Clinical trial NCT02455583: An Assessment of an HIV Prevention Intervention (Project AIM) Among Junior Secondary School Students in Eastern Botswana
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV prevention
Sexual activity biomarker
Youth
Adolescents
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Ministry of Education and Skills Development, Botswana
name: Education Development Center, Inc.
First posted: 2015-05-28
Enrollment: 4732
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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.

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

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.

Primary outcomes:
measure: Difference in HSV-2 incidence between the intervention and control arm
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: 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
timeFrame: Longitudinal Cohort: baseline, 12 months, and 24 months
measure: Sexual thoughts measured by frequency of thoughts about engaging in sexual activity
timeFrame: Longitudinal Cohort: baseline, 12 months, and 24 months
measure: Attitudes towards education and frequency of thoughts and feelings about the future and hopelessness
timeFrame: Longitudinal Cohort: baseline, 12 months, and 24 months
measure: Attitudes towards partner concurrency, transactional sex, and sexual risk communication with a partner
timeFrame: Longitudinal Cohort: baseline, 12 months, and 24 months
measure: Intention to engage in sexual activity
timeFrame: Longitudinal Cohort:baseline, 12 months, and 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Botswana
facility: 50 Junior Secondary schools
state: Eastern Botswana
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Kim S Miller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Botswana: Minsitry of Education and Skills Development
name: Nontobeko S Tau
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.