Improving HIV Treatment Outcomes for People Who Use Drugs: Adapting and Piloting a Drug-use Use Stigma-reduction Intervention in HIV Care and Treatment Clinics in Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 14
- 主要终点
- Appropriateness of Intervention Measure
研究概览
简要总结
The goal of this study is to adapt and pilot an effective health facility HIV stigma-reduction intervention to address drug use stigma in human immunodeficiency Virus (HIV) Care and Treatment clinics (CTCs) in Tanzania, a barrier to HIV care for People Living with HIV (PLWH) who use drugs. In Tanzania, there are an estimated 300,000 People Who use Drugs (PWUD), primarily heroin. HIV prevalence among PWUD who do not inject (18-25%) and those who do inject (35%) is 4-7 times higher than in the general population (5%). PWUD face high levels of stigma, including when they try to seek HIV treatment at HIV CTCs, presenting a barrier to linkage and retention in HIV treatment for this highly HIV vulnerable group. Reducing drug use stigma in HIV CTCs is critical to improving access to and retention in HIV treatment services for PWUD. In response to this need, the investigators will: 1) Adapt a health facility HIV stigma-reduction participatory training intervention to address drug use stigma in HIV CTCs (Aim 1). 2) Pilot test the adapted drug use stigma-reduction intervention for acceptability, appropriateness, and feasibility (Aim 2).
The investigators will achieve Aim 1 through a systematic, multi-stage adaptation process that will include a formative phase of in-depth interviews with PLWH who use drugs and CTC staff to inform initial adaptation of the Health Policy Plus (HP+) intervention. Stakeholders, including PLWH who use drugs and CTC staff, will provide feedback on the initial materials through a participatory workshop, leading to a training manual that will be reviewed by topic experts and then finalized. Experienced Tanzanian HIV stigma-reduction trainers will deliver the intervention to CTC staff. The pilot test will include 150 staff (the study participants) based in seven CTCs in Dar-es-Salaam. A mixed methods evaluation will comprise pre-post surveys, observation of trainings, and post-training focus group discussions with staff (study participants) who complete the intervention and trainers. Changes in CTC staff (study participants) mean scores on stigma scales from pre- to post-intervention will be assessed, along with measures of intervention acceptability, appropriateness, and feasibility (measured at end line only). Post-intervention focus group discussions will explore themes around the experience of participating in the drug use stigma-reduction training.
详细描述
The goal of this R21 application is to adapt and pilot an effective health facility human immunodeficiency virus (HIV) stigma reduction intervention to address drug use stigma in HIV CTCs in Tanzania, a barrier to linkage and retention in HIV care PLWH who use drugs. Reducing drug used stigma in HIV CTCs will improve access to and retention in HIV treatment services for PWUD, a key population at elevated risk for HIV, thereby improving individual health outcomes, reducing onward transmission of HIV, and contributing to achievement of the global and national 95-95-95 targets. The investigators propose to do this by adapting (Aim 1) and testing for acceptability, appropriateness and feasibility (Aim 2) a drug use stigma-reduction intervention for HIV CTCs, guided by the eight-step ADAPT-ITT model. The study has two phases. First, the investigators will adapt the participatory training from an evidence-based health facility HIV stigma-reduction intervention (the HP+ total facility approach) to address drug use stigma among HIV CTC staff and then pilot test it with staff (study participants) in seven CTCs in three municipalities of Dar-es-Salaam. The first seven steps of the ADAPT-ITT model will guide AIM 1-the adaptation process, and step eight will guide AIM 2.
Step 1: Assess. Formative research will provide contextual information from PLWH who use drugs and CTC staff, to inform the adaptation of the HP+ intervention to focus on drug use stigma. Given the sensitivity of the topic and concerns about privacy and confidentiality, the investigators will employ individual in-depth interviews with both PLWH who use drugs and CTC staff.
In-depth interviews with PLWH who use opioids: 18 respondents aged 18 or older in the following categories: Medicated Assisted Therapy (MAT) clients living with HIV who get HIV treatment at CTCs; MAT clients not on HIV treatment; PLWH who use opioids who are not on MAT or HIV treatment. With PLWH the investigators will seek to understand the types of drug use stigma (experienced, anticipated, and perceived) that they encounter in relationship to CTCs, the specific manifestations of those types of stigma, and how this stigma influences HIV care linkage and retention among respondents living with HIV. The investigators will also explore what respondents view as driving drug use stigma in CTCs.
In-depth interviews with CTC staff: Fourteen staff from high volume clinics located in areas where people who use drugs congregate or live, who have direct interactions with clients split by type of staff (clinical and non-clinical). The in-depth interviews will focus on capturing stigmatizing attitudes and practices toward PWUD and understanding the underlying drivers of drug use stigma in CTCs (e.g., fear, lack of knowledge, attitudes and beliefs), as well as the who, when, and where drug use stigma occurs in the course of staff-client interactions.
All interviews will be recorded, transcribed, and translated. A multi-stage, modified grounded theory approach to analysis will be deployed, which will include inductive and deductive development of initial codebooks. Coding and analysis will continue iteratively to discover additional themes and issues. The findings will be described in thematic summaries, tables, and diagrams.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Intervention pilot testing phase:
- •This will include CTC staff and other staff within the medical facility where the CTC is physically housed who come into direct contact with clients attending the CTC (guards, receptionists, lab and pharmacy staff), who work in one of the seven clinics selected for this study.
排除标准
- •Under the age of
- •Refusal to Consent.
- •PLWH participants who appear to be too impaired to provide informed consent or answer questions accurately will be ineligible.
结局指标
主要结局
Appropriateness of Intervention Measure
时间窗: Endline Survey (weeks 17-24, 3 months after participant had completed training)
A 4-item scale that measures the degree to which staff (study participants) find the intervention acceptable. Each item consists of a 5-point Likert scale, with 5 indicating the highest degree of agreement with the item. The score is calculated by taking the mean of the responses. Scores range from 1-5. Higher values correspond to a higher degree of agreement that the intervention is acceptable to the respondent. The questions are: 1. (INSERT INTERVENTION) seems fitting. 2. (INSERT INTERVENTION) seems suitable. 3. (INSERT INTERVENTION) seems applicable. 4. (INSERT INTERVENTION) seems like a good match.
Acceptability of Intervention Measure
时间窗: Endline Survey (weeks 17-24, 3 months after participant had completed training)
A 4-item scale that measures the degree to which staff (study participants) find the intervention acceptable. Each item consists of a 5-point Likert scale, with 5 indicating the highest degree of agreement with the item. The score is calculated by taking the mean of the responses. Scores range from 1-5. Higher values correspond to a higher degree of agreement that the intervention is acceptable to the respondent. The questions are: 1. (INSERT INTERVENTION) meets my approval. 2. (INSERT INTERVENTION) is appealing to me. 3. I like (INSERT INTERVENTION). 4. I welcome (INSERT INTERVENTION).
Modified Opening Minds Scale for Health Providers (OMS-HC)
时间窗: Baseline survey (weeks 1-3) and Endline Survey (weeks 17-24, 3 months after participant had completed training)
8-item scale measuring stigma in staff (study participants) working in HIV clinics toward people who use drugs. 5-point Likert scale: 5 indicating the highest degree of agreement with the statement. The score is calculated additively with a range of 8-40. Higher scores indicate a higher level of stigma. Included items * If I were under treatment for drug addiction, I would not disclose this to any of my colleagues. * If I had drug addiction, I would seek treatment at a health facility away from the one I work in. * I would see myself as weak if I had drug addiction and could not fix it myself * I would be reluctant to seek help if I had drug addiction * Despite my professional beliefs, I have negative reactions towards people who use drugs * I would not want a person with addiction, even if it were managed, to work with children. * Healthcare providers do not need to be advocates for people who use drugs. * I am afraid to provide health services to people who use drugs
Feasibility of Intervention Measure
时间窗: Endline Survey (weeks 17-24, 3 months after participant had completed training)
A 4-item scale that measures staff's (study participants') perception of the feasibility of the intervention in their context. Each item consists of a 5-point Likert scale, with 5 indicating the highest degree of agreement with the item. The score is calculated by taking the mean of the responses. Scores range from 1-5. Higher values correspond to a higher degree of agreement that the intervention is feasible in the respondent's context.. The questions are: 1. (INSERT INTERVENTION) seems implementable. 2. (INSERT INTERVENTION) seems possible. 3. (INSERT INTERVENTION) seems doable. 4. (INSERT INTERVENTION) seems easy to use.
次要结局
- Knowledge About Drug Use and How to Provide HIV Services to People Who Use Drugs(Baseline survey (weeks 1-3) and Endline Survey (weeks 17-24, 3 months after participant had completed training))
- Modified Bogardus Social Distance Scale(Baseline survey (weeks 1-3) and Endline Survey (weeks 17-24, 3 months after participant had completed training))