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Clinical Trial Summary

The goal of this study is to adapt and pilot an effective health facility HIV stigma-reduction intervention to address drug use stigma in HIV care and treatment clinics (CTCs) in Tanzania, a barrier to linkage and retention in 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. Although most heroin is inhaled or ingested, an estimated 10% (30,000) of PWUD inject. 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. Therefore, 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, including people with lived experience of drug use, will be trained to deliver the intervention to CTC staff. The pilot test will include 150 health workers 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 intervention participants and trainers. Changes in CTC staff's mean scores on stigma scales from pre- to post-intervention will be assessed, along with measures of intervention acceptability, appropriateness, and feasibility. Focus groups will explore themes around the experience of participating in the drug use stigma-reduction training.

Clinical Trial Description

Detailed Study Description The goal of this R21 application is to adapt and pilot an effective health facility HIV stigma reduction intervention to address opioid use stigma in HIV care and treatment clinics (CTCs) in Tanzania, a barrier to linkage and retention in HIV care for people living with HIV (PLWH) who use opioids. Reducing opioid stigma in HIV CTCs will improve access to and retention in HIV treatment services for PWUO, 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 90-90-90 targets. The investigators propose to do this by adapting (Aim 1) and testing for acceptability, appropriateness and feasibility (Aim 2) an opioid 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 a health facility HIV stigma-reduction intervention, the health policy plus (HP+) total facility approach to address opioid use stigma among HIV CTC staff and then pilot test it 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 opioids and CTC staff, to inform the adaptation of the HP+ intervention to focus on opioid 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 opioids and CTC staff. In-depth interviews with PLWH who use opioids: 18 respondents aged 18 or older, split evenly by biological sex, in the following categories: Medicated assisted therapy (MAT) clients living with HIV who get HIV treatment at CTCs (4); MAT clients not on HIV treatment (4); PLWH who use opioids who are not on MAT or HIV treatment. With PLWH the investigators will seek to understand the types of drug (opioid) 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 opioid stigma in CTCs. In-depth interviews with CTC staff: Fourteen staff from high volume clinics located in areas where people who use opioids congregate or live, who have direct interactions with clients split evenly by type of staff (clinical and non-clinical). The in-depth interviews will focus on capturing stigmatizing attitudes and practices toward people who use drugs (PWUDS) 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. Two staff with prior qualitative analysis experience will code the interviews. The findings will be described in thematic summaries, tables, and diagrams. Step 2: Decision. Guided by the formative results and the study team's experience working with service delivery for PWUD and developing and adapting stigma-reduction intervention tools for a range of audiences, an in-person meeting will be held to conduct the first round of adaptation of the HP+ intervention training curriculum materials. The investigators will develop four, 3-hour participatory training modules that can be delivered flexibly across multiple partial days of training. Existing HP+ participatory training modules will be assessed for their appropriateness in terms of training modality (e.g., discussion, role play, reflection) and the specific content that needs to be adjusted (e.g., case studies, pictures, drivers of stigma) to focus on opioid use stigma. New materials for identified gaps will be developed, for example, around opioid use as a medical condition. Step 3: Administer. Next, the training materials will be put through a dry run-a 2-day participatory stakeholder workshop with 15 participants, including HIV CTC staff, people with lived experience of opioid use, CBO staff providing services to PWUO, and municipality and ministry of health representatives. Workshop participants will be asked to provide feedback on their overall perceptions and experience of the training (e.g., did it resonate, was it engaging, did it cover the right topics, exercises that should be dropped, gaps that remain to be filled). They will also be asked to comment on the approach and content of each specific exercise, including relevance, appropriateness, and content (including any visual materials). Step 4: Produce. The study team will review and discuss stakeholder workshop feedback, refining the training manual in response. Step 5: Topical experts. Five HIV stigma-reduction training and opioid use experts will review the adapted manual to provide feedback on its congruence with stigma-reduction training principles, the scientific literature, and observed experience of PWUD trying to access HIV treatment. Step 6: Integrate will involve a final revision of the manual incorporating feedback from the topical experts. Step 7: Comprehensive training will be provided to a team of four trainers with lived experience of opioid use, who will deliver the intervention training under the supervision of Kimara Peer's two stigma-reduction master trainers. Step 8: Pilot test. The drug-use stigma-reduction intervention will be delivered in seven HIV CTCs with high client loads located in areas within the three identified municipalities where PWUD congregate or live. These types of CTCs have on average 20 to 25 staff (clinical and non-clinical) who come into direct contact with clients. Staff of all levels will be trained together, which has been shown to have multiple benefits. Training will be on site at the facility and delivered to all 20-25 staff together in four, 3-hour participatory sessions. Timing of the sessions will be negotiated with each facility to ensure minimal disruption to service delivery, as has been done successfully for the HP+ intervention. Training will be delivered by six stigma-reduction trainers from a local community-based organization (Kimara Peers) who have 20 years of delivering HIV stigma-reduction training, including to health workers, and who also run outreach services and a drop-in center for PWUD. The training team will include people of lived experience of opioid use. A mixed-methods approach will be used for assessment: pre-post intervention surveys, training observation, and focus group discussions with intervention participants and trainers. Trainers will complete a process rating form at the end of each session focusing on issues of feasibility, coverage of session content, disruptions, issues raised during the session, and level of participant engagement with the material. The training team will maintain attendance rosters for each session, noting when participants leave the room and whether and when they return. Dr. Mlunde (site PI) and the research coordinator will each observe, between them, half of all sessions across the seven facilities, recording observations on the same issues captured by the facilitators, as well as facilitator fidelity to the training manual material and facilitator-participant interaction. Participant views on the training will be captured through focus groups, one in each facility (8-12 intervention participants per group of clinical and non-clinical staff). Focus groups will be recorded, transcribed, translated, and analyzed using the same process described above for formative work in Aim 1. Topics will focus on acceptance and appropriateness of training modalities and content, as well as areas where participants wanted more focus. Questions on the length and timing of sessions will also be discussed. ;

Study Design

NCT number NCT04863898
Study type Observational
Source RTI International
Contact Linda B Mlunde, MD, MSc, PhD
Phone +255 685 061 690
Email [email protected]
Status Recruiting
Start date February 17, 2021
Completion date April 2022