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Suubi4Her: Combination Intervention for Adolescent Girls Transitioning Into Adulthood in Uganda

Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03307226
Enrollment
1260
Registered
2017-10-11
Start date
2018-03-23
Completion date
2021-03-30
Last updated
2024-09-03

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

Conditions

HIV/AIDS

Keywords

Suubi, Adolescent Girls, Poverty, Economic Empowement Interventions, Adherence to HIV antiretroviral therapy, HIV/AIDS-impacted girls, Uganda, Cost-effectiveness

Brief summary

This study examines the impact and cost associated with Suubi4Her, an innovative combination intervention that aims to prevent HIV risk behaviors among 15-17 year-old girls living in communities heavily affected by poverty and HIV/AIDS in Uganda. Participants will be randomly assigned at the school level into one of three study conditions: 1) Savings (Youth Development Accounts - YDA) - with a 1:1 incentive match rate - for education and microenterprise development; 2) Savings (YDA) + Multiple Family Groups intervention; 3) Control condition receiving standard health and sex education provided in schools. The intervention will last for 24 months. Assessments will be conducted at baseline, 12, 24 and 36 months. Assessments will include biologically confirmed STIs, proportion of HIV infections during the study period, and for HIV+ participants markers for ART adherence. The study aims to examine the impact of the Suubi4Her intervention on behavioral health functioning, and protecting adolescent girls against known HIV risk factors. The study will also examine the cost-effectiveness of each intervention condition.

Detailed description

Aligned with the NIH priority of addressing disparities in new HIV infections and the UNAIDS call for implementing combination HIV prevention approaches, the proposed study will examine the impact and cost associated with Suubi4Her, an innovative combination intervention that aims to prevent HIV risk behaviors among 14-17 year-old girls living in communities heavily affected by poverty and HIV/AIDS in Uganda. In sub-Saharan Africa (SSA), family financial stress can compromise the support available to adolescents, with girls living in poverty exhibiting higher rates of risky sexual behavior increasing their vulnerability in acquiring HIV and other STIs. At the same time, internalizing mental health disorders such as depression and low self-esteem disproportionately affect girls and may be contributing to HIV risk behavior. Against that backdrop, support over and above health and sex education is needed to help adolescent girls in SSA successfully transition into young adulthood. The proposed study is informed by two previously tested interventions - asset-based matched savings accounts (YDA) and family strengthening through Multiple Family Groups (MFG) which have successfully been implemented with younger primary school-going adolescents. Suubi4Her will test the theory that youth cognitive and behavioral change is influenced by economic stability while examining if enhanced intra-familial support and communication are needed to maintain positive behavioral health functioning and reinforce engagement in protective health behaviors. Nested within 47 secondary schools across four districts of Uganda heavily impacted by HIV/AIDS, 1260 older girls (ages 14-17 at enrollment) will be randomly assigned (at school level) to one of three study conditions: 1) Savings (Youth Development Accounts - YDA)- with a 1:1 incentive match rate - for education and microenterprise development; 2) Savings (YDA) + MFG intervention; 3) Control condition receiving standard health and sex education provided in schools. The intervention will be provided for 24 months. Assessments at baseline,12, 24, and 36-months will include biomedical data to measure our primary sexual-risk outcome:1) proportion of girls' biologically confirmed STIs (Gonorrhea, Trichomonas and Chlamydia); and secondary outcomes: 2) the proportion of new HIV infections during the study period, and 3) for HIV+ girls, viral load and CD4 as markers of ART adherence. The study aims are to: 1) Examine whether the Suubi4Her intervention is effective in protecting adolescent girls against known HIV risk factors (including economically-motivated sex and intimate partner violence). 2) Elucidate the effects of the Suubi4Her intervention on behavioral health functioning (i.e., depression, self-efficacy and hopelessness) and examine the effects of these variables as potential mechanisms of change, mediating the relationship between each intervention and HIV risk reduction. 3) Evaluate the cost-effectiveness of each intervention condition. The study will also use the Child Depression Index and Beck Hopelessness Scale to examine the efficacy of interventions in improving mental health in this vulnerable population.

Interventions

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)

BEHAVIORALYDA + 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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

(1) female; (2) enrolled in first year of secondary school in Rakai, Masaka, Lwengo or Kalungu districts; (3) age 14-17 years; (4) living within a family (broadly defined and not an institution or orphanage, as those in institutions have different familial needs)

Exclusion criteria

(5) they have a cognitive or severe psychiatric impairment that would prevent comprehension of study procedures as assessed during the Informed Consent process or; (6) they are unwilling or unable to commit to completing the study. We will not exclude girls because of their HIV, STI and/or pregnancy status. Analysis will be adjusted to account for these baseline factors. Girls testing positive for HIV, STI or pregnancy will be referred for care and support.

Design outcomes

Primary

MeasureTime frameDescription
Proportion With STIs From Baseline to Follow-up AssessmentsBaselineProportion 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)

Secondary

MeasureTime frameDescription
Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)BaselineProportion positive for HIV at baseline
Change in Adherence to HIV Treatment From Baseline to Follow-up AssessmentsbaselineFor HIV+ participants, adherence to HIV treatment regimen outcomes as measured through viral load and CD4 counts
Cost-Effectiveness AnalysesEvery 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.

Countries

Uganda

Participant flow

Participants by arm

ArmCount
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)
471
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
381
Usual Care
Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health
408
Total1,260

Baseline characteristics

CharacteristicYouth Development Accounts (YDA)TotalUsual CareYDA + Multiple Family Groups (MFG)
Age, Continuous15.5 years
STANDARD_DEVIATION 0.8
15.4 years
STANDARD_DEVIATION 0.9
15.2 years
STANDARD_DEVIATION 0.9
15.4 years
STANDARD_DEVIATION 0.9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
471 Participants1260 Participants408 Participants381 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
Uganda
471 participants1260 participants408 participants381 participants
Sex: Female, Male
Female
471 Participants1260 Participants408 Participants381 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 4711 / 3810 / 408
other
Total, other adverse events
0 / 4710 / 3810 / 408
serious
Total, serious adverse events
0 / 4710 / 3810 / 408

Outcome results

Primary

Proportion With STIs From Baseline to Follow-up Assessments

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)

Time frame: Baseline

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Youth Development Accounts (YDA)Proportion With STIs From Baseline to Follow-up AssessmentsNumber of girls biologically confirmed positive for STIs or positive pregnancy test at Baseline43 Participants
Youth Development Accounts (YDA)Proportion With STIs From Baseline to Follow-up AssessmentsNumber of girls biologically confirmed negative for STIs or positive pregnancy test at baseline428 Participants
YDA + Multiple Family Groups (MFG)Proportion With STIs From Baseline to Follow-up AssessmentsNumber of girls biologically confirmed positive for STIs or positive pregnancy test at Baseline20 Participants
YDA + Multiple Family Groups (MFG)Proportion With STIs From Baseline to Follow-up AssessmentsNumber of girls biologically confirmed negative for STIs or positive pregnancy test at baseline361 Participants
Usual CareProportion With STIs From Baseline to Follow-up AssessmentsNumber of girls biologically confirmed positive for STIs or positive pregnancy test at Baseline29 Participants
Usual CareProportion With STIs From Baseline to Follow-up AssessmentsNumber of girls biologically confirmed negative for STIs or positive pregnancy test at baseline379 Participants
Primary

Proportion With STIs From Baseline to Follow-up Assessments

Proportion 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)

Time frame: 12 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Youth Development Accounts (YDA)Proportion With STIs From Baseline to Follow-up AssessmentsProportion of girls biologically confirmed positive for STIs or positive pregnancy test at 12 months22 Participants
Youth Development Accounts (YDA)Proportion With STIs From Baseline to Follow-up AssessmentsProportion of girls biologically confirmed negative for STIs or positive pregnancy test at 12 months435 Participants
YDA + Multiple Family Groups (MFG)Proportion With STIs From Baseline to Follow-up AssessmentsProportion of girls biologically confirmed positive for STIs or positive pregnancy test at 12 months22 Participants
YDA + Multiple Family Groups (MFG)Proportion With STIs From Baseline to Follow-up AssessmentsProportion of girls biologically confirmed negative for STIs or positive pregnancy test at 12 months344 Participants
Usual CareProportion With STIs From Baseline to Follow-up AssessmentsProportion of girls biologically confirmed negative for STIs or positive pregnancy test at 12 months381 Participants
Usual CareProportion With STIs From Baseline to Follow-up AssessmentsProportion of girls biologically confirmed positive for STIs or positive pregnancy test at 12 months15 Participants
Secondary

Change in Adherence to HIV Treatment From Baseline to Follow-up Assessments

For HIV+ participants, adherence to HIV treatment regimen outcomes as measured through viral load and CD4 counts

Time frame: baseline

Population: Viral load and CD4 data were not collected and hence the data cannot be reported.

Secondary

Cost-Effectiveness Analyses

Cost-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.

Time frame: Every year for five years

Secondary

Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)

Proportion positive for HIV at baseline

Time frame: Baseline

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Youth Development Accounts (YDA)Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)Number positive for HIV3 Participants
Youth Development Accounts (YDA)Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)Number negative for HIV468 Participants
YDA + Multiple Family Groups (MFG)Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)Number positive for HIV1 Participants
YDA + Multiple Family Groups (MFG)Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)Number negative for HIV380 Participants
Usual CareProportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)Number positive for HIV4 Participants
Usual CareProportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)Number negative for HIV404 Participants
Secondary

Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)

Proportion Positive for HIV Infections at 12 months

Time frame: 12 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Youth Development Accounts (YDA)Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)Number positive for HIV4 Participants
Youth Development Accounts (YDA)Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)Number negative for HIV453 Participants
YDA + Multiple Family Groups (MFG)Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)Number positive for HIV2 Participants
YDA + Multiple Family Groups (MFG)Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)Number negative for HIV364 Participants
Usual CareProportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)Number positive for HIV4 Participants
Usual CareProportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)Number negative for HIV392 Participants

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026