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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH113486-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Youth Development Accounts (YDA) | Experimental | Youth Development Accounts (YDA)
|
|
| YDA + Multiple Family Groups (MFG) | Experimental | YDA + Multiple Family Groups (MFG)
|
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| Usual Care | No Intervention | Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Youth Development Accounts (YDA) | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline |
| 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up) | Proportion positive for HIV at baseline | Baseline |
| Change in Adherence to HIV Treatment From Baseline to Follow-up Assessments |
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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.
Participants must be female.
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| Name | Affiliation | Role |
|---|---|---|
| Fred Ssewamala, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Center for Child Health and Development | Masaka | 256 | Uganda | |||
| International Center for Child Health and Development |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42030316 | Derived | Nabayinda J, Sensoy Bahar O, Namatovu P, Nabunya P, Kizito S, Kabarambi A, Thames A, Ssewamala FM. Acceptability of Suubi+Adherence intervention to improve ART adherence in Southern Uganda: A qualitative analysis. PLoS One. 2026 Apr 24;21(4):e0347112. doi: 10.1371/journal.pone.0347112. eCollection 2026. | |
| 40570278 | Derived | Ssewamala FM, Tozan Y, Brathwaite R, Kiyingi J, Namatovu P, Bahar OS, Nabunya P, Nartey PB, Neilands TB. Cost-Effectiveness of an Economic Empowerment and Family Intervention on Mental Health Among School-Going Adolescent Girls in Uganda, 2017-2022. Am J Public Health. 2025 Sep;115(9):1408-1416. doi: 10.2105/AJPH.2025.308135. Epub 2025 Jun 26. |
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Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per CFR Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Columbia University School of Social Work Office of Sponsored Projects' data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Youth Development Accounts (YDA) | 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) |
| FG001 | YDA + Multiple Family Groups (MFG) | 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 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 |
| FG002 | Usual Care | Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Youth Development Accounts (YDA) | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Count of Participants | Participants | Baseline |
|
baseline, 12 months, 24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Youth Development Accounts (YDA) | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fred Ssewamala | Washington University in St. Louis | 3149358521 | fms1@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2018 | Jul 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| YDA + Multiple Family Groups (MFG) | Behavioral | 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 |
|
For HIV+ participants, adherence to HIV treatment regimen outcomes as measured through viral load and CD4 counts
| baseline |
| 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. | Every year for five years |
| Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up) | Proportion Positive for HIV Infections at 12 months | 12 months |
| Masaka |
| Uganda |
| 37715767 | Derived | Karimli L, Nabunya P, Ssewamala FM, Dvalishvili D. Combining Asset Accumulation and Multifamily Group Intervention to Improve Mental Health for Adolescent Girls: A Cluster-Randomized Trial in Uganda. J Adolesc Health. 2024 Jan;74(1):78-88. doi: 10.1016/j.jadohealth.2023.08.012. Epub 2023 Sep 16. |
| 37062582 | Derived | Filiatreau LM, Tutlam N, Brathwaite R, Byansi W, Namuwonge F, Mwebembezi A, Sensoy-Bahar O, Nabunya P, Neilands TB, Cavazos-Rehg P, McKay M, Ssewamala FM. Effects of a Combination Economic Empowerment and Family Strengthening Intervention on Psychosocial Well-being Among Ugandan Adolescent Girls and Young Women: Analysis of a Cluster Randomized Controlled Trial (Suubi4Her). J Adolesc Health. 2023 May;72(5S):S33-S40. doi: 10.1016/j.jadohealth.2022.11.250. |
| 37062580 | Derived | Byansi W, Ssewamala FM, Neilands TB, Mwebembezi A, Nakigozi G. Patterns of and Factors Associated With Mental Health Service Utilization Among School-Going Adolescent Girls in Southwestern Uganda: A Latent Class Analysis. J Adolesc Health. 2023 May;72(5S):S24-S32. doi: 10.1016/j.jadohealth.2022.09.037. |
| 36747149 | Derived | Sensoy Bahar O, Nabunya P, Namuwonge F, Samtani S, Ssentumbwe V, Namuli F, Magorokosho N, Ssewamala FM. "It gives you a road map of what to do to solve your problems": acceptability of a combination HIV prevention intervention among adolescent girls in Uganda. BMC Public Health. 2023 Feb 6;23(1):249. doi: 10.1186/s12889-023-15083-2. |
| 36603167 | Derived | Ssewamala FM, Brathwaite R, Neilands TB. Economic Empowerment, HIV Risk Behavior, and Mental Health Among School-Going Adolescent Girls in Uganda: Longitudinal Cluster-Randomized Controlled Trial, 2017-2022. Am J Public Health. 2023 Mar;113(3):306-315. doi: 10.2105/AJPH.2022.307169. Epub 2023 Jan 5. |
| 35660128 | Derived | Byansi W, Ssewamala FM, Neilands TB, Sensoy Bahar O, Nabunya P, Namuwonge F, McKay MM. The Short-Term Impact of a Combination Intervention on Depressive Symptoms Among School-Going Adolescent Girls in Southwestern Uganda: The Suubi4Her Cluster Randomized Trial. J Adolesc Health. 2022 Sep;71(3):301-307. doi: 10.1016/j.jadohealth.2022.04.008. Epub 2022 Jun 1. |
| 33238965 | Derived | Nabunya P, Damulira C, Byansi W, Muwanga J, Bahar OS, Namuwonge F, Ighofose E, Brathwaite R, Tumwesige W, Ssewamala FM. Prevalence and correlates of depressive symptoms among high school adolescent girls in southern Uganda. BMC Public Health. 2020 Nov 25;20(1):1792. doi: 10.1186/s12889-020-09937-2. |
| 29871619 | Derived | Ssewamala FM, Bermudez LG, Neilands TB, Mellins CA, McKay MM, Garfinkel I, Sensoy Bahar O, Nakigozi G, Mukasa M, Stark L, Damulira C, Nattabi J, Kivumbi A. Suubi4Her: a study protocol to examine the impact and cost associated with a combination intervention to prevent HIV risk behavior and improve mental health functioning among adolescent girls in Uganda. BMC Public Health. 2018 Jun 5;18(1):693. doi: 10.1186/s12889-018-5604-5. |
| BG001 | YDA + Multiple Family Groups (MFG) | 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 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 |
| BG002 | Usual Care | Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | YDA + Multiple Family Groups (MFG) | 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 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 |
| OG002 | Usual Care | Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health |
|
|
| 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) | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up) | Proportion positive for HIV at baseline | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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 | Viral load and CD4 data were not collected and hence the data cannot be reported. | Posted | baseline |
|
|
| 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. | Not Posted | Feb 2025 | Every year for five years | 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 | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 471 |
| 0 |
| 471 |
| 0 |
| 471 |
| EG001 | YDA + Multiple Family Groups (MFG) | 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 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 | 1 | 381 | 0 | 381 | 0 | 381 |
| EG002 | Usual Care | Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health | 0 | 408 | 0 | 408 | 0 | 408 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
|