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NCT04863898

Addressing Drug Use Stigma in Human Immunodeficiency Virus (HIV) Care and Treatment Clinics in Tanzania

Completed NA Results posted Last updated 2 December 2024
What this trial tests

NA trial testing Drug-use stigma reduction intervention for HIV care and treatment clinic staff in Drug Use Stigma in HIV Treatment Clinics in 151 participants. Completed in 1 July 2022.

Timeline
17 February 2021
Primary endpoint
1 July 2022
1 July 2022

Quick facts

Lead sponsorRTI International
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment151
Start date17 February 2021
Primary completion1 July 2022
Estimated completion1 July 2022
Sites7 locations across Tanzania

Drugs / interventions tested

Conditions studied

Sponsor

RTI International — full company profile →

Who can join

18 and older, any sex, with Drug Use Stigma in HIV Treatment Clinics. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Modified Opening Minds Scale for Health Providers (OMS-HC) Primary · 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 mysel

Baseline
GroupValue95% CI
Staff (Study Participants) Working in HIV Care and Treatment Clinics22.92± 4.78
Endline
GroupValue95% CI
Staff (Study Participants) Working in HIV Care and Treatment Clinics16.82± 4.02
Feasibility of Intervention Measure Primary · 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

GroupValue95% CI
Staff (Study Participants) Working in HIV Care and Treatment Clinics4.7± 0.33
Acceptability of Intervention Measure Primary · 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).

GroupValue95% CI
Staff (Study Participants) Working in HIV Care and Treatment Clinics4.72± 0.35
Appropriateness of Intervention Measure Primary · 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 g

GroupValue95% CI
Staff (Study Participants) Working in HIV Care and Treatment Clinics4.82± 0.33
Knowledge About Drug Use and How to Provide HIV Services to People Who Use Drugs Secondary · Baseline survey (weeks 1-3) and Endline Survey (weeks 17-24, 3 months after participant had completed training)

Self-reported knowledge. Likert scale (1-5): 8-10 items (2 additional items for clinical staff (CS)). Scores (range:1-5), calculated by taking the mean value of responses to all questions. Higher scores correspond to higher degrees of knowledge and therefore a better outcome. Items * I feel * I have a working knowledge of drugs and drug related problems. * safe providing HIV services to people who use drugs (PWUD) * I feel I know enough about {insert below item} to carry out my role providing HIV services to PWUD * the causes of drug problems * the physical effects of drug use *

Baseline
GroupValue95% CI
Pre-post With HIV Care and Treatment Clinic Staff3.4± 0.71
Endline
GroupValue95% CI
Pre-post With HIV Care and Treatment Clinic Staff4.37± 0.49
Modified Bogardus Social Distance Scale Secondary · Baseline survey (weeks 1-3) and Endline Survey (weeks 17-24, 3 months after participant had completed training)

6-item scale measuring social distance, or (un)willingness to interact with a person who uses drugs in different social interactions. 4-point Likert scale, with 4 indicating a response of "definitely yes" and 1 indicating "definitely no". The score is calculated additively with a range of 6-24. Higher scores correspond to higher degrees of social distance and therefore a worse outcome. Included items * Would you feel ashamed if people knew someone in your family has drug addiction? * Would you be afraid to have a conversation with someone who uses drugs? * Would you be disturbed about workin

Baseline
GroupValue95% CI
Pre-post With HIV Care and Treatment Clinic Staff12.6± 3.16
Endline
GroupValue95% CI
Pre-post With HIV Care and Treatment Clinic Staff8.34± 2.07

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing