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Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa
NA trial testing Project Khanya in Human Immunodeficiency Virus in 66 participants. Completed in 7 April 2020.
| Lead sponsor | University of Maryland, College Park |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 30 July 2018 |
| Primary completion | 12 February 2020 |
| Estimated completion | 7 April 2020 |
| Sites | 2 locations across South Africa, United States |
University of Maryland, College Park
Adults 18 to 65, any sex, with Human Immunodeficiency Virus or Alcohol-Related Disorders. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of prescribed antiviral therapy agent (medications) taken as measured by real time wireless motoring device
| Group | Value | 95% CI |
|---|---|---|
| Project Khanya | 60.0 | ± 37.1 |
| ESOC | 28.2 | ± 32.1 |
Substance use measured with urinalysis.
| Group | Value | 95% CI |
|---|---|---|
| Project Khanya | 25 | |
| ESOC | 23 | |
| Project Khanya | 1 | |
| ESOC | 3 |
Substance use measured with phosphatidylethanol (PEth) concentration, which is an objective biomarker of alcohol use that can detect blood collected up to 21 days after alcohol consumption. Minimum detection value is 8 ng/mL. Higher PEth values indicate greater concentration of alcohol. Values of ≥ 50 ng/mL indicate unhealthy drinking.
| Group | Value | 95% CI |
|---|---|---|
| Project Khanya | 484.2 | ± 398.7 |
| ESOC | 414.7 | ± 389.6 |
World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST). It is a measure used to assess substance use risk for alcohol, cannabis, cocaine, opiates, and amphetamines, hallucinogens, and other drugs. Standardized cutoff scores are used to categorize risk levels: low risk (0-3 for illicit drugs/0-10 for alcohol), moderate risk (4-26 for illicit drugs/11-26 for alcohol), or high risk (\> 26) for substance use-related problems.
| Group | Value | 95% CI |
|---|---|---|
| Project Khanya | 23 | |
| ESOC | 25 | |
| Project Khanya | 3 | |
| ESOC | 1 |
Substance use measured with urinalysis.
| Group | Value | 95% CI |
|---|---|---|
| Project Khanya | 20 | |
| ESOC | 24 | |
| Project Khanya | 7 | |
| ESOC | 5 |
Substance use measured with phosphatidylethanol (PEth) concentration, which is an objective biomarker of alcohol use that can detect blood collected up to 21 days after alcohol consumption. Minimum detection value is 8 ng/mL. Higher PEth values indicate greater concentration of alcohol. Values of ≥ 50 ng/mL indicate unhealthy drinking.
| Group | Value | 95% CI |
|---|---|---|
| Project Khanya | 538.4 | ± 554.4 |
| ESOC | 386.1 | ± 392.6 |
World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST). It is a measure used to assess substance use risk for alcohol, cannabis, cocaine, opiates, and amphetamines, hallucinogens, and other drugs. Standardized cutoff scores are used to categorize risk levels: low risk (0-3 for illicit drugs/0-10 for alcohol), moderate risk (4-26 for illicit drugs/11-26 for alcohol), or high risk (\> 26) for substance use-related problems.
| Group | Value | 95% CI |
|---|---|---|
| Project Khanya | 24 | |
| ESOC | 22 | |
| Project Khanya | 3 | |
| ESOC | 7 |
15-item acceptability subscale of a pragmatic, quantitative assessment based on RE-AIM developed by the Applied Mental Health Research group (AMHR) at Johns Hopkins University. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater acceptability. Qualitative interviews will also be conducted with intervention participants at the end of the study to assess acceptability guided by RE-AIM and the Proctor model.
| Group | Value | 95% CI |
|---|---|---|
| Project Khanya | 2.98 | ± .04 |
14-item feasibility subscale of a pragmatic, quantitative assessment based on RE-AIM developed by the Applied Mental Health Research group (AMHR) at Johns Hopkins University. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater feasibility. Qualitative interviews will also be conducted with intervention participants at the end of the study to assess feasibility guided by RE-AIM and the Proctor model.
| Group | Value | 95% CI |
|---|---|---|
| Project Khanya | 2.98 | ± .18 |
Independent fidelity ratings of a randomly selected subset (20%) of intervention sessions using a fidelity assessment developed for each session that includes 15-19 items that map onto each core intervention component, and factors unique to the peer delivery implementation strategy (i.e., appropriate self-disclosure, stigmatizing behaviors, common factors including warmth and non-judgment).
| Group | Value | 95% CI |
|---|---|---|
| Project Khanya | 91.7 | ± 13.3 |
Intervention participant attendance and retention (i.e., the mean number of intervention sessions attended by intervention participants)
| Group | Value | 95% CI |
|---|---|---|
| Project Khanya | 4.77 | ± 1.96 |
Percentage of patients with a suppressed viral load (\<400 copies/ml)
| Group | Value | 95% CI |
|---|---|---|
| Project Khanya | 16 | |
| ESOC | 22 | |
| Project Khanya | 11 | |
| ESOC | 7 |
Time frame: While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Project Khanya | ESOC | Pre-Randomization |
|---|---|---|---|---|
| Death | General disorders | — | — | — |
| Hospitalization | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hospitalization | Psychiatric disorders | — | — | — |
| Hospitalization | Surgical and medical procedures | — | — | — |
| Hospitalization | Pregnancy, puerperium and perinatal conditions | — | — | — |
| Hospitalization | General disorders | — | — | — |
| Hospitalization | Injury, poisoning and procedural complications | — | — | — |
| Hospitalization | General disorders | — | — | — |
Most-reported serious reactions: Death, Hospitalization, Hospitalization, Hospitalization, Hospitalization, Hospitalization, Hospitalization, Hospitalization.
Data from ClinicalTrials.gov NCT03529409 adverse events section.
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).
7 peer-reviewed publications reference this trial (live from Europe PMC):
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