HIVAIMNCT02455583
An Assessment of an HIV Prevention Intervention (Project AIM) Among Junior Secondary School Students in Eastern Botswana
A study testing Project AIM (Adult Identity Mentoring) in people with HIV, run by Centers for Disease Control and Prevention at 1 site in Botswana.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Project AIM (Adult Identity Mentoring)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,732 participants
- Where
- 1 siteBotswana
- Study dates
- Aug 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Botswana1 site
50 Junior Secondary schools
Multiple Locations, Eastern Botswana
About this study
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.
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.
Read the 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
- Being tested
- Project AIM (Adult Identity Mentoring)
- Keywords
- HIV prevention, Sexual activity biomarker, Youth, Adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project AIM (Adult Identity Mentoring)Behavioural
Project AIM consists of 14 sessions that are delivered twice a week. Each session is 40 minutes long.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Project AIM (Adult Identity Mentoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in HSV-2 incidence between the intervention and control arm
Measured: 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
Measured: Longitudinal Cohort: baseline, 12 months, and 24 months
Sexual thoughts measured by frequency of thoughts about engaging in sexual activity
Measured: Longitudinal Cohort: baseline, 12 months, and 24 months
Attitudes towards education and frequency of thoughts and feelings about the future and hopelessness
Measured: Longitudinal Cohort: baseline, 12 months, and 24 months
Attitudes towards partner concurrency, transactional sex, and sexual risk communication with a partner
Measured: Longitudinal Cohort: baseline, 12 months, and 24 months
Intention to engage in sexual activity
Measured: Longitudinal Cohort:baseline, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startAug 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,732 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Ministry of Education and Skills Development, Botswana, Education Development Center, Inc.
- Responsible party
- Sponsor
- Investigators
- Kim S Miller, PhD, Principal investigator, Centers for Disease Control and PreventionNontobeko S Tau, Principal investigator, Botswana: Minsitry of Education and Skills Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455583
- Sponsor's protocol ID
- 6451
- Acronym
- AIM
- Status last verified
- Jul 2017
- First submitted
- 6 Jan 2015
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16182145
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02455583
- Acronym / sponsor ID
- AIM / 6451
- Conditions
- HIV
- Keywords
- HIV prevention, Sexual activity biomarker, Youth, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,732 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Ministry of Education and Skills Development, Botswana, Education Development Center, Inc.
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Project AIM (Adult Identity Mentoring)Form 1 learners at the 25 intervention schools will receive the Project AIM intervention and LIVING (standard of care). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project AIM (Adult Identity Mentoring)Project AIM consists of 14 sessions that are delivered twice a week. Each session is 40 minutes long. | Behavioural | Intervention |
Primary outcome
Difference in HSV-2 incidence between the intervention and control arm
Time frame: Baseline and 24 months
5 secondary outcomes
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
Sexual thoughts measured by frequency of thoughts about engaging in sexual activity
Time frame: 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
Attitudes towards partner concurrency, transactional sex, and sexual risk communication with a partner
Time frame: Longitudinal Cohort: baseline, 12 months, and 24 months
Intention to engage in sexual activity
Time frame: Longitudinal Cohort:baseline, 12 months, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Background: PubMed 16182145Clark 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim S Miller, PhD principal investigator
Centers for Disease Control and Prevention
Nontobeko S Tau principal investigator
Botswana: Minsitry of Education and Skills Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project AIM (Adult Identity Mentoring) in people with HIV, run by Centers for Disease Control and Prevention at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in HSV-2 incidence between the intervention and control arm (time frame: Baseline and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.