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

NCT02455583 | Completed

• 1 other identifier: 6451
• Study Type: interventional
• Target: 4,732
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV prevention; Sexual activity biomarker; Youth; Adolescents

Outcome Measures

Primary Outcomes (1)

• Difference in HSV-2 incidence between the intervention and control arm

  Baseline and 24 months

Secondary Outcomes (5)

• 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

  Longitudinal Cohort: baseline, 12 months, and 24 months

• Sexual thoughts measured by frequency of thoughts about engaging in sexual activity

  Longitudinal Cohort: baseline, 12 months, and 24 months

• Attitudes towards education and frequency of thoughts and feelings about the future and hopelessness

  Longitudinal Cohort: baseline, 12 months, and 24 months

• Attitudes towards partner concurrency, transactional sex, and sexual risk communication with a partner

  Longitudinal Cohort: baseline, 12 months, and 24 months

• Intention to engage in sexual activity

  Longitudinal Cohort:baseline, 12 months, and 24 months

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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)

Interventions

Project AIM (Adult Identity Mentoring) BEHAVIORAL

Project AIM consists of 14 sessions that are delivered twice a week. Each session is 40 minutes long.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Ministry of Education and Skills Development, Botswana: collaborator
• Education Development Center, Inc.: collaborator

Study Sites (1)

50 Junior Secondary schools

Multiple Locations, Eastern Botswana, Botswana

Location

Related Publications (1)

• Clark LF, Miller KS, Nagy SS, Avery J, Roth DL, Liddon N, Mukherjee S. Adult identity mentoring: reducing sexual risk for African-American seventh grade students. J Adolesc Health. 2005 Oct;37(4):337. doi: 10.1016/j.jadohealth.2004.09.024.

  PMID: 16182145 BACKGROUND

Study Officials

• Kim S Miller, PhD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Nontobeko S Tau

  Botswana: Minsitry of Education and Skills Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: May 28, 2015
• Study Start: August 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 13, 2018

Record last verified: 2017-07

Locations

BO (1)