An interventional study of 3H+ (Holistic Health for HIV) and HHRP+ (Holistic Health Recovery Program) in Risk Behavior, Medication Adherence and HIV, sponsored by University of Connecticut. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by University of Connecticut · Not applicable, Interventional, and Prevention
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.
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).
136 studies on the registry are indexed under Risk-Taking; 18 are open to participants now.
This study's enrollment of 106 is below the median of 255 across 117 interventional studies indexed under Risk-Taking.
Browse Risk-Taking studies →University of Connecticut is the lead sponsor of 135 studies on the registry; 19 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: 3H+ (Holistic Health for HIV)
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.
Behavioral: HHRP+ (Holistic Health Recovery Program)
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.
12 two-hour group sessions addressing HIV risk reduction behavior and recovery for opioid-dependent individuals living with HIV.
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.
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.
| Milestone | Holistic Health for HIV (3H+) | Holistic Health Recovery Program (HHRP+) |
|---|---|---|
| Started | 52 | 54 |
| Completed | 32 | 18 |
| Not completed | 20 | 36 |
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).
| participants | 3H+ Group | HHRP+ Group |
|---|---|---|
| Number of Participants in Each Condition With Optimal ART Adherence | 27 ± 0.063 | 29 ± 0.066 |
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.
| Participants | Holistic Health for HIV (3H+) | Holistic Health Recovery Program (HHRP+) |
|---|---|---|
| Viral Suppression | 45 ± 0.048 | 34 ± 0.066 |
Collected over Adverse event collection occurred starting at baseline, and then continued at post-intervention,and then at the 3 month and 6-month follow-up points.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Holistic Health for HIV (3H+) | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| HHRP+ | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
| Age, Categorical(Participants) | 3H+ Group | HHRP+ Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 52 | 54 | 106 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | 3H+ Group | HHRP+ Group | Total |
|---|---|---|---|
| Female | 22 | 21 | 43 |
| Male | 30 | 33 | 63 |
| Region of Enrollment(participants) | 3H+ Group | HHRP+ Group | Total |
|---|---|---|---|
| United States | 52 | 54 | 106 |
| Race (NIH/OMB)(Participants) | 3H+ Group | HHRP+ Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 26 | 15 | 41 |
| White | 11 | 22 | 33 |
| More than one race | 15 | 17 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | 3H+ Group | HHRP+ Group | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 17 | 31 |
| Not Hispanic or Latino | 37 | 37 | 74 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Anti-retroviral Therapy (ART) Adherence(Participants) | 3H+ Group | HHRP+ Group | Total |
|---|---|---|---|
| Count of participants | 32 | 33 | 65 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2012 to primary completion in Jun 2018, 69 months.
Results were first posted in Aug 2025, 7 years 2 months after primary completion.
Of 65 non-industry interventional studies with no phase under Risk-Taking, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 48. This study's 69 months is above that.
Counting every sponsor, half of 68 studies reached it within 28 months; a quarter within 7 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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