Trial Outcomes & Findings for Suubi4Her: Combination Intervention for Adolescent Girls Transitioning Into Adulthood in Uganda (NCT NCT03307226)
NCT ID: NCT03307226
Last Updated: 2024-09-03
Results Overview
Proportion of girls biologically confirmed STIs (Gonorrhea, Tirchomonas, and Chlamydia) or positive pregnancy test at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1260 participants
Primary outcome timeframe
Baseline
Results posted on
2024-09-03
Participant Flow
Participant milestones
| Measure |
Youth Development Accounts (YDA)
Youth Development Accounts (YDA)
* Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
* Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
Youth Development Accounts (YDA): Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
|
YDA + Multiple Family Groups (MFG)
YDA + Multiple Family Groups (MFG)
* Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
* Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs)
* Multiple Family Groups sessions focused on strengthening family relationships and mental health
YDA + Multiple Family Groups (MFG): Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development 12 Financial Management workshops on asset-building, saving and investing in Income Generating Activities (IGAs) 18 Multiple Family Groups sessions focused on strengthening family relationships and mental health
|
Usual Care
Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health
|
|---|---|---|---|
|
Overall Study
STARTED
|
471
|
381
|
408
|
|
Overall Study
COMPLETED
|
441
|
344
|
380
|
|
Overall Study
NOT COMPLETED
|
30
|
37
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Suubi4Her: Combination Intervention for Adolescent Girls Transitioning Into Adulthood in Uganda
Baseline characteristics by cohort
| Measure |
Youth Development Accounts (YDA)
n=471 Participants
Youth Development Accounts (YDA)
* Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
* Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
Youth Development Accounts (YDA): Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
|
YDA + Multiple Family Groups (MFG)
n=381 Participants
YDA + Multiple Family Groups (MFG)
* Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
* Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs)
* Multiple Family Groups sessions focused on strengthening family relationships and mental health
YDA + Multiple Family Groups (MFG): Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development 12 Financial Management workshops on asset-building, saving and investing in Income Generating Activities (IGAs) 18 Multiple Family Groups sessions focused on strengthening family relationships and mental health
|
Usual Care
n=408 Participants
Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health
|
Total
n=1260 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.5 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
15.4 years
STANDARD_DEVIATION 0.9 • n=7 Participants
|
15.2 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
15.4 years
STANDARD_DEVIATION 0.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
471 Participants
n=5 Participants
|
381 Participants
n=7 Participants
|
408 Participants
n=5 Participants
|
1260 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
471 Participants
n=5 Participants
|
381 Participants
n=7 Participants
|
408 Participants
n=5 Participants
|
1260 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Uganda
|
471 participants
n=5 Participants
|
381 participants
n=7 Participants
|
408 participants
n=5 Participants
|
1260 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselineProportion of girls biologically confirmed STIs (Gonorrhea, Tirchomonas, and Chlamydia) or positive pregnancy test at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
Outcome measures
| Measure |
Youth Development Accounts (YDA)
n=471 Participants
Youth Development Accounts (YDA)
* Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
* Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
Youth Development Accounts (YDA): Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
|
YDA + Multiple Family Groups (MFG)
n=381 Participants
YDA + Multiple Family Groups (MFG)
* Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
* Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs)
* Multiple Family Groups sessions focused on strengthening family relationships and mental health
YDA + Multiple Family Groups (MFG): Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development 12 Financial Management workshops on asset-building, saving and investing in Income Generating Activities (IGAs) 18 Multiple Family Groups sessions focused on strengthening family relationships and mental health
|
Usual Care
n=408 Participants
Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health
|
|---|---|---|---|
|
Proportion With STIs From Baseline to Follow-up Assessments
Number of girls biologically confirmed positive for STIs or positive pregnancy test at Baseline
|
43 Participants
|
20 Participants
|
29 Participants
|
|
Proportion With STIs From Baseline to Follow-up Assessments
Number of girls biologically confirmed negative for STIs or positive pregnancy test at baseline
|
428 Participants
|
361 Participants
|
379 Participants
|
PRIMARY outcome
Timeframe: 12 monthsProportion of girls biologically confirmed STIs (Gonorrhea, Trichomonas, and Chlamydia) or positive pregnancy test at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
Outcome measures
| Measure |
Youth Development Accounts (YDA)
n=457 Participants
Youth Development Accounts (YDA)
* Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
* Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
Youth Development Accounts (YDA): Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
|
YDA + Multiple Family Groups (MFG)
n=366 Participants
YDA + Multiple Family Groups (MFG)
* Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
* Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs)
* Multiple Family Groups sessions focused on strengthening family relationships and mental health
YDA + Multiple Family Groups (MFG): Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development 12 Financial Management workshops on asset-building, saving and investing in Income Generating Activities (IGAs) 18 Multiple Family Groups sessions focused on strengthening family relationships and mental health
|
Usual Care
n=396 Participants
Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health
|
|---|---|---|---|
|
Proportion With STIs From Baseline to Follow-up Assessments
Proportion of girls biologically confirmed positive for STIs or positive pregnancy test at 12 months
|
22 Participants
|
22 Participants
|
15 Participants
|
|
Proportion With STIs From Baseline to Follow-up Assessments
Proportion of girls biologically confirmed negative for STIs or positive pregnancy test at 12 months
|
435 Participants
|
344 Participants
|
381 Participants
|
SECONDARY outcome
Timeframe: BaselineProportion positive for HIV at baseline
Outcome measures
| Measure |
Youth Development Accounts (YDA)
n=471 Participants
Youth Development Accounts (YDA)
* Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
* Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
Youth Development Accounts (YDA): Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
|
YDA + Multiple Family Groups (MFG)
n=381 Participants
YDA + Multiple Family Groups (MFG)
* Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
* Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs)
* Multiple Family Groups sessions focused on strengthening family relationships and mental health
YDA + Multiple Family Groups (MFG): Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development 12 Financial Management workshops on asset-building, saving and investing in Income Generating Activities (IGAs) 18 Multiple Family Groups sessions focused on strengthening family relationships and mental health
|
Usual Care
n=408 Participants
Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health
|
|---|---|---|---|
|
Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)
Number positive for HIV
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)
Number negative for HIV
|
468 Participants
|
380 Participants
|
404 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: Viral load and CD4 data were not collected and hence the data cannot be reported.
For HIV+ participants, adherence to HIV treatment regimen outcomes as measured through viral load and CD4 counts
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every year for five yearsCost-effectiveness analyses measuring the cost of achieving an agreed upon benefit, such as an additional year of schooling, employment, or a reduction in a disease. Costs will be measured on a per person basis. The costs of the intervention will include all program costs. Research costs will not be included.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsProportion Positive for HIV Infections at 12 months
Outcome measures
| Measure |
Youth Development Accounts (YDA)
n=457 Participants
Youth Development Accounts (YDA)
* Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
* Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
Youth Development Accounts (YDA): Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
|
YDA + Multiple Family Groups (MFG)
n=366 Participants
YDA + Multiple Family Groups (MFG)
* Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
* Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs)
* Multiple Family Groups sessions focused on strengthening family relationships and mental health
YDA + Multiple Family Groups (MFG): Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development 12 Financial Management workshops on asset-building, saving and investing in Income Generating Activities (IGAs) 18 Multiple Family Groups sessions focused on strengthening family relationships and mental health
|
Usual Care
n=396 Participants
Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health
|
|---|---|---|---|
|
Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)
Number negative for HIV
|
453 Participants
|
364 Participants
|
392 Participants
|
|
Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)
Number positive for HIV
|
4 Participants
|
2 Participants
|
4 Participants
|
Adverse Events
Youth Development Accounts (YDA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
YDA + Multiple Family Groups (MFG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place