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

NCT ID: NCT02455583

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4732 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-09-30

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.

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Form 1 learners at the 25 intervention schools will receive the Project AIM intervention and LIVING (standard of care).

Group Type: EXPERIMENTAL

Project AIM (Adult Identity Mentoring)

Intervention Type: BEHAVIORAL

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

Interventions

Project AIM (Adult Identity Mentoring)

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Education and Skills Development, Botswana

UNKNOWN

Sponsor Role: collaborator

Education Development Center, Inc.

INDUSTRY

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim S Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Nontobeko S Tau

Role: PRINCIPAL_INVESTIGATOR

Botswana: Minsitry of Education and Skills Development

Locations

50 Junior Secondary schools

Multiple Locations, Eastern Botswana, Botswana

Countries

Botswana

References

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.

Reference Type: BACKGROUND

PMID: 16182145 (View on PubMed)

Other Identifiers

6451

Identifier Type: -

Identifier Source: org_study_id