Implementing a Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries: a Process and Outcome Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 9
- 主要终点
- Effectiveness of a community values and preferences informed LDSS/N distribution program on increasing LDSS uptake among people who inject drugs
研究概览
简要总结
Implementation and evaluation of a distribution program for low dead-space syringes/needles (LDSS/N) in Armenia, Georgia, and Tanzania, Egypt, Nigeria, Vietnam, India, Ukraine, and South Africa. This study aims to generate evidence on best practice LDSS/N distribution programs which will enhance acceptability and sustain high levels of LDSS/N uptake.
People who inject drugs and access needle and syringe programs will be invited to attend up to three focus group discussion rounds (with 25 participants in each focus group round) to inform and provide feedback on a concurrent distribution program of LDSS/N.
Throughout distribution, a cohort study will be run alongside distribution with 240 participants enrolled per country (with the exception of Nigeria, where 480 participants will be recruited) who will undergo HIV and HCV testing and answer surveys on their sociodemographic and behavioral status. Key informant interviews will also be held with participating staff and stakeholders to evaluate the feasibility and acceptability of this program.
Primary outcomes assessed through this study include 1) community values and preferences for LDSS/N, 2) barriers and facilitators to accessing LDSS/N, 3) feasibility and effectiveness of the distribution program on increasing LDSS/N uptake, 4) model the potential public health impact and cost effectiveness of LDSS/N distribution in this setting.
详细描述
This study will recruit people who inject drugs to inform and evaluate the selection and distribution of low dead-space needles and syringes (LDSS/N) at their existing NSP services.
The interventions include: low- dead-space needles and syringes; and knowledge mobilisation through Focus Group Discussions (FGDs) and peer education.
Specifically, in Phase 1, people who inject drugs will be recruited at each study site to participate in FGDs, in which they will be presented with a selection of new LDSS/N products, provided information about their advantages regarding blood borne virus (BBV) transmission risk, and invited to discuss their values and preferences regarding needle- and syringe choice to inform the selection of LDSS/N to be piloted for scaled up distribution at their study sites.
Following the FGDs, during Phase 2 people who inject drugs who are registered clients at participating NSP services can enroll in a 6-week pilot period during which they will have access to a small selection of new LDSS/N products alongside the usual services they access at the study site or needle and syringe program (NSP). When the 6 week pilot phase concludes, participants will be invited to participate in a second round of FGDs, where they will be asked reflect on their experiences using the new LDSS/N products and share their opinions on which products to select for scaled up distribution to all clients accessing the study sites.
In Phase 3, a small selection LDSS/N (2-5) will be made available alongside the usual needles- and syringes and other existing harm reduction services at the study site/NSPs. During this period, two forms of data will be collected, 1) routine programmatic data, and 2) data from a concurrent cohort study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥18 years (note that country-specific protocols may include participants aged ≥16 where appropriate and relevant);
- •Reporting a history of recent (past month) injection drug use;
- •Accessing the NSP to receive injecting equipment at either a facility, mobile service or through outreach and have an accompanying assigned program unique ID;
- •Able to understand and communicate in the local language(s);
- •If self-reporting HCV/HIV negative status, interested in and agreeing to undergo HCV and HIV testing; and
- •Willing and able to provide informed consent to take part in the study.
排除标准
- 未提供
结局指标
主要结局
Effectiveness of a community values and preferences informed LDSS/N distribution program on increasing LDSS uptake among people who inject drugs
时间窗: 18 months
Defined as reported exclusive use of LDSS/N vs not exclusive use of LDSS/N
次要结局
- Barriers and facilitators to access and uptake of LDSS/N among people who inject drugs(18 months)
- Understanding community values and preferences for LDSS/N in the context of other harm reduction supplies available to people who inject drugs(18 months)
- Model the potential public health impact (HCV and HIV infections averted) and cost-effectiveness of LDSS/N distribution for people who inject drugs within harm reduction settings(18 months)
- Identifying the enablers and challenges affecting the supply chain for LDSS/N(18 months)
- Document the legal, social, and regularity enablers and challenges affecting the successful introduction and maintenance of LDSS/N distribution(18 months)
- Differences in blood borne virus (HIV/HCV) incidence between those who exclusively use LDSS/N and those who do not(18 months)
- Evaluate LDSS/N demand creation approaches(18 months)