Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03307226 |
Recruitment Status :
Active, not recruiting
First Posted : October 11, 2017
Last Update Posted : May 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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HIV/AIDS | Behavioral: Youth Development Accounts (YDA) Behavioral: YDA + Multiple Family Groups (MFG) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1260 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Prevention |
Official Title: | Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda |
Actual Study Start Date : | March 23, 2018 |
Estimated Primary Completion Date : | February 1, 2022 |
Estimated Study Completion Date : | August 31, 2022 |
Arm | Intervention/treatment |
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Experimental: Youth Development Accounts (YDA)
Youth Development Accounts (YDA)
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Behavioral: 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) |
Experimental: YDA + Multiple Family Groups (MFG)
YDA + Multiple Family Groups (MFG)
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Behavioral: 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 |
No Intervention: Usual Care
Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health
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- Change in proportion of STIs from baseline to follow-up assessments [ Time Frame: Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up) ]Change in proportion of girls biologically confirmed STIs (Gonorrhea, Tirchomonas, and Chlamydia) at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
- Change in proportion of new HIV infections [ Time Frame: Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up) ]Change in the proportion of new HIV infections at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
- Change in adherence to HIV treatment from baseline to follow-up assessments [ Time Frame: Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up) ]For HIV+ participants, adherence to HIV treatment regimen outcomes as measured through viral load and CD4 counts
- Cost-Effectiveness Analyses [ Time Frame: Every year for five years ]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.

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Ages Eligible for Study: | 14 Years to 17 Years (Child) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Participants must be female. |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307226
Uganda | |
International Center for Child Health and Development | |
Masaka, Uganda, 256 | |
International Center for Child Health and Development | |
Masaka, Uganda |
Principal Investigator: | Fred Ssewamala, PhD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT03307226 |
Other Study ID Numbers: |
201703102 1R01MH113486-01 ( U.S. NIH Grant/Contract ) |
First Posted: | October 11, 2017 Key Record Dates |
Last Update Posted: | May 18, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Suubi Adolescent Girls Poverty Economic Empowement Interventions |
Adherence to HIV antiretroviral therapy HIV/AIDS-impacted girls Uganda Cost-effectiveness |
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |