Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04863898
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2021-03-29
Brief Title:
Addressing Drug Use Stigma in Human Immunodeficiency Virus HIV Care and Treatment Clinics in Tanzania
Sponsor:
RTI International
Organization:
RTI International
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 300000 People Who use Drugs PWUD primarily heroin Although most heroin is inhaled or ingested an estimated 10 30000 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 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
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 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 eg 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 teams 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 25-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 eg discussion role play reflection and the specific content that needs to be adjusted eg 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 eg 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 Peers 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 25 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
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 eg 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 teams 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 25-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 eg discussion role play reflection and the specific content that needs to be adjusted eg 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 eg 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 Peers 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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21TW011786-01 | NIH | None | httpsreporternihgovquickSearch1R21TW011786-01 |