Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa
Completed · Not applicable
Conditions studied: Human Immunodeficiency Virus, Alcohol-Related Disorders, Drug Use
In brief
The purpose of this study is to test the effectiveness and implementation of a brief, integrated behavioral intervention for HIV medication adherence and substance use in the HIV care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors using a task sharing model in local HIV clinics. The behavioral intervention will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as described in study endpoint section below).
Key facts
- Study ID
- NCT03529409
- Run by
- University of Maryland, College Park
- People needed
- 66
- Starts
- 2018-07-30
- Expected to finish
- 2020-04-07
- Last updated by the study team
- 2022-05-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- HIV positive and on ART
- 18-65 years of age
- Elevated substance use risk (ASSIST score greater than or equal to 4 for drugs or greater than or equal to 11 for alcohol)
- Have at least one of the following:
- Not attained viral suppression from first line ART (VL>400 copies/mL)
- On second-line ART treatment
- Reinitiated first-line treatment within the past three months
- Had a pharmacy non-refill at least once in the past 3 months
You may not qualify if…
- Inability to provide informed consent or complete procedures in English or isiXhosa
- Severe risk/likely dependence for opiates (ASSIST score >26) because opiate substitution therapy may not be available
- Severe alcohol dependence symptoms that may warrant medical management of potential withdrawal symptoms
- Active, untreated, major mental illness (with untreated psychosis or mania) that would interfere with the paraprofessional adapted intervention
Where it is running
- University of Maryland — College Park, Maryland, United States
- University of Cape Town — Cape Town, South Africa
Full record on ClinicalTrials.gov
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