跳至主要内容
临床试验/NCT07708519
NCT07708519进行中(未招募)不适用

A Multi-level Intervention to Reduce Stigma to Improve HIV Prevention and Treatment Outcomes for People Struggling to Access and Remain in Care.

Makerere University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
1
主要终点
PrEP adherence

研究概览

简要总结

The overall goal of the Ssinga Nze study ("Ssinga Nze" means "If it were me" in Luganda, the local language) is to reduce HIV-related stigma and improve access to HIV care, including antiretroviral treatment (ART) and HIV pre-exposure prophylaxis (PrEP), as well as increase linkage to care among people affected by HIV in Uganda.

The HIV pandemic has a disproportionate impact on populations at risk of HIV, or living with HIV, who struggle to access and remain in HIV prevention or treatment. Stigma is 'a behavioral manifestation of self or societal disapproval of a condition affecting those who are stigmatized.' HIV-associated stigma is 'negative attitudes and beliefs about people with HIV.' The National Institutes of Health recognizes it as a critical and complex barrier to the uptake and use of PrEP and ART. Much work remains in addressing HIV-related stigma and scaling up treatment and prevention coverage for people affected by HIV. Two evidence-based HIV stigma reduction interventions are available -- (1) Health Policy Plus (HP+) Total Facility Approach (TFA) to Stigma Reduction (a clinic-level intervention) and (2) HIV Education, Empathy and Empowerment (HIVE3) (an individual-level intervention) -- but these have not been adapted and implemented for people affected by HIV in sub-Saharan Africa. HP+ and HIVE3 are complementary interventions that could be combined to reduce stigma at the health facility and individual levels.

However, research is needed to determine if the adapted multi-level HP+/HIVE3 intervention, Ssinga Nze (which means "If it was me" in Luganda), reduces HIV-related stigma and improves HIV outcomes for people affected by HIV. To explore these questions, we will conduct a randomized wait-list controlled trial to evaluate the preliminary effectiveness of Ssinga Nze on PrEP adherence and viral suppression, compared to the standard of care, using a status-neutral approach-that is, engagement in care regardless of HIV status. We will also employ qualitative methods to examine the mechanisms of intervention delivery. By leveraging the interdisciplinary expertise of our multi-national research team and working at four health facilities in Central Uganda (Entebbe Regional Referral Hospital, Kisenyi Health Center IV, Kitebi Health Center III and Nsangi Health Center III), we will implement the following Specific Aims:

Aim 1: Adapt the multilevel PRISM stigma reduction intervention to address HIV-related stigma for populations struggling to access and remain in HIV prevention and treatment in Uganda (intervention adaptation).

Aim 2: Conduct a pilot hybrid type 1 effectiveness-implementation trial to test the preliminary effectiveness of the adapted multilevel Ssinga Nze HIV-related stigma reduction intervention on (a) HIV pre-exposure prophylaxis (PrEP) adherence or (b) viral suppression among people with HIV who struggle to remain on treatment using a status-neutral approach (intervention implementation).

Aim 3: Evaluate the implementation of Ssinga Nze using qualitative methods (intervention evaluation).

Clinic-level implementation outcomes include adoption, fidelity, and sustainability, assessed through key informant interviews, training attendance sheets, observation checklists, and rapid feedback surveys.

Individual-level outcomes include: (1) PrEP adherence at 3 months post-intervention, assessed by urine tenofovir levels (primary outcome), (2) viral suppression defined as HIV viral load below 50 copies/mL, and (3) stigma reduction at 3 months post-intervention (secondary outcomes).

This multi-level approach to implementing stigma reduction interventions will improve PrEP and antiretroviral treatment (ART) adherence outcomes among people affected by HIV, build stigma research capacity in Uganda, and generate actionable data for scale-up and program implementation in Uganda and sub-Saharan Africa.

详细描述

SCIENTIFIC PREMISE AND THEORETICAL MODEL This study is based on scientific and programmatic evidence that stigma occurring at multiple social-ecological levels hampers access to and motivation for HIV prevention and treatment. It highlights the need for multilevel, evidence-based interventions that use HIV status-neutral approaches. Guided by the social-ecological model, Logie's adaptation for stigma, previous research, and, most critically, input from people affected by HIV in Uganda on prioritizing intervention levels, we propose adapting and combining interventions at the individual and health facility levels. Specifically, at the macro/institutional level, we will focus on healthcare facilities (HCF) and adapt the Health Policy Plus Total Facility Approach for Stigma Reduction [HP+]. At the intrapersonal/individual level, we will adapt the HIV Empathy, Education & Empowerment (HIVE3) intervention. HCFs in Uganda are central to the delivery of HIV prevention and treatment services, and stigma within them impedes access for people affected by HIV. Also, they face ongoing stigma in all dimensions of their lives, fueling internalized, perceived, and anticipated stigma, which can undermine HIV prevention and treatment service engagement.

OVERALL DESIGN The overall goal of the Ssinga Nze study is to address HIV-related stigma and improve access to HIV care, including ART and PrEP uptake and linkage to care among people affected by HIV in Uganda. Specifically, we will adapt (Aim 1) and pilot test Ssinga Nze through a hybrid type 1 effectiveness-implementation trial of the HP+ intervention at the healthcare facility (HCF) level (organizational) and HIVE3 at the individual (intrapersonal) level (Aim 2) to (1) change stigmatizing interactions between HCF staff and people affected by HIV and create more welcoming health facilities by working at multiple levels within the health facility to reduce stigma; (2) offer peer support to individuals to help them cope with and challenge stigma and reduce internalized stigma; (3) develop skills, agency, and social assets among peers and within HCF staff to address stigma; and (4) strengthen partnerships between HCF and civil society organizations through joint intervention design and implementation.

FACILITY-LEVEL INTERVENTION - HP+ HIV stigma-reduction "Total Facility" Approach (TFA) In the PRISM-Ghana study, the original HP+ HIV stigma reduction TFA approach was adapted as part of a multilevel intervention to address HIV-related stigma at the healthcare level by changing drivers of stigma and discrimination among all facility staff, including clinical and nonclinical staff. Grounded in behavior change informed by social cognitive theory principles, the approach focuses on creating space for interpersonal interactions (contact strategies), creating empathy, and building efficacy for stigma reduction through awareness, skills, knowledge building, action planning, and design and implementation of stigma-reduction activities. Consequently, the intervention focuses on improving HCF staff capacity through participatory stigma-reduction training workshops for all staff and integrating a stigma-reduction focus into institutional processes and structures. HP+ addresses immediately actionable drivers of HIV-related stigma in health facilities, including lack of awareness of stigma, fear, attitudes, beliefs, and myths and misconceptions, through participatory training and facility-developed stigma-reduction activities. Doing so catalyzes tangible action because it makes HCF staff realize they can cause meaningful change, produce immediately visible results, and institute long-term changes to permanently reduce HIV-related stigma for people affected by HIV. Recognizing HCF staff as leaders within and beyond the facility helps them effectively use their new understanding of what HIV-related stigma is, why they should address it, and what they need to do to reduce it. Partnerships are built between HCF staff and people affected by HIV through joint training and stigma-reduction intervention implementation teams.

Selected HCF staff (from intervention facilities) and clients (usually not from intervention clinics) form joint intervention teams to deliver the participatory training to HFS and lead other stigma-reduction interventions at the facility. They receive a 5-day training-of-trainers workshop followed by on-site mentoring as they deliver the first round of participatory training to their peers at the HCF level. Each session includes a mix of selected clinical and nonclinical staff from across departments, with numbers, times, and dates determined by facility schedules. The modular training format and the mix of staff across levels and departments allow for flexibility in delivery to accommodate facility schedules and reduce disruption of service delivery. Stigma-reduction leaders, also called champions, are organically identified and supported by HCF management, and are provided with a small grant to develop and implement follow-up in-service stigma-reduction activities - such as a complaint system, staff recognition, and posters - for the HCF.

The initial development and pilot test of the HP+ approach were conducted in Ghana, in partnership with local government and civil society. It aimed to reduce HIV-related stigma in health facilities. At 6-month follow-up, there were greater reductions in intervention facilities relative to the control for most HIV-stigma drivers, such as unnecessary fear of HIV transmission (24%; p<0.001) and preferences not to treat people affected by HIV (14.2%; p=0.001) [50]. Feasibility and acceptability were demonstrated through (a) management demanding that the project train more staff than initially intended, (b) the high completion rate after 2 days of training (91%), (c) the large number of staff trained (1,228) in a short period, and (d) the ability of management and trainers to schedule staff training in a manner that did not disrupt facility operations. Additionally, facilities donated space for training and staff time to attend. Under the PRISM study, which further adapted HP+ to focus on HIV-related stigma, over 1,000 staff were trained in two 4-month waves (treatment and wait-list control). All trainees who started the 2-day training completed it, for a 100% attendance rate. Preliminary difference-in-difference results (unpublished) show that intervention facilities demonstrated significant improvements relative to control facilities on a subscale measuring beliefs and attitudes about gender nonconformity and sexual diversity at both 3 months (p=0.03) and 6 months (p=0.02) post-intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Aged 18 years or older
  • Self-identification as a sex worker
  • Able and willing to provide written informed consent

排除标准

  • unwilling to provide written informed consent for study procedures
  • have a physical or mental condition that prohibits informed consent and participation in study procedures.

结局指标

主要结局

PrEP adherence

时间窗: Three months

PrEP adherence, measured by urine tenofovir detection (≥1,500 ng/ml), will be compared between intervention and wait-list control groups using a generalized estimating equations (GEE) model with identity link, exchangeable correlation structure and robust variance estimates.

次要结局

  • HIV viral suppression(Three months)
  • HIV-related stigma reduction in health facilities(Three months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

This Trial Aims to Evaluate the Effect of Two HIV... | 临床试验