N/A
N=66
Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa
Human Immunodeficiency Virus · Alcohol-Related Disorders · Drug Use
Bottom Line
View on ClinicalTrials.gov: NCT03529409 ↗Enrolled (actual)
66
Serious AEs
13.6%
Results posted
Oct 2021
Primary outcome: Primary: Changes in HIV Medication Adherence Throughout Intervention Phase — 60.0; 28.2 percentage of days adherent to Wisepill — p=.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Project Khanya (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, College Park
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in HIV Medication Adherence Throughout Intervention Phase |
60.0; 28.2 | .01 sig |
| PRIMARY Biological Measure of Substance Use |
538.4; 386.1 | .44 |
| PRIMARY Biological Measure of Substance Use |
538.4; 386.1 | .44 |
| PRIMARY Changes in Self-reported Substance Use |
4.61; 4.96 | .85 |
| SECONDARY Biological Measure of Substance Use |
538.4; 386.1 | .44 |
| SECONDARY Biological Measure of Substance Use |
538.4; 386.1 | .44 |
| SECONDARY Changes in Self-reported Substance Use |
4.61; 4.96 | .85 |
| SECONDARY Intervention Acceptability |
2.98 | — |
| SECONDARY Intervention Feasibility |
2.98 | — |
| SECONDARY Intervention Fidelity |
91.7 | — |
| SECONDARY Intervention Uptake |
4.77 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03529409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.