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临床试验/NCT06027671
NCT06027671招募中不适用

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

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
2
主要终点
HIV RNA (viral load) suppression at 6 months

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The investigators will perform individual randomization blocked by the correctional facility. Study staff will open numbered envelopes with the allocation following enrolment. Participants will be randomized 1:1 to one of the study arms using sequential envelopes with study arm determination sealed inside. Randomization will be stratified by study site and by sex. The randomization lists for each site/sex combination will be generated through randomly permuted blocks of two, four, and six study assignments with an equal number of group assignments within each block. Study assignments will be masked to staff performing outcome assessments (in-person and telephonic interviews) and the investigators until all outcome data have been collected.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • <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.

研究组 & 干预措施

Care-as-usual (CAU) arm

No Intervention

Per DCS routine, at release, participants will receive a referral letter form the DCS health services and, in most cases, will be provided with a 28-day supply of ART.

Full -SPARCS intervention arm

Experimental

The Full-SPARCS component comprises one individual pre-release session, one individual post-release session, and 12 approximately every-other-week (approximately every two weeks) post-release group sessions extending six months post-release. The SPARCS curriculum is designed to build goal setting, prioritizing, and planning skills during the 12 sessions.

During each Full-SPARCS session, participants will work with facilitators to set, review, and update personal goals using standardized goal-setting worksheets. These goal sheets will document participant objectives, action steps, timelines, and progress assessments.

干预措施: Full-SPARCS Intervention (Behavioral)

结局指标

主要结局

HIV RNA (viral load) suppression at 6 months

时间窗: 6 months

HIV RNA suppression will be defined as a viral load \<1000 copies/mL. Participants without viral load data will be assumed to have a viral load \>1000 c/mL.

次要结局

  • HIV RNA (viral load) suppression at 12 months(12 months)
  • Cost-effectiveness(up to 12 months)
  • Percentage of participants receiving ART at 6 months(6 months)
  • Percentage of participants receiving ART at 12 months(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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