Digital Intervention to Address Stigma Among Pregnant Adolescents Living With HIV

NCT05383755 | Completed Results

• 2 other identifiers: R21TW0117881805399
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

HIV; Adolescent; Social Stigma; Mother-to-Child Transmission; Pregnancy in Adolescence; Software; Parents; Caregivers; Prevention; Self Disclosure; Cell Phone; Self Efficacy

Outcome Measures

Primary Outcomes (6)

• User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure

  Aim 1 Phase 3 Acceptability of Final Prototype. Quantitative measure adapted for this study; overall objective quality (engagement, functionality, aesthetics, information); self-report survey items assessing overall objective quality of the digital intervention. Scale title: Adapted User version Mobile Application Rating Scale (uMARS; Low quality=1, High quality =5). App objective quality mean scores Min=4.25, Max=5.00. Higher scores mean perception of higher quality.

  Immediately post-intervention approximately 10 minutes

• User Version Mobile Application Rating Scale (uMARS) - Subjective Quality Measure (Composite Measure)

  Aim 1 Phase 3 Acceptability of Final Prototype. Quantitative data; overall subjective quality; self-report survey items assessing overall subjective quality of the digital intervention. Scale title: Adapted User version Mobile Application Rating Scale (uMARS; Low quality=1, High quality =5). App subjective quality mean scores: Min=3.67, Max=5.00. Higher scores indicate perception of higher quality.

  Immediately post-intervention approximately 10 minutes

• HIV/AIDS Stigma Instrument - People Living With HIV (PWLA)

  Aim 1 Phase 3. Change in perception of experienced stigma (e.g., "Someone stopped being my friend.") (Never, Once or twice, Several times, Most of the time)(14 summed items; scale score range 0-42 with higher values indicating more stigma)

  Two weeks post-intervention

• Internalized Pregnancy-Related Stigma Scale

  Aim 1 Phase 3. Change in internalized pregnancy-related stigma among adolescents. Example item:"Becoming pregnant and having a baby as a teen makes me feel ashamed and bad about myself;" Response Options: Agree, Disagree) (4 summed items; scale score range 0-4 with higher values indicating more stigma). Adapted for pregnancy-related stigma from the Internalized AIDS-Related Stigma Scale.

  Two weeks post-intervention

• Self-efficacy to Make an Effective Decision to Disclose HIV Status

  Aim 1 Phase 3. Change in the respondent's confidence in making an effective decision to disclose HIV status to a family member. Question Item: "How confident are you that you could make an effective decision of whether to tell a family member that you are HIV-positive?" (1 item; 11-pt scale: 0-10; 0=cannot do, 10=certain can do). Higher scores mean more confidence.

  Two weeks post-intervention

• Self-efficacy to Make an Effective Decision to Disclose Pregnancy

  Aim 1 Phase 3. Change in respondent's confidence in making an effective decision to disclose pregnancy to a family member. Question Item: "How confident are you that you could make an effective decision of whether to tell a family member that you are pregnant?" (1 item, 11-pt scale: 0-10; 0=cannot do, 10=certain can do; higher scores mean higher confidence). Adapted from self-efficacy to make an effective decision to disclose HIV status.

  Two weeks post-intervention

Secondary Outcomes (36)

• Self-efficacy for Knowing it is Safe to Disclose HIV Status

  Two weeks post-intervention

• Internalized AIDS-Related Stigma Scale

  Two weeks post-intervention

• Response to Stress Questionnaire - HIV/AIDS Stigma: Disengaging Coping Subscale

  Two weeks post-intervention

• Qualitative Theme, Disclosure Experiences. Sub-Theme: Direct Disclosure

  Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.

• Qualitative Theme, Disclosure Experiences. Sub-Theme: Indirect Disclosure

  Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.

Study Arms (1)

Digital intervention

EXPERIMENTAL

Digital intervention for pregnant adolescents living with HIV.

Behavioral: Digital intervention for pregnant adolescents living with HIV

Interventions

Digital intervention for pregnant adolescents living with HIV BEHAVIORAL

The newly developed digital intervention uses illustrative characters to deliver didactic content to (1) raise awareness about stigma and its effects and understanding of disclosure and social support's importance, (2) increase self-efficacy and communication skills for disclosure and enlistment of caregivers as social support allies, and (3) tell stories to demonstrate how peers in similar situations have successfully coped with stigma, disclosed their pregnancies and/or HIV, and sought support from caregivers. Each module takes 20-30 minutes to complete.

Digital intervention

Eligibility Criteria

• Age: 15 Years - 19 Years
• Gender Eligibility Details: Only female adolescents who are currently pregnant will be eligible to be in the study.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female
• Living with HIV
• Pregnant
• Unmarried
• years old

You may not qualify if:

• Participated in a prior study activity
• Does not show adequate understanding of consent

Sponsors & Collaborators

• Pacific Institute for Research and Evaluation: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Kenya Medical Research Institute: collaborator
• 3-C Institute for Social Development: collaborator

Study Sites (1)

The Kenya Medical Research Institute - Centre for Global Health Research

Kisumu, 40100, Kenya

Location

MeSH Terms

Conditions

Social Stigma

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Results Point of Contact

• Title: Dr. Winfred (Winnie) K. Luseno
• Organization: Pacific Institute for Research and Evaluation (PIRE)

wluseno@pire.org

+1 (919) 265-2618

Study Officials

• Winfred (Winnie) K. Luseno, PhD

  Pacific Institute for Research and Evaluation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: The newly developed digital intervention uses illustrative characters to deliver didactic content to (1) raise awareness about stigma and its effects and understanding of disclosure and social support's importance, (2) increase self-efficacy and communication skills for disclosure and enlistment of caregivers as social support allies, and (3) tell stories to demonstrate how peers in similar situations have successfully coped with stigma, disclosed their pregnancies and/or HIV, and sought support from caregivers. Each module takes 20-30 minutes to complete.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 20, 2022
• Study Start: March 30, 2022
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)