Clinical trial NCT01501864: School Support as Structural HIV Prevention for Adolescent Orphans in Kenya
Official title: School Support as Structural HIV Prevention for Adolescent Orphans in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Keywords: HIV prevention
HSV-2
Schooling
Kenya
Orphans
School support
Lead sponsor: Pacific Institute for Research and Evaluation
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Moi University
name: University of North Carolina, Chapel Hill
First posted: 2011-12-30
Enrollment: 835
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 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.

Eligibility criteria: Inclusion Criteria:

* Orphan (one or both parents deceased)
* In Grade 7 or 8 in a primary school participating in the study

Primary outcomes:
measure: Dropped out of school
timeFrame: From date of randomization until drop out from school, up to 3 years
measure: Change from baseline in ever had sexual intercourse at 1 year
timeFrame: Baseline and 1 year
measure: Change from baseline in ever had sexual intercourse at 2 years
timeFrame: Baseline and 2 years
measure: Change from baseline in ever had sexual intercourse at 3 years
timeFrame: Baseline and 3 years
measure: HIV Incidence
timeFrame: 3 years
measure: HSV-2 Incidence
timeFrame: 3 years
Secondary outcomes:
measure: Ever married or ever pregnant
timeFrame: From date of randomization until marriage or preganancy, up to 3 years
measure: Health-related quality of life
timeFrame: Baseline and 1 year
measure: Health-related quality of life
timeFrame: Baseline and 2 years
measure: Health-related quality of life
timeFrame: Baseline and 3 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Pacific Institute for Research and Evaluation
state: North Carolina
city: Eldoret
country: Kenya
facility: Moi University, Department of Nursing Sciences
Study officials:
affiliation: Pacific Institute for Research and Evaluation
name: Hyunsan Cho, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hallfors 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.
citation: Cho 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.