Trial results for a digital intervention aimed at addressing stigma among pregnant adolescents living with HIV were posted on ClinicalTrials.gov on 2026-02-12. The intervention demonstrated high user satisfaction, with an objective quality measure scoring a mean of 4.81 on a scale.
Background
Pregnant adolescents living with HIV (ALHIV) in Kenya frequently encounter significant stigma and challenges in disclosing their HIV and pregnancy status to family members. This situation can severely impact their well-being and access to support. Effective interventions are crucial to mitigate the effects of stigma, strengthen communication skills, and foster social support, particularly from family caregivers, who are an important yet often underappreciated resource for this vulnerable population.
Trial design
This completed study, designated as Phase NA, enrolled 169 participants. The trial focused on conditions including Mother to Child Transmission, Pregnancy in Adolescence, Social Stigma, Self Disclosure, and HIV. The study developed and evaluated a digital intervention for pregnant unmarried ALHIV, designed to address the effects of stigma and enhance communication skills.
Key results
The trial reported several key measurements for the digital intervention group:
- User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure: A mean score of 4.81 (Standard Deviation 0.22) on a scale was observed.
- User Version Mobile Application Rating Scale (uMARS) - Subjective Quality Measure (Composite Measure): A mean score of 4.67 (Standard Deviation 0.47) on a scale was observed.
- HIV/AIDS Stigma Instrument - People Living With HIV (PWLA): A mean score of 2.31 on a scale was observed.
- Internalized Pregnancy-Related Stigma Scale: A mean score of 1 on a scale was observed.
- Self-efficacy to Make an Effective Decision to Disclose HIV Status: A mean score of 7.66 (Standard Deviation 3.59) on a scale was observed.
- Self-efficacy to Make an Effective Decision to Disclose Pregnancy: A mean score of 8.14 (Standard Deviation 3.81) on a scale was observed.
- Self-efficacy for Knowing it is Safe to Disclose HIV Status: A mean score of 7.59 (Standard Deviation 3.79) on a scale was observed.
- Internalized AIDS-Related Stigma Scale: A mean score of 0.55 on a scale was observed.
- Response to Stress Questionnaire - HIV/AIDS Stigma: Disengaging Coping Subscale: A mean score of 6.66 on a scale was observed.
- Regarding disclosure experiences: 11 Participants reported Direct Disclosure, 2 Participants reported Indirect Disclosure, and 20 Participants reported Caregiver Initiated Disclosure.
Key analyses also reported several mean differences:
- A Mean Difference (Net) of -0.28 was observed.
- A Mean Difference (Net) of -0.34 was observed.
- A Mean Difference (Net) of 1.38 was observed.
- A Mean Difference (Net) of 3.03 was observed.
- A Mean Difference (Net) of 1.35 was observed.
- A Mean Difference (Net) of -0.45 was observed.
What this means
The posted results indicate that the digital intervention for pregnant adolescents living with HIV was well-received by users, as evidenced by high objective and subjective quality scores on the uMARS scale. The data also provides specific measurements on various aspects of stigma, self-efficacy related to disclosure, and actual disclosure experiences. While mean differences are reported in the analyses, without further context such as baseline comparisons or statistical significance, the full clinical impact of these changes requires additional interpretation. These findings contribute to understanding the potential of digital tools in supporting this population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05383755, titled "Digital Intervention to Address Stigma Among Pregnant Adolescents Living With HIV", were posted on 2026-02-12 on clinicaltrials.gov.