Trial results for Zenyth, a telehealth intervention for bacterial sexually transmitted infection screening in HIV patients, were posted on ClinicalTrials.gov on 2025-07-01, indicating that 74 out of 75 participants scheduled a pre-test session.
Background
In the United States, gay and bisexual men living with human immunodeficiency virus (HIV) experience a significant burden of bacterial sexually transmitted infections (STIs), including gonorrhea, chlamydia, and syphilis. Timely diagnosis and treatment of these infections are crucial to prevent health complications and reduce transmission rates. This study aimed to assess the willingness of gay and bisexual men living with HIV to collect and return specimens for bacterial STI testing when supported by live audio/video conferencing.
Trial design
This completed study, identified as Phase NA, enrolled 75 participants. The trial focused on individuals with Sexually Transmitted Diseases, Gonorrhea, Chlamydia, Syphilis, and HIV. The intervention involved a Motivational Interviewing-based telehealth approach designed to facilitate bacterial STI screening.
Key results
The trial results highlighted participant engagement and changes in STI-related knowledge and self-efficacy:
- Engagement in Telehealth Sessions:
- 74 participants scheduled a pre-test session.
- 69 participants joined the pre-test session within 30 minutes of the start time.
- 57 participants scheduled a post-test session.
- 55 participants joined the post-test session within 30 minutes of the start time.
- Specimen Return and Quality:
- 57 participants returned each type of specimen within 6 weeks of box delivery.
- 57 participants returned each type of specimen within 6 weeks of box delivery.
- 57 participants returned each type of specimen within 6 weeks of box delivery.
- 54 participants returned each type of specimen within 6 weeks of box delivery.
- 57 participants provided specimens of adequate quality for lab testing.
- 56 participants provided specimens of adequate quality for lab testing.
- 55 participants provided specimens of adequate quality for lab testing.
- 47 participants provided specimens of adequate quality for lab testing.
- Changes in Knowledge and Self-Efficacy:
- A paired sample t-test showed a mean difference of 0.82 in STI-related knowledge scores (pre-intervention and post-intervention) with a p-value of 0.01, rejecting the null hypothesis that the mean difference is 0.
- A paired sample t-test showed a mean difference of -1.29 in self-efficacy for specimen self-collection scores (pre-intervention and post-intervention) with a p-value of 0.01, rejecting the null hypothesis that the mean difference is 0.
What this means
The results of the Zenyth trial suggest that a telehealth intervention incorporating motivational interviewing can effectively engage gay and bisexual men living with HIV in bacterial STI screening. High rates of participation in both pre- and post-test sessions, along with a substantial number of returned and adequately collected specimens, indicate the feasibility and acceptability of this approach. The statistically significant improvements in STI-related knowledge and self-efficacy for specimen self-collection further support the potential of telehealth to empower patients in managing their sexual health. These findings imply that such interventions could be a valuable tool in public health strategies to improve STI diagnosis and treatment among this vulnerable population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06100250, titled "Zenyth: Motivational Interviewing-based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening", were posted on 2025-07-01 on clinicaltrials.gov.