Меню
Идёт набор NCT07425925

Digital Peer-support-based Anti-HIV Stigma Intervention Among Adolescents Living With HIV in Ethiopia

Без фазы С лечением HIV-related Stigma Psychological Wellbeing Retention in Care

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Peer support based digital anti-HIV stigma intervention, A standard in-clinic in-person psychosocial support.
Кому может быть актуально
Состояния в реестре: HIV-related Stigma, Psychological Wellbeing, Retention in Care. Базовые параметры: 14 лет — 22 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Ethiopia
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Feasibility and Effectiveness of Digital Peer-support-based Anti-HIV Stigma Intervention in Improving Clinical Outcomes Among Adolescents Living With HIV in Ethiopia

Обзор

Advances in HIV care and treatment turned a once deadly disease into a chronic condition where people living with HIV, including perinatally HIV acquired children, can now lead a healthy life and live longer with their highly effective antiretroviral therapy. Despite the advancements and successes in HIV care and treatment, HIV-related stigma remained a challenge to people living with HIV and for the provision of the available successful treatment and support. Stigma and discrimination related to HIV infection inhibit health-seeking behaviour, clinical outcomes, physical and psychosocial wellbeing and is a major obstacle for timely diagnosis. Peer support programs to people living with HIV appeared to have improved self-confidence of members and consequently reduced self-stigma and improved their coping ability against external stigma. However, these services are limited in terms of geography owing to lack of adequate financing to cover operational costs for adolescents coming from rural areas and space and facility limitation to accommodate large groups. The eHealth services have potential to provide some of the services offered in the in-person sessions of the peer support group. Despite this important potential of eHealth services, they are underutilized and are not often used to target HIV-related stigma in adolescents living with HIV. The present study will investigate whether the digital peer-support anti-HIV stigma reduces internalized and anticipated stigma among adolescents living with HIV (ALHIV) in South Ethiopia. Further, we will explore the health-related outcomes including adolescent's psychological wellbeing, retention in care and sustained viral load suppression.

Подробное описание

Introduction The advent of the antiretroviral therapy (ART) and its widespread use have turned HIV/AIDS, a condition once considered as a death sentence, into a chronic disease with perinatally HIV infected children are now living longer and transition into adulthood. Despite this clinical success story, psychological wellbeing of adolescents is overlooked, mainly due to HIV-related stigma, as interventions to reduce stigma did not often target children.

Stigma and discrimination related to HIV infection inhibit health-seeking behavior, clinical outcomes, physical and psychosocial wellbeing and is a major obstacle for timely diagnosis and linkage to care, including adherence to antiretroviral therapy. As a counter to negative experiences, peer-support group by people living with HIV improved self-confidence of members and consequently reduced self-stigma and improved their coping ability against external stigma.

The eHealth, which comprise a range of information and communication resources and tools including text messaging, videos and social media, is uniquely positioned to share interactive health information pseudonymously. However, there is a lack of digital peer-support group interventions for adolescents with a focus on HIV stigma reduction. While different eHealth services provide social support and have the potential to target interventions delivered in the traditional methods, only a few have used it, mostly for ART adherence interventions.

A recent review of stigma reduction interventions in people living with HIV reported a lack of well-designed intervention studies investigating stigma reduction to wither the challenge of HIV-related stigma in HIV care and support. Thus, there is a need for anti-stigma interventions and the effect on health-related outcomes among adolescents living with HIV.

The in-person in-clinic psychosocial peer-support is widely implemented, but this important program had shortfalls with operational logistics. The program, for example, has been severely interrupted during the high picks of covid-19 restrictions, there were also issues of accessibility and the need to travel long distance, unintended disclosure, and funding availability to run programs.

A recent systematic review identified that adolescents and caregivers identified psychosocial needs as their priority where stigma and HIV status disclosure were the most reported challenges. Despite effective anti-stigma interventions are reported among adults living with HIV, there is limited evidence of effective anti-stigma interventions among adolescents living with HIV. The intervention approaches used in previous interventions include information-based approaches, skills building, counselling/support groups, and contact with affected groups. Most interventions, however, used more than one approach though 81% targeted a single domain of stigma and 85% targeted a single socio-ecologic level.

Using a digital peer support-based intervention, the present study will bridge the gaps in previous studies by targeting more than one stigma mechanism and ecological levels and by assessing the impact of anti-HIV stigma interventions. The present study will investigate whether the digital peer-support anti-HIV stigma reduces internalized and anticipated stigma among ALHIV in South Ethiopia. Further, we will explore the health-related outcomes including adolescent's psychological wellbeing, retention in care and sustained viral load suppression.

Objective Evaluate the effect of digital peer-support-based intervention on anticipated- and internalized HIV-stigma, psychological wellbeing, and retention in care among adolescents and youth living with HIV.

Methods We follow the MRC framework for complex intervention as methodologic guide, and to evaluate the intervention, we will conduct a quasi-experimental study for the duration of 16 weeks. Validated tools tested in Ethiopian context in the project will be used to measure the primary outcome, internalized- and anticipated-HIV-related stigma. The twelve item short version of the Berger HIV-related stigma scale, the HIV stigma scale-12 (HSS-12), will be used to measure HIV-related stigma. The scale has a Likert scale response options, 1 "Strongly disagree" to 4"Strongly agree". The possible score range for the total HSS-12 scale will be 12 to 48. Higher values indicate a higher level of stigma. The secondary outcomes include psychological wellbeing, mainly depression and anxiety, and retention in care. The Patient Health Questionnaire-9 (PHQ-9) will be used to measure depression and the Generalized Anxiety Disorder-7 (GAD-7) will be used to measure anxiety. Both PHQ-9 and GAD-7 have response options in Likert scale ranging from 0"never at all" to 3"almost always". For the PHQ-9, possible score range is 0 to 27, and for the GAD-7, it is 0 to 21, where higher values indicate a worse outcome. Retention in care will be measured based on proportion of kept visits from a total scheduled visits during the past 12-months preceding the assessment period. A linear mixed model will be used to estimate effect of the intervention on psychological and/or clinical outcomes; a structured equation modelling will be used to designate possible causal pathways for the outcomes of interest.

Вмешательства

  • Поведенческое Peer support based digital anti-HIV stigma intervention
    Participants in the intervention arm will remotely attend educational sessions facilitated by peer leaders and supervised by healthcare providers and members of the research team. They will receive audiovisual content as part of modules (two modules in 12 sessions) designed to enhance both individual and social life skills. The intervention group will be organized into seven groups, each consisting at most 20 participants. Peer leaders, who received training on facilitation skills, will facilita
  • Поведенческое A standard in-clinic in-person psychosocial support
    In arm 2, the control arm, participants will receive the existing psychosocial support routinely provided in the hospitals where they receive care. As part of this in-clinic peer support, adolescents living with HIV meet monthly to sit together and discuss a topic under the supervision of an assigned healthcare provider. After the discussion, they spend time playing together, followed by sharing a meal before departing, with a small transport allowance provided.

Первичные конечные точки

  • HIV-related stigma: internalised and anticipated [Срок оценки: From enrollment at baseline to the end of intervention at 16 weeks.]
Вторичные конечные точки (2)
  • Psychological well-being [Срок оценки: From enrollment at baseline to the end of intervention at 16 weeks.]
  • Retention in care [Срок оценки: From enrollment at baseline to the end of intervention at 16 weeks.]

Критерии участия

Критерии включения

  • Adolescents who have been disclosed of their HIV status
  • adolescents and young people between the age of 15 and 22 years old
  • receiving antiretroviral medications; and
  • completed at least first cycle primary school education (i.e. grade 4).

Критерии исключения

  • Participants with known diagnosed mental health condition
  • Participants with hearing loss or loss of vision

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Ethiopia · 5 центров
  • Arba Minch General Hospital — Arba Minch
  • Dilla University Teaching Hospital — Dara
  • Sawula General Hospital — Gofa
  • Jinka General Hospital — Jinka
  • Wolaita Sodo University Comprehensive Specialized Hospital — Sodo

Публикации

  • Levis B, Benedetti A, Thombs BD; DEPRESsion Screening Data (DEPRESSD) Collaboration. Accuracy of Patient Health Questionnaire-9 (PHQ-9) for screening to detect major depression: individual participant data meta-analysis. BMJ. 2019 Apr 9;365:l1476. doi: 10.1136/bmj.l1476. PMID 30967483
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. PMID 16717171
  • Kane JC, Elafros MA, Murray SM, Mitchell EMH, Augustinavicius JL, Causevic S, Baral SD. A scoping review of health-related stigma outcomes for high-burden diseases in low- and middle-income countries. BMC Med. 2019 Feb 15;17(1):17. doi: 10.1186/s12916-019-1250-8. PMID 30764819
  • Dyer J, Wilson K, Badia J, Agot K, Neary J, Njuguna I, Kibugi J, Healy E, Beima-Sofie K, John-Stewart G, Kohler P. The Psychosocial Effects of the COVID-19 Pandemic on Youth Living with HIV in Western Kenya. AIDS Behav. 2021 Jan;25(1):68-72. doi: 10.1007/s10461-020-03005-x. PMID 32816193
  • Chem ED, Ferry A, Seeley J, Weiss HA, Simms V. Health-related needs reported by adolescents living with HIV and receiving antiretroviral therapy in sub-Saharan Africa: a systematic literature review. J Int AIDS Soc. 2022 Aug;25(8):e25921. doi: 10.1002/jia2.25921. PMID 35983685
  • Mark D, Hrapcak S, Ameyan W, Lovich R, Ronan A, Schmitz K, Hatane L. Peer Support for Adolescents and Young People Living with HIV in sub-Saharan Africa: Emerging Insights and a Methodological Agenda. Curr HIV/AIDS Rep. 2019 Dec;16(6):467-474. doi: 10.1007/s11904-019-00470-5. PMID 31776974
  • Biru M, Lunqvist P, Molla M, Jerene D, Hallstrom I. Hope for the Future But Fear the Risk of Stigma: Ethiopian Family Caregivers' Lived Experience of Caring for Their HIV Positive Child Two Years After Starting Antiretroviral Treatment. Compr Child Adolesc Nurs. 2018 Dec;41(4):293-309. doi: 10.1080/24694193.2017.1372531. Epub 2017 Dec 8. PMID 29220598
  • Andersson GZ, Reinius M, Eriksson LE, Svedhem V, Esfahani FM, Deuba K, Rao D, Lyatuu GW, Giovenco D, Ekstrom AM. Stigma reduction interventions in people living with HIV to improve health-related quality of life. Lancet HIV. 2020 Feb;7(2):e129-e140. doi: 10.1016/S2352-3018(19)30343-1. Epub 2019 Nov 24. PMID 31776098

Идентификаторы

NCT: NCT07425925 · Dnr 2023-04045-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗