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N/A N=70 Supportive Care

Digital Intervention to Address Stigma Among Pregnant Adolescents Living With HIV

Mother to Child Transmission · Pregnancy in Adolescence · Social Stigma · Self Disclosure · HIV

Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure — 4.81 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Digital intervention for pregnant adolescents living with HIV (Behavioral)
Age
Pediatric, Adult · 15+ yrs
Sex
Female
Sponsor
Pacific Institute for Research and Evaluation
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure
4.81
PRIMARY
User Version Mobile Application Rating Scale (uMARS) - Subjective Quality Measure (Composite Measure)
4.67
PRIMARY
HIV/AIDS Stigma Instrument - People Living With HIV (PWLA)
2.31
PRIMARY
Internalized Pregnancy-Related Stigma Scale
1
PRIMARY
Self-efficacy to Make an Effective Decision to Disclose HIV Status
7.66
PRIMARY
Self-efficacy to Make an Effective Decision to Disclose Pregnancy
8.14
SECONDARY
Self-efficacy for Knowing it is Safe to Disclose HIV Status
7.59
SECONDARY
Internalized AIDS-Related Stigma Scale
.55
SECONDARY
Response to Stress Questionnaire - HIV/AIDS Stigma: Disengaging Coping Subscale
6.66
SECONDARY
Qualitative Theme, Disclosure Experiences. Sub-Theme: Direct Disclosure
11
SECONDARY
Qualitative Theme, Disclosure Experiences. Sub-Theme: Indirect Disclosure
2
SECONDARY
Qualitative Theme, Disclosure Experiences. Sub-Theme: Caregiver Initiated Disclosure
20
SECONDARY
Qualitative Theme, Disclosure Experiences. Sub-Theme: Mediated Disclosure
18
SECONDARY
Qualitative Theme, Disclosure Experiences. Sub-Theme: Accidental Disclosure
5
SECONDARY
Qualitative Theme, Perceptions About Stigma. Sub-Theme: HIV-Related Stigma Worse Than Pregnancy-Related Stigma
19
SECONDARY
Qualitative Theme, Perceptions About Stigma. Sub-Theme: Pregnancy-Related Stigma is Worse Than HIV-Related Stigma
6
SECONDARY
Qualitative Theme, Perspectives About Stigma. Sub-Theme: HIV-Related and Pregnancy-Related Stigma Equally Bad
2
SECONDARY
Qualitative Theme, Perceptions About Social Support. Sub-Theme: No Support Received
22
SECONDARY
Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Improved After Pregnancy Disclosure
5
SECONDARY
Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Worsened After Pregnancy Disclosure
12
SECONDARY
Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Improved After HIV Disclosure
SECONDARY
Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Worsened After HIV Disclosure
2
SECONDARY
Qualitative Theme, Perceptions About Social Support. Sub-Theme: No Change in Support After Pregnancy Disclosure
19
SECONDARY
Qualitative Theme, Perceptions About Social Support. Sub-Theme: No Change in Support After HIV Disclosure
4
SECONDARY
Qualitative Theme: Number of Adolescents Who Reported That Their Caregivers Were Aware About Their Pregnancy at Time of Their Interview.
44; 2
SECONDARY
Qualitative Theme: Number of Adolescents Who Reported That Their Caregivers Were Aware About Their HIV Status at Time of Their Interview.
32; 12; 2
SECONDARY
Acceptability of Initial Prototype: Colors Used
4.45
SECONDARY
Acceptability of Initial Prototype: Adolescent Character
4.23
SECONDARY
Acceptability of Initial Prototype: Healthcare Provider Character
4.86
SECONDARY
Acceptability of Initial Prototype: Sister Character
4.23
SECONDARY
Acceptability of Initial Prototype: Mother Character
4.14
SECONDARY
Acceptability of Initial Prototype: Father Character
3.77
SECONDARY
Acceptability of Initial Prototype: Brother Character
3.50
SECONDARY
Acceptability of Initial Prototype: Home Background
4.67
SECONDARY
Acceptability of Initial Prototype: Health Facility Background
4.68
SECONDARY
Acceptability of Initial Prototype: Story
4.73
SECONDARY
Acceptability of Initial Prototype: Message
4.82
SECONDARY
Qualitative Theme, Caregivers' Perceptions About Engaging Them: Liked Idea of App for Caregivers
16
SECONDARY
Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement in Group Setting
5
SECONDARY
Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement Via Written Media
4
SECONDARY
Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement Via Radio Advertisements.
1
SECONDARY
Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement in Healthcare Setting.
1

Summary

Pregnant adolescents living with HIV (ALHIV) in Kenya frequently experience stigma and difficulty telling a family member about their HIV and pregnancy status. This study will develop and evaluate a digital intervention for pregnant unmarried ALHIV to address the effects of stigma and strengthen communication skills. Family caregivers are an important yet underappreciated and understudied source of social support for pregnant unmarried ALHIV. The study will also identify acceptable approaches to involve family caregivers in addressing the detrimental effects of the intersecting stigmas faced by pregnant ALHIV. Together, these approaches are expected to improve engagement in PMTCT services among pregnant ALHIV. The study specific aims are to: (1) Develop and evaluate a digital intervention for pregnant unmarried ALHIV aged 15-19 to increase awareness of stigma and its consequences; improve disclosure self-efficacy and skills; and facilitate enlistment of family caregivers as social support allies to enhance uptake of PMTCT services; and (2) Identify acceptable approaches to increase awareness about stigma and enhance skills in communication and provision of social support among family caregivers. We will use data from individual interviews with pregnant ALHIV and joint interviews with pregnant ALHIV/caregiver dyads to develop initial intervention specifications and mock-ups. We will then conduct focus groups to obtain feedback on sample materials in order to refine the materials and develop an intervention prototype. We will then conduct a pilot to evaluate acceptability, usability, and preliminary efficacy of the prototype. All participating adolescents will receive a session in using the digital intervention with a mobile phone or tablet. The research team will ask questions both before the session and two weeks after the session in order to assess the intervention's usability and acceptability and preliminary improvements in the adolescents regarding stigma, disclosure, and social support. We will conduct focus groups with caregivers to identify acceptable approaches to involve them. Data will be used to finalize content and specifications of the digital intervention for pregnant ALHIV and will provide the framework for a future complementary intervention for caregivers, which will both be tested in a larger R34 or R01 trial.

Eligibility Criteria

Inclusion criteria for adolescent participants:

  • Female
  • Living with HIV
  • Pregnant
  • Unmarried
  • 15-19 years old

Exclusion criteria for all participants:

  • Does not meet all inclusion criteria
  • Participated in a prior study activity
  • Does not show adequate understanding of consent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05383755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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