Clinical trial NCT05383755: Digital Intervention to Address Stigma Among Pregnant Adolescents Living With HIV
Official title: Development of a Digital Intervention to Address Stigma Among Pregnant Unmarried Adolescents Living With HIV
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mother to Child Transmission
Pregnancy in Adolescence
Social Stigma
Self Disclosure
HIV
Keywords: HIV
Adolescent
Social Stigma
Mother-to-Child Transmission
Pregnancy in Adolescence
Software
Parents
Caregivers
Prevention
Self Disclosure
Cell Phone
Self Efficacy
Lead sponsor: Pacific Institute for Research and Evaluation
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: Kenya Medical Research Institute
name: 3-C Institute for Social Development
First posted: 2022-05-20
Enrollment: 198
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 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.
Primary purpose: SUPPORTIVE_CARE

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. 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Acceptability of the digital intervention
timeFrame: Immediately post-intervention
measure: Usability of the digital intervention
timeFrame: Immediately post-intervention
measure: Anticipated HIV stigma from family members
timeFrame: Two weeks post-intervention
measure: Internalized pregnancy stigma
timeFrame: Two weeks post-intervention
measure: HIV disclosure self-efficacy
timeFrame: Two weeks post-intervention
measure: Pregnancy disclosure self-efficacy
timeFrame: Two weeks post-intervention
Secondary outcomes:
measure: Safe disclosure behaviors
timeFrame: Two weeks post-intervention
measure: Internalized HIV stigma
timeFrame: Two weeks post-intervention
measure: HIV stigma coping
timeFrame: Two weeks post-intervention
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: The Kenya Medical Research Institute - Centre for Global Health Research
Study officials:
affiliation: Pacific Institute for Research and Evaluation
name: Winfred (Winnie) K. Luseno, PhD
role: PRINCIPAL_INVESTIGATOR
References: