HIV, Medication Adherence, Risk Behavior
Conditions
Keywords
viral load, HIV, CD4, methadone maintenance, substance use, Antiretroviral therapy (ART)
Brief summary
This study will test whether 3H+ (Holistic Health for HIV) is comparable to the original HHRP+ (Holistic Health Recovery Program) in reducing HIV risk behaviors and improving ART (Antiretroviral Therapy) adherence in a randomized controlled comparative effectiveness trial among 256 HIV+ persons in drug treatment who report unsafe injection drug use practices or sexual risk behavior.
Detailed description
HIV-infected drug users (DUs) remain a target population as they represent a significant vector for the transmission of new HIV infections (Avants et al., 2004; Margolin et al., 2003), which occur through preventable drug- and sex-related HIV risk behaviors. Though numerous evidence-based HIV risk reduction interventions are now widely available as complete intervention packages, few evidence-based interventions have been designed for implementation within common drug treatment community-based organizations (CBOs), such as methadone maintenance programs (MMPs), where many high-risk HIV-infected drug users seek treatment. Moreover, the few evidence-based interventions that are applicable to drug treatment CBOs are not designed to be community-friendly and, hence, are unlikely to be implemented as intended or durable within these critical settings. The investigators have developed a significantly shortened version of the comprehensive evidence-based Holistic Health Recovery Program (HHRP; Avants et al., 2004; Margolin et al., 2003). This shortened version, Holistic Health for HIV (3H+), has demonstrated feasibility and acceptability as well as preliminary evidence of effectiveness in an uncontrolled study within a resource-limited drug treatment CBO. Therefore, this randomized controlled comparative effectiveness trial (RCT) will test the efficacy and cost-effectiveness of 3H+ versus the original gold standard evidence-based intervention(EBI), Holistic Health Recovery Program for HIV+s (HHRP+), targeting HIV+ drug users (DUs).
Interventions
BEHAVIORAL3H+ (Holistic Health for HIV)
Four weekly HIV-risk reduction groups and an additional booster group held at week twelve summarizing the previous sessions' content, designed for opioid-dependent individuals living with HIV.
BEHAVIORALHHRP+ (Holistic Health Recovery Program)
12 two-hour group sessions addressing HIV risk reduction behavior and recovery for opioid-dependent individuals living with HIV.
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
APT Foundation, Inc.
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV positive * Opioid dependent and enrolled in methadone maintenance treatment * Report drug- or sex-related HIV risk behavior in previous 6 months * Able to read and understand the questionnaires, the Audio Computer Assisted Self Interview (ACASI), and consent form * Available for the full duration of the study with no anticipated circumstances impeding participation * Not actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of the PI who is a licensed clinical psychologist in Connecticut.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Each Condition With Optimal ART Adherence | Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months. | Anti-retroviral therapy (ART) adherence was assessed by self-report using the visual analogue scale (VAS). The VAS measures adherence continuously from 0 to 100%, with higher scores indicating better adherence to the medication. A greater number of participants with optimal ART adherence is better. Optimal ART adherence is defined as a score \>95% on the visual analog scale (VAS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression | Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months. | Number of participants in each condition with viral load suppression at the 6-month assessment point. Viral suppression (VS) is defined as someone having HIV-1 RNA\<50 copies/mL. A greater number of participants with VL suppression is a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3H+ Group 3H+ (Holistic for HIV) group patients will receive the standard of drug treatment care (i.e., methadone maintenance treatment and case management) plus four weekly 60-minute HIV risk reduction groups, and a 60-minute booster session at 12 weeks, led by two facilitators trained and supervised by a licensed clinical psychologist. 3H+ is an HIV risk reduction and ART adherence intervention that provides coping skills training and is delivered in a group modality, addressing high risk drug- and sex-related HIV risk behaviors and ART adherence for opioid-dependent individuals living with HIV.
3H+ (Holistic Health for HIV): Four weekly HIV-risk reduction groups and an additional booster group held at week twelve summarizing the previous sessions' content, designed for opioid-dependent individuals living with HIV. | 52 |
| HHRP+ Group HHRP+ (Holistic Health Recovery Program) is comprised of 12 two-hour weekly manual-guided group sessions with comprehensive HIV risk reduction content that addresses the medical, emotional, and spiritual needs of opioid-dependent individuals living with HIV. Each session is designed to last 2 hours and is co-facilitated by two trained facilitators, who address potential motivational conflicts of HIV+ individuals by providing them with self-protective as well as altruistic reasons for examining and changing their HIV risk behaviors and improving adherence behavior. Material is presented using cognitive remediation strategies.
HHRP+ (Holistic Health Recovery Program): 12 two-hour group sessions addressing HIV risk reduction behavior and recovery for opioid-dependent individuals living with HIV. | 54 |
| Total | 106 |
Baseline characteristics
| Characteristic | 3H+ Group | HHRP+ Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 54 Participants | 106 Participants |
| Anti-retroviral Therapy (ART) Adherence | 32 Participants | 33 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 17 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 37 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 15 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 17 Participants | 32 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 22 Participants | 33 Participants |
| Region of Enrollment United States | 52 participants | 54 participants | 106 participants |
| Sex: Female, Male Female | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Male | 30 Participants | 33 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 54 |
| other Total, other adverse events | 0 / 52 | 0 / 54 |
| serious Total, serious adverse events | 0 / 52 | 0 / 54 |
Outcome results
Primary
Number of Participants in Each Condition With Optimal ART Adherence
Anti-retroviral therapy (ART) adherence was assessed by self-report using the visual analogue scale (VAS). The VAS measures adherence continuously from 0 to 100%, with higher scores indicating better adherence to the medication. A greater number of participants with optimal ART adherence is better. Optimal ART adherence is defined as a score \>95% on the visual analog scale (VAS).
Time frame: Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| 3H+ Group | Number of Participants in Each Condition With Optimal ART Adherence | 27 participants | 0.063 |
| HHRP+ Group | Number of Participants in Each Condition With Optimal ART Adherence | 29 participants | 0.066 |
Secondary
Viral Suppression
Number of participants in each condition with viral load suppression at the 6-month assessment point. Viral suppression (VS) is defined as someone having HIV-1 RNA\<50 copies/mL. A greater number of participants with VL suppression is a better outcome.
Time frame: Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|
| 3H+ Group | Viral Suppression | 45 Participants | 0.048 |
| HHRP+ Group | Viral Suppression | 34 Participants | 0.066 |