Suubi4Her: Combination Intervention for Adolescent Girls Transitioning Into Adulthood in Uganda

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-23

Study Completion Date

2021-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda

NCT07002866

HIV Prevention

RECRUITING NA

Suubi+Adherence4Youth

NCT05600621

HIV

ACTIVE_NOT_RECRUITING NA

Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence

NCT01790373

HIV

ACTIVE_NOT_RECRUITING NA

Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents

NCT04528732

HIV/AIDS

COMPLETED NA

Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda

NCT04030520

HIV/AIDS

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

HIV/AIDS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Youth Development Accounts (YDA)

Intervention Type 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)

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

Group Type EXPERIMENTAL

YDA + Multiple Family Groups (MFG)

Intervention Type 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

Usual Care

Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes