NCT03307226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

March 23, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

September 3, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

2.9 years

First QC Date

October 2, 2017

Results QC Date

July 22, 2024

Last Update Submit

August 26, 2024

Conditions

HIV/AIDS

Keywords

SuubiAdolescent GirlsPovertyEconomic Empowement InterventionsAdherence to HIV antiretroviral therapyHIV/AIDS-impacted girlsUgandaCost-effectiveness

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

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

    Baseline

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

    baseline

  • Cost-Effectiveness Analyses

    Every year for five years

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

    12 months

Study Arms (3)

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)

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

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

Interventions

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)

Youth Development Accounts (YDA)
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

YDA + Multiple Family Groups (MFG)

Eligibility Criteria

Age14 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be female.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • (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)

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

International Center for Child Health and Development

Masaka, 256, Uganda

Location

International Center for Child Health and Development

Masaka, Uganda

Location

Related Publications (9)

  • 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.

    PMID: 40570278DERIVED

  • 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.

    PMID: 37715767DERIVED

  • 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.

    PMID: 37062582DERIVED

  • 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.

    PMID: 37062580DERIVED

  • 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.

    PMID: 36747149DERIVED

  • 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.

    PMID: 36603167DERIVED

  • 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.

    PMID: 35660128DERIVED

  • 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.

    PMID: 33238965DERIVED

  • 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.

    PMID: 29871619DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Dr. Fred Ssewamala
Organization
Washington University in St. Louis
fms1@wustl.edu
3149358521

Study Officials

  • Fred Ssewamala, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 11, 2017

Study Start

March 23, 2018

Primary Completion

February 10, 2021

Study Completion

March 30, 2021

Last Updated

September 3, 2024

Results First Posted

September 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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.

Locations

UG(2)