Digital Intervention to Address Stigma Among Pregnant Adolescents Living With HIV

HIV Clinical Trial

Official title:

Development of a Digital Intervention to Address Stigma Among Pregnant Unmarried Adolescents Living With HIV

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05383755
• Other study ID #: R21TW011788
• Secondary ID: 1805399R21TW0117
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: May 30, 2024

Study information

• Verified date: November 2023
• Source: Pacific Institute for Research and Evaluation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Description:

Our two-year study will consist of qualitative approaches for intervention development, and a mixed methods pilot study to assess the newly developed intervention's acceptability, usability, and preliminary efficacy (Aim 1). We will also conduct focus group discussions (FGDs) with family caregivers to identify acceptable approaches to strengthen their supportive roles (Aim 2). For the Aim 1 research, multi-methods will be used spanning three phases: (1) in-depth interviews (IDIs) with ALHIV and dyadic interviews (DIs) with ALHIV/caregiver pairs; (2) FGDs with ALHIV and (3) a pilot study with ALHIV. In the pilot study, we will evaluate our newly developed digital intervention for pregnant adolescents living with HIV (ALHIV) in Kenya (N = 30). The intervention will be designed to increase awareness of stigma regarding HIV and pregnancy, improve disclosure self-efficacy skills, and facilitate enlistment of family members as social support allies. The goal of the intervention is to enhance uptake of services for prevention of mother-to-child transmission of HIV (PMTCT). Using a single pre-post intervention group quasi-experimental design, the study will assess usability, acceptability, and preliminary improvements in stigma and disclosure measures. We will use a mixed method approach (i.e., quantitative and qualitative data collection) to evaluate the intervention. All participants will receive the intervention. The adolescents included in the pilot study will be female, living with HIV, pregnant, unmarried, ages 15-19 years old and include both rural and urban youth. There will be three contacts with study participants. At the first contact, all participants will be consented and complete a baseline quantitative survey. At the second contact, participants will receive a one-on-one intervention session. During the intervention session, they will be provided with a mobile phone with internet access, guided on how to access the digital intervention, receive a guided tour of the website, and have their questions answered. After the tour, they will be asked to explore the website and complete specific tasks without research staff assistance (e.g., to actively engage with selected modules). While exploring the website, participants will be asked to "think aloud" and share thoughts and questions as they arise. These qualitative data of participants' thoughts during the session will be audio recorded and field staff notes will be written. On completion of the intervention tasks, participants will return the mobile phone to the research staff and complete a quantitative survey assessing the intervention's acceptability and usability. At the third contact, two weeks after the intervention session, we will collect follow up survey data to assess maintenance/persistence of intervention effects after a short duration exposure. Survey measures at baseline and two-week follow up will include demographics, stigma about HIV and pregnancy, disclosure self-efficacy for HIV and pregnancy, and disclosure of HIV and pregnancy to caregivers. Descriptive analyses will be conducted of the quantitative data to describe time-related patterns and assess clinically meaningful improvements in our measures.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 198
• Est. completion date: May 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion criteria for adolescent participants:

• Female

• Living with HIV

• Pregnant

• Unmarried

• 15-19 years old

Inclusion criteria for caregiver participants:

• Family member (e.g., parent, guardian, grandparent, sibling, or other relative) of an unmarried pregnant adolescent living with HIV

• Responsible for the adolescents (e.g., for care, shelter, food)

• Age 20 or older

• Caregiver participants in dyad interviews also must be a family member caregiver of the adolescent in the dyad interview

Exclusion criteria for all participants:

• Does not meet all inclusion criteria

• Participated in a prior study activity

• Does not show adequate understanding of consent

• Caregivers will be excluded if they are the romantic/sexual partner of a pregnant ALHIV (rather than family member).

Related Conditions & MeSH terms

• HIV
• Mother to Child Transmission
• Pregnancy in Adolescence
• Social Stigma

Intervention

Behavioral:
• Digital intervention for pregnant adolescents living with HIV
The newly developed digital intervention will include SMS for reminder purposes and Web-based components such as virtual simulations, gamified elements, and didactic content to educate and build relevant skills (e.g., disclosure self-efficacy) to facilitate social support from caregiving family members. The intervention will (1) raise awareness about the intersecting stigmas of HIV and pregnancy; (2) highlight the effects of these stigmas on disclosure and social support; and (3) increase self-efficacy and communication skills for disclosure and enlistment of family members as social support allies. The goal of the intervention is to improve PMTCT engagement among pregnant unmarried ALHIV. Our theory-informed Web-based intervention will be use 3C Institute's Dynamic e-Learning Platform (DeLP), a customizable software platform that implements the evidence-based cognitive theory of multimedia learning (CTML) to effectively engage users.

Locations

Country	Name	City	State
Kenya	The Kenya Medical Research Institute - Centre for Global Health Research	Kisumu

Sponsors (4)

Lead Sponsor	Collaborator
Pacific Institute for Research and Evaluation	3-C Institute for Social Development, Fogarty International Center of the National Institute of Health, Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the digital intervention	Qualitative data of participant reactions and field staff notes collected during the intervention session; self-report survey items assessing acceptability of the intervention (e.g., "How satisfied were you with the intervention activities?;" Response categories: "Very satisfied," "mostly satisfied," "indifferent" "mostly dissatisfied," "very dissatisfied").	Immediately post-intervention
Primary	Usability of the digital intervention	Qualitative data of participant reactions and field staff notes collected during the intervention session; self-report survey items assessing usability of the intervention (e.g., "The intervention website was easy to use;" Response categories: "Strongly agree," "agree," "disagree," "strongly disagree").	Immediately post-intervention
Primary	Anticipated HIV stigma from family members	Reduction in self-report measure of anticipated HIV stigma from family members (e.g., "Family members will treat me differently because of my HIV status;" Response categories: "very unlikely," "unlikely," "neither unlikely nor likely," "likely," "very likely").	Two weeks post-intervention
Primary	Internalized pregnancy stigma	Reduction in self-report measure of internalized pregnancy stigma (e.g., "Becoming pregnant and having a baby as a teen makes me feel ashamed and bad about myself;" Response categories: "disagree," "neutral," "agree").	Two weeks post-intervention
Primary	HIV disclosure self-efficacy	Increase in self-report measure of HIV disclosure self-efficacy (e.g., "How confident are you that you could tell your caregiver you are HIV-positive?;" Response categories: "not very confident," "not confident," "neutral," "confident," "very confident").	Two weeks post-intervention
Primary	Pregnancy disclosure self-efficacy	Increase in self-report measure of pregnancy disclosure self-efficacy (e.g., "How confident are you that you could tell your caregiver you are pregnant?;" Response categories: "not very confident," "not confident," "neutral," "confident," "very confident").	Two weeks post-intervention
Secondary	Safe disclosure behaviors	Increase in self-report of having disclosed HIV and/or pregnancy status to a caregiver. Although adolescents will not be told expressly to disclose their HIV-positive and/or pregnancy status, we will assess if the intervention inspires them to disclose their status to a caregiver that they consider safe and trustworthy.	Two weeks post-intervention
Secondary	Internalized HIV stigma	Decrease in self-report measure of internalized HIV stigma (e.g., "You feel guilty that you are HIV positive;" Response categories: "agree," "disagree").	Two weeks post-intervention
Secondary	HIV stigma coping	Positive change in self-report measure of HIV stigma coping (e.g., "I deal with the problems related to the stigma of HIV/AIDS by wishing they would just go away, that everything would work itself out;" Scale of 1 to 4 with response categories: "not at all" to "a lot").	Two weeks post-intervention