Promoting Safer Sexual Dual Protection Behaviors for Female University Students to Reduce Risks of Both STI/HIV and Unintended Pregnancy

NCT06952582 | Completed

• 1 other identifier: Bonsakoo2003&Ebanufbanti2009
• Study Type: interventional
• Target: 1,020
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Young women are at the greatest risk for STI/HIV infections and unintended pregnancy resulting from unsafe sexual practices. While there is a growing interest in promoting dual protection as a means of preventing both risks of HIV/STIs and unwanted pregnancy simultaneously, there is limited evidence of effective interventions and strategies for promoting dual protection behaviors in youth based on theoretical models. This study aimed to evaluate the effectiveness of an information-motivation-behavioral skills (IMB) model-based safer sexual dual protection (SSDP) intervention to promote safer sexual dual protection behaviors among female university students in Ethiopia. Methods: We conducted a quasi-experimental nonrandomized control group design with a pretest-posttest study to assess changes in the levels of knowledge, motivation, behavioral skills, and practice of safe sexual dual protection behaviors with dual protection use in the intervention group compared to the control group. We recruited 1,020 female university students from two campuses of Mattu University using non-randomized assignment of each campus to either the intervention group or the control group. We collected data from both groups using a self-administered questionnaire at baseline and six months post-intervention. At both times, the collected data were cleaned, edited, and analyzed using SPSS version 23. For the baseline data analysis, we used descriptive statistics to summarize the distribution of participants based on their demographic characteristics and levels of information, motivation, behavioral skills, and behaviors. We also conducted bivariate and multivariate analyses using Structural Equation Modeling (SEM) with AMOS 23 (Teo, 2009; Kline, 2023) to examine correlates and predictors of risky and safer sexual practices and dual protection use and identify important variables to be addressed in targeted intervention for this population. Then, based on the elicitation research findings, we designed IMB-model-based SSDP interventions consisting of 16-hrs sessions to be delivered over a 6 weeks period. To evaluate the intervention effects at posttest, we performed a series of statistical analyses, such as chi-square (χ2) tests of differences between the two groups, along with 95% CI for the differences, and logistic regression analysis of the intervention effects, along with AOR for the effect size measure, after controlling for the effects of other confounding variables.

Conditions

Sexually Transmitted Infections(STIs); HIV/AIDS; Unintended Pregnancy

Keywords

IMB model,; HIV risk reduction,; Safer sexual dual protection behaviors,; Dual protection use

Outcome Measures

Primary Outcomes (1)

• Dual protection use

  Percentage (%) of dual protection use among sexually active participants at last sexual intercourse

  at 6 months post-intervention

Secondary Outcomes (3)

• Knowledge of safer sexual dual protection behaviors

  at 6 months post-intervention

• Motivation to practice safer dual protection behaviors

  at 6 months post-intervention

• Behavioral skills for practicing safer sexual dual protection behaviors

  at 6 months post-intervention

Study Arms (2)

Control group

NO INTERVENTION

The control group will only receive the usual standard HIV education programs for university students.

Safer sexual dual protection (SSDP) intervention

EXPERIMENTAL

The intervention group will receive the IMB model-based safer sexual dual protection intervention designed to promote safer sexual dual protection behaviors, including abstinence and dual protection use, for both sexually inexperienced and sexually experienced female university students to reduce the risk of both STI/HIV and unwanted pregnancy.

Behavioral: The IMB model-based safer sexual dual protection educational intervention

Interventions

The IMB model-based safer sexual dual protection educational intervention BEHAVIORAL

The IMB model based safe sexual dual protection education was designed to provide factual information about sexual risks of STI/HIV and unwanted pregnancy and the benefits of safer sexual dual protection behaviors including abstinence and dual protection use, enhance motivation to practice primary sexual abstinence for sexually inexperienced youth and dual protection use for sexually experienced young women, and teach specific behavioral skills required for practicing abstinence and/or negotiate safer sex with partners to use condoms/dual protection for simultaneous prevention of both risks of STI/HIV and unwanted pregnancy among youth at risk.

Safer sexual dual protection (SSDP) intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Unmarried female students, willing to participate and provide informed consent

You may not qualify if:

• Married female students, critically ill and unable to participate in the study.

Sponsors & Collaborators

• Jimma University: lead

Study Sites (1)

Metu University

Metu, Oromiya, Ethiopia

Location

Related Publications (14)

• Teo, T. Structural equation modeling in educational research: Concepts and applications. Chicago: Sense Publishers.2009.

  BACKGROUND

• SJ, M. A measure of AIDS prevention information, motivation, behavioral skills and behavior. Handbook of sexuality-related measures, 1998, 328-337.

  BACKGROUND

• HIV/AIDS, J. U. HIV prevention among adolescent girls and young women. Geneva, Switzerland. 2016

  BACKGROUND

• Fisher JD, Fisher WA, Bryan AD, Misovich SJ. Information-motivation-behavioral skills model-based HIV risk behavior change intervention for inner-city high school youth. Health Psychol. 2002 Mar;21(2):177-86.

  PMID: 11950108 BACKGROUND

• Fisher JD, Fisher WA, Williams SS, Malloy TE. Empirical tests of an information-motivation-behavioral skills model of AIDS-preventive behavior with gay men and heterosexual university students. Health Psychol. 1994 May;13(3):238-50. doi: 10.1037//0278-6133.13.3.238.

  PMID: 8055859 BACKGROUND

• Fisher JD, Fisher WA, Misovich SJ, Kimble DL, Malloy TE. Changing AIDS risk behavior: effects of an intervention emphasizing AIDS risk reduction information, motivation, and behavioral skills in a college student population. Health Psychol. 1996 Mar;15(2):114-23. doi: 10.1037//0278-6133.15.2.114.

  PMID: 8681919 BACKGROUND

• Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.

  PMID: 1594721 BACKGROUND

• Federal, H. Federal HIV/ AIDS prevention and control office (FHAPCO). HIV/AIDS National Strategic Plan for Ethiopia, 2025. AIDS prevention and control office (FHAPCO), 2021.

  BACKGROUND

• Demographic, N. Health survey 2011. Central Statistical Agency. Ethiopia ICF International Calverton, Maryland, USA .2012

  BACKGROUND

• CSA, C. Ethiopia demographic and health survey: key indicators report. Central Statistical Agency, 2016

  BACKGROUND

• Berer M. Dual protection: more needed than practised or understood. Reprod Health Matters. 2006 Nov;14(28):162-70. doi: 10.1016/S0968-8080(06)28262-4.

  PMID: 17101435 BACKGROUND

• Bazargan M, Stein JA, Bazargan-Hejazi S, Hindman DW. Using the information-motivation behavioral model to predict sexual behavior among underserved minority youth. J Sch Health. 2010 Jun;80(6):287-95. doi: 10.1111/j.1746-1561.2010.00503.x.

  PMID: 20573141 BACKGROUND

• Bazargan M, Kelly EM, Stein JA, Husaini BA, Bazargan SH. Correlates of HIV risk-taking behaviors among African-American college students: the effect of HIV knowledge, motivation, and behavioral skills. J Natl Med Assoc. 2000 Aug;92(8):391-404.

  PMID: 10992684 BACKGROUND

• Aborode AT, Alexiou A, Ahmad S, Yasir Essar M, Chibueze OS, Al-Zahrani Y, Ayomide OE, Batiha GE. HIV/AIDS Epidemic and COVID-19 Pandemic in Africa. Front Genet. 2021 Aug 31;12:670511. doi: 10.3389/fgene.2021.670511. eCollection 2021. No abstract available.

  PMID: 34539728 BACKGROUND

Related Links

• Open Science Framework (OSF) repository

MeSH Terms

Conditions

Sexually Transmitted Diseases; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Banti N Feyisa, MPH/RH

  Jimma University, Jimma, Ethiopia

  PRINCIPAL INVESTIGATOR

• Gurmesa T Debelew, Professor

  Jimma University, Jimma, Ethiopia

  STUDY CHAIR

• Zewude B Koricha, Professor

  Jimma University, Behavioral Science and Society, Jimma, Ethiopia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters of Public Health in Reproductive Health

Model Details: On the basis of elicitation research findings, the IMB model-based safer sexual dual protection intervention was designed to promote safer sexual dual protection behaviors, including abstinence and dual protection use, for both sexually inexperienced and sexually experienced female university students to reduce the risk of both STI/HIV and unwanted pregnancy. Participants in intervention group will receive the IMB model-based safer sexual dual protection education, while participants in control group will receive the usual standard HIV education.

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: May 1, 2025
• Study Start: April 1, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IDP and supporting information will be available immediately following publication and for no end date.
• Access Criteria: The IPD and supporting information will be made available to public in an appropriate data repository and under the terms of the CC0 Public Domain Dedication license and can be accessed by everyone who needs it with a responsible use and for further analyses.

Locations

ET (1)