Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda

• ClinicalTrials.gov Identifier: NCT03307226
• Recruitment Status: Active, not recruiting
• First Posted: October 11, 2017
• Last Update Posted: May 18, 2020
• Sponsor: Washington University School of Medicine
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV/AIDS	Behavioral: Youth Development Accounts (YDA); Behavioral: YDA + Multiple Family Groups (MFG)	Not Applicable

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

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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)	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); 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); 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

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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)
2. 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
3. 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.

Eligibility Criteria

• 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

Criteria

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.

Contacts and Locations

Locations

Uganda

International Center for Child Health and Development

Masaka, Uganda, 256

International Center for Child Health and Development

Masaka, Uganda

Sponsors and Collaborators

Washington University School of Medicine

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Fred Ssewamala, PhD; Washington University School of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• 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
• 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

Keywords provided by Washington University School of Medicine:

Suubi; Adolescent Girls; Poverty; Economic Empowement Interventions; Adherence to HIV antiretroviral therapy; HIV/AIDS-impacted girls; Uganda; Cost-effectiveness

Additional relevant MeSH terms:

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