Trial · NCT06129916
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Satisfaction Questionnaire for Medication 1.4 assessed through patient reported outcomes on effectiveness, side-effects, convenience and global satisfaction in relation to the medication | 48 weeks | The primary measure for treatment satisfaction will be collected through the Treatment Satisfaction Questionnaire for Medication 1.4 at 48 weeks. This is a generic measure of treatment satisfaction with medication. It has 14 questions divided into subscales (effectiveness; side effects, convenience and global satisfaction). Response are on a Likert-scale of 5 or 7 points except for 1 yes/no question on the presence of side effects. The scores are calculated for each of the subscales, which range from 0 to100 with higher scores indicating higher patient satisfaction with medication. |
| Primary | Retention in Care | 48 weeks | The primary measure for retention in care will be estimated as the proportion of people on LADB at 48 weeks |
| Primary | Nonmedical opioid use | 48 weeks | Assess degree of non-medical opioid use in the last month measured at week 48, in terms of number of days that non-medical opioids were not used in the last 4 weeks. |
| Secondary | % of participants who have received testing for HIV and Hepatitis C (HCV) at 48 weeks, frequency of testing, % testing positive for antibodies to HIV or HCV and % linked to treatment and % retained into treatment | 48 weeks | Retention into HIV treatment will be measured through self-report using a predefined threshold of adherence (80 to 100%) in consultation with sites as well as through recoding return visits for medication refills. Retention into HCV treatment will be measured as the proportion of those completing treatment and who have sustained virologic response 12 weeks after treatment. These data will be extracted from clinical records at programme sites. |
| Secondary | % of participants with self reported symptoms of depression at 48 weeks. | 48 weeks | Measured through the self-completion scale (PHQ-9 \[9-question Patient Health Questionnaire\] with scale from 0-3, lower score indicating better mental health |
| Secondary | % of participants with self-reported symptoms of anxiety at 48 weeks. | 48 weeks | Measured through the self-completion scale GAD-7 \[Generalized Anxiety Disorder 7) with scale from 0-3, lower score indicating better mental health |
| Secondary | % of participants reporting recent thoughts of or attempts at suicide at 48 weeks. | 48 weeks | This will be taken from other studies among people who inject drugs with "suicidality" specified as recent (within last 4 weeks) thoughts of and attempts at suicide. |
| Secondary | Patient-reported outcomes using the EuroQol measures of health status | 48 weeks | Patient-reported outcomes (PROMs) assessing health-related quality of life will include the EQ5D-5L, which measures the five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (range 1-5, lower score indicates better health) |
| Secondary | Patient-reported outcomes using the EuroQol visual analogue scale (EQVAS) | 48 weeks | Patient-reported outcomes (PROMs) assessing health-related quality of life using a visual analogue scale EQVAS (range 0-100, higher score indicates better health). |
| Secondary | % of participants reporting a non-fatal overdose in the last 6 months | 48 weeks | This will be defined as losing consciousness due to a drug-related overdose (opioids or ATS) in the last 6 months. |
| Secondary | % of participants reporting risky levels of alcohol use (range 0-12, higher score indicates higher risk alcohol use). | 48 weeks | Self-reported alcohol use will be measured using the Alcohol Use Disorders Identification Test (AUDIT) |
| Secondary | % of participants reporting experience of Stigma and discrimination is measured through the substance use stigma mechanism scale (SU-SMS) (range 1-5, higher scores denote greater stigma and discrimination) | 48 weeks | Stigma and discrimination will be measured using the substance use stigma mechanism scale that measures enacted and internalized stigma from family and health care workers. |
| Secondary | % of participants reporting being arrested by the police in the last 6 months measured at 48 weeks. | 48 weeks | This is a self reported measure: "In the last 6 months, have you been arrested or detained or charged by police in (XX location) for any reason?" |
| Secondary | % of participants who have been in prison in the last 6 months measured at 48 weeks | 48 weeks | This is a self-reported measure: "In the last 6 months, have you spent time in prison, jail or a young offenders institute?" |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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