Clinical trial NCT06952582: Promoting Safer Sexual Dual Protection Behaviors for Female University Students to Reduce Risks of Both STI/HIV and Unintended Pregnancy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infections(STIs)
HIV/AIDS
Unintended Pregnancy
Keywords: IMB model,
HIV risk reduction,
Safer sexual dual protection behaviors,
Dual protection use
Lead sponsor: Jimma University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 1020
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Dual protection use
timeFrame: at 6 months post-intervention
Secondary outcomes:
measure: Knowledge of safer sexual dual protection behaviors
timeFrame: at 6 months post-intervention
measure: Motivation to practice safer dual protection behaviors
timeFrame: at 6 months post-intervention
measure: Behavioral skills for practicing safer sexual dual protection behaviors
timeFrame: at 6 months post-intervention
Other outcomes:
Locations:
city: Metu
country: Ethiopia
facility: Metu University
state: Oromia
Study officials:
affiliation: Jimma University, Jimma, Ethiopia
name: Banti N Feyisa, MPH/RH
role: PRINCIPAL_INVESTIGATOR
affiliation: Jimma University, Jimma, Ethiopia
name: Gurmesa T Debelew, Professor
role: STUDY_CHAIR
affiliation: Jimma University, Behavioral Science and Society, Jimma, Ethiopia
name: Zewude B Koricha, Professor
role: STUDY_DIRECTOR
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