Risk BehaviorNCT01741311

Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

A study testing 3H+ (Holistic Health for HIV) and HHRP+ (Holistic Health Recovery Program) in people with Risk Behavior and Medication Adherence, run by University of Connecticut at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Risk Behavior, Medication Adherence, HIV
What is being tested?: 3H+ (Holistic Health for HIV) and HHRP+ (Holistic Health Recovery Program)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteUnited States
Study dates: Sep 2012to Jun 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

APT Foundation
New Haven, Connecticut, 06511

Other trials in United States

About this study

Read the 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).

Conditions: Risk Behavior, Medication Adherence, HIV
Being tested: 3H+ (Holistic Health for HIV), HHRP+ (Holistic Health Recovery Program)
Keywords: viral load, HIV, CD4, methadone maintenance, substance use, Antiretroviral therapy (ART)
Medical subject headings: Risk-Taking, Medication Adherence, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3H+ (Holistic Health for HIV)Behavioural
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.
HHRP+ (Holistic Health Recovery Program)Behavioural
12 two-hour group sessions addressing HIV risk reduction behavior and recovery for opioid-dependent individuals living with HIV.

Study groups in NCT01741311
Study group	Role	What they receive
3H+ Group	Experimental	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. Receives: Behavioral: 3H+ (Holistic Health for HIV)
HHRP+ Group	Active comparator	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. Receives: Behavioral: HHRP+ (Holistic Health Recovery Program)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.

Secondary outcomes (1)

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.
Measured: Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Jun 2018

First posted4 Dec 2012 (estimated)
Study startSep 2012
Primary completionJun 2018
Study completionJun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Risk BehaviorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01741311
Sponsor's protocol ID: H12-050
Other IDs: R01DA032290
Status last verified: Aug 2025
First submitted: 30 Nov 2012
Last updated: 8 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Avants SK, Margolin A, Usubiaga MH, Doebrick C. Targeting HIV-related outcomes with intravenous drug users maintained on methadone: a randomized clinical trial of a harm reduction group therapy. J Subst Abuse Treat. 2004 Mar;26(2):67-78. doi: 10.1016/S0740-5472(03)00159-4.
PubMed 15050083
Margolin A, Avants SK, Warburton LA, Hawkins KA, Shi J. A randomized clinical trial of a manual-guided risk reduction intervention for HIV-positive injection drug users. Health Psychol. 2003 Mar;22(2):223-8.
PubMed 12683743

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Secondary HIV Prevention and Adherence Among HIV-infected Drug Users
ClinicalTrials.gov ID: NCT01741311
Acronym / sponsor ID: H12-050
Conditions: Risk Behavior, Medication Adherence, HIV
Keywords: viral load, HIV, CD4, methadone maintenance, substance use, Antiretroviral therapy (ART)
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: University of ConnecticutUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), Yale University, APT Foundation, Inc.
Study start: Sep 2012 (actual)
Primary completion: Jun 2018 (actual)
Study completion: Jun 2018 (actual)
First posted: 4 Dec 2012 (estimated)
Results: Posted 8 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
3H+ Group	Experimental	Behavioral: 3H+ (Holistic Health for HIV)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.
HHRP+ Group	Active comparator	Behavioral: HHRP+ (Holistic Health Recovery Program)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	3H+ Group
HHRP+ (Holistic Health Recovery Program)12 two-hour group sessions addressing HIV risk reduction behavior and recovery for opioid-dependent individuals living with HIV.	Behavioural	HHRP+ Group

Primary outcome

Number of Participants in Each Condition With Optimal ART Adherence
Time frame: 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).

1 secondary outcome

Viral Suppression
Time frame: Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.

Results and safety

Results posted to the registry on 8 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Holistic Health for HIV (3H+)	52	32
Holistic Health Recovery Program (HHRP+)	54	18

Primary outcome: Number of Participants in Each Condition With Optimal ART Adherence

Time frame: Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.. Number. Unit: participants

Measure	3H+ Group n = 52	HHRP+ Group n = 54
Value	27 (0.063)	29 (0.066)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Holistic Health for HIV (3H+)	0 of 52 (0%)	0 of 52 (0%)	0 of 52
HHRP+	0 of 54 (0%)	0 of 54 (0%)	0 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15050083Avants SK, Margolin A, Usubiaga MH, Doebrick C. Targeting HIV-related outcomes with intravenous drug users maintained on methadone: a randomized clinical trial of a harm reduction group therapy. J Subst Abuse Treat. 2004 Mar;26(2):67-78. doi: 10.1016/S0740-5472(03)00159-4.
Background: PubMed 12683743Margolin A, Avants SK, Warburton LA, Hawkins KA, Shi J. A randomized clinical trial of a manual-guided risk reduction intervention for HIV-positive injection drug users. Health Psychol. 2003 Mar;22(2):223-8.
University of Connecticut Center for Health, Intervention, and Prevention (CHIP)Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael C Copenhaver, Ph.D. principal investigator

University of Connecticut

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants in Each Condition With Optimal ART Adherence (time frame: Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01741311, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.