HIV/AIDSNCT03307226
Suubi4Her: Combination Intervention for Adolescent Girls Transitioning Into Adulthood in Uganda
A study testing Youth Development Accounts (YDA) and YDA + Multiple Family Groups (MFG) in people with HIV/AIDS, run by Washington University School of Medicine at 2 sites in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Youth Development Accounts (YDA) and YDA + Multiple Family Groups (MFG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,260 participants
- Where
- 2 sitesUganda
- Study dates
- 23 Mar 2018to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
International Center for Child Health and Development
Masaka, 256
International Center for Child Health and Development
Masaka
About this study
Official title: Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Youth Development Accounts (YDA), YDA + Multiple Family Groups (MFG)
- Keywords
- Suubi, Adolescent Girls, Poverty, Economic Empowement Interventions, Adherence to HIV antiretroviral therapy, HIV/AIDS-impacted girls, Uganda, Cost-effectiveness
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth Development Accounts (YDA)Behavioural
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)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Youth Development Accounts (YDA) | Experimental | 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) Receives: Behavioral: Youth Development Accounts (YDA) |
| YDA + Multiple Family Groups (MFG) | Experimental | 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 Receives: Behavioral: YDA + Multiple Family Groups (MFG) |
| Usual Care | No intervention | Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 12 months
Secondary outcomes (4)
Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)
Proportion positive for HIV at baseline
Measured: 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
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start23 Mar 2018
- Primary completion10 Feb 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Fred Ssewamala, Washington University School of Medicine
- Investigators
- Fred Ssewamala, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307226
- Sponsor's protocol ID
- 201703102
- Other IDs
- 1R01MH113486-01
- Status last verified
- Aug 2024
- First submitted
- 2 Oct 2017
- Last updated
- 3 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 42030316Ssewamala 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.
PubMed 40570278Karimli 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.
PubMed 37715767Filiatreau 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.
PubMed 37062582Byansi 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.
PubMed 37062580Sensoy 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.
PubMed 36747149Ssewamala 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.
PubMed 36603167Byansi 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.
PubMed 35660128Nabunya 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.
PubMed 33238965Ssewamala 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.
PubMed 29871619
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda
- ClinicalTrials.gov ID
- NCT03307226
- Acronym / sponsor ID
- 201703102
- Conditions
- HIV/AIDS
- Keywords
- Suubi, Adolescent Girls, Poverty, Economic Empowement Interventions, Adherence to HIV antiretroviral therapy, HIV/AIDS-impacted girls, Uganda, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,260 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Posted 3 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Youth Development Accounts (YDA) | Experimental | 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) | Experimental | Behavioral: 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 |
| Usual Care | No intervention | –Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | 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 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 | Behavioural | YDA + Multiple Family Groups (MFG) |
Primary outcome
Proportion With STIs From Baseline to Follow-up Assessments
Time frame: Baseline
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)
Proportion With STIs From Baseline to Follow-up Assessments
Time frame: 12 months
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)
4 secondary outcomes
Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)
Time frame: Baseline
Change in Adherence to HIV Treatment From Baseline to Follow-up Assessments
Time frame: baseline
Cost-Effectiveness Analyses
Time frame: Every year for five years
Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42030316Nabayinda 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.
- Derived from this study: PubMed 40570278Ssewamala 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.
- Derived from this study: PubMed 37715767Karimli 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.
- Derived from this study: PubMed 37062582Filiatreau 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.
- Derived from this study: PubMed 37062580Byansi 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.
- Derived from this study: PubMed 36747149Sensoy 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.
- Derived from this study: PubMed 36603167Ssewamala 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.
- Derived from this study: PubMed 35660128Byansi 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.
- Derived from this study: PubMed 33238965Nabunya 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.
- Derived from this study: PubMed 29871619Ssewamala 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.
- Individual participant dataSharing planned: 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.
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RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Ssewamala, PhD principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youth Development Accounts (YDA) and YDA + Multiple Family Groups (MFG) in people with HIV/AIDS, run by Washington University School of Medicine at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion With STIs From Baseline to Follow-up Assessments (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03307226, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.