Development of a Digital Intervention to Address Stigma Among Pregnant Unmarried Adolescents Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure
研究概览
简要总结
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.
详细描述
Our two-year study consisted of qualitative approaches for intervention development, and a single arm pre/post pilot study to assess the newly developed intervention's acceptability, usability, and preliminary efficacy (Aim 1). We also conducted focus group discussions (FGDs) with family caregivers to identify acceptable approaches to strengthen their supportive roles (Aim 2). For Aim 1, multi-methods were used spanning three phases: (1) in-depth interviews (IDIs) with pregnant adolescents living with HIV (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 evaluated our newly developed digital intervention for pregnant adolescents living with HIV (ALHIV) in Kenya (N = 30). The intervention was 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 was 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 assessed usability, acceptability, and preliminary improvements in stigma, disclosure, and social support measures. All participants received the intervention. The adolescents included in the pilot study were female, living with HIV, pregnant, unmarried, ages 15-19 years old. We included both rural and urban youth. There were two contacts with study participants. At the first contact, all participants were consented, completed a baseline quantitative survey, and received the intervention. During the intervention session, they were provided with a mobile phone/tablet with internet access, guided on how to access the digital intervention, received a guided tour of the website, and had their questions answered. After the tour, they were asked to review the intervention content. After reviewing the intervention content, participants completed a quantitative survey assessing the intervention's acceptability and usability. At the second contact, two weeks after the intervention session, follow up survey data was collected to assess maintenance/persistence of intervention effects after a short duration exposure. Survey measures at baseline and two-week follow up included demographics, stigma about HIV and pregnancy, disclosure self-efficacy for HIV and pregnancy, and disclosure of HIV and pregnancy to caregivers. Descriptive analyses were conducted of the quantitative data to describe time-related patterns and assess clinically meaningful improvements in our measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 19 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for adolescent participants:
- •Living with HIV
- •Unmarried
- •15-19 years old
排除标准
- •for all participants:
- •Does not meet all inclusion criteria
- •Participated in a prior study activity
- •Does not show adequate understanding of consent
研究组 & 干预措施
Digital intervention
Digital intervention for pregnant adolescents living with HIV.
干预措施: Digital intervention for pregnant adolescents living with HIV (Behavioral)
结局指标
主要结局
User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure
时间窗: Immediately post-intervention approximately 10 minutes
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.
User Version Mobile Application Rating Scale (uMARS) - Subjective Quality Measure (Composite Measure)
时间窗: Immediately post-intervention approximately 10 minutes
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.
HIV/AIDS Stigma Instrument - People Living With HIV (PWLA)
时间窗: Two weeks post-intervention
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)
Internalized Pregnancy-Related Stigma Scale
时间窗: Two weeks post-intervention
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.
Self-efficacy to Make an Effective Decision to Disclose HIV Status
时间窗: Two weeks post-intervention
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.
Self-efficacy to Make an Effective Decision to Disclose Pregnancy
时间窗: Two weeks post-intervention
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.
次要结局
- Qualitative Theme, Disclosure Experiences. Sub-Theme: Mediated 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: Accidental 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, Perceptions About Stigma. Sub-Theme: HIV-Related Stigma Worse Than Pregnancy-Related Stigma(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.)
- Qualitative Theme, Disclosure Experiences. Sub-Theme: Caregiver Initiated Disclosure(Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.)
- 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, Perceptions About Stigma. Sub-Theme: Pregnancy-Related Stigma is Worse Than HIV-Related Stigma(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, Perspectives About Stigma. Sub-Theme: HIV-Related and Pregnancy-Related Stigma Equally Bad(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, Perceptions About Social Support. Sub-Theme: No Support Received(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, Perceptions About Social Support. Sub-Theme: Support Improved After Pregnancy 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, Perceptions About Social Support. Sub-Theme: Support Worsened After Pregnancy 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, Perceptions About Social Support. Sub-Theme: Support Improved After HIV 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, Perceptions About Social Support. Sub-Theme: Support Worsened After HIV 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, Perceptions About Social Support. Sub-Theme: No Change in Support After Pregnancy 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, Perceptions About Social Support. Sub-Theme: No Change in Support After HIV 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: Number of Adolescents Who Reported That Their Caregivers Were Aware About Their Pregnancy at Time of Their Interview.(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: Number of Adolescents Who Reported That Their Caregivers Were Aware About Their HIV Status at Time of Their Interview.(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, Caregivers' Perceptions About Engaging Them: Preferred Engagement in Group Setting(Focus groups were done during Aim 2 Rounds 1 and 2 in June and December 2023. Caregivers took part in one focus group. Each focus group lasted 2 hours.)
- Acceptability of Initial Prototype: Colors Used(Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.)
- Acceptability of Initial Prototype: Adolescent Character(Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.)
- Acceptability of Initial Prototype: Healthcare Provider Character(Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.)
- Acceptability of Initial Prototype: Sister Character(Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.)
- Acceptability of Initial Prototype: Mother Character(Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.)
- Acceptability of Initial Prototype: Father Character(Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.)
- Acceptability of Initial Prototype: Brother Character(Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.)
- Acceptability of Initial Prototype: Home Background(Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.)
- Acceptability of Initial Prototype: Health Facility Background(Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.)
- Acceptability of Initial Prototype: Story(Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.)
- Acceptability of Initial Prototype: Message(Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.)
- Qualitative Theme, Caregivers' Perceptions About Engaging Them: Liked Idea of App for Caregivers(Focus groups were done during Aim 2 Rounds 1 and 2 in June and December 2023. Caregivers took part in one focus group. Each focus group lasted 2 hours.)
- Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement Via Written Media(Focus groups were done during Aim 2 Rounds 1 and 2 in June and December 2023. Caregivers took part in one focus group. Each focus group lasted 2 hours.)
- Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement Via Radio Advertisements.(Focus groups were done during Aim 2 Rounds 1 and 2 in June and December 2023. Caregivers took part in one focus group. Each focus group lasted 2 hours.)
- Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement in Healthcare Setting.(Focus groups were done during Aim 2 Rounds 1 and 2 in June and December 2023. Caregivers took part in one focus group. Each focus group lasted 2 hours.)
研究者
Winfred K. Luseno
Senior Research Scientist
Pacific Institute for Research and Evaluation