An interventional study of Youth Development Accounts (YDA) and YDA + Multiple Family Groups (MFG) in HIV/AIDS, sponsored by Washington University School of Medicine. Completed at 2 sites in Uganda. Open to female participants aged 14 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention
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Among 17 studies in Acquired Immunodeficiency Syndrome by Washington University School of Medicine — 1 open to participants now, 4 under way, none of them phase 3. Acquired Immunodeficiency Syndrome · Washington University School of Medicine.
Among the 17 studies in Acquired Immunodeficiency Syndrome by Washington University School of Medicine, this one is the 6th largest by enrollment, is the only one that started in 2018, is one of 13 with no phase, and was the 6th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →1 of the 17 studies in Acquired Immunodeficiency Syndrome by Washington University School of Medicine is open now, in 1 country. Recruiting first, the newest first:
Washington University School of Medicine · Sites in Zambia
Ages 18+
By country, each count listing its studies:
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 14 Years to 17 Years · female · healthy volunteers too.
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17 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,260 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 388 across the 17 interventional studies. Of the 10 that completed or were terminated, 6 (60%) have results posted.
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Washington University School of Medicine is the lead sponsor of 1,805 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 17 studies in Acquired Immunodeficiency Syndrome by Washington University School of Medicine, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(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 process or; (6) they are unwilling or unable to commit to completing the study.
We will not exclude girls because of their , 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Behavioral: Youth Development Accounts (YDA)
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
Behavioral: YDA + Multiple Family Groups (MFG)
Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health
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) 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
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
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
Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)
Proportion positive for HIV at baseline
Time frame: Baseline
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
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
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
| Milestone | Youth Development Accounts (YDA) | YDA + Multiple Family Groups (MFG) | Usual Care |
|---|---|---|---|
| Started | 471 | 381 | 408 |
| Completed | 441 | 344 | 380 |
| Not completed | 30 | 37 | 28 |
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)
| Participants | Youth Development Accounts (YDA) | YDA + Multiple Family Groups (MFG) | Usual Care |
|---|---|---|---|
| Number of girls biologically confirmed positive for STIs or positive pregnancy test at Baseline | 43 | 20 | 29 |
| Number of girls biologically confirmed negative for STIs or positive pregnancy test at baseline | 428 | 361 | 379 |
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)
| Participants | Youth Development Accounts (YDA) | YDA + Multiple Family Groups (MFG) | Usual Care |
|---|---|---|---|
| Proportion of girls biologically confirmed positive for STIs or positive pregnancy test at 12 months | 22 | 22 | 15 |
| Proportion of girls biologically confirmed negative for STIs or positive pregnancy test at 12 months | 435 | 344 | 381 |
Proportion positive for HIV at baseline
| Participants | Youth Development Accounts (YDA) | YDA + Multiple Family Groups (MFG) | Usual Care |
|---|---|---|---|
| Number positive for HIV | 3 | 1 | 4 |
| Number negative for HIV | 468 | 380 | 404 |
For HIV+ participants, adherence to HIV treatment regimen outcomes as measured through viral load and CD4 counts
No measurements were reported for this outcome.
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.
Results for this outcome have not been posted.
Proportion Positive for HIV Infections at 12 months
| Participants | Youth Development Accounts (YDA) | YDA + Multiple Family Groups (MFG) | Usual Care |
|---|---|---|---|
| Number positive for HIV | 4 | 2 | 4 |
| Number negative for HIV | 453 | 364 | 392 |
Collected over baseline, 12 months, 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Youth Development Accounts (YDA) | 0/471 (0%) | 0/471 (0%) | 0/471 (0%) |
| YDA + Multiple Family Groups (MFG) | 1/381 (0.3%) | 0/381 (0%) | 0/381 (0%) |
| Usual Care | 0/408 (0%) | 0/408 (0%) | 0/408 (0%) |
| Age, Continuous(years) | Youth Development Accounts (YDA) | YDA + Multiple Family Groups (MFG) | Usual Care | Total |
|---|---|---|---|---|
| Mean | 15.5 ± 0.8 | 15.4 ± 0.9 | 15.2 ± 0.9 | 15.4 ± 0.9 |
| Sex: Female, Male(Participants) | Youth Development Accounts (YDA) | YDA + Multiple Family Groups (MFG) | Usual Care | Total |
|---|---|---|---|---|
| Female | 471 | 381 | 408 | 1260 |
| Male | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Youth Development Accounts (YDA) | YDA + Multiple Family Groups (MFG) | Usual Care | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 471 | 381 | 408 | 1260 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Youth Development Accounts (YDA) | YDA + Multiple Family Groups (MFG) | Usual Care | Total |
|---|---|---|---|---|
| Uganda | 471 | 381 | 408 | 1260 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Ran from Mar 2018 to primary completion in Feb 2021, 34 months.
Results were first posted in Sep 2024, 3 years 6 months after primary completion.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 34 months is above that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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