HIV Clinical Trial
Official title:
Development of a Digital Intervention to Address Stigma Among Pregnant Unmarried Adolescents Living With HIV
Verified date | November 2023 |
Source | Pacific Institute for Research and Evaluation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Kenya | The Kenya Medical Research Institute - Centre for Global Health Research | Kisumu |
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 |
Kenya,
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 |
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