Same-Day Antiretroviral Therapy as a Behavioral Design Intervention to Reduce Stigma in Key Affected Populations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Reductions in patient HIV and multi-dimensional stigma
研究概览
简要总结
The goal of this study is to develop and implement a same-day ART (SD-ART) protocol for key affected populations with HIV in Peru. The development of the protocol will be guided by asynchronous online focus groups with HIV experts to define eligibility criteria and essential components of the protocol, as well as nominal group technique focus groups and in-depth interviews to identify barriers and facilitators to SD-ART implementation. Finally, investigators will pilot the SD-ART protocol with patients and clinicians using a prospective, longitudinal design integrated into routine HIV care.
详细描述
The proposed study has 3 aims:
- Conduct asynchronous online focus groups (AOFGs) and flowcharting to map the current ART initiation process and design a streamlined same-day antiretroviral therapy (SD-ART) protocol as a behavioral design.
- Assess the multi-level barriers and facilitators to refine and implement an SD-ART protocol from the perspectives of patients, clinicians, and administrators, considering the high levels of stigma and suboptimal HIV treatment outcomes. Findings from Aims 1 and 2 will guide Aim 3.
- Pilot-test the protocol-concordant SD-ART strategy in newly diagnosed People with HIV where investigators will assess and follow multi-level stigma constructs in patients and providers, analyzed through longitudinal dyadic analyses, to provide the evidence for SD-ART as a behavioral design intervention that reduces stigma.
The focus of this registration is the trial in aim 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV experts will be selected from National Societies of HIV experts according to the following criteria: 1) 18 years old or older; 2) Be an HIV expert, including those from NGOs providing HIV care, and international specialists; 3) Provide informed consent.
- •NGT Focus Groups (FG)
- •Staff members
- •18 years old or older.
- •Be a clinical staff member at Hospital Dos de Mayo or Patrucco Primary Health Center.
- •Provide informed consent.
- •PWH receiving HIV care
- •18 years old or older.
- •Identify as member of a KAP.
- •Receive HIV care at Hospital Dos de Mayo or Patrucco Primary Health.
- •Provide informed consent.
- •PWH who dropped out of HIV care
- •18 years old or older.
- •Identify as a member of a KAP.
- •Previously received HIV care at Hospital Dos de Mayo or Patrucco Primary Health but dropped out of care, as identified through patient registries.
- •Provide informed consent.
- •In-depth interviews
- •1) 18 years old or older.
- •2) Be the director of Hospital Dos de Mayo or Patrucco primary health center or the HIV director at the Ministry of Health
- •3) Provide informed consent
- •Clinical Staff Dyadic Surveys
- •1) 18 years old or older.
- •2) Be an HIV provider at Hospital Dos de Mayo or Raul Patrucco Primary Health Center.
- •3) Provide HIV care to one of the 125 PWH
- •4) Provide informed consent.
- •Patient Dyadic Surveys
- •1) 18 years old or older.
- •2) Identify as a member of a KAP.
- •3) Be newly diagnosed with HIV and eligible for SD-ART based on clinical criteria identified from Aims 1 and
- •4) Provide informed consent.
排除标准
- 未提供
研究组 & 干预措施
Clinicians prescribing ART
People With HIV (PWH)
SD-ART protocol for PWH prescribed by their HIV clinicians
干预措施: SD-ART (Behavioral)
结局指标
主要结局
Reductions in patient HIV and multi-dimensional stigma
时间窗: baseline, month 1, month 3, month 6, month 9, and month 12
Assessed using a modified 10-item version of the Berger HIV stigma scale, which has been previously translated into Spanish and validated in Peru. Total score range from 40 to 160. Higher scores denote higher levels of HIV stigma.
Provider stigma toward patients
时间窗: baseline, month 1, month 3, month 6, month 9, and month 12
Measured through feeling thermometers (on a scale from 0-100) of various identity groups (people with HIV, sexual minorities, people who use drugs).
Everyday Discrimination Scale
时间窗: baseline, month 1, month 3, month 6, month 9, and month 12
This is a 5-item scale that is rated on a 6-point scale (range from 0 to 30), with higher scores denoting higher levels of multi-dimensional stigma and experiences with discrimination
次要结局
未报告次要终点