Sexually Transmitted Infections(STIs)NCT06952582
Promoting Safer Sexual Dual Protection Behaviors for Female University Students to Reduce Risks of Both STI/HIV and Unintended Pregnancy
A study testing The IMB model-based safer sexual dual protection educational intervention in people with Sexually Transmitted Infections(STIs) and HIV/AIDS, run by Jimma University at 1 site in Ethiopia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infections(STIs), HIV/AIDS, Unintended Pregnancy
- What is being tested?
- The IMB model-based safer sexual dual protection educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Apr 2023to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unmarried female students, willing to participate and provide informed consent
Who cannot join
- Married female students, critically ill and unable to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Information-motivation-behavioral Skill Model-based Safer Sexual Dual Protection Intervention on Knowledge, Motivation, Behavioral Skills and Practice of Abstinence and Dual Protection Use Among Female University Students in Ethiopia: A Quasi-experimental Study
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.
Read the detailed description
Introduction The dual burden of HIV/AIDS and unwanted pregnancy continues to be a major public health concern worldwide, with young women disproportionately affected. In 2020, of the estimated 1.5 of people newly infected with HIV worldwide, approximately 260,000 were adolescent girls and young women aged 15--24 years, 83% of whom were in sub-Saharan Africa. In Ethiopia, although the adult HIV prevalence rate declined from 1.5% in 2011 to 0.93% in 2019, women remained disproportionately affected compared with men (1.22% vs. 0.64%), and the highest prevalence was observed among unmarried young women (9%). In addition, the rates of unwanted pregnancies among young women in Ethiopia remain high, with approximately 37% of unwanted pregnancies occurring among young women aged 20--24 years.
In response to the HIV epidemic, many HIV/AIDS prevention programs have emphasized safer sexual practices, such as abstinence, mutual monogamy, and condom use, as effective strategies for reducing the risk of HIV infection among youth. In addition, because young women are at increased risk and vulnerable to STI/HIV and unwanted pregnancy from unsafe premarital sex, and both can be prevented simultaneously be the same safer sexual practices as dual protection, the recent WHO/UNAIDS recommendation on HIV prevention for young women emphasizes the need for dual protection: defined as safer sexual behaviors that provide simultaneous protection against both HIV/STI and unwanted pregnancy through abstinence, consistent condom use, or dual-method use as complementary strategies for youth in settings with high HIV burden.
To achieve the maximum preventive effects, condoms are the only barrier method available to reduce the risk of STI/HIV infections and prevent pregnancy when used correctly and consistently, either alone or with other contraceptive methods as a dual protection among sexually active young women. Abstinence is the only sure way and most effective (100%) to avoid the risks of both HIV/STIs and unwanted pregnancy among unmarried youth who choose to remain abstinent. However, although trends in the use of contraceptive methods among unmarried sexually active young women in Ethiopia increased to 55% in 2016, only 4% used condoms, indicating that they were not dually protected and thus remained at an increased risk of HIV infection. Despite dual protection options for youth, there is limited evidence of effective interventions and strategies for promoting dual protection for youth in Ethiopia.
To date, school-based comprehensive sexuality education (CSE) has been considered the most effective strategy for protecting youth from the risk of HIV/STI and unwanted pregnancy by improving knowledge, attitudes, skills, and behaviors, such as delay of sexual debut, condom use, and contraceptive use. However, while young women may also need dual protection options to simultaneously prevent both risks of HIV/STIs and unwanted pregnancy, most of the existing sexual health education curriculum makes no explicit reference to dual protection messages for youth and thus remains unknown and not practiced. In addition, it is clear from research that for sexual health education intervention to be more effective in promoting sexual health behavior change, it must be guided by appropriate theoretical models for the development, implementation, and evaluation of the programs. Evidence from intervention studies indicates that theoretically derived and empirically based interventions can successfully promote the adoption of protective sexual behaviors among youth.
Theoretical perspectives Various behavioral theories have been applied to understand HIV risk behaviors and to promote safer sexual behaviors. Information-motivation-behavioral skills model is one that has been widely used in the areas of HIV prevention and received considerable attention and support for its comprehensiveness, specification of relationships, and ease of translating into targeted interventions to promote HIV prevention behaviors. The IMB model asserts that information, motivation, and behavioral skills are fundamental determinants of HIV-preventive behaviors. The model specifies that information and motivation work through behavioral skills to indirectly affect HIV-preventive behaviors. The model also assumes that information and motivation may have a direct effect on preventive behavior when complicated behavioral skills are not necessary for practice, such as abstinence, as opposed to using condoms by sexually active young women.
The IMB model's constructs are also regarded as a highly generalizable approach to understanding and promoting sexual health behaviors across populations and behaviors of interest. Within the IMB model, it is assumed that specific information, motivation, and behavioral skills can be most relevant to specific preventive practices, such as abstinence and condom use, within specific populations. Thus, the IMB model suggests that specification of the information, motivation, and behavioral skills content most relevant to the practice of a specific preventive behavior (abstinence and condom use) and identification of the IMB model's constructs that most powerfully influence the practice of preventive behavior are crucial to the design of effective conceptually and empirically targeted prevention interventions for specific populations. However, despite the recommendation for its application to a range of sexual health behaviors across populations and behaviors of interest, there is limited research using the IMB model to understand and promote safer sexual dual protection behaviors with dual protection use among young women at risk of STI/HIV infection and unwanted pregnancy. To fill these gaps, this study aimed to evaluate the effectiveness of an IMB model-based safer sexual dual protection intervention to improve levels of knowledge, motivation, behavioral skills, and practice of safer sexual dual protection behaviors, including abstinence and dual protection use, among female university students in Ethiopia.
Significance of the study:
Given that there is an increased risk and vulnerability of young women to STI/HIV and unwanted pregnancy from unsafe sex practice, and both can be prevented simultaneously by the same safer sexual practices as dual protection, understanding patterns and predictors of risky sexual practices and promoting safer sexual dual protection behaviors using theoretical models is essential for improving sexual and reproductive health of youth in settings with high HIV burden. Thus, by focusing on the application of the IMB model to promote safer sexual dual protection behaviors among youth, this study provides novel insights into the interplay between information, motivation, and behavioral skills to promote safer sexual dual protection practices among female university students. These insights will not only advance our theoretical understanding of the sexual behavior of youths but also inform the development of more comprehensive interventions that address the diverse needs of young people in settings with high HIV burden.
- Being tested
- The IMB model-based safer sexual dual protection educational intervention
- Keywords
- IMB model,, HIV risk reduction,, Safer sexual dual protection behaviors,, Dual protection use
- Medical subject headings
- Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The IMB model-based safer sexual dual protection educational interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The IMB model-based safer sexual dual protection educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual protection use
Percentage (%) of dual protection use among sexually active participants at last sexual intercourse
Measured: at 6 months post-intervention
Secondary outcomes (3)
Knowledge of safer sexual dual protection behaviors
Percentage (%) of students who have higher knowledge of safer sexual dual protection behaviors
Measured: at 6 months post-intervention
Motivation to practice safer dual protection behaviors
Percentage (%) of students who have a positive attitude toward safer sexual dual protection behaviors
Measured: at 6 months post-intervention
Behavioral skills for practicing safer sexual dual protection behaviors
Percentage (%) of students who have higher self-efficacy for safer sexual dual protection behaviors
Measured: at 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Apr 2023
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted Infections(STIs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banti Negero Feyisa, Jimma University
- Investigators
- Banti N Feyisa, MPH/RH, Principal investigator, Jimma University, Jimma, EthiopiaGurmesa T Debelew, Professor, Study chair, Jimma University, Jimma, EthiopiaZewude B Koricha, Professor, Study director, Jimma University, Behavioral Science and Society, Jimma, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952582
- Sponsor's protocol ID
- Bonsakoo2003&Ebanufbanti2009
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The underlying data supporting the conclusion of this article will be made available to public in an appropriate data repository and under the terms of the CC0 Public Domain Dedication license. The specific IPD to be shared will include: 1\. SPSS Datasets: consisting of survey responses of participants' levels of information, motivation, behavioral skills and risky and safer sexual behaviors among female university students at pretest and posttest measures.
Publications
Teo, T. Structural equation modeling in educational research: Concepts and applications. Chicago: Sense Publishers.2009.
SJ, M. A measure of AIDS prevention information, motivation, behavioral skills and behavior. Handbook of sexuality-related measures, 1998, 328-337.
HIV/AIDS, J. U. HIV prevention among adolescent girls and young women. Geneva, Switzerland. 2016
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.
PubMed 11950108Fisher 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.
PubMed 8055859Fisher 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.
PubMed 8681919Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.
PubMed 1594721Federal, H. Federal HIV/ AIDS prevention and control office (FHAPCO). HIV/AIDS National Strategic Plan for Ethiopia, 2025. AIDS prevention and control office (FHAPCO), 2021.
Demographic, N. Health survey 2011. Central Statistical Agency. Ethiopia ICF International Calverton, Maryland, USA .2012
CSA, C. Ethiopia demographic and health survey: key indicators report. Central Statistical Agency, 2016
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.
PubMed 17101435Bazargan 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.
PubMed 20573141Bazargan 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.
PubMed 10992684Aborode 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.
PubMed 34539728
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Information-motivation-behavioral Skill Model-based Safer Sexual Dual Protection Intervention on Knowledge, Motivation, Behavioral Skills and Practice of Abstinence and Dual Protection Use Among Female University Students in Ethiopia: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT06952582
- Acronym / sponsor ID
- Bonsakoo2003&Ebanufbanti2009
- Keywords
- IMB model,, HIV risk reduction,, Safer sexual dual protection behaviors,, Dual protection use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (actual)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction The dual burden of HIV/AIDS and unwanted pregnancy continues to be a major public health concern worldwide, with young women disproportionately affected. In 2020, of the estimated 1.5 of people newly infected with HIV worldwide, approximately 260,000 were adolescent girls and young women aged 15--24 years, 83% of whom were in sub-Saharan Africa. In Ethiopia, although the adult HIV prevalence rate declined from 1.5% in 2011 to 0.93% in 2019, women remained disproportionately affected compared with men (1.22% vs. 0.64%), and the highest prevalence was observed among unmarried young women (9%). In addition, the rates of unwanted pregnancies among young women in Ethiopia remain high, with approximately 37% of unwanted pregnancies occurring among young women aged 20--24 years.
In response to the HIV epidemic, many HIV/AIDS prevention programs have emphasized safer sexual practices, such as abstinence, mutual monogamy, and condom use, as effective strategies for reducing the risk of HIV infection among youth. In addition, because young women are at increased risk and vulnerable to STI/HIV and unwanted pregnancy from unsafe premarital sex, and both can be prevented simultaneously be the same safer sexual practices as dual protection, the recent WHO/UNAIDS recommendation on HIV prevention for young women emphasizes the need for dual protection: defined as safer sexual behaviors that provide simultaneous protection against both HIV/STI and unwanted pregnancy through abstinence, consistent condom use, or dual-method use as complementary strategies for youth in settings with high HIV burden.
To achieve the maximum preventive effects, condoms are the only barrier method available to reduce the risk of STI/HIV infections and prevent pregnancy when used correctly and consistently, either alone or with other contraceptive methods as a dual protection among sexually active young women. Abstinence is the only sure way and most effective (100%) to avoid the risks of both HIV/STIs and unwanted pregnancy among unmarried youth who choose to remain abstinent. However, although trends in the use of contraceptive methods among unmarried sexually active young women in Ethiopia increased to 55% in 2016, only 4% used condoms, indicating that they were not dually protected and thus remained at an increased risk of HIV infection. Despite dual protection options for youth, there is limited evidence of effective interventions and strategies for promoting dual protection for youth in Ethiopia.
To date, school-based comprehensive sexuality education (CSE) has been considered the most effective strategy for protecting youth from the risk of HIV/STI and unwanted pregnancy by improving knowledge, attitudes, skills, and behaviors, such as delay of sexual debut, condom use, and contraceptive use. However, while young women may also need dual protection options to simultaneously prevent both risks of HIV/STIs and unwanted pregnancy, most of the existing sexual health education curriculum makes no explicit reference to dual protection messages for youth and thus remains unknown and not practiced. In addition, it is clear from research that for sexual health education intervention to be more effective in promoting sexual health behavior change, it must be guided by appropriate theoretical models for the development, implementation, and evaluation of the programs. Evidence from intervention studies indicates that theoretically derived and empirically based interventions can successfully promote the adoption of protective sexual behaviors among youth.
Theoretical perspectives Various behavioral theories have been applied to understand HIV risk behaviors and to promote safer sexual behaviors. Information-motivation-behavioral skills model is one that has been widely used in the areas of HIV prevention and received considerable attention and support for its comprehensiveness, specification of relationships, and ease of translating into targeted interventions to promote HIV prevention behaviors. The IMB model asserts that information, motivation, and behavioral skills are fundamental determinants of HIV-preventive behaviors. The model specifies that information and motivation work through behavioral skills to indirectly affect HIV-preventive behaviors. The model also assumes that information and motivation may have a direct effect on preventive behavior when complicated behavioral skills are not necessary for practice, such as abstinence, as opposed to using condoms by sexually active young women.
The IMB model's constructs are also regarded as a highly generalizable approach to understanding and promoting sexual health behaviors across populations and behaviors of interest. Within the IMB model, it is assumed that specific information, motivation, and behavioral skills can be most relevant to specific preventive practices, such as abstinence and condom use, within specific populations. Thus, the IMB model suggests that specification of the information, motivation, and behavioral skills content most relevant to the practice of a specific preventive behavior (abstinence and condom use) and identification of the IMB model's constructs that most powerfully influence the practice of preventive behavior are crucial to the design of effective conceptually and empirically targeted prevention interventions for specific populations. However, despite the recommendation for its application to a range of sexual health behaviors across populations and behaviors of interest, there is limited research using the IMB model to understand and promote safer sexual dual protection behaviors with dual protection use among young women at risk of STI/HIV infection and unwanted pregnancy. To fill these gaps, this study aimed to evaluate the effectiveness of an IMB model-based safer sexual dual protection intervention to improve levels of knowledge, motivation, behavioral skills, and practice of safer sexual dual protection behaviors, including abstinence and dual protection use, among female university students in Ethiopia.
Significance of the study:
Given that there is an increased risk and vulnerability of young women to STI/HIV and unwanted pregnancy from unsafe sex practice, and both can be prevented simultaneously by the same safer sexual practices as dual protection, understanding patterns and predictors of risky sexual practices and promoting safer sexual dual protection behaviors using theoretical models is essential for improving sexual and reproductive health of youth in settings with high HIV burden. Thus, by focusing on the application of the IMB model to promote safer sexual dual protection behaviors among youth, this study provides novel insights into the interplay between information, motivation, and behavioral skills to promote safer sexual dual protection practices among female university students. These insights will not only advance our theoretical understanding of the sexual behavior of youths but also inform the development of more comprehensive interventions that address the diverse needs of young people in settings with high HIV burden.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: The IMB model-based safer sexual dual protection educational interventionThe 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Unmarried female students, willing to participate and provide informed consent
Key exclusion criteria (1 listed)
- Married female students, critically ill and unable to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The IMB model-based safer sexual dual protection educational interventionThe 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. | Behavioural | Safer sexual dual protection (SSDP) intervention |
Primary outcome
Dual protection use
Time frame: at 6 months post-intervention
Percentage (%) of dual protection use among sexually active participants at last sexual intercourse
3 secondary outcomes
Knowledge of safer sexual dual protection behaviors
Time frame: at 6 months post-intervention
Motivation to practice safer dual protection behaviors
Time frame: at 6 months post-intervention
Behavioral skills for practicing safer sexual dual protection behaviors
Time frame: at 6 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- BackgroundTeo, T. Structural equation modeling in educational research: Concepts and applications. Chicago: Sense Publishers.2009.
- BackgroundSJ, M. A measure of AIDS prevention information, motivation, behavioral skills and behavior. Handbook of sexuality-related measures, 1998, 328-337.
- BackgroundHIV/AIDS, J. U. HIV prevention among adolescent girls and young women. Geneva, Switzerland. 2016
- Background: PubMed 11950108Fisher 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.
- Background: PubMed 8055859Fisher 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.
- Background: PubMed 8681919Fisher 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.
- Background: PubMed 1594721Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.
- BackgroundFederal, H. Federal HIV/ AIDS prevention and control office (FHAPCO). HIV/AIDS National Strategic Plan for Ethiopia, 2025. AIDS prevention and control office (FHAPCO), 2021.
- BackgroundDemographic, N. Health survey 2011. Central Statistical Agency. Ethiopia ICF International Calverton, Maryland, USA .2012
- BackgroundCSA, C. Ethiopia demographic and health survey: key indicators report. Central Statistical Agency, 2016
- Background: PubMed 17101435Berer 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.
- Background: PubMed 20573141Bazargan 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.
- Open Science Framework (OSF) repositoryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The underlying data supporting the conclusion of this article will be made available to public in an appropriate data repository and under the terms of the CC0 Public Domain Dedication license. The specific IPD to be shared will include: 1. SPSS Datasets: consisting of survey responses of participants' levels of information, motivation, behavioral skills and risky and safer sexual behaviors among female university students at pretest and posttest measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Banti N Feyisa, MPH/RH principal investigator
Jimma University, Jimma, Ethiopia
Gurmesa T Debelew, Professor study chair
Jimma University, Jimma, Ethiopia
Zewude B Koricha, Professor study director
Jimma University, Behavioral Science and Society, Jimma, Ethiopia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The IMB model-based safer sexual dual protection educational intervention in people with Sexually Transmitted Infections(STIs) and HIV/AIDS, run by Jimma University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual protection use (time frame: at 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06952582, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.