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

2 maj 2022 uppdaterad av: Fred Ssewamala, Washington University School of Medicine
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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

1260

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Masaka, Uganda, 256
        • International Center for Child Health and Development
      • Masaka, Uganda
        • International Center for Child Health and Development

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

14 år till 17 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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)
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)
Experimentell: 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
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
Inget ingripande: Usual Care
Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in proportion of STIs from baseline to follow-up assessments
Tidsram: 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)
Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in proportion of new HIV infections
Tidsram: 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)
Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
Change in adherence to HIV treatment from baseline to follow-up assessments
Tidsram: 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
Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
Cost-Effectiveness Analyses
Tidsram: 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.
Every year for five years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Fred Ssewamala, PhD, Washington University School of Medicine

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

23 mars 2018

Primärt slutförande (Faktisk)

10 februari 2021

Avslutad studie (Faktisk)

30 mars 2021

Studieregistreringsdatum

Först inskickad

2 oktober 2017

Först inskickad som uppfyllde QC-kriterierna

5 oktober 2017

Första postat (Faktisk)

11 oktober 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 maj 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 maj 2022

Senast verifierad

1 maj 2022

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på HIV/AIDS

Kliniska prövningar på Youth Development Accounts (YDA)

3
Prenumerera