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Trial Outcomes & Findings for The Getting Off App for Methamphetamine-Using Gay and Bisexual Men (NCT NCT03884946)

NCT ID: NCT03884946

Last Updated: 2026-01-29

Results Overview

Days of participant self-reported methamphetamine use in the past 30 days.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

226 participants

Primary outcome timeframe

from baseline to 9-months post randomization

Results posted on

2026-01-29

Participant Flow

Participant milestones

Participant milestones
Measure
Immediate Delivery (ID; n=113)
Getting Off is a 24-session Cognitive Behavioral Therapy (CBT) intervention specifically designed to intervene on the intersectionality of methamphetamine use and concomitant sexual risk behaviors among SMM, and to increase advancement along the HIV prevention and care continua. Critical CBT skills within Getting Off include, for example, education on internal and external triggers, thought stopping, relapse prevention, relapse analysis including the identification of emotional states that can signal relapse, and the adoption of prosocial and healthy behaviors. All sessions are embedded within the specific cultural, social, and sexual components of methamphetamine use among SMM. Throughout the 24 sessions, equal content is given to the reduction of methamphetamine use and sexual risk behaviors.
Delayed Delivery (DD; n=113)
The participants in the DD group received the same intervention as those in the ID group, but after a 30-day delayed period.
Overall Study
STARTED
113
113
Overall Study
COMPLETED
85
94
Overall Study
NOT COMPLETED
28
19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Getting Off App for Methamphetamine-Using Gay and Bisexual Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Immediate Delivery
n=113 Participants
Getting Off is a 24-session Cognitive Behavioral Therapy (CBT) intervention specifically designed to intervene on the intersectionality of methamphetamine use and concomitant sexual risk behaviors among SMM, and to increase advancement along the HIV prevention and care continua. Critical CBT skills within Getting Off include, for example, education on internal and external triggers, thought stopping, relapse prevention, relapse analysis including the identification of emotional states that can signal relapse, and the adoption of prosocial and healthy behaviors. All sessions are embedded within the specific cultural, social, and sexual components of methamphetamine use among SMM. Throughout the 24 sessions, equal content is given to the reduction of methamphetamine use and sexual risk behaviors.
Delayed Delivery
n=113 Participants
The Delayed Delivery group received the exact same Getting Off app, but after a 30-day delay.
Total
n=226 Participants
Total of all reporting groups
Age, Continuous
45.3 years
STANDARD_DEVIATION 9.5 • n=41 Participants
45.3 years
STANDARD_DEVIATION 10.3 • n=1581 Participants
45.3 years
STANDARD_DEVIATION 9.9 • n=4626 Participants
Sex: Female, Male
Female
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
Sex: Female, Male
Male
113 Participants
n=41 Participants
113 Participants
n=1581 Participants
226 Participants
n=4626 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
40 Participants
n=41 Participants
37 Participants
n=1581 Participants
77 Participants
n=4626 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
63 Participants
n=41 Participants
67 Participants
n=1581 Participants
130 Participants
n=4626 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
10 Participants
n=41 Participants
9 Participants
n=1581 Participants
19 Participants
n=4626 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=41 Participants
3 Participants
n=1581 Participants
4 Participants
n=4626 Participants
Race (NIH/OMB)
Asian
1 Participants
n=41 Participants
2 Participants
n=1581 Participants
3 Participants
n=4626 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=41 Participants
0 Participants
n=1581 Participants
1 Participants
n=4626 Participants
Race (NIH/OMB)
Black or African American
27 Participants
n=41 Participants
29 Participants
n=1581 Participants
56 Participants
n=4626 Participants
Race (NIH/OMB)
White
52 Participants
n=41 Participants
44 Participants
n=1581 Participants
96 Participants
n=4626 Participants
Race (NIH/OMB)
More than one race
11 Participants
n=41 Participants
11 Participants
n=1581 Participants
22 Participants
n=4626 Participants
Race (NIH/OMB)
Unknown or Not Reported
20 Participants
n=41 Participants
24 Participants
n=1581 Participants
44 Participants
n=4626 Participants
Region of Enrollment
United States
113 Participants
n=41 Participants
113 Participants
n=1581 Participants
226 Participants
n=4626 Participants
Baseline Methamphetamine Use
13.6 days
STANDARD_DEVIATION 11.3 • n=41 Participants
14.5 days
STANDARD_DEVIATION 11.8 • n=1581 Participants
14.4 days
STANDARD_DEVIATION 11.3 • n=4626 Participants

PRIMARY outcome

Timeframe: from baseline to 9-months post randomization

Population: Gay and bisexual men that use methamphetamine

Days of participant self-reported methamphetamine use in the past 30 days.

Outcome measures

Outcome measures
Measure
Immediate Delivery (ID)
n=113 Participants
Participants who were randomized into the ID condition were immediately given a unique user passcode to access the intervention app
Delayed Delivery (DD)
n=113 Participants
Participants who were randomized into the DD arm received their unique user passcode 30 days post-randomization
Methamphetamine Use
Baseline
13.6 days
Standard Deviation 11.3
15.3 days
Standard Deviation 11.2
Methamphetamine Use
1 month
10.9 days
Standard Deviation 10.3
14.5 days
Standard Deviation 11.8
Methamphetamine Use
2 months
—
14.4 days
Standard Deviation 10.7
Methamphetamine Use
3 months
9.4 days
Standard Deviation 10.0
13.4 days
Standard Deviation 11.6
Methamphetamine Use
6 months
10.2 days
Standard Deviation 10.7
13.2 days
Standard Deviation 11.6
Methamphetamine Use
9 months
8.8 days
Standard Deviation 9.6
11.7 days
Standard Deviation 11.5

PRIMARY outcome

Timeframe: From baseline to 9-months post randomization

Population: gay and bisexual men that use methamphetamine

Days participants self-reported methamphetamine injection use in past 30 days

Outcome measures

Outcome measures
Measure
Immediate Delivery (ID)
n=113 Participants
Participants who were randomized into the ID condition were immediately given a unique user passcode to access the intervention app
Delayed Delivery (DD)
n=113 Participants
Participants who were randomized into the DD arm received their unique user passcode 30 days post-randomization
Methamphetamine Injection
Baseline
2.2 days
Standard Deviation 5.5
2.3 days
Standard Deviation 5.9
Methamphetamine Injection
1 month
1.2 days
Standard Deviation 4.4
2.3 days
Standard Deviation 5.8
Methamphetamine Injection
2 months
—
2.4 days
Standard Deviation 6.1
Methamphetamine Injection
3 months
0.7 days
Standard Deviation 2.8
1.6 days
Standard Deviation 4.6
Methamphetamine Injection
6 months
1.3 days
Standard Deviation 4.7
1.6 days
Standard Deviation 5.4
Methamphetamine Injection
9 months
0.8 days
Standard Deviation 2.9
0.8 days
Standard Deviation 3.4

PRIMARY outcome

Timeframe: baseline to 9-months post randomization

Population: gay and bisexual men that use methamphetamine

Reporting condomless anal intercourse in the past 30 days (yes/no)

Outcome measures

Outcome measures
Measure
Immediate Delivery (ID)
n=113 Participants
Participants who were randomized into the ID condition were immediately given a unique user passcode to access the intervention app
Delayed Delivery (DD)
n=113 Participants
Participants who were randomized into the DD arm received their unique user passcode 30 days post-randomization
Condomless Anal Intercourse
Baseline
63 Participants
54 Participants
Condomless Anal Intercourse
1 month
40 Participants
55 Participants
Condomless Anal Intercourse
2 months
—
36 Participants
Condomless Anal Intercourse
3 months
32 Participants
36 Participants
Condomless Anal Intercourse
6 months
38 Participants
35 Participants
Condomless Anal Intercourse
9 months
40 Participants
32 Participants

PRIMARY outcome

Timeframe: 9-months post randomization

Population: gay and bisexual men that use methamphetamine

Reporting condomless anal intercourse while high on methamphetamine in the past 30 days (yes/no)

Outcome measures

Outcome measures
Measure
Immediate Delivery (ID)
n=113 Participants
Participants who were randomized into the ID condition were immediately given a unique user passcode to access the intervention app
Delayed Delivery (DD)
n=113 Participants
Participants who were randomized into the DD arm received their unique user passcode 30 days post-randomization
Condomless Anal Intercourse While High on Methamphetamine
Baseline
56 Participants
49 Participants
Condomless Anal Intercourse While High on Methamphetamine
1 month
30 Participants
42 Participants
Condomless Anal Intercourse While High on Methamphetamine
2 months
—
30 Participants
Condomless Anal Intercourse While High on Methamphetamine
3 months
26 Participants
32 Participants
Condomless Anal Intercourse While High on Methamphetamine
6 months
26 Participants
28 Participants
Condomless Anal Intercourse While High on Methamphetamine
9 months
26 Participants
23 Participants

SECONDARY outcome

Timeframe: 9-months post randomization

Population: gay and bisexual men that use methamphetamine

Starting to receive ART among HIV sero-positive participants who were not on ART at baseline (yes/no)

Outcome measures

Outcome measures
Measure
Immediate Delivery (ID)
n=15 Participants
Participants who were randomized into the ID condition were immediately given a unique user passcode to access the intervention app
Delayed Delivery (DD)
n=16 Participants
Participants who were randomized into the DD arm received their unique user passcode 30 days post-randomization
ART Initiation
2 Participants
5 Participants

SECONDARY outcome

Timeframe: 9-months post randomization

Population: gay and bisexual men that use methamphetamine

Starting to receive PrEP among HIV sero-negative participants who were not on PrEP at baseline (Yes/No)

Outcome measures

Outcome measures
Measure
Immediate Delivery (ID)
n=34 Participants
Participants who were randomized into the ID condition were immediately given a unique user passcode to access the intervention app
Delayed Delivery (DD)
n=37 Participants
Participants who were randomized into the DD arm received their unique user passcode 30 days post-randomization
PrEP Initiation
4 Participants
7 Participants

Adverse Events

Immediate Delivery

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Delayed Delivery

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

Dr. Cathy J. Reback

Friends Research Institute

Phone: 800-705-7757

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place