Contraception, Hiv
Conditions
Keywords
Drug shops, Pro-sociality, Adolescent health, HIV self-testing, Contraception
Brief summary
The goal of the study is to operationalize and test the preliminary impact of providing regular customer feedback from adolescent girls and young women (AGYW) to drug shopkeepers on the distribution of contraceptives and HIV self-testing to AGYW over 12 months.
Detailed description
The investigators will cross-randomize 120 drug shops enrolled in the parent Malkia Klabu effectiveness cluster-randomized controlled trial (CRCT; NCT05357144), stratified by CRCT study arm, to one of three initial conditions: 1. No feedback. AGYW customer feedback will be collected, but not shared with the shopkeeper. 2. Private feedback. Biweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers. 3. Public feedback: Shopkeepers will get biweekly summarized reports of AGYW customer feedback, gold stars reflecting the level of AGYW customer feedback (e.g., 1-5 star rating) will be placed in the shop in a visible location, and shopkeepers will be invited to an awards ceremony every 6 months to recognize shopkeepers who receive high levels of positive AGYW customer feedback. The investigators will phase in the 2 interventions (Private and Public Feedback) on a staggered basis to control for both shop-specific and time-specific trends for the primary outcomes.
Interventions
BEHAVIORALHarnessing prosocial and social image motivations for behavior change
The investigators will collect AGYW customer feedback using a short USSD-based survey and randomize whether shopkeepers receive 1) No feedback; 2) Private feedback; or 3) Public feedback
Sponsors
University of California, Berkeley
Health for a Prosperous Nation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Randomized controlled trial; the investigators will phase in the 2 interventions (Private and Public Feedback) on a staggered basis. All shops will receive No Feedback during the first 6 months. One third of shops (\ N=40) will be assigned to No Feedback between 6-12 months; one third of shops (\ N=40) will be assigned to Private Feedback between 6-12 months; one third of shops (\ N=40) will be assigned to Public Feedback between 6-12 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Shopkeepers enrolled in the parent CRCT
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of All Products Sold | 12 months | Mean number of all products sold per shop per month |
| Quantity of HIV Self-test Kits Distributed | 12 months | Mean number of HIV self-test kits sold per shop every month |
| Quantity of Sexual and Reproductive Health Products Sold | 12 months | Mean number of sexual and reproductive health products sold per shop every month |
| Quantity of Contraceptives Distributed | 18 months | Mean number of contraceptives distributed per shop every 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of Condoms Sold | 12 months | Mean number of condoms sold per shop every month |
| Quantity of Emergency Contraception Sold | 12 months | Mean number of emergency contraception sold per shop every month |
| Quantity of Oral Contraception Sold | 12 months | Mean number of oral contraception sold per shop every month |
| Quantity of Pregnancy Tests Sold | 12 months | Mean number of pregnancy tests sold per shop every month |
Countries
Tanzania
Participant flow
Recruitment details
Please note that for the purposes of this study, participants refer to each drug shop owner or representative enrolled in the study. Each drug shop enrolled one participant. There are no other participants in this study. Shops were recruited on a rolling basis within each arm. The wards are geographical units that were the unit of randomization (cluster). All shops within each ward had the same treatment assignment.
Participants by arm
| Arm | Count |
|---|---|
| No Feedback No feedback for 12 months.
No feedback: AGYW customer feedback will be collected but not shared with shopkeepers
Harnessing prosocial and social image motivations for behavior change: The investigators will collect AGYW customer feedback using a short USSD-based survey and randomize whether shopkeepers receive 1) No feedback; 2) Private feedback; or 3) Public feedback | 44 |
| No Feedback - Private Feedback No feedback for 6 months, private feedback for 6 months.
Private feedback: Biweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers
Harnessing prosocial and social image motivations for behavior change: The investigators will collect AGYW customer feedback using a short USSD-based survey and randomize whether shopkeepers receive 1) No feedback; 2) Private feedback; or 3) Public feedback | 49 |
| No Feedback - Public Feedback No feedback for 6 months, public feedback for 6 months.
Public feedback: Shopkeepers will get biweekly summarized reports of AGYW customer feedback, gold stars reflecting the level of AGYW customer feedback (e.g., 1-5 star rating) will be placed in the shop in a visible location, and shopkeepers will be invited to an awards ceremony every 6 months to recognize shopkeepers who receive high levels of positive AGYW customer feedback
Harnessing prosocial and social image motivations for behavior change: The investigators will collect AGYW customer feedback using a short USSD-based survey and randomize whether shopkeepers receive 1) No feedback; 2) Private feedback; or 3) Public feedback | 51 |
| Total | 144 |
Baseline characteristics
| Characteristic | No Feedback - Public Feedback | Total | No Feedback | No Feedback - Private Feedback |
|---|---|---|---|---|
| Age, Continuous | 30.2 years STANDARD_DEVIATION 8.7 | 34.4 years STANDARD_DEVIATION 11.9 | 34.9 years STANDARD_DEVIATION 10.6 | 38.6 years STANDARD_DEVIATION 14.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Sex: Female, Male Female | 32 Participants | 90 Participants | 26 Participants | 32 Participants |
| Sex: Female, Male Male | 19 Participants | 52 Participants | 18 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 49 | 0 / 51 |
| other Total, other adverse events | 0 / 44 | 0 / 49 | 0 / 51 |
| serious Total, serious adverse events | 0 / 44 | 0 / 49 | 0 / 51 |
Outcome results
Primary
Quantity of All Products Sold
Mean number of all products sold per shop per month
Time frame: 12 months
Population: It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Feedback | Quantity of All Products Sold | 11.87 items sold | Standard Deviation 34.19 |
| Private Feedback | Quantity of All Products Sold | 17.05 items sold | Standard Deviation 36.14 |
| Public Feedback | Quantity of All Products Sold | 20.11 items sold | Standard Deviation 51.09 |
95% CI: [-18, 113]Regression, Linear
95% CI: [38, 189]Regression, Linear
Primary
Quantity of Contraceptives Distributed
Mean number of contraceptives distributed per shop every 2 weeks
Time frame: 18 months
Population: The customer feedback intervention ended due to the early termination of the parent study. As a result, these data were not collected beyond 12 months, therefore we cannot report on this 18 month outcome. The 12-month outcome is reported under Outcome 3. This study used the same participants as as the parent study and when the parent study terminated so did this study. All data collection ceased when the parent study terminated, after 12 months of this study.
Primary
Quantity of HIV Self-test Kits Distributed
Mean number of HIV self-test kits sold per shop every month
Time frame: 12 months
Population: It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Feedback | Quantity of HIV Self-test Kits Distributed | 153.53 Items sold | Standard Deviation 203.84 |
| Private Feedback | Quantity of HIV Self-test Kits Distributed | 181.13 Items sold | Standard Deviation 209.49 |
| Public Feedback | Quantity of HIV Self-test Kits Distributed | 239.13 Items sold | Standard Deviation 286.7 |
95% CI: [-1.87, 2.24]Regression, Linear
95% CI: [-0.73, 3.82]Regression, Linear
Primary
Quantity of HIV Self-test Kits Distributed
Mean number of HIV self-test kits distributed per shop every 2 weeks
Time frame: 18 months
Population: The customer feedback intervention ended due to the early termination of the parent study. As a result, these data were not collected beyond 12 months, therefore we cannot report on this 18 month outcome. The 12-month outcome is reported under Outcome 1. This study used the same participants as as the parent study and when the parent study terminated so did this study. All data collection ceased when the parent study terminated, after 12 months of this study.
Primary
Quantity of Sexual and Reproductive Health Products Sold
Mean number of sexual and reproductive health products sold per shop every month
Time frame: 12 months
Population: It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Feedback | Quantity of Sexual and Reproductive Health Products Sold | 9.68 Items sold | Standard Deviation 9.38 |
| Private Feedback | Quantity of Sexual and Reproductive Health Products Sold | 9.27 Items sold | Standard Deviation 9.06 |
| Public Feedback | Quantity of Sexual and Reproductive Health Products Sold | 10.70 Items sold | Standard Deviation 9.95 |
95% CI: [-2.92, 18]Regression, Linear
95% CI: [0.64, 31]Regression, Linear
Secondary
Quantity of Condoms Sold
Mean number of condoms sold per shop every month
Time frame: 12 months
Population: It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Feedback | Quantity of Condoms Sold | 3.19 items sold | Standard Deviation 11.16 |
| Private Feedback | Quantity of Condoms Sold | 6.36 items sold | Standard Deviation 21.18 |
| Public Feedback | Quantity of Condoms Sold | 4.63 items sold | Standard Deviation 11.12 |
95% CI: [-1.37, 8.63]Regression, Linear
95% CI: [-1.5, 4.5]Regression, Linear
Secondary
Quantity of Emergency Contraception Sold
Mean number of emergency contraception sold per shop every month
Time frame: 12 months
Population: It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Feedback | Quantity of Emergency Contraception Sold | 1.56 items sold | Standard Deviation 5.06 |
| Private Feedback | Quantity of Emergency Contraception Sold | 2.60 items sold | Standard Deviation 6.57 |
| Public Feedback | Quantity of Emergency Contraception Sold | 3.28 items sold | Standard Deviation 9.96 |
95% CI: [-0.36, 7.3]Regression, Linear
95% CI: [-0.54, 7.3]Regression, Linear
Secondary
Quantity of Oral Contraception Sold
Mean number of oral contraception sold per shop every month
Time frame: 12 months
Population: It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Feedback | Quantity of Oral Contraception Sold | 4.21 items sold | Standard Deviation 13.83 |
| Private Feedback | Quantity of Oral Contraception Sold | 3.30 items sold | Standard Deviation 8.58 |
| Public Feedback | Quantity of Oral Contraception Sold | 7.04 items sold | Standard Deviation 19.98 |
95% CI: [-3.38, 3.72]Regression, Linear
95% CI: [0.42, 15]Regression, Linear
Secondary
Quantity of Pregnancy Tests Sold
Mean number of pregnancy tests sold per shop every month
Time frame: 12 months
Population: It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Feedback | Quantity of Pregnancy Tests Sold | 2.91 items sold | Standard Deviation 6.99 |
| Private Feedback | Quantity of Pregnancy Tests Sold | 4.79 items sold | Standard Deviation 8.79 |
| Public Feedback | Quantity of Pregnancy Tests Sold | 5.15 items sold | Standard Deviation 11.8 |
95% CI: [-0.11, 5.02]Regression, Linear
95% CI: [0.33, 6.25]Regression, Linear