Trial Outcomes & Findings for Secondary HIV Prevention and Adherence Among HIV-infected Drug Users (NCT NCT01741311)
NCT ID: NCT01741311
Last Updated: 2025-08-08
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.
Results posted on
2025-08-08
Participant Flow
Participant milestones
| Measure |
Holistic Health for HIV (3H+)
Holistic Health for HIV (experimental intervention)
|
Holistic Health Recovery Program (HHRP+)
Holistic Health Recovery Program (comparison condition in this non-inferiority trial)
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
54
|
|
Overall Study
COMPLETED
|
32
|
18
|
|
Overall Study
NOT COMPLETED
|
20
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Secondary HIV Prevention and Adherence Among HIV-infected Drug Users
Baseline characteristics by cohort
| Measure |
3H+ Group
n=52 Participants
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.
|
HHRP+ Group
n=54 Participants
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.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=99 Participants
|
54 participants
n=107 Participants
|
106 participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Anti-retroviral Therapy (ART) Adherence
|
32 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
3H+ Group
n=52 Participants
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.
|
HHRP+ Group
n=54 Participants
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.
|
|---|---|---|
|
Number of Participants in Each Condition With Optimal ART Adherence
|
27 participants
0.063
|
29 participants
0.066
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
3H+ Group
n=52 Participants
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.
|
HHRP+ Group
n=54 Participants
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.
|
|---|---|---|
|
Viral Suppression
|
45 Participants
0.048
|
34 Participants
0.066
|
Adverse Events
Holistic Health for HIV (3H+)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HHRP+
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place