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| ID | Type | Description | Link |
|---|---|---|---|
| K01DA056306 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This is a pilot trial designed to assess the feasibility and acceptability of an intervention aimed at improving adherence to antiretroviral therapy (ART), viral suppression, and engagement in HIV care. The intervention will address behavioral coping strategies, HIV care engagement behaviors, and substance use management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Participants in this arm will attend a structured, group-based behavioral support program consisting of five weekly sessions. The intervention is designed for individuals living with HIV who use substances. It focuses on strategies for managing stress, reducing barriers to care, and improving engagement in HIV-related health services and overall wellness. |
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| Control Arm | Placebo Comparator | Participants in this arm will attend five weekly group-based sessions where non-intervention-related movies are shown. This condition is intended to control for time and group exposure without delivering active behavioral content related to the study outcomes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wellness, Intervention Strategies and HIV Care (WISH) | Behavioral | A structured behavioral group program consisting of five weekly sessions, each approximately 60-90 minutes in length. The intervention is designed for individuals living with HIV who use substances and focuses on: managing stress, addressing barriers to care, and enhancing engagement with HIV-related health services. Sessions are delivered in a small-group format and facilitated by trained staff using a manualized curriculum. |
| Measure | Description | Time Frame |
|---|---|---|
| The Client Satisfaction Questionnaire (CSQ-8) | The Client Satisfaction Questionnaire-8 (CSQ-8) consists of eight items, each rated on a 4-point Likert scale. Total scores range from 8 to 32, with higher scores indicating greater satisfaction with the services received. | 6 Months |
| Acceptability of Intervention Measure (AIM) | The AIM consists of 4 items rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree). Total scores range from 4 to 20, with higher scores indicating greater acceptability of the intervention. | 5 Weeks |
| Participant Retention Rate | The percentage of participants who complete the intervention protocol. Calculated as (number of participants completing the study ÷ number enrolled) × 100%. A retention rate of ≥70% will indicate protocol adherence feasibility. | 5 Weeks |
| Participant Enrollment Rate | The proportion of participants enrolled out of those screened for eligibility. This will be calculated as (number enrolled ÷ number screened) × 100%. An enrollment rate of ≥70% will be considered feasible, based on clinical standards in the literature. | 6 Months |
| Number of Staff Members Required for Study Implementation | Total number of staff members involved in intervention delivery and data collection, documented throughout the pilot period. | 6 Months |
| Feasibility of Intervention Measure (FIM) | The FIM includes 4 items rated on a 5-point Likert scale, from 1 (completely disagree) to 5 (completely agree). Total scores range from 4 to 20, with higher scores indicating greater perceived feasibility of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Binary Measure of Optimal Adherence to ART (≥85%) | Adherence will be assessed using participant self-report over the prior three months. A binary outcome will be calculated: participants with an adherence rate of 85% or higher will be classified as "optimal adherence," and those below 85% as "non-optimal adherence." This measure reflects adherence to the assigned intervention. | 6 Months |
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Inclusion Criteria:
• Participants must:
Be at least 18 years of age
Self-report biological characteristics consistent with the population under study
Be HIV-positive
Report use of at least one of the following substances in the last 90 days:
Be English-speaking
Be able and willing to provide informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer P Jain, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oakland MWCCS Site Office | Oakland | California | 94612 | United States | ||
| SF MWCCS Site Office |
De-identified data will be made available beginning 12 months after the completion of data collection through a secure, NIH-approved data repository. Access will be granted to qualified researchers who provide a data use request and comply with data sharing agreements. Shared data will not include direct identifiers and will be limited to information consistent with participant consent.
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IPD will be available beginning 12 months after the primary completion date of the study. IPD will be available for up to 5 years after the initial release date, or longer if the repository's policies permit extended access.
De-identified individual participant data (IPD) and supporting documentation (such as the data dictionary) will be made available to qualified researchers whose proposed use of the data has been approved by the study PI. Approved users will be granted access through a secure NIH-designated repository, contingent upon completion of a data use agreement. Shared data will include baseline characteristics, outcome measures, and other variables as outlined in the data management and sharing plan, excluding any direct identifiers.
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D006262 | Health |
| D008722 | Methods |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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| Movie Night Club - Attention and Time Matched Control | Behavioral | Weekly 90-minute group sessions over 5 weeks in which participants watch non-therapeutic, neutral-content movies in a group setting. Sessions are facilitated to control for social interaction and time spent in a structured group environment but do not include any therapeutic content. |
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| 5 Weeks |
| Binary Measure of HIV Viral Suppression (<200 copies/mL) | HIV viral load will be measured using plasma HIV RNA nucleic acid tests. Viral suppression is defined as <200 copies/mL, and non-suppression as >200 copies/mL, in accordance with Department of Health and Human Services and AIDS Clinical Trials Group guidelines. | Baseline, 3 months, and 6 months |
| Cumulative Adherence to TDF/TAF as Measured by Drug Concentration in Hair Samples | Cumulative adherence will be assessed by quantifying levels of tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) in hair samples. Drug concentrations will be measured using validated LC-MS/MS assays. Higher drug levels indicate greater cumulative adherence. | 6 Months |
| San Francisco |
| California |
| 94115 |
| United States |