Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03884946 |
| Other study ID # |
R01DA045562 |
| Secondary ID |
R01DA045562 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 30, 2019 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Friends Research Institute, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A commonly used manualized outpatient methamphetamine intervention for gay and bisexual men,
"Getting Off," is being translated into a mobile phone application (i.e., app) available for
download through common app marketplaces. The application will provide games, guided lessons,
informational support, and resources to gay and bisexual men seeking to reduce their
methamphetamine use and risky sexual behaviors.
Description:
The research team will conduct formative research to translate the 24 Getting Off sessions
from a group-based manual-driven intervention to a computerized app, conduct alpha phase
post-development bug testing, conduct beta phase usability pilot testing, and refine the app
according to alpha- and beta-phase testing. Four focus groups will provide input on the
development of the Getting Off app (further input will be obtained through an ongoing
Consumer Advisory Board and usability pilot testing) with: 1) out-of-treatment,
methamphetamine-using MSM (n=~8); 2) methamphetamine-using men who have sex with men (MSM)
who are currently in outpatient treatment in the brick-and-mortar Getting Off program at the
study site (n=~8); 3) prior methamphetamine-using MSM with a minimum of one year recovery who
have completed a minimum 18/24 sessions (75%) of the brick-and-mortar Getting Off program;
and, 4) prior methamphetamine-using MSM with a minimum of one year recovery who have had no
previous experience or knowledge of the Getting Off intervention (n=~8). The focus groups
will be structured to provide guidance on translating Getting Off into an app that is
responsive to culture (e.g., sexuality; HIV prevention/care including pre-exposure
prophylaxis (PrEP) uptake, adherence and persistence, antiretroviral therapy (ART) adherence,
viral load suppression) and methamphetamine treatment needs.
Following app development, and to ensure benchmarks have been met, alpha phase testing will
uncover and remove unwanted bugs, and beta phase usability pilot testing will be conducted
with members of the target population (N=30) to test the feasibility, acceptability, and
preliminary effects of the Getting Off app. Furthermore, the pilot testing will be utilized
to ensure the functionality of the app (i.e., that the app is user-friendly and all features
function appropriately).
Behavioral assessments will be conducted at baseline and at 1-month follow-up.
The study team will then conduct a randomized controlled trial (RCT) to evaluate reductions
of methamphetamine use and HIV sexual risk behaviors, and increased advancement along the HIV
Prevention or Care Continuum, using three approaches: a) two-arm RCT to determine
intervention effects through comparison of the immediate delivery (ID; n=150) and delayed
delivery (DD; n=150) arms; b) an observed treatment effects analysis powered for prospective
sub-group to compare longitudinal pre/post data from the pooled ID and DD arms (N=300); and,
c) a two-arm historical matched comparison design to evaluate the outcomes of the Getting Off
app (ID+DD; N=300) relative to a matched sample of participants having previously attended
the brick-and-mortar group-based Getting Off intervention (N~600; total N=900).
Following screening, informed consent and baseline assessments, participants will be
randomized into one of two arms: Arm A: Immediate access to the Getting Off app (ID); or, Arm
B: Participants will have access to the Getting Off app after a delayed 30-day period (DD).
Participants in both arms will receive the same Getting Off app and participants in both arms
will be given 30-days to engage with the app. The randomized two-arm repeated measures design
will assess participants at 1-, 2- (DD arm only), 3-, 6-, and 9-months post-randomization to
determine longitudinal intervention effects, observed treatment effects, and a historical
comparison with a matched sample of participants who have attended the brick-and-mortar
group-based Getting Off intervention.
