Trial Outcomes & Findings for Addressing Drug Use Stigma in Human Immunodeficiency Virus (HIV) Care and Treatment Clinics in Tanzania (NCT NCT04863898)

Last Updated: 2024-12-02

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

151 participants

Primary outcome timeframe

Baseline survey (weeks 1-3) and Endline Survey (weeks 17-24, 3 months after participant had completed training)

Results posted on

2024-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Staff (Study Participants) Working in HIV Care and Treatment Clinics Pre-post with staff (study participants) working in HIV care and treatment clinics Drug-use stigma reduction intervention for staff (study participants) working in HIV care and treatment clinics: We will adapt the HP+ health facility HIV stigma-reduction intervention to focus on drug stigma in HIV CTCs. The intervention will address key stigma drivers, including fear, awareness of stigma, and stigmatizing attitudes and beliefs, through a participatory training approach that involves all levels of staff (study participants) and is grounded in social cognitive theory principles. The approach seeks to reduce stigma through fostering empathy, interpersonal interactions (contact strategies) and building efficacy for stigma reduction through awareness, skills, and knowledge building. The intervention consists of five-2.5 hour participatory training sessions.
Overall Study STARTED	151
Overall Study Baseline Survey	151
Overall Study Stigma Reduction Intervention	141
Overall Study Endline Survey	148
Overall Study COMPLETED	141
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Staff (Study Participants) Working in HIV Care and Treatment Clinics Pre-post with staff (study participants) working in HIV care and treatment clinics Drug-use stigma reduction intervention for staff (study participants) working in HIV care and treatment clinics: We will adapt the HP+ health facility HIV stigma-reduction intervention to focus on drug stigma in HIV CTCs. The intervention will address key stigma drivers, including fear, awareness of stigma, and stigmatizing attitudes and beliefs, through a participatory training approach that involves all levels of staff (study participants) and is grounded in social cognitive theory principles. The approach seeks to reduce stigma through fostering empathy, interpersonal interactions (contact strategies) and building efficacy for stigma reduction through awareness, skills, and knowledge building. The intervention consists of five-2.5 hour participatory training sessions.
Overall Study Away from study clinic during intervention training period	2
Overall Study Preferred not to answer on endline survey why they did not participate in the training	1
Overall Study Lost to Follow-up	3
Overall Study Self reported at endline that they had not received information about the training	1
Overall Study No longer employed at clinic	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-post With HIV Care and Treatment Clinic Staff n=151 Participants Pre-post with HIV care and treatment clinic staff Drug-use stigma reduction intervention for HIV care and treatment clinics: We will adapt the HP+ health facility HIV stigma-reduction intervention to focus on drug stigma in HIV CTCs. The intervention will address key stigma drivers, including fear, awareness of stigma, and stigmatizing attitudes and beliefs, through a participatory training approach that involves all levels of staff and is grounded in social cognitive theory principles. The approach seeks to reduce stigma through fostering empathy, interpersonal interactions (contact strategies) and building efficacy for stigma reduction through awareness, skills, and knowledge building. The intervention consists of five-2.5 hour participatory training sessions.
Age, Continuous	36 years n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	151 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Tanzania	151 participants n=5 Participants
Highest level of school attended Did not go to school	0 participants n=5 Participants
Highest level of school attended Primary	32 participants n=5 Participants
Highest level of school attended Secondary	40 participants n=5 Participants
Highest level of school attended College/University	79 participants n=5 Participants
Position in health facility Clinical staff	81 Participants n=5 Participants
Position in health facility Non Clinical Staff	70 Participants n=5 Participants
Years worked in health facility	4 years n=5 Participants
Years worked in HIV care and treatment clinic	4 years n=5 Participants
Number of clients treated in past month who use drugs	3 Clients n=5 Participants
Staff (study participant) count by clinic Clinic 1	24 Participants n=5 Participants
Staff (study participant) count by clinic Clinic 2	12 Participants n=5 Participants
Staff (study participant) count by clinic Clinic 3	33 Participants n=5 Participants
Staff (study participant) count by clinic Clinic 4	26 Participants n=5 Participants
Staff (study participant) count by clinic Clinic 5	23 Participants n=5 Participants
Staff (study participant) count by clinic Clinic 6	16 Participants n=5 Participants
Staff (study participant) count by clinic Clinic 7	17 Participants n=5 Participants
Social Desirability Bias	6.695 units on a scale STANDARD_DEVIATION 1.999797 • n=5 Participants
Level of contact with people who use drugs Low Contact	48 Participants n=5 Participants
Level of contact with people who use drugs High Contact	103 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline survey (weeks 1-3) and Endline Survey (weeks 17-24, 3 months after participant had completed training)

Population: Staff (study participants) who completed the training intervention and answered all of the component questions of the OMS scale

Outcome measures

Outcome measures
Measure	Staff (Study Participants) Working in HIV Care and Treatment Clinics n=132 Participants Single arm, Pre-post with staff (study participants) working in HIV care and treatment clinics Drug use stigma reduction training intervention for staff (study participants) working in HIV care and treatment clinics. The intervention consists of five-2.5 hour participatory training sessions. We will adapt the HP+ health facility HIV stigma-reduction intervention to focus on drug stigma in HIV CTCs. The intervention will address key stigma drivers, including fear, awareness of stigma, and stigmatizing attitudes and beliefs, through a participatory training approach that involves all levels of staff and is grounded in social cognitive theory principles. The approach seeks to reduce stigma through fostering empathy, interpersonal interactions (contact strategies) and building efficacy for stigma reduction through awareness, skills, and knowledge building.
Modified Opening Minds Scale for Health Providers (OMS-HC) Baseline	22.92 score on a scale Standard Deviation 4.78
Modified Opening Minds Scale for Health Providers (OMS-HC) Endline	16.82 score on a scale Standard Deviation 4.02

PRIMARY outcome

Timeframe: Endline Survey (weeks 17-24, 3 months after participant had completed training)

Population: Clinic Staff who were participants in the study who completed the training intervention

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.

Outcome measures

Outcome measures
Measure	Staff (Study Participants) Working in HIV Care and Treatment Clinics n=141 Participants Single arm, Pre-post with staff (study participants) working in HIV care and treatment clinics Drug use stigma reduction training intervention for staff (study participants) working in HIV care and treatment clinics. The intervention consists of five-2.5 hour participatory training sessions. We will adapt the HP+ health facility HIV stigma-reduction intervention to focus on drug stigma in HIV CTCs. The intervention will address key stigma drivers, including fear, awareness of stigma, and stigmatizing attitudes and beliefs, through a participatory training approach that involves all levels of staff and is grounded in social cognitive theory principles. The approach seeks to reduce stigma through fostering empathy, interpersonal interactions (contact strategies) and building efficacy for stigma reduction through awareness, skills, and knowledge building.
Feasibility of Intervention Measure	4.7 score on a scale Standard Deviation 0.33

PRIMARY outcome

Timeframe: Endline Survey (weeks 17-24, 3 months after participant had completed training)

Population: Participants who completed the training intervention

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).

Outcome measures

Outcome measures
Measure	Staff (Study Participants) Working in HIV Care and Treatment Clinics n=141 Participants Single arm, Pre-post with staff (study participants) working in HIV care and treatment clinics Drug use stigma reduction training intervention for staff (study participants) working in HIV care and treatment clinics. The intervention consists of five-2.5 hour participatory training sessions. We will adapt the HP+ health facility HIV stigma-reduction intervention to focus on drug stigma in HIV CTCs. The intervention will address key stigma drivers, including fear, awareness of stigma, and stigmatizing attitudes and beliefs, through a participatory training approach that involves all levels of staff and is grounded in social cognitive theory principles. The approach seeks to reduce stigma through fostering empathy, interpersonal interactions (contact strategies) and building efficacy for stigma reduction through awareness, skills, and knowledge building.
Acceptability of Intervention Measure	4.72 score on a scale Standard Deviation 0.35

PRIMARY outcome

Timeframe: Endline Survey (weeks 17-24, 3 months after participant had completed training)

Population: Participants who completed the training intervention

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.

Outcome measures

Outcome measures
Measure	Staff (Study Participants) Working in HIV Care and Treatment Clinics n=141 Participants Single arm, Pre-post with staff (study participants) working in HIV care and treatment clinics Drug use stigma reduction training intervention for staff (study participants) working in HIV care and treatment clinics. The intervention consists of five-2.5 hour participatory training sessions. We will adapt the HP+ health facility HIV stigma-reduction intervention to focus on drug stigma in HIV CTCs. The intervention will address key stigma drivers, including fear, awareness of stigma, and stigmatizing attitudes and beliefs, through a participatory training approach that involves all levels of staff and is grounded in social cognitive theory principles. The approach seeks to reduce stigma through fostering empathy, interpersonal interactions (contact strategies) and building efficacy for stigma reduction through awareness, skills, and knowledge building.
Appropriateness of Intervention Measure	4.82 score on a scale Standard Deviation 0.33

SECONDARY outcome

Timeframe: Baseline survey (weeks 1-3) and Endline Survey (weeks 17-24, 3 months after participant had completed training)

Population: Participants who completed the training intervention

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 * the psychological effects of drugs * the factors which put people at risk of developing drug problems * I feel I know enough about {insert below item} to provide appropriate services to PWUD * drug addiction as a brain disease * the social effects of drug use * drug-to drug interactions (CS only) * co-occurring conditions (CS only)

Outcome measures

Outcome measures
Measure	Staff (Study Participants) Working in HIV Care and Treatment Clinics n=141 Participants Single arm, Pre-post with staff (study participants) working in HIV care and treatment clinics Drug use stigma reduction training intervention for staff (study participants) working in HIV care and treatment clinics. The intervention consists of five-2.5 hour participatory training sessions. We will adapt the HP+ health facility HIV stigma-reduction intervention to focus on drug stigma in HIV CTCs. The intervention will address key stigma drivers, including fear, awareness of stigma, and stigmatizing attitudes and beliefs, through a participatory training approach that involves all levels of staff and is grounded in social cognitive theory principles. The approach seeks to reduce stigma through fostering empathy, interpersonal interactions (contact strategies) and building efficacy for stigma reduction through awareness, skills, and knowledge building.
Knowledge About Drug Use and How to Provide HIV Services to People Who Use Drugs Baseline	3.4 score on a scale Standard Deviation 0.71
Knowledge About Drug Use and How to Provide HIV Services to People Who Use Drugs Endline	4.37 score on a scale Standard Deviation 0.49

SECONDARY outcome

Timeframe: Baseline survey (weeks 1-3) and Endline Survey (weeks 17-24, 3 months after participant had completed training)

Population: Participants who completed the training intervention and answered all of the component questions of the Modified Bogardus Social Distance Scale

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 working at the same health facility with someone who uses drugs? * Would you stop being friends with someone who uses drugs? * Would you feel upset or disturbed being in the same room with someone who uses drugs? * Would you marry someone who uses drugs? (reverse coded)

Outcome measures

Outcome measures
Measure	Staff (Study Participants) Working in HIV Care and Treatment Clinics n=141 Participants Single arm, Pre-post with staff (study participants) working in HIV care and treatment clinics Drug use stigma reduction training intervention for staff (study participants) working in HIV care and treatment clinics. The intervention consists of five-2.5 hour participatory training sessions. We will adapt the HP+ health facility HIV stigma-reduction intervention to focus on drug stigma in HIV CTCs. The intervention will address key stigma drivers, including fear, awareness of stigma, and stigmatizing attitudes and beliefs, through a participatory training approach that involves all levels of staff and is grounded in social cognitive theory principles. The approach seeks to reduce stigma through fostering empathy, interpersonal interactions (contact strategies) and building efficacy for stigma reduction through awareness, skills, and knowledge building.
Modified Bogardus Social Distance Scale Baseline	12.6 score on a scale Standard Deviation 3.16
Modified Bogardus Social Distance Scale Endline	8.34 score on a scale Standard Deviation 2.07

Adverse Events

Staff (Study Participants) Working in HIV Care and Treatment Clinics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Laura Nyblade, Fellow

RTI International

Phone: 202-728-1961

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place