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An Assessment of an HIV Prevention Intervention (Project AIM) Among Junior Secondary School Students in Eastern Botswana (AIM)

12. februar 2018 opdateret af: Centers for Disease Control and Prevention

An Assessment of an HIV Prevention Intervention (Project AIM) on Youth Sexual Intentions, Sexual Behaviors and HSV-2 Incidence and Prevalence in Junior Secondary Schools in Eastern Botswana.

The purpose of this study is to examine the effectiveness of an HIV prevention intervention called Project AIM (Adult Identity Mentoring) to delay onset of sexual activity and reduce sexual risk behaviors among students (approximate ages 12- 17 years) in junior secondary schools (Form 1 - 3) in Eastern Botswana.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Few behavioral intervention models exist that focus on pre-sexually active adolescents in high-prevalence environments. As a result, there is a paucity of scientific research on HIV education models that impact risk factors among pre-sexual adolescents or that address the underlying causes and contextual factors associated with the sexual risk behaviors that leave adolescents vulnerable to HIV infection. Project AIM (Adult Identity Mentoring) is an evidence-based youth development HIV prevention intervention designed for youth ages 11-14 years. The goals of Project AIM are to provide youth with the motivation to enact safe choices and to address social barriers to sexual risk prevention such as hopelessness, peer pressure, and risk opportunities in low income environments. Results of a United States (U.S.)-based behavioral study have demonstrated a positive effect in reducing sexual intentions and increasing sexual abstinence. Project AIM has not previously been evaluated for use in an African context.

The purpose of this 50 site, stratified, cluster, randomized control trial is to examine the efficacy of Project AIM to delay onset of sexual activity and reduce sexual risk behaviors among students (approximate ages 12- 17 years) in junior secondary schools (JSS) in Eastern Botswana.The study will involve enrolling a longitudinal cohort consisting of Form 1 students who will be randomized to either the intervention (Project AIM) or control condition and followed from the start of the Form 1 year to the end of the Form 3 year.

Outcomes will be assessed through participant self-report of sexual risk behavior and HSV-2 testing as a biomarker of self-reported sexual activity. Participants will complete a behavioral survey three times (baseline, 12 months, and 24 months) and HSV-2 testing two times (baseline and 24 months).

Effective implementation of Project AIM as part of the school health curriculum in Botswana would provide an evidence-based, in-school program option to aid and inform HIV prevention efforts for young adolescents across southern Africa. Implementation of the program will also build on existing programmatic efforts and infrastructure and attempt to demonstrate how the addition of an evidence-based, multi-component HIV prevention program will strengthen current youth HIV prevention policies and programming. In addition, rates of herpes simplex virus type 2 (HSV-2) from the study will provide the region with sexual risk behavior data and HSV-2 prevalence estimates for young adolescents in Eastern Botswana, which can inform public health recommendations as well as national policies for sexual/reproductive health and education among this population.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4732

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Eastern Botswana
      • Multiple Locations, Eastern Botswana, Botswana
        • 50 Junior Secondary schools

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Currently enrolled in Form 1 at one of the 50 selected schools (longitudinal cohort)
  • Fluent and literate in English or Setswana
  • Able and willing to provide written informed assent (age 17 or under) or informed consent (age 18 and over)
  • Parent/guardian provides permission (if age 17 or under) for child to participate

Exclusion Criteria:

- All youth who meet the inclusion criteria may fully participate in the study. No sub-segments of the population will be excluded from participation. Individual students may be excluded from participation by school or study staff due to circumstances in which participation is deemed to not be in the best interest of the student, such as excessive emotional distress.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Standard of Care
All Form 1 learners at 25 of the 50 schools will receive HIV prevention sessions from the Botswana life skills education program for junior secondary school students called LIVING.
Eksperimentel: Intervention
Form 1 learners at the 25 intervention schools will receive the Project AIM intervention and LIVING (standard of care).
Project AIM consists of 14 sessions that are delivered twice a week. Each session is 40 minutes long.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Difference in HSV-2 incidence between the intervention and control arm
Tidsramme: Baseline and 24 months
Baseline and 24 months

Sekundære resultatmål

Resultatmål
Tidsramme
Self-reported sexual and sexual risk-related behavior measured by sexual initiation, number of sexual partners and frequency of alcohol use, sexual intercourse, and condom use
Tidsramme: Longitudinal Cohort: baseline, 12 months, and 24 months
Longitudinal Cohort: baseline, 12 months, and 24 months
Sexual thoughts measured by frequency of thoughts about engaging in sexual activity
Tidsramme: Longitudinal Cohort: baseline, 12 months, and 24 months
Longitudinal Cohort: baseline, 12 months, and 24 months
Attitudes towards education and frequency of thoughts and feelings about the future and hopelessness
Tidsramme: Longitudinal Cohort: baseline, 12 months, and 24 months
Longitudinal Cohort: baseline, 12 months, and 24 months
Attitudes towards partner concurrency, transactional sex, and sexual risk communication with a partner
Tidsramme: Longitudinal Cohort: baseline, 12 months, and 24 months
Longitudinal Cohort: baseline, 12 months, and 24 months
Intention to engage in sexual activity
Tidsramme: Longitudinal Cohort:baseline, 12 months, and 24 months
Longitudinal Cohort:baseline, 12 months, and 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Kim S Miller, PhD, Centers for Disease Control and Prevention
  • Ledende efterforsker: Nontobeko S Tau, Botswana: Minsitry of Education and Skills Development

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2014

Primær færdiggørelse (Faktiske)

1. september 2017

Studieafslutning (Faktiske)

1. september 2017

Datoer for studieregistrering

Først indsendt

6. januar 2015

Først indsendt, der opfyldte QC-kriterier

22. maj 2015

Først opslået (Skøn)

28. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2018

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 6451

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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