Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UM2HD111102 | U.S. NIH Grant/Contract | View source | |
| UM2HD111076 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk.
IMPACT is a Human Immunodeficiency Virus (HIV) status-neutral, behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk. This study will evaluate the effectiveness of IMPACT and determine feasibility of implementing IMPACT for translation into real-world practice using a hybrid effectiveness-implementation design.
The IMPACT intervention includes 10 sessions: 2 sessions of HIV sexual risk reduction (RR) counseling, 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and sexual RR counseling-including pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on strategies for slip-ups and recurrence management.
The enhanced Standard of Care (eSOC) group includes two HIV sexual RR sessions.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMPACT Group | Experimental | Participants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with two-thirds being allocated to the IMPACT intervention. |
|
| Enhanced Standard of Care (eSOC) Group | Active Comparator | Participants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with one-third being allocated to the eSOC intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMPACT | Behavioral | The IMPACT intervention includes 10 sessions: 2 sessions of HIV sexual risk reduction (RR) counseling, 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and sexual RR counseling (including PrEP or ART and HIV care), and 1 final session on strategies for slip-ups and recurrence management. |
| Measure | Description | Time Frame |
|---|---|---|
| Distinct acts of condomless sex without the protection of PrEP or viral suppression. | The number of times participants report engaging in condomless sex without the protection of PrEP (for those not living with HIV) or viral suppression (for those living with HIV). | Participants will recall and report acts of condomless sex and medication adherence for the 30 days prior to each of 4 visits: Baseline, Month 4, Month 8 and Month 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Days of stimulant use | The number of days participants report having used stimulants | Participants will recall and report the number of days they used stimulants out of the 30 days prior to each of 4 visits and will also have urine drug testing done. The visits are at: Baseline, Month 4, Month 8 and Month 12. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Ricketts | Contact | 240-453-2786 | erinricketts@westat.com |
| Name | Affiliation | Role |
|---|---|---|
| Katie Biello, PhD, MPH | Brown University | Study Chair |
| Matthew Mimiaga, ScD, MPH | University of California, Los Angeles | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
The study is a two-arm, multi-site, randomized controlled trial (RCT). IMPACT is a status-neutral intervention that uses behavioral activation (BA)-an evidence-based, cognitive behavior therapy-as a treatment for stimulant use and sexual risk reduction (RR) counseling for adolescents and young adults.
The IMPACT intervention includes 10 sessions: 2 sessions of HIV sexual risk reduction (RR) counseling, 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and sexual RR counseling-including pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on strategies for slip-ups and recurrence management.
The enhanced Standard of Care (eSOC) group includes two HIV sexual RR sessions.
Not provided
Not provided
Not provided
Not provided
|
| eSOC | Behavioral | The eSOC group includes 2 sessions of HIV sexual RR counseling. |
|
| Brown University | Recruiting | Providence | Rhode Island | 02912 | United States |
|