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Trial record 45 of 126 for:    HSV-2

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

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ClinicalTrials.gov Identifier: NCT02455583
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
Ministry of Education and Skills Development, Botswana
Education Development Center, Inc.
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Project AIM (Adult Identity Mentoring) Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4732 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : August 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: 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.
Experimental: Intervention
Form 1 learners at the 25 intervention schools will receive the Project AIM intervention and LIVING (standard of care).
Behavioral: Project AIM (Adult Identity Mentoring)
Project AIM consists of 14 sessions that are delivered twice a week. Each session is 40 minutes long.




Primary Outcome Measures :
  1. Difference in HSV-2 incidence between the intervention and control arm [ Time Frame: Baseline and 24 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Longitudinal Cohort: baseline, 12 months, and 24 months ]
  2. Sexual thoughts measured by frequency of thoughts about engaging in sexual activity [ Time Frame: Longitudinal Cohort: baseline, 12 months, and 24 months ]
  3. Attitudes towards education and frequency of thoughts and feelings about the future and hopelessness [ Time Frame: Longitudinal Cohort: baseline, 12 months, and 24 months ]
  4. Attitudes towards partner concurrency, transactional sex, and sexual risk communication with a partner [ Time Frame: Longitudinal Cohort: baseline, 12 months, and 24 months ]
  5. Intention to engage in sexual activity [ Time Frame: Longitudinal Cohort:baseline, 12 months, and 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455583


Locations
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Botswana
50 Junior Secondary schools
Multiple Locations, Eastern Botswana, Botswana
Sponsors and Collaborators
Centers for Disease Control and Prevention
Ministry of Education and Skills Development, Botswana
Education Development Center, Inc.
Investigators
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Principal Investigator: Kim S Miller, PhD Centers for Disease Control and Prevention
Principal Investigator: Nontobeko S Tau Botswana: Minsitry of Education and Skills Development

Publications:
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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02455583     History of Changes
Other Study ID Numbers: 6451
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: July 2017
Keywords provided by Centers for Disease Control and Prevention:
HIV prevention
Sexual activity biomarker
Youth
Adolescents