NCT06952582

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

Completed NA Last updated 1 May 2025

What this trial tests

NA trial testing The IMB model-based safer sexual dual protection educational intervention in Sexually Transmitted Infections(STIs) in 1,020 participants. Completed in 20 December 2023.

Timeline

1 April 2023

Primary endpoint
20 December 2023

20 December 2023

Quick facts

Lead sponsor	Jimma University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,020
Start date	1 April 2023
Primary completion	20 December 2023
Estimated completion	20 December 2023
Sites	1 location across Ethiopia

Drugs / interventions tested

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

Conditions studied

• Sexually Transmitted Infections(STIs) — all drugs for Sexually Transmitted Infections(STIs) →
• HIV/AIDS — all drugs for HIV/AIDS →
• Unintended Pregnancy — all drugs for Unintended Pregnancy →

Sponsor

Jimma University

Who can join

Adults 18 to 25, female only, with Sexually Transmitted Infections(STIs) or HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.