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

February 12, 2018 updated by: Centers for Disease Control and Prevention

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4732

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Botswana
    • Eastern Botswana
      • Multiple Locations, Eastern Botswana, Botswana
        • 50 Junior Secondary schools

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Difference in HSV-2 incidence between the intervention and control arm
Time Frame: Baseline and 24 months
Baseline and 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Longitudinal Cohort: baseline, 12 months, and 24 months
Sexual thoughts measured by frequency of thoughts about engaging in sexual activity
Time Frame: Longitudinal Cohort: baseline, 12 months, and 24 months
Longitudinal Cohort: baseline, 12 months, and 24 months
Attitudes towards education and frequency of thoughts and feelings about the future and hopelessness
Time Frame: Longitudinal Cohort: baseline, 12 months, and 24 months
Longitudinal Cohort: baseline, 12 months, and 24 months
Attitudes towards partner concurrency, transactional sex, and sexual risk communication with a partner
Time Frame: Longitudinal Cohort: baseline, 12 months, and 24 months
Longitudinal Cohort: baseline, 12 months, and 24 months
Intention to engage in sexual activity
Time Frame: Longitudinal Cohort:baseline, 12 months, and 24 months
Longitudinal Cohort:baseline, 12 months, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centers for Disease Control and Prevention

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Education Development Center, Inc.
Ministry of Education and Skills Development, Botswana

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6451

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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