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ISRCTN
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ISRCTN69038234
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ClinicalTrials.gov identifier
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Public title
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Integrated human immunodeficiency virus (HIV)-sexually transmitted infections (STI) risk reduction intervention program among youths
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Scientific title
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Human immunodeficiency virus (HIV)-sexually transmitted infections (STI) risk reduction program among undergraduate students at a Northern Nigerian University: a randomised controlled field trial
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Acronym
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IHSRIPY
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Serial number at source
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001
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Study hypothesis
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1. The intervention group will show greater increase in human immunodeficiency virus (HIV)-related and sexually transmitted infection (STI) knowledge immediately post-intervention and during follow up assessments than the control group
2. The intervention group will report greater reduction in HIV-related and STI related risk behaviours at follow up assessments than the control group
3. The intervention group will exhibit higher increase in positive attitude scores towards HIV and STI prevention immediately post-intervention and during follow up assessments than the control group
4. The intervention group will show higher increase in positive HIV-related stigma score immediately post-intervention and during follow up assessments than the control group
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Lay summary
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Ethics approval
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1. Malaysia: Human Research Ethics Committee, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, approved on 6th June 2008
2. Nigeria: Human Research Ethics Committee, Ahmadu Bello University Zaria approved on 14th July 2008
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Study design
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Randomised controlled field trial
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Countries of recruitment
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Nigeria
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Disease/condition/study domain
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Human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), sexually transmitted infections (STI)
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Participants - inclusion criteria
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1. Bonafide student of Ahmadu Bello University
2. Aged less than 25 years, either sex
3. Single
4. Students willing to complete the 6-month planned follow-up assessment
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Participants - exclusion criteria
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1. Students with documented mental, emotional, or cognitive problem identified by self-reporting or information from the students' department
2. Students in final year of their study
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Anticipated start date
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01/09/2008
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Anticipated end date
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01/03/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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240
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Interventions
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A randomised controlled field trial design to investigate the impact of an HIV-STI intervention program on participants' HIV- and STI-related knowledge, sexual risk behaviours, attitudes towards HIV and STI prevention, and disentanglement of stigma. Participants were randomised to either the intervention group or the control group. An 8-hour integrated HIV-STI prevention program comprising of four structured modules was developed and delivered to the intervention group, while the control group received another 8-hour program on career development. Two-way repeated measure ANOVA was applied to assess the effectiveness of the intervention. The outcome measures were assessed at baseline, immediately post-intervention, at 3 months and 6 months post-intervention for both arms.
Contact details of joint sponsor:
Ahmadu Bello University, Zaria (Nigeria)
Department of Community Medicine
Faculty of Medicine
P.M.B 09, Samaru Zaria
Nigeria
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Primary outcome measure(s)
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1. HIV-related and STI knowledge at baseline, 3 and 6 months post-intervention
2. HIV-related and STI risk behaviours at baseline, 3 and 6 months post-intervention
3. HIV-related and STI attitude at baseline, 3 and 6 months post-intervention
4. HIV-related stigma at baseline, 3 and 6 months post-intervention
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Secondary outcome measure(s)
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Evaluation of the effectiveness of a school-based risk-reduction intervention program on behavioural risk factors for HIV and STI. Assessed at baseline, immediate post-intervention (except sexual risk behaviors and number of partners), 3 and 6 months post-intervention.
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Sources of funding
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1. Investigator intiatied and funded (Nigeria)
2. Ahmadu Bello University, Zaria (Nigeria) - logistical support only
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Trial website
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Publications
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Contact name
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Dr
Saad
Abdulmumin
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Address
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Department of Community Medicine
Faculty of Medicine
Universiti Putra Malaysia
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City/town
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Serdang
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Zip/Postcode
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43400
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Country
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Malaysia
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Email
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elsaad99@yahoo.com
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Sponsor
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Universiti Putra Malaysia (Malaysia)
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Address
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c/o Dr Saad Abdulmumin
Department of Community of Health
Faculty of Medicine
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City/town
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Serdang
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Zip/Postcode
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43400
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Country
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Malaysia
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Email
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elsaad99@yahoo.com
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Sponsor website:
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http://www.upm.edu.my/
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Date applied
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03/02/2010
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Last edited
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26/02/2010
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Date ISRCTN assigned
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26/02/2010
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