Clinical trial NCT04863898: Addressing Drug Use Stigma in Human Immunodeficiency Virus (HIV) Care and Treatment Clinics in Tanzania
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use Stigma in HIV Treatment Clinics
Keywords: Stigma
drug use
people who use drugs
HIV
intervention
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
name: Fogarty International Center of the National Institute of Health
First posted: 2021-04-28
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study to test a drug-use stigma-reduction intervention with staff (study participants) who work in HIV care and treatment clinics. Participants were enrolled, not clinics. This is a single arm study (no comparison group), pre and post survey design with qualitative data collection post pilot intervention.
Primary purpose: OTHER

Brief 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 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.

Detailed description: 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.

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, the study team will conduct the first round of adaptation of the HP+ intervention training curriculum materials. The investigators will develop five, 2.5-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 drug use stigma. New materials for identified gaps will be developed, for example, around drug 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 key stakeholders, including HIV CTC staff, people with lived experience of drug use, Community Based Organization staff providing services to PWUD, MAT medical providers, 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. Two HIV stigma-reduction training 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: Trainers, Kimara Peer's two stigma-reduction master trainers and a MAT provider expert and the Principal Investigator (PI) and site PI will work together to finalize training plans.

Step 8: Pilot test. The drug-use stigma-reduction training intervention will be delivered to staff (study participants) 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 in five, 2.5 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 two master 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 and a MAT provider, and an addiction specialist. The training team will include people of lived experience of drug use, who will participate as a panel in one of the sessions.

A mixed-methods approach will be used for assessment: pre-post intervention surveys, training observation, and focus group discussions with CTC staff (study participants) for each cohort of trainees, and one with the intervention 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 staff (study participants) leave the room and whether and when they return. The site PI and a member of the field staff 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. Staff (study participants) views on the training will be captured through post-intervention focus groups with 8-12 staff (study participants) who completed the training, one for each cohort of staff trained across clinics. 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* Under the age of 18.
* Refusal to Consent.
* PLWH participants who appear to be too impaired to provide informed consent or answer questions accurately will be ineligible.

Primary outcomes:
measure: Modified Opening Minds Scale for Health Providers (OMS-HC)
timeFrame: Baseline survey (weeks 1-3) and Endline Survey (weeks 17-24, 3 months after participant had completed training)
measure: Feasibility of Intervention Measure
timeFrame: Endline Survey (weeks 17-24, 3 months after participant had completed training)
measure: Acceptability of Intervention Measure
timeFrame: Endline Survey (weeks 17-24, 3 months after participant had completed training)
measure: Appropriateness of Intervention Measure
timeFrame: Endline Survey (weeks 17-24, 3 months after participant had completed training)
Secondary outcomes:
measure: Knowledge About Drug Use and How to Provide HIV Services to People Who Use Drugs
timeFrame: Baseline survey (weeks 1-3) and Endline Survey (weeks 17-24, 3 months after participant had completed training)
measure: Modified Bogardus Social Distance Scale
timeFrame: Baseline survey (weeks 1-3) and Endline Survey (weeks 17-24, 3 months after participant had completed training)
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: Amana Hospital
city: Dar Es Salaam
country: Tanzania
facility: Buguruni Health Center
city: Dar Es Salaam
country: Tanzania
facility: Magomeni Health Center
city: Dar Es Salaam
country: Tanzania
facility: Mbagala Kuu
city: Dar Es Salaam
country: Tanzania
facility: Mbagala Rangi Tatu
city: Dar Es Salaam
country: Tanzania
facility: Mnazi Mmoja Hospital
city: Dar Es Salaam
country: Tanzania
facility: Tandale Health Center
Study officials:
affiliation: RTI International
name: Laura C Nyblade, PhD
role: PRINCIPAL_INVESTIGATOR
References: