeepers.
|
9 Participants
n=77 Participants • There are 2 missings from the dataset for eduction--this question was not answered by 2 shopkeepers.
|
11 Participants
n=155 Participants • There are 2 missings from the dataset for eduction--this question was not answered by 2 shopkeepers.
|
|
Education of respondent
Secondary or less
|
30 Participants
n=78 Participants • There are 2 missings from the dataset for eduction--this question was not answered by 2 shopkeepers.
|
25 Participants
n=77 Participants • There are 2 missings from the dataset for eduction--this question was not answered by 2 shopkeepers.
|
55 Participants
n=155 Participants • There are 2 missings from the dataset for eduction--this question was not answered by 2 shopkeepers.
|
|
Education of respondent
Certificate or diploma
|
42 Participants
n=78 Participants • There are 2 missings from the dataset for eduction--this question was not answered by 2 shopkeepers.
|
38 Participants
n=77 Participants • There are 2 missings from the dataset for eduction--this question was not answered by 2 shopkeepers.
|
80 Participants
n=155 Participants • There are 2 missings from the dataset for eduction--this question was not answered by 2 shopkeepers.
|
|
Education of respondent
Some or completed university
|
4 Participants
n=78 Participants • There are 2 missings from the dataset for eduction--this question was not answered by 2 shopkeepers.
|
5 Participants
n=77 Participants • There are 2 missings from the dataset for eduction--this question was not answered by 2 shopkeepers.
|
9 Participants
n=155 Participants • There are 2 missings from the dataset for eduction--this question was not answered by 2 shopkeepers.
|
|
N of years in business (Median)
|
3.8 Years
n=79 Participants
|
4.3 Years
n=78 Participants
|
4.0 Years
n=157 Participants
|
|
N Shopkeepers
One
|
60 Participants
n=79 Participants
|
56 Participants
n=78 Participants
|
116 Participants
n=157 Participants
|
|
N Shopkeepers
Two
|
18 Participants
n=79 Participants
|
20 Participants
n=78 Participants
|
38 Participants
n=157 Participants
|
|
N Shopkeepers
Three
|
1 Participants
n=79 Participants
|
2 Participants
n=78 Participants
|
3 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: 12-15 monthsPopulation: While the study intended to collect data for 24 months, unanticipated changes to Tanzania's government oversight structure led to the premature termination of the trial in January 2024. Access to the participant data ended when the trial was terminated. Approval to access the data required for this outcome measure was not granted before termination and will not be granted in the future. Therefore, no data were collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12-15 monthsPopulation: While the study intended to collect data for 24 months, unanticipated changes to Tanzania's government oversight structure led to the premature termination of the trial in January 2024. Access to the participant data ended when the trial was terminated. Approval to access the data required for this outcome measure was not granted before termination and will not be granted in the future. Therefore, no data were collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12-15 monthsPopulation: While the study intended to collect data for 24 months, unanticipated changes to Tanzania's government oversight structure led to the premature termination of the trial in January 2024. Access to the participant data ended when the trial was terminated. Approval to access the data required for this outcome measure was not granted before termination and will not be granted in the future. Therefore, no data were collected for this outcome measure.
Data on antiretroviral therapy (ART) initiation abstracted from routinely collected health facility data, disaggregated by sex and age, aggregated to the catchment area level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12-15 monthsDistribution 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.
Outcome measures
| Measure |
Intervention
n=79 Shops
DLDMs in wards randomized to the intervention received the following intervention components:
1. Training on the Maisha Meds point-of-sale electronic inventory system to be used to record sales as well as continuous customer service support;
2. Training on how to use HIVST kits and training on how to provide "girl-friendly" care, including contraceptive counseling;
3. Linkage with 1-2 peer navigators and 1 study-affiliated health facility nurse or caregiver to provide Malkia Klabu members with referrals for care outside the breadth of DLDM care (i.e., injectable contraceptives, STI testing, PrEP);
4. All study-related commodities, including HIVST kits affixed with information for the local study-affiliated public health facility for confirmatory testing or PrEP in addition to the referral contacts; two sequin bags for the prizes; club membership cards; prizes for the prize bags; two tablets (one for inventory, one for young women engagement); and product displays. Shops were required to procure the other study-related products of interest (contraceptives, UPTs) per business-as-usual; and
5. Biweekly reimbursement for sales of products to Malkia Klabu members recorded in Maisha Meds at a set wholesale price.
|
Standard of Care
n=78 Shops
DLDMs in wards randomized to the control arm received the same training on Maisha Meds and HIVST kits as well as a monthly supply of HIVST kits for distribution to young women only, with a "Free for young women" sticker affixed and referral information for the local public health facility affixed for confirmatory testing. Other sexual health products were sold as per normal business operations and no reimbursements were provided for sales to young women. Restocking of HIVST kits was contingent upon recorded HIVST kit distribution to young women.
|
|---|---|---|
|
Distribution of HIV Self-test Kits to Adolescent Girls and Young Women
|
10469 HIVSTs distributed
|
11292 HIVSTs distributed
|
SECONDARY outcome
Timeframe: 12-15 monthsDistribution 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.
Outcome measures
| Measure |
Intervention
n=79 Shops
DLDMs in wards randomized to the intervention received the following intervention components:
1. Training on the Maisha Meds point-of-sale electronic inventory system to be used to record sales as well as continuous customer service support;
2. Training on how to use HIVST kits and training on how to provide "girl-friendly" care, including contraceptive counseling;
3. Linkage with 1-2 peer navigators and 1 study-affiliated health facility nurse or caregiver to provide Malkia Klabu members with referrals for care outside the breadth of DLDM care (i.e., injectable contraceptives, STI testing, PrEP);
4. All study-related commodities, including HIVST kits affixed with information for the local study-affiliated public health facility for confirmatory testing or PrEP in addition to the referral contacts; two sequin bags for the prizes; club membership cards; prizes for the prize bags; two tablets (one for inventory, one for young women engagement); and product displays. Shops were required to procure the other study-related products of interest (contraceptives, UPTs) per business-as-usual; and
5. Biweekly reimbursement for sales of products to Malkia Klabu members recorded in Maisha Meds at a set wholesale price.
|
Standard of Care
n=78 Shops
DLDMs in wards randomized to the control arm received the same training on Maisha Meds and HIVST kits as well as a monthly supply of HIVST kits for distribution to young women only, with a "Free for young women" sticker affixed and referral information for the local public health facility affixed for confirmatory testing. Other sexual health products were sold as per normal business operations and no reimbursements were provided for sales to young women. Restocking of HIVST kits was contingent upon recorded HIVST kit distribution to young women.
|
|---|---|---|
|
Distribution Contraception to Adolescent Girls and Young Women
|
11049 contraceptive packs sold
|
382 contraceptive packs sold
|
SECONDARY outcome
Timeframe: 12-15 monthsPopulation: While the study intended to collect data for 24 months, unanticipated changes to Tanzania's government oversight structure led to the premature termination of the trial in January 2024. Access to the participant data ended when the trial was terminated. Approval to access the data required for this outcome measure was not granted before termination and will not be granted in the future. Therefore, no data were collected for this outcome measure.
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%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12-15 monthsPopulation: While the study intended to collect data for 24 months, unanticipated changes to Tanzania's government oversight structure led to the premature termination of the trial in January 2024. Access to the participant data ended when the trial was terminated. Approval to access the data required for this outcome measure was not granted before termination and will not be granted in the future. Therefore, no data were collected for this outcome measure.
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%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12-15 monthsPopulation: While the study intended to collect data for 24 months, unanticipated changes to Tanzania's government oversight structure led to the premature termination of the trial in January 2024. Access to the participant data ended when the trial was terminated. Approval to access the data required for this outcome measure was not granted before termination and will not be granted in the future. Therefore, no data were collected for this outcome measure.
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%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12-15 monthsPopulation: While the study intended to collect data for 24 months, unanticipated changes to Tanzania's government oversight structure led to the premature termination of the trial in January 2024. Access to the participant data ended when the trial was terminated. Approval to access the data required for this outcome measure was not granted before termination and will not be granted in the future. Therefore, no data were collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=79 participants at risk
DLDMs in wards randomized to the intervention received the following intervention components:
1. Training on the Maisha Meds point-of-sale electronic inventory system to be used to record sales as well as continuous customer service support;
2. Training on how to use HIVST kits and training on how to provide "girl-friendly" care, including contraceptive counseling;
3. Linkage with 1-2 peer navigators and 1 study-affiliated health facility nurse or caregiver to provide Malkia Klabu members with referrals for care outside the breadth of DLDM care (i.e., injectable contraceptives, STI testing, PrEP);
4. All study-related commodities, including HIVST kits affixed with information for the local study-affiliated public health facility for confirmatory testing or PrEP in addition to the referral contacts; two sequin bags for the prizes; club membership cards; prizes for the prize bags; two tablets (one for inventory, one for young women engagement); and product displays. Shops were required to procure the other study-related products of interest (contraceptives, UPTs) per business-as-usual; and
5. Biweekly reimbursement for sales of products to Malkia Klabu members recorded in Maisha Meds at a set wholesale price.
|
Control
n=78 participants at risk
DLDMs in wards randomized to the control arm received the same training on Maisha Meds and HIVST kits as well as a monthly supply of HIVST kits for distribution to young women only, with a "Free for young women" sticker affixed and referral information for the local public health facility affixed for confirmatory testing. Other sexual health products were sold as per normal business operations and no reimbursements were provided for sales to young women. Restocking of HIVST kits was contingent upon recorded HIVST kit distribution to young women.
|
|---|---|---|
|
General disorders
False positive HIV test
|
1.3%
1/79 • From enrollment until the end of follow-up, up to 13 months
|
0.00%
0/78 • From enrollment until the end of follow-up, up to 13 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place