Integrated human immunodeficiency virus (HIV)-sexually transmitted infections (STI) risk reduction intervention program among youths

ISRCTN	ISRCTN69038234
DOI	https://doi.org/10.1186/ISRCTN69038234
Protocol serial number	001
Sponsor	Universiti Putra Malaysia (Malaysia)
Funders	Investigator intiatied and funded (Nigeria), Ahmadu Bello University, Zaria (Nigeria) - logistical support only

Submission date: 03/02/2010
Registration date: 26/02/2010
Last edited: 26/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Saad Abdulmumin
Scientific

Department of Community Medicine
Faculty of Medicine
Universiti Putra Malaysia
Serdang
43400
Malaysia

Email	elsaad99@yahoo.com

Study information

Primary study design	Interventional
Study design	Randomised controlled field trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	IHSRIPY
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	01/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	240
Key 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
Key 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
Date of first enrolment	01/09/2008
Date of final enrolment	01/03/2009

Locations

Countries of recruitment

Malaysia
Nigeria

Study participating centre

Department of Community Medicine

Serdang
43400
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes