NCT01501864

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
835

participants targeted

Target at P75+ for phase_2 hiv

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_2 hiv

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

5.2 years

First QC Date

November 3, 2011

Last Update Submit

September 22, 2017

Conditions

HIV

Keywords

HIV preventionHSV-2SchoolingKenyaOrphansSchool support

Outcome Measures

Primary Outcomes (6)

  • Dropped out of school

    From date of randomization until drop out from school, up to 3 years

  • Change from baseline in ever had sexual intercourse at 1 year

    Baseline and 1 year

  • Change from baseline in ever had sexual intercourse at 2 years

    Baseline and 2 years

  • Change from baseline in ever had sexual intercourse at 3 years

    Baseline and 3 years

  • HIV Incidence

    3 years

  • HSV-2 Incidence

    3 years

Secondary Outcomes (4)

  • Ever married or ever pregnant

    From date of randomization until marriage or preganancy, up to 3 years

  • Health-related quality of life

    Baseline and 1 year

  • Health-related quality of life

    Baseline and 2 years

  • Health-related quality of life

    Baseline and 3 years

Study Arms (2)

School Support Group

EXPERIMENTAL

School Support Intervention

Behavioral: School Support Intervention

Control

NO INTERVENTION

No school support

Interventions

School Support InterventionBEHAVIORAL

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.

School Support Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pacific Institute for Research and Evaluation

Chapel Hill, North Carolina, 27514, United States

Location

Moi University, Department of Nursing Sciences

Eldoret, Kenya

Location

Related Publications (3)

  • 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.

    PMID: 29107569DERIVED

  • 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.

    PMID: 26139208DERIVED

  • 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.

    PMID: 25378660DERIVED

Study Officials

  • Hyunsan Cho, Ph.D.

    Pacific Institute for Research and Evaluation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2011

First Posted

December 30, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2016

Study Completion

March 31, 2017

Last Updated

September 26, 2017

Record last verified: 2017-09

Locations

US(1)KE(1)