HIVPhase 2NCT01501864
School Support as Structural HIV Prevention for Adolescent Orphans in Kenya
A Phase 2 study testing School Support Intervention in people with HIV, run by Pacific Institute for Research and Evaluation at 2 sites in 2 countries.
Trial summary
The purpose of this study is to test whether school support can keep adolescent Kenyan orphans in school, reduce sexual risk behaviors, and prevent HIV /HSV-2 infection. 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?
- School Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 835 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2011to 31 Mar 2017
- Phase
- Phase 2
- 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
- Orphan (one or both parents deceased)
- In Grade 7 or 8 in a primary school participating in the study
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Pacific Institute for Research and Evaluation
Chapel Hill, North Carolina, 27514
About this study
The purpose of this study is to test whether school support can keep adolescent Kenyan orphans in school, reduce sexual risk behaviors, and prevent HIV /HSV-2 infection.
Read the detailed description
This study examines the impact of school support as a structural intervention, tested among adolescent orphans in Siaya District, Nyanza Province, Kenya.
Aims for the proposed study are: 1) To experimentally test whether providing comprehensive school support to Kenyan orphaned boys and girls will reduce school dropout, reduce sexual risk behaviors, and prevent HIV/HSV-2 infection; 2) To conduct a process evaluation of the implementation of the program; and 3) To conduct comparative cost effectiveness analyses, specifying the intervention's cost and return on investment as evidenced by cost per unit improvement in the primary outcomes of school enrollment, delay of sexual debut and prevention of risk behaviors and HIV/HSV-2 infection, as well as by gains in health-related quality of life.
- Conditions
- HIV
- Being tested
- School Support Intervention
- Keywords
- HIV prevention, HSV-2, Schooling, Kenya, Orphans, School support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School Support InterventionBehavioural
Comprehensive school support is provided that includes payment of school fees, school uniform, and a nurse researcher who monitors attendance and addresses problems that may lead to school absence and dropout.
| Study group | Role | What they receive |
|---|---|---|
| School Support Group | Experimental | School Support Intervention Receives: Behavioral: School Support Intervention |
| Control | No intervention | No school support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dropped out of school
Measured: From date of randomization until drop out from school, up to 3 years
Change from baseline in ever had sexual intercourse at 1 year
Measured: Baseline and 1 year
Change from baseline in ever had sexual intercourse at 2 years
Measured: Baseline and 2 years
Change from baseline in ever had sexual intercourse at 3 years
Measured: Baseline and 3 years
HIV Incidence
Measured: 3 years
HSV-2 Incidence
Measured: 3 years
Secondary outcomes (4)
Ever married or ever pregnant
Measured: From date of randomization until marriage or preganancy, up to 3 years
Health-related quality of life
Measured: Baseline and 1 year
Health-related quality of life
Measured: Baseline and 2 years
Health-related quality of life
Measured: Baseline and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 835 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Institute for Research and Evaluation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Moi University, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Hyunsan Cho, Ph.D., Principal investigator, Pacific Institute for Research and Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501864
- Sponsor's protocol ID
- PIRE-0580
- Other IDs
- R01MH092215
- Status last verified
- Sep 2017
- First submitted
- 3 Nov 2011
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cho H, Mbai I, Luseno WK, Hobbs M, Halpern C, Hallfors DD. School Support as Structural HIV Prevention for Adolescent Orphans in Western Kenya. J Adolesc Health. 2018 Jan;62(1):44-51. doi: 10.1016/j.jadohealth.2017.07.015. Epub 2017 Nov 6.
PubMed 29107569Hallfors DD, Cho H, Mbai II, Millimo BW, Atieno C, Okumu D, Luseno WK, Hartman S, Halpern CT, Hobbs MM. Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya. Sex Transm Infect. 2015 Sep;91(6):395-400. doi: 10.1136/sextrans-2015-052025. Epub 2015 Jul 2.
PubMed 26139208Cho H, Luseno W, Halpern C, Zhang L, Mbai I, Milimo B, Hallfors DD. Discordance of HIV and HSV-2 biomarkers and self-reported sexual behaviour among orphan adolescents in Western Kenya. Sex Transm Infect. 2015 Jun;91(4):260-5. doi: 10.1136/sextrans-2014-051720. Epub 2014 Nov 6.
PubMed 25378660
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Support as Structural HIV Prevention for Adolescent Orphans in Kenya
- ClinicalTrials.gov ID
- NCT01501864
- Acronym / sponsor ID
- PIRE-0580
- Conditions
- HIV
- Keywords
- HIV prevention, HSV-2, Schooling, Kenya, Orphans, School support
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 835 participants (actual)
- Lead sponsor
- Pacific Institute for Research and EvaluationUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Moi University, University of North Carolina, Chapel Hill
- Study start
- Jul 2011 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 30 Dec 2011 (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 test whether school support can keep adolescent Kenyan orphans in school, reduce sexual risk behaviors, and prevent HIV /HSV-2 infection.
Detailed description
This study examines the impact of school support as a structural intervention, tested among adolescent orphans in Siaya District, Nyanza Province, Kenya.
Aims for the proposed study are: 1) To experimentally test whether providing comprehensive school support to Kenyan orphaned boys and girls will reduce school dropout, reduce sexual risk behaviors, and prevent HIV/HSV-2 infection; 2) To conduct a process evaluation of the implementation of the program; and 3) To conduct comparative cost effectiveness analyses, specifying the intervention's cost and return on investment as evidenced by cost per unit improvement in the primary outcomes of school enrollment, delay of sexual debut and prevention of risk behaviors and HIV/HSV-2 infection, as well as by gains in health-related quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School Support Group | Experimental | Behavioral: School Support InterventionSchool Support Intervention |
| Control | No intervention | –No school support |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Orphan (one or both parents deceased)
- In Grade 7 or 8 in a primary school participating in the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| School Support InterventionComprehensive school support is provided that includes payment of school fees, school uniform, and a nurse researcher who monitors attendance and addresses problems that may lead to school absence and dropout. | Behavioural | School Support Group |
Primary outcome
Dropped out of school
Time frame: From date of randomization until drop out from school, up to 3 years
Change from baseline in ever had sexual intercourse at 1 year
Time frame: Baseline and 1 year
Change from baseline in ever had sexual intercourse at 2 years
Time frame: Baseline and 2 years
Change from baseline in ever had sexual intercourse at 3 years
Time frame: Baseline and 3 years
HIV Incidence
Time frame: 3 years
HSV-2 Incidence
Time frame: 3 years
4 secondary outcomes
Ever married or ever pregnant
Time frame: From date of randomization until marriage or preganancy, up to 3 years
Health-related quality of life
Time frame: Baseline and 1 year
Health-related quality of life
Time frame: Baseline and 2 years
Health-related quality of life
Time frame: Baseline and 3 years
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 26 Sep 2017.
- Derived from this study: PubMed 29107569Cho H, Mbai I, Luseno WK, Hobbs M, Halpern C, Hallfors DD. School Support as Structural HIV Prevention for Adolescent Orphans in Western Kenya. J Adolesc Health. 2018 Jan;62(1):44-51. doi: 10.1016/j.jadohealth.2017.07.015. Epub 2017 Nov 6.
- Derived from this study: PubMed 26139208Hallfors DD, Cho H, Mbai II, Millimo BW, Atieno C, Okumu D, Luseno WK, Hartman S, Halpern CT, Hobbs MM. Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya. Sex Transm Infect. 2015 Sep;91(6):395-400. doi: 10.1136/sextrans-2015-052025. Epub 2015 Jul 2.
- Derived from this study: PubMed 25378660Cho H, Luseno W, Halpern C, Zhang L, Mbai I, Milimo B, Hallfors DD. Discordance of HIV and HSV-2 biomarkers and self-reported sexual behaviour among orphan adolescents in Western Kenya. Sex Transm Infect. 2015 Jun;91(4):260-5. doi: 10.1136/sextrans-2014-051720. Epub 2014 Nov 6.
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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.
Hyunsan Cho, Ph.D. principal investigator
Pacific Institute for Research and Evaluation
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing School Support Intervention in people with HIV, run by Pacific Institute for Research and Evaluation at 2 sites in 2 countries.
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 2 inclusion and 0 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 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Kenya. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dropped out of school (time frame: From date of randomization until drop out from school, up to 3 years). The study lists 6 primary outcomes in all. 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 NCT01501864, which also lists 3 linked publications.
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 26 Sep 2017.