Condition category
Infections and Infestations
Date applied
03/02/2010
Date assigned
26/02/2010
Last edited
26/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Saad Abdulmumin

ORCID ID

Contact details

Department of Community Medicine
Faculty of Medicine
Universiti Putra Malaysia
Serdang
43400
Malaysia
elsaad99@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

001

Study information

Scientific title

Human immunodeficiency virus (HIV)-sexually transmitted infections (STI) risk reduction program among undergraduate students at a Northern Nigerian University: a randomised controlled field trial

Acronym

IHSRIPY

Study hypothesis

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

Ethics approval

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

Study design

Randomised controlled field trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), sexually transmitted infections (STI)

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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.

Overall trial start date

01/09/2008

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

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

Recruitment start date

01/09/2008

Recruitment end date

01/03/2009

Locations

Countries of recruitment

Nigeria

Trial participating centre

Department of Community Medicine
Serdang
43400
Malaysia

Sponsor information

Organisation

Universiti Putra Malaysia (Malaysia)

Sponsor details

c/o Dr Saad Abdulmumin
Department of Community of Health
Faculty of Medicine
Serdang
43400
Malaysia
elsaad99@yahoo.com

Sponsor type

University/education

Website

http://www.upm.edu.my/

Funders

Funder type

Other

Funder name

Investigator intiatied and funded (Nigeria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ahmadu Bello University, Zaria (Nigeria) - logistical support only

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes