Clinical Trials Directory

Trials / Completed

CompletedNCT02455583

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

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
4,732 (actual)
Sponsor
Centers for Disease Control and Prevention · Federal
Sex
All
Age
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALProject AIM (Adult Identity Mentoring)Project AIM consists of 14 sessions that are delivered twice a week. Each session is 40 minutes long.

Timeline

Start date
2014-08-01
Primary completion
2017-09-01
Completion
2017-09-01
First posted
2015-05-28
Last updated
2018-02-13

Locations

1 site across 1 country: Botswana

Source: ClinicalTrials.gov record NCT02455583. Inclusion in this directory is not an endorsement.