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Идёт набор NCT06027671

Structured Peer-delivered ART and Reentry Community Strategy

Без фазы С лечением 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: Full-SPARCS Intervention.
Кому может быть актуально
Состояния в реестре: Retention in Care. Базовые параметры: от 18 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
ЮАР
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Structured Peer-delivered Antiretroviral Therapy (ART) and Reentry Community Strategy to Overcome Barriers to HIV Care Continuity During Community Re-entry From Incarceration in South Africa

Обзор

The overarching goal of this study is to implement a transition community adherence club strategy (Full-SPARCS) for HIV-positive individuals transitioning from correctional to community settings in South Africa. The investigators seek to provide actionable findings to inform policy decisions to contribute to HIV care continuity with this population. The investigators note that effectiveness and scalability often conflict with intervention design; thus, the investigators have proposed testing whether a group approach is effective and the investigators will assess the costs of each component * To compare the effectiveness of Full-SPARCS to care as usual to achieve HIV RNA suppression 6 months following correctional facility release * To assess determinants of implementation of Full-SPARCS * To assess the scalability through costing and cost effectiveness analysis of Full-SPARCS

Подробное описание

Background: The South African government has devoted resources towards HIV care in correctional facilities that have resulted in antiretroviral therapy (ART) coverage of \>90% and viral load (VL) suppression of \>80% among incarcerated people living with HIV (PLWH). However, despite free post-release care, the investigators previously observed that only an estimated 34% were in care three months post-release. The investigators developed, tested, and manualized the Structured Peer-delivered ART and Re-entry Community Strategy (SPARCS) to overcome post-incarceration barriers specific to PLWH returning to the community.8-10 In the investigators randomized controlled pilot of SPARCS, 6-month post-release, continuity of care was 61% in the intervention arm compared to 36% in the usual care arm (p=0.001), demonstrating effectiveness. Full-SPARCS involves 12 biweekly peer facilitator-led group sessions spanning six months post-release. Full-SPARCS is designed to increase self-efficacy, social support, and life skills through facilitated group discussion and curriculum including planning, problem solving, financial literacy, and living with HIV.

Methods: This research study will be conducted in Gauteng Province. Recruitment will occur within correctional facilities of the Department of Correctional Services (DCS) - Modderbee, Kgosi Mampuru II, and Johannesburg. All study interventions will occur following release in either Ekurhuleni District, Tshwane District or Johannesburg District. The study population will be comprised of adult (≥18 years old) corrections inmates, either male or female, with known HIV infection and are receiving ART within the correctional facility and are expected to be released back into the community within 3 months of study enrollment Participants will be randomized 1:1 to either the standard of care or Full-SPARCS using sequential envelopes with study arm determination sealed inside. Study staff will contact participants to ascertain care status and update contact information at one week, one month, three months, six months, nine months, and twelve months from release. Participants assigned to Full-SPARCS will be asked to attend biweekly sessions. Full-SPARCS activities will include - structured curriculum, symptom screening, and routine laboratory monitoring.

Study sample: A total of 400 participants will be randomized to one of the two arms.

Significance: The proposed study is consistent with NIH HIV/AIDS highest priority research and the South African National Strategic Plan on HIV, Tuberculosis (TB), and Sexually Transmitted Infections (STIs) 2017-2022. The research addresses the HIV/AIDS Research Priority of "retention and engagement in these services, and achievement and maintenance of optimal prevention and treatment responses." It also addresses "health disparities" through a focus on recently released inmates, a marginalized population, and fits with the South African National Strategic Plan prioritizing inmates as a key population for HIV services.

Вмешательства

  • Поведенческое Full-SPARCS Intervention
    Within 14 days of release, participants will have one-on-one contact with a facilitator to update locator information, continue rapport building, review disclosure plans, provide a reminder of SPARCS logistics, and assign or remind the participant to a SPARCS group based on their location of residence and timing of release (depending on whether this occurred pre-release). Each Full-SPARCS meeting lasts approximately 2 hours, and the sessions occur in a private space in a community venue (e.g., c

Первичные конечные точки

  • HIV RNA (viral load) suppression at 6 months [Срок оценки: 6 months]
Вторичные конечные точки (4)
  • HIV RNA (viral load) suppression at 12 months [Срок оценки: 12 months]
  • Cost-effectiveness [Срок оценки: up to 12 months]
  • Percentage of participants receiving ART at 6 months [Срок оценки: 6 months]
  • Percentage of participants receiving ART at 12 months [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Incarcerated at one of the participating study enrolment sites, awaiting trial (un-sentenced) and sentenced individuals.
  • Diagnosed with HIV and ART at the time of enrolment.
  • Anticipated release or trial date within three months of study enrolment.
  • Self-report expected to reside in an unrestricted environment within Ekurhuleni, Tshwane, or Johannesburg districts of Gauteng Province and within proximity to one of the SPARCS intervention sites (i.e., within 20km, 45-minute travel time, or two local taxi minibus rides)
  • Willing to participate in study post-release follow-up activities and provide contact information for post-release follow-up.

Критерии исключения

  • <18 years of age.
  • Condition (severe cognitive dysfunction or mental illness) rendering the individual unable to provide informed consent.
  • Unable to provide informed consent to participate in the study.
  • Assessment by DCS health staff indicating that the individual requires a high intensity of care exceeding that which can be provided in a differentiated model of care setting.
  • Not released from the correctional facility during the period of intervention delivery.
  • Release to a region outside of Gauteng.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

ЮАР · 1 центр
  • The Aurum Institute - Head office — Johannesburg

Идентификаторы

NCT: NCT06027671 · IRB00386911

Первоисточники (государственные реестры)

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